GUIDELINES FOR INFORMED CONSENT FOR ENDOSCOPIC PROCEDURES

Transcription

1 11 BRITISH SOCIETY OF GASTROENTEROLOGY GUIDELINES FOR INFORMED CONSENT FOR ENDOSCOPIC PROCEDURES Written and approved by the British Society of Gastroenteroogy January

2 These guideines have been produced on behaf of the British Society of Gastroenteroogy by: Professor G D Be, Consutant Gastroenteroogist, Sunderand (Chairman) Dr G Neae, Consutant Gastroenteroogist, Cambridge (Secretary) Dr M Wikinson, Consutant Gastroenteroogist, Guy's Hospita London Dr A Tanner, Consutant Gastroenteroogist, Stockton on Tees Sister Diana Campbe, Endoscopy Unit, Princess Roya Hospita Teford Sister Pat Bottri, OBE, Day Case Unit, RVI Newcaste upon Tyne Mr R McCoy, Consutant Surgeon, Manchester Dr A Morris, Consutant Gastroenteroogist, Liverpoo Dt T K Daneshmend, Consutant Gastroenteroogist, Exeter

3 Guideines for Informed Consent for Endoscopy Procedures 1 INFORMED CONSENT FOR ENDOSCOPIC PROCEDURES INTRODUCTION Informed consent is a cornerstone of good medica practice. Whenever possibe patients shoud remain responsibe for themseves. Cinicians must respect the need to maintain the autonomy and sef-determination of patients. Correcty performed informed consent aso acts as a shied against compaints by patients and caims of mapractice against doctors. Gastroenteroogists most often face the question of informed consent in reation to the performance of endoscopic procedures. In the USA about 1% of medica iabiity caims have been reated to endoscopic procedures. 1 There are no satisfactory data for the UK but in a review of 31 caims against endoscopists in Engand and Waes it appeared that in at east 12 instances patients consented to the procedure after itte or no expanation. In 6 of these cases the caimants stated, apparenty with good reason, that had they known of the risk:benefit ratio they woud not have undergone the procedure (or at east they woud have had to be convinced that there was no reasonabe aternative). It is estimated that more than haf the patients woud not have made caims had they received a reasonabe expanation of the reason for the procedure and the risks invoved. 2 DEPARTMENT OF HEALTH GUIDELINES Over the ast 30 years informed consent for a medica procedure has been transformed from an ethica concept to a ega requirement. The NHS Management Executive have produced guideines for informed consent 3 :- The patient s rights 1. A patient has the right under common aw to give or withhod consent prior to examination or treatment. This is one of the basic principes of heath care. Subject to certain exceptions the doctor or heath professiona and/or heath authority may face an action for damages if a patient is examined or treated without consent. 2. Patients are entited to receive sufficient information in a way they can understand about the proposed treatments, the possibe aternatives and any substantia risks, so that they can make a baanced judgement. Patients must be aowed to decide whether they wi agree to the treatment and they may refuse treatment or withdraw consent at any time. 3. Care shoud be taken to respect the patient s wishes. This is particuary important when patients may be invoved in the training of professionas in various discipines..an expana-

4 2 Guideines for Informed Consent for Endoscopy Procedures tion shoud be given of the need for practica experience and agreement obtained before proceeding... The heath professiona s roe in advising the patient and obtaining consent to treatment The most important eement of a consent procedure is the duty to ensure that patients understand the nature and purpose of the proposed treatment. When a patient has not been given appropriate information then consent may not aways have been obtained despite the signature on the form. Advising the patient Where a choice of treatment might reasonaby be offered the heath professiona may aways advise the patient of his/her recommendation together with reasons for seecting a particuar course of action. Enough information must normay be given to ensure that they understand the nature, consequences and any substantia risks of the treatment proposed so that they are abe to take on decisions based on that information.. Obtaining consent Consent to treatment may be impied or express.. Express consent is given when the patient confirms their agreement to a procedure or treatment in cear and expicit terms, whether oray or in writing.. Ora consent may be sufficient for the vast majority of contacts with..heath professionas. Written consent shoud be obtained for any procedure or treatment carrying any substantia risk or substantia side-effect. Consent form The main purpose of written consent is to provide documentary evidence that an expanation of the proposed procedure or treatment was given and that consent was sought and obtained.. GENERAL MEDICAL COUNCIL S GUIDANCE The GMC has recenty provided guidance on informed consent 4. Some of the guidance of reevance to obtaining consent for endoscopic procedures is reproduced here: Patients must be given sufficient information, in a way that they can understand, to enabe them to exercise their right to make informed decisions about their care. This right is protected in aw, and you are expected to be aware of the ega principes set by reevant case aw in this area. Effective communication is the key to enabing patients to make informed decisions. You must take appropriate steps to find out what patients want to know and ought to know about their condition and its treatment. Open, hepfu diaogue of this kind with patients eads to carity of objectives and understanding, and strengthens the quaity of the doctor-patient reationship. Patients have a right to information about their condition and the treatment options avaiabe to them. The amount of information you give each patient wi vary according to factors such as, the nature of the condition, the compexity of the treatment, the risks associated with the treatment or procedure, and the pa-

