Consenting in Endoscopy

The module covers:

  1. How to consent
  2. What is a valid consent
  3. Who can consent the patient
  4. What information should be provided
  5. How the information should be given
  6. Where to consent
  7. Consent form
  8. Additional consents
  9. Withdrawal of consent
  10. What is capacity and how to assess
  11. Photography and endoscopy
  12. Consent for patients who lacks mental capacity:
  13. What does IMCA mean
  14. What is advance directive
  15. Resolving disagreements
  16. Consenting young adults
  17. What is Gillick’s competency
  18. Which form to fill in
  19. Foreign language
  20. What should you tell in different endoscopic procedures

How to consent

  1. Read the request card, quick scan of the medical notes and nursing admission clerking which will summarize the current medications and past medical history
  2. Introduce yourself and your role
  3. Make sure you are talking to the right patient
  4. Double check on the indication- check patient’s understanding of the need for endoscopy and also see whether there has been any change in the symptoms since the request
  5. Quickly check for any allergy
  6. Think clotting and check for any relevant drugs ( warfarin, clopidogrel, LMWH)
  7. Explain the procedure in simple terms
  8. Explain the common side effects (side effects are called common if they happen in >10% cases normally)
  9. Explain the serious side effect (side effects are rare if they happen in <1% cases normally)
  10. Discuss the alternative-e.g. barium enema, CT colonoscopy rather than colonoscopy
  11. Discuss sedation
  12. Consent for follow on procedure ( e.g. polypectomy, biopsy, taking photograph)
  13. Check capacity if in doubt- particularly in inpatient situation

What is a valid consent

For consent to be valid, the patient must:

  1. Be adequately informed (This means having received sufficient information to understand the procedure, its benefits, and the risk of harms that may arise)
  2. Be competent to take the particular decision (Competency means the patient is able to understand, retain, use or weigh up the information needed to make a decision and can communicate their wishes. Failure on any one of these 4 elements of the test will render the patient incompetent)
  3. Not be acting under duress or be coerced (directly or indirectly) into any particular decision.
  4. All competent patients have the right to choose alternatives, refuse or withdraw consent at anytime.
  5. Written consent formally confirms that an exchange of information (clinical and non clinical) has occurred between the patient and the healthcare professional and that on the basis of the information exchange, the patient has agreed to proceed.
  6. Where an adult patient lacks mental capacity (either temporarily or permanently) to give or withhold consent for themselves, no-one else can give consent on their behalf unless there is a valid Personal Welfare Lasting Power of Attorney (LPA). This should not be confused with a Property LPA, which has a restricted application.

Who can consent the patient

  1. Ideally the person actually treating the patient should seek the patient’s consent but this may have practical difficulties.
  2. You may seek consent on behalf of colleagues if you are capable of performing the procedure in question
  3. Or if you have been specially trained to seek consent for that procedure (Endoscopy nurses are capable of taking consent providing they have been trained to do so)
  4. You must be capable of answering any reasonable question that a patient may ask, and know who to seek further advice from when unusual or novel situations arise.
  5. The arrangements adopted locally should be recorded within the Trust Consent Policy, and be formally approved under local Governance procedures.

What information should be provided?

  • Information should include details about the process of the procedure (for example; the appointment, hospital, endoscopy suite, management of drugs and diabetes, arrangements on arrival and subsequent discharge, and contact numbers)- normally this is done by the endoscopy office/ the letter sent to the patient.
  • The procedure itself (including sedation) and aftercare
  • The benefits and risks (complications and side effects) of the proposed treatment
  • The possible alternative options both to the proposed intervention and in the case of procedure failure.
  • The taking and retention of tissue samples
  • The taking of photographic or video record
  • The skilled supervision of and presence of any trainees
  • The use of any experimental technique.

How the information should be given

  1. Patients must be offered as much information as they reasonably need to make their decision.
  2. Also it must be in a form they can understand, and adequate time to read and understand the information must be given.
  3. Failings in any of these areas may mean that their consent is invalid.
  4. There should be provision to increase the detail of information if requested.