5 Guideines for Informed Consent for Endoscopy Procedures 3 tient s own wishes. For exampe, patients may need more information to make an informed decision about a procedure which carries a high risk of faiure or adverse side effects; or about an investigation for a condition which, if present, coud have serious impications for the patient s empoyment, socia or persona ife. whether doctors in training wi be invoved, and the extent to which students may be invoved in an investigation or treatment; a reminder that patients can change their mind about the decision at any time; a reminder that patients have a right to seek a second opinion The information which patients want or ought to know, before deciding whether to consent to treatment or an investigation, may incude: detais of the diagnosis, and prognosis, and the ikey prognosis if the condition is eft untreated; uncertainties about the diagnosis incuding options for further investigation prior to treatment; options for treatment or management of the condition, incuding the option not to treat; the purpose of a proposed investigation or treatment; detais of the procedures or therapies invoved, incuding subsidiary treatment such as methods of pain reief; how the patient shoud prepare for the procedure; and detais of what the patient might experience during or after the procedure incuding common and serious side effects; for each option, expanations of the ikey benefits and the probabiities of success; and discussion of any serious or frequenty occurring risks, and of any ifestye changes which may be caused by, or necessitated by the treatment; advice about whether a proposed treatment is experimenta; how and when the patient s condition and any side effects wi be monitored or re-assessed; the name of the doctor who wi have overa responsibiity for the treatment; When providing information you must do your best to find out about patients individua needs and priorities. For exampe, patients beiefs, cuture, occupation or other factors may have a bearing on the information they need in order to reach a decision. You shoud not make assumptions about patients views, but discuss these matters with patients, and ask them whether they have any concerns about the treatment or the risks it may invove. You shoud provide patients with appropriate information, which shoud incude an expanation of any risks to which they may attach particuar significance. Ask patients whether they have understood the information and whether they woud ike more before making a decision. You shoud raise with patients the possibiity of additiona probems coming to ight during a procedure when the patient is unconscious or otherwise unabe to make a decision. You shoud seek consent to treat any probems which you think may arise and ascertain whether there are any procedures to which the patient woud object, or prefer to give further thought to before you proceed. You must abide by patients decisions on these issues. If, in exceptiona circumstances you decide, whie the patient is unconscious, to treat a condition which fas outside the scope of the patient s consent, your decision may

6 4 Guideines for Informed Consent for Endoscopy Procedures be chaenged in the courts, or be the subject of a compaint to your empoying authority or the GMC. You must therefore be prepared to expain and justify your decision. You must te the patient what you have done and why as soon as the patient is sufficienty recovered to understand. Obtaining informed consent cannot be an isoated event. It invoves a continuing diaogue between you and your patients which keeps them abreast of changes in their condition and the treatment or investigation you propose. Whenever possibe, you shoud discuss treatment options at a time when the patient is best abe to understand and retain the information. To be sure that your patient understands, you shoud give cear expanations and give the patient time to ask questions. In particuar, you shoud: use up to date written materia, visua and other aids to expain compex aspects of the investigation, diagnosis or treatment; and make arrangements, wherever possibe, to meet particuar anguage and communication needs, for exampe through transations, independent interpreters, signers, or the patient s representative. Where appropriate, discuss with patients the possibiity of bringing a reative or friend, or making a tape recording of the consutation; expain the probabiities of success or the risk of faiure of, or harm associated with options for treatment, using accurate data; ensure that information which the patient may find distressing is given to them in a considerate way. Provide patients with information about counseing services and patient support groups, where appropriate; aow patients sufficient time to refect, before and after making a decision, especiay where the information is compex or the severity of the risks is great. Where patients have difficuty understanding information, or there is a ot of information to absorb, it may be appropriate to provide it in manageabe amounts, with appropriate written or other backup materia, over a period of time, or to repeat it; invove nursing or other members of the heath care team in discussions with the patient, where appropriate. They may have vauabe knowedge of the patient s background or particuar concerns, for exampe in identifying what risks the patient shoud be tod about; ensure that, where treatment is not to start unti some time after consent has been obtained, the patient is given a cear route for reviewing their decision with the person providing the treatment. If you are the doctor providing a treatment or undertaking an investigation, it is your responsibiity to discuss it with the patient and obtain their consent, as you wi have a comprehensive understanding of the procedure or treatment, how it is carried out, and the risks attached to it. Where this is not practicabe, you may deegate these tasks provided you ensure that the person to whom you deegate: is suitaby trained and quaified; has sufficient knowedge of the proposed investigation or treatment, and understands the risks invoved; acts in accordance with this guidance.