Where to consent

  1. In the clinic/ward where the endoscopy was first suggested- however the person must be trained to take the consent. Easy to do in speciality clinic situation.
  2. Postal consent
  3. On the day of the procedure ( but sufficient time must be given for the patient to decide after balancing pros and cons AND definitely not INSIDE the Endoscopy room)

Consent forms

  1. A signature on a consent form does not itself prove the consent is valid. The consent form is to record the patient’s decision and acknowledge the information exchange and the discussions that have taken place.
  2. Consent can be withdrawn, without reason, at anytime and a signed consent form does not negate any of patient’s legal rights.
  3. Consent form 1 – Patient agreement to investigation or treatment
  4. Consent form 2 - Parental agreement to investigation or treatment for a child or young person
  5. Consent form 3 – Patient/parental agreement to investigation or treatment (procedures where consciousness not impaired )
  6. Consent form 4- Form for adults who are unable to consent to investigation or treatment

Withdrawal of consent

  1. If an un-sedated patient withdraws consent during a procedure, the procedure must be immediately terminated and the event recorded in the notes.
  2. If a sedated patient begins to struggle and by physical and verbal act withdraws consent, the situation is entirely different. It is the responsibility of the endoscopist to act in the patient’s best interests.
  3. If this event occurs at a crucial time, which will have an impact on a successful outcome, for example, removal of a bile duct stone, then it would be wise to pause, attempt to regain co-operation and complete, perhaps with additional sedation.
  4. If the situation deteriorates, is irretrievable, and patient safety is likely to become compromised, then termination of the procedure is recommended. A written record must be made.

Additional consents:

  1. Even common interventions such as mucosal biopsy and polypectomy must be specifically consented. The consent obtained must also explicitly cover the retention of any tissue.
  2. Should an unexpected pathology be discovered, which incidentally will require endoscopic treatment, and the patient has not been fully consented, then it is recommended not to proceed at once. Additional consent should be sought and the procedure performed at a later time. An example of this might be: the later dilatation of an oesophageal stricture coincidentally found at the time of a diagnostic gastroscopy.
  3. However if the chance discovery, was considered to be life threatening, for example, a distended varix that suddenly began bleeding during diagnostic gastroscopy, then active intervention would clearly be necessary in the patient’s immediate best interests.

Photography and endoscopy:

  1. Photographic and video recordings which are made for treating or assessing a patient must not be used for any purpose other than the patient’s care or the audit of that care, without the express consent of the patient or a person with parental responsibility for the patient. The one exception to this principle is the following situation.
  2. Photographic and video recordings, made for treating or assessing a patient and from which there is no possibility that the patient might be recognised, may be used within the clinical setting for education or research purposes without express consent from the patient, as long as this policy is well publicised. However, express consent must be sought for any form of publication.
  3. If you wish to use such a recording for education, publication or research purposes, you must seek consent in writing, ensuring that the person giving consent is fully aware of the possible uses of the material. In particular, the person must be made aware that you may not be able to control future use of the material once it has been placed in the public domain.
  4. If you wish to make an external photographic or video recording of a patient specifically for education, publication or research purposes, you must first seek their written consent
  5. A situation may sometimes arise where you wish to make a recording specifically for education, publication or research purposes, but the patient is temporarily unable to give or withhold consent because, for example, they are sedated or unconscious. In such cases, you may make such a recording, but you must seek consent as soon as the patient regains capacity.

What is capacity and how to assess capacity:

  1. Adults are always assumed to be competent unless demonstrated otherwise. The Mental Capacity Act 2005 requires a presumption that every adult patient has the capacity to make decisions about their care and treatment and to decide whether to agree to, or refuse, any proposed medical intervention.
  2. Competency or capacity means the patient is able to understand, retain, use or weigh up the information needed to make a decision and can communicate their wishes. Failure on any one of these 4 elements of the test will render the patient incompetent.
  3. If you have doubts about their competence, the question to ask is: “can this patient understand, retain and use or weigh up the information needed to make this decision and communicate his decision?”
  4. When patients may be able to make simple decisions, but not complex ones there is an added responsibility to assess their capabilities with great care. Clinicians must support and engage patients to the limit of their capacity.
  5. Unexpected decisions do not prove the patient is incompetent, but may indicate a need for further information or explanation
  6. A record of a formal assessment of competence may be necessary using assessment tools available from local Mental Capacity Act websites.
  7. There are assessment tool kits available to guide clinicians through an assessment process (e.g. www.hants.gov.uk/mental-capacity-tool kit.pdf ), and of course help can be sought from more experienced colleagues including a psychiatrist when necessary.

Consent for patients who lacks mental capacity

  1. Typical examples where there may be a lack of mental capacity are:
    • Stroke or brain injury
    • Mental health problem (patients not subject to a section order)
    • Dementia
    • Learning disability
    • Altered level of consciousness because of illness or treatment
    • Substance misuse
  2. Standard model consent form 4, which requires the additional signature of a doctor who knows the patient and confirm that the treatment is in their best interests should be used for this type of consent. Always try to get the stakeholders’ agreement with the plan.

What does IMCA mean:

  1. In situations where an incompetent patient has no identified relatives or significant friends other than paid carers, an IMCA (The Independent Mental Capacity Advocate)  must be engaged to represent and support them when important or potentially life saving decisions are to be made.
  2. The IMCA will not make a decision for the patient, but clinicians have a legal and professional duty to take full account of the information and advice given by the IMCA.

What is advance directive:

  1. If a currently incompetent patient has clearly indicated in the past, while competent, an intention to refuse treatment in certain circumstances (an ‘advance decision’ also called an advance directive’), and those circumstances arise, you must abide by that decision if it is valid and applicable.
  2. Advance directives about life-sustaining treatment must be made in writing and contain a specific statement which specifically confirms that the advance decision applies even if their life is at risk. The decision must be signed by the patient, (or by someone else appointed by them), in the presence of a witness, who must also sign the document.

Resolving disagreements

  1. You should aim to reach a consensus about a patient’s care and treatment, by giving adequate time for discussions between the parties.
  2. Where differences of opinion cannot be resolved satisfactorily, you should consult more experienced colleagues.
  3. In complex cases where it is difficult to reach agreement, you may also find it helpful to seek multi-disciplinary clinical and ethical review, independent of the healthcare team.
  4. As a last resort a judicial review resulting in a binding declaration can be carried out by a Judge in the Court of Protection (in England and Wales) Further information is available on www.doh.gov.uk/consent

Consenting young adults

  1. Young people aged 16 and 17 are presumed to have the competence to give consent for themselves.
  2. Younger mature and intelligent children who understand fully what is involved in the proposed procedure can also give consent (although their parents will ideally be involved).
  3. In other cases, someone with parental responsibility must give consent on the child’s behalf (unless they cannot be reached in an emergency)
  4. If a competent child consents to treatment, a parent cannot over-ride that consent.
  5. Legally, a parent can consent if a competent child refuses, but it is likely that taking such a serious step will be rare.
  6. Only people with ‘parental responsibility’ are entitled to give consent on behalf of their children. You must be aware that not all parents have parental responsibility for their children (for example, unmarried fathers do not automatically have such responsibility although they can acquire it). If you are in any doubt about whether the person with the child has parental responsibility for that child, you must check

What is Gillick’s competency

  1. Gillick competence is a term originating in England and is used in medical law to decide whether a child (16 years or younger) is able to consent to his or her own medical treatment, without the need for parental permission or knowledge.
  2. Mrs Gillick, a mother of ten (five girls, five boys), sought a declaration that prescribing contraception was illegal because the doctor would commit an offence of encouraging sex with a minor, and that it would be treatment without consent as consent vested in the parent.
  3. Lord Scarman’s test is generally considered to be the test of ‘Gillick competency’. He required that a child could consent if they fully understood the medical treatment that is proposed:
  4. “As a matter of Law the parental right to determine whether or not their minor child below the age of sixteen will have medical treatment terminates if and when the child achieves sufficient understanding and intelligence to understand fully what is proposed.” Lord Scarman.