7 Guideines for Informed Consent for Endoscopy Procedures 5 You wi remain responsibe for ensuring that, before you start any treatment, the patient has been given sufficient time and information to make an informed decision, and has given consent to the procedure or investigation. LEGAL ASPECTS OF INFORMED CONSENT expaining the procedure and aternatives to the patient the roe of trainees ensuring that the procedure is performed with appropriate ski the after-care is adequate the foow-up is we-defined (eg it is cear who is to take responsibiity for acting on the histoogy report) The nature of the ega process The question of negigence is based in tort aw. A tort is a civi wrong. The basic principes are simpe:- 1. Does the defendant owe a duty to the paintiff? 2. Was there a breach of that duty? (this constitutes iabiity) 3. Did the accident cause damage? (causation) 4. What was the nature of the damage and its effect? (condition and prognosis) 5. What are the damages in financia terms? (quantum) The nature of duty The cinician-patient reationship impies a duty to be exercised by the doctor 1. The reationship may be created without the cinician actuay meeting the patient ie a reationship exists as soon as a cinician receives a request for an endoscopic examination. 2. The imits of that reationship must be ceary defined. The endoscopist is responsibe for:- determining the degree of urgency of the appointment the need for any associated procedure The nature of informed consent Discosure is the crux of informed consent. The essentia eements are ensuring that the patient understands:- 1. The nature of the proposed procedure 2. The reason for the procedure 3. The benefits of the procedure 4. The risks and compications of the procedure 5. Aternatives to the procedure (incuding an assessment of the reative risk : benefit ratios) 6. The nature of the anaesthetic or sedation to be empoyed. It is advised that sedation shoud foow the recommendations of the BSG 5. The reationship between guideines and the aw In busy cinica practice it is not possibe to satisfy NHS guideines meticuousy and those in charge of the ega process recognise the difficuties. The document produced by the NHS Executive states the two key exampes of case aw which are used to provide practica hep: The standard of care required of the doctor concerned in a cases is aid down in Boam v Friern Hospita Management Committee (1957) 1 WLR 582, namey, that he or she must act in accordance with a responsibe body of reevant professiona opinion.

8 6 Guideines for Informed Consent for Endoscopy Procedures..in the case of Sidaway v Governors of Bethem Roya Hospita (1985) AC871 Lord Bridge indicated that a decision on what degree of discosure of risks is best cacuated to assist a particuar patient to make a rationa choice as to whether or not to undergo a particuar treatment must primariy be a matter of cinica judgement...(however) a judge might... come to the concusion that the discosure of a particuar risk was so obviousy necessary to an informed choice that no reasonaby prudent medica man woud fai to make it...(lord Bridge further stated that) it is the obigation of the doctor to have regard to the best interests of the patient but at the same time to make avaiabe to the patient sufficient information to enabe the patient to reach a baanced judgement if he chooses to do so. 3 Athough these statements beg important questions (such as: what is a substantia risk? what is a body of responsibe medica opinion? and what is a particuar risk that no prudent medica man woud fai to mention?) they are hepfu in determining ega outcome. It has been suggested that the patient shoud be tod of adverse events of a minor and temporary nature which have an incidence of more than 10% and serious events with an incidence of more than 0.5%. A senior ega opinion emphasised that these are no more than guideines and that the aw wi judge every case on its merits. 6 Certainy it is necessary for the doctor to answer a questions put to him by the patient fuy and truthfuy. In the practice of gastrointestina endoscopy it woud seem that patients shoud be provided with written information warning of the risks of PEG - perforation, infection and aspiration Coonoscopy and fexibe sigmoidoscopy (especiay with poypectomy) - perforation of the coon or beeding It must be emphasised that ALL endoscopic procedures (even simpe OGD) carry a risk (a be it extremey sma) of producing beeding or perforation to the ining of the part of the aimentary tract being examined. For upper gastro-intestina endoscopy, athough specia care is taken to protect the dentition, the patient shoud te the endoscopist if he has a oose tooth, a denta crown or denta bridgework. The state of any oose teeth, denta crowns etc shoud be in the nurse checkist and recorded. INFORMED CONSENT IN PRACTICE It is undesirabe that a units shoud work to an identica protoco. Each unit shoud deveop a code of practice suitabe to its mode of operation. Arranging for a patient to sign a consent form immediatey before the procedure does not constitute informed consent. The patient shoud be fuy informed by the endoscopist, ideay at east 24 hours before the procedure, and then be asked to sign a consent form. For busy units these are impossibe standards. Nevertheess there are means of approaching the idea. The foowing guideines are suggested:- 1 The cinician proposing an endoscopic procedure shoud expain why this needs to be performed and shoud describe its essentia eements Diatation of a stricture - perforation. ERCP - acute pancreatitis, choangitis, perforation and beeding 2 The patient shoud receive an appropriatey written pamphet aong with the appointment. This pamphet shoud cover the issues described

9 Guideines for Informed Consent for Endoscopy Procedures 7 above in the section on discosure and expain the arrangements for foowup. If the patient is given an appointment for an endoscopy session during which trainees wi be present this shoud be mentioned. 3 The patient shoud compete 2 checkists: one to cover important aspects of genera heath and the other to indicate that he has read the pamphet and has been given the opportunity to ask questions. For some units it may be appropriate to ask the patient to sign the consent form at home if he is satisfied that he has been given a the information he woud ike. 7 4 On arriva at the Endosopy Unit the patient shoud be wecomed and interviewed by a quaified endoscopy nurse who shoud check the eve of understanding, provide further expanation and re-assurance, dea with any residua concerns and convey such concerns to the endoscopist. 8 5 The endoscopist shoud then dea with any ast minute questions. If the consent form has not been signed previousy the endoscopist shoud now ask for a signature. (Appendix B) These suggestions provide for reasonabe informed consent but it is important to treat each patient as an individua (who is scared!). No protoco can repace friendy carefu discussion with the patient both before and after the procedure. FURTHER ISSUES 1 How best to give the patient a rea opportunity to understand the nature of the procedure before signing the consent form 1.1 The purpose and nature of the procedure shoud be expained verbay by the cinician requesting the test. The patient shoud be given an expanatory eafet and, if in agreement with the proposed procedure may sign the consent form at home possiby in the presence of a reative If the patient has minor queries these may be discussed by teephone with a quaified endoscopy nurse or by an appropriatey experienced GP. 1.3 The patient may prefer not to sign unti after further discussion with a quaified nurse on the day of the procedure. 1.4 The patient may prefer to deay signing unti he/she has had more detaied discussion with the endoscopist just before the procedure is to be performed. 2 How best to obtain informed consent from hospita in-patients Sick patients may require time and simpe expanation before they are in a position to give consent. There shoud be greater emphasis on (a) patient autonomy respecting the right of a patient to withhod consent and (b) cose iaison with the referring medica team so that the gastroenteroogist acts as a cinician with the patent s overa interests at heart rather than simpy a technica expert. If a patient is truy incompetent to give consent, then the doctor is expected to act in his/her best interests - it must be very rare (see beow) that appication is needed to a court.

10 8 Guideines for Informed Consent for Endoscopy Procedures 2.1 Ideay, if a ward doctor thinks that an endoscopic procedure is indicated then he shoud request an opinion from the appropriate speciaist who shoud see and assess the patient on the ward. This is particuary true for ERCP, PEG and other interventiona procedures and for patients in highrisk categories (eg those beeding from the gut). If the speciaist agrees with the request then he shoud expain the procedure and the risks to the patient before obtaining consent. 2.2 In practice this may be impossibe. Each ward shoud have appropriate eafets so that the patient may read about the procedure or have it expained to him by a competent person. Cose iaison with wards and endoscopy staff can hep the exchange of reevant information both verba and written. Immediatey before the procedure the endoscopist shoud take care to cear up any residua worries. 3 What to do if a patient refuses essentia treatment 3.1 In practice this is an exceptionay rare occurrence. Every effort shoud be made by the consutant, backed up by the GP to arrive at a sensibe decision. 3.2 If there are doubts about the vaidity of refusa to undergo essentia treatment for a ife-threatening situation (eg the patient s capacity is diminished by iness, medications, fase assumptions or misinformation) then an appication may be made to a court. 4 Endoscopic Procedures invoving insertion of a ong-term prosthesis Three endoscopic procedures differ from a others because they have both short and ong-term consequences. These are insertion of a stent through an oesophagea or other stricture, insertion of a biiary stent and insertion of a gastrostomy tube. The expanation of these procedures needs to incude not ony detais of the procedure and possibe eary compications, but aso detais of ong-term management and potentia probems.(appendix A). These procedures are often carried out for sick patients in hospita. Another doctor and heath care team may be invoved. It is important that the appropriateness of the procedure in the patient s overa management shoud be agreed with them. Since the endoscopist has speciaist knowedge of the technique proposed, his/ her opinion may make an important contribution in this regard. Many patients for whom per-cutaneous insertion of a gastrostomy is considered suffer from cerebra handicap or dysfunction. Such patients often have difficuty in comprehension and/ or communication. Capacity to give consent may vary from time to time, and imited capacity may make it essentia that expanation is given simpy, sowy and on more than one occasion. Consent may ony be possibe oray or by gesture but, since gastrostomy is an invasive procedure, a reasonabe degree of certainty that the patient has consented pus discussion with reatives, is needed in every case. In such circumstances, previousy decared wishes, especiay if written as an advance directive, are hepfu in assessing a person s response. Joint guidance issued by the British Medica Association and the Law Society warns against therapeutic overenthusiasm when the doctor s opinion of the patient s best interests conficts

11 Guideines for Informed Consent for Endoscopy Procedures 9 with what the patient wants. In this situation it is tempting, but ethicay and egay wrong, for the doctor to underestimate the capacity of the patient in order to achieve what the doctor beieves to be in the patient s best interests. For a mentay incompetent adut, the doctor makes a decision after discussion with a concerned on the basis of the patient s best interest. 5 Who is responsibe for informed consent from an individua patient? 5.1 The aw takes the view that the responsibiity for obtaining informed consent ies with the endoscopist who is to perform the procedure. The endoscopist cannot deegate this responsibiity except to a person who has been fuy instructed for the specific case. The endoscopist shoud ensure consent has been obtained Athough a nurse may not take deegated responsibiity for obtaining informed consent, if it is her opinion that the patient is not adequatey informed then she has a duty to inform the endoscopist and to record that she has done so Who takes responsibiity for minors? 6.1 If the parents are married at the time of birth of the chid both have parenta responsibiity. An unmarried mother has soe responsibiity uness the father has acquired responsibiity by Court Order or a Parent Responsibiity Agreement. 6.2 Parents or guardians consent on behaf of a chid up to the age of 16 years. Chidren of ess than 16 years who fuy understand the issues may consent for themseves, even in the face of parenta refusa. (Note: Parents cannot over-ride a chid s consent but can over-ride a refusa). 6.3 Parents or guardians shoud consent on behaf of a mentay-impaired adoescent up to the age of 18 years. 6.4 If parents refuse essentia treatment or if there is confict between the parents then it may be necessary to ask the Court for permission to treat. 7 Who takes responsibiity for mentay-impaired aduts? 7.1 For a mentay-impaired adut the cinician takes responsibiity to do his best for the patient. Of course the cinician shoud discuss the issues in detai with parents and carers but a third party shoud not be asked to sign a consent form. The cinician shoud write in the case record what he has done and why, especiay if parents or carers express misgivings. For difficut cases it is prudent to get the support of an appropriatey-trained cinica coeague and this is especiay so if the opinion of a parent/carer is to be over-ridden. Normay this shoud be the responsibiity of a consutant. 7.2 Treatment can be awfuy withhed from a patient in a persistent vegetative state where there is no hope of recovery and the patient woud die shorty provided that responsibe medica opinion fet that continuing treatment was futie (this is a resut of the ruing regarding Tony Band who was crushed in the Hisborough Stadium disaster). It is not certain whether or not the same ruing woud hod for cases of severe cerebra pasy. It has been suggested that if the circumstances are cear, doctors do not

12 10 Guideines for Informed Consent for Endoscopy Procedures even need to appy to Court for a decaration (Frenchay Heathcare Trust - v- S [1994] 2 AER 403) but if there is any doubt a ega ruing shoud be sought. (This is important for an endoscopist asked to provide a feeding ine via a PEG). 7.3 In an emergency the endoscopist takes responsibiity and no consent is necessary. 8 Jehovah s Witnesses 8.1 Refusa to receive a transfusion of bood or bood products by a competent Jehovah s witness must be accepted as irrefutabe. Specific guideines prepared by the Jehovah s Witnesses are avaiabe to aid decision making. 8.2 If it is deemed that the chid of a Jehovah s Witness requires transfusion