Postal consenting:

  1. An open access clinic is defined as, one which offers General Practitioners the opportunity to refer patients for an investigation or treatment directly, without the need for patients to be seen in outpatients before it is undertaken. Endoscopy is often included in the treatment protocols of one-stop clinics.
  2. The consent form (usually signed at home), is integrated within the information pack, which is posted to the patient and brought by the patient to the clinic.
  3. An opportunity for further discussion must always be offered, and confirmation of consent is recorded, before the procedure begins.
  4. This remote or postal consenting process has been successfully piloted over many years and now, when it has been implemented through appropriate local clinical governance procedures has not impeded accreditation for CNST (Clinical Negligence Scheme for Trusts) by the NHSLA (NHS Litigation Authority).
  5. Each endoscopic procedure pack has accompanying unique consent literature, which contains an integrated model consent form. If used, and with local customisation changes only being permitted, will be recognised and accepted by the NHSLA. These documents have been designed for the sole and exclusive use of the clinic and endoscopic service concerned and for no other purpose.
  6. It is suggested that endoscopic procedures which can be considered for this type of remote and advanced consenting are;
    • Diagnostic gastroscopy,
    • Therapeutic gastroscopy (oesophageal dilatation for peptic stricture and achalasia, oesophageal stenting, variceal treatment, botox injection therapy), flexible sigmoidoscopy, colonoscopy with polypectomy or endoscopic mucosal resection
    • Combined gastroscopy and colonoscopy
    • Endoscopic ultrasound.
  7. The quality of this methodology is further strengthened by Trusts using a standardised process, where possible, using material that can be downloaded from the BSG website.
  8. Procedures such as PEG insertion and ERCP, although sometimes performed as day cases, are recognised as being more complex both technically and clinically. It is recommended that the advance consent process is inappropriate here, and that more conventional methodology should be employed where the patient is consented within the hospital environment, with informational material having been made available in advance, but with timely consenting within the hospital environment; usually using DOH model consent forms 1 or 4.

Foreign language:

  1. Trusts are committed to ensuring that patients whose first language is not English receive the written and verbal information they need and are able to communicate appropriately with healthcare staff.
  2. Remember, it is not appropriate to use children/relatives to interpret for family members who do not speak English.
  3. Trusts can subscribe to ‘Language Line’ a telephone interpreting service. This is a 24hour service which enables you to communicate quickly and easily with non-English speaking people in their own language.
  4. Other helpful guidance is found in the toolkit, Bridging the Gap, produced by Sheffield Health Authority and the Commission for Racial Equality.

What should you tell in different endoscopic procedures

Gastroscopy
Risks of the procedure

  1. Common side effects- sore throat, abdominal bloating
  2. Mechanical damage to teeth or bridgework
  3. Perforation or tear of the lining of the gullet or stomach (risk approx 1 in 2000 cases)
  4. Bleeding (may need admission to the hospital)
  5. Sedation can occasionally cause problems with breathing, heart rate and blood pressure. If any of these problems do occur, they are normally short lived.
  6. Allergic reaction to sedative or throat spray

Gastroscopy plus dilatation

  1. Risks of gastroscopy (as above)
  2. Risks of dilatation-
    1. Bleeding- usually not serious and settles quickly
    2. Perforation- approximately 1% and may require surgery. Sometimes the perforation is small, for example where the guide wire has caused a small puncture, and this can be managed without surgery but will always require admission to hospital. There is a higher risk of perforation (up to 10%) when there is a complex disease or a tumour of the gullet present.
    3. Perforation rates following dilation of: Benign stricture < 1%; Malignant stricture < 5%; Achalasia < 5%; Gastric outlet obstruction< 5%.
  3. Risks of sedation- Sedation can occasionally cause problems with breathing, heart rate and blood pressure. If any of these problems do occur, they are normally short lived.

Gastroscopy plus stenting

  • Risks of gastroscopy
  • Risks of stent- complications occur in 10% of patients.
    • Incorrect positioning of the stent (requiring stent repositioning)
    • Subsequent movement of the stent from its correct position (requiring stent repositioning)
    • Bleeding.
    • Perforation of the gullet or stomach (5%)
    • Stent blockage by cancerous growths. This can normally be treated with further endoscopic procedures.
  • Risks of sedation- Sedation can occasionally cause problems with breathing, heart rate and blood pressure. If any of these problems do occur, they are normally short lived.

Gastroscopy plus botulinum injection

  • Risks of gastroscopy
  • Risks of botulinum injection- Adverse reactions to Botulinum Toxin are uncommon but include skin rashes and occasional chest pain or heartburn.
  • Risks of sedation- Sedation can occasionally cause problems with breathing, heart rate and blood pressure. If any of these problems do occur, they are normally short lived.

Gastroscopy plus variceal treatment

  • Risks of gastroscopy
  • Risks of variceal treatment- Complications are less with banding than with injection. Sometimes injection therapy has to be used. In the non emergency situation the risks of complication are minimal (1-2%).
    • Chest discomfort- resolves in a few hours
    • Occasionally the procedure does cause some bleeding but this is usually not serious and settles quickly. Hospital admission would be required if it persisted
    • Varices ulcerate after injection or banding. This may lead to formation of a stricture especially if repeated procedures are required.
  • Risks of sedation- Sedation can occasionally cause problems with breathing, heart rate and blood pressure. If any of these problems do occur, they are normally short lived.

Flexible sigmoidoscopy

  • Perforation (risk approximately 1 for every 15,000 examinations) or tear of the lining of the bowel. An operation is nearly always required to repair the hole. The risk of perforation is higher with polyp removal.
  • Bleeding may occur at the site of biopsy or polyp removal (risk approximately 1 for every 100-200 examinations where this is performed). Typically minor in degree, such bleeding may either simply stop on its own or if it does not, be controlled by cauterization or injection treatment.
  • Risks of sedation (if used)- Sedation can occasionally cause problems with breathing, heart rate and blood pressure. If any of these problems do occur, they are normally short lived.

Colonoscopy

  • Perforation (risk approximately 1 for every 1,000 examinations) or tear of the lining of the bowel. An operation is nearly always required to repair the hole. The risk of perforation is higher with polyp removal.
  • Bleeding may occur at the site of biopsy or polyp removal (risk approximately 1 for every 100-200 examinations where this is performed). Typically minor in degree, such bleeding may either simply stop on its own or if it does not, be controlled by cauterization or injection treatment.
  • Risks of sedation- Sedation can occasionally cause problems with breathing, heart rate and blood pressure. If any of these problems do occur, they are normally short lived.

ERCP

  • Risks of gastroscopy
  • Risk of bleeding post sphincterotomy- 1-2% ( risk of death 0.3%)
  • In prospective large-scale risk factor studies, the reported pancreatitis rates ranged from 1.3% to 8.6% (average 5%). In young females the rate is higher, about 10-14%.
  • Risk of infection: Pancreaticobiliary infection occurs in 0.4–0.8% of endoscopic biliary procedures.
  • Risks of sedation- Sedation can occasionally cause problems with breathing, heart rate and blood pressure. If any of these problems do occur, they are normally short lived.

References and acknowledgements:

1.
 2.Guidance for Obtaining a Valid Consent for Elective Endoscopic Procedure- BSG April 2008

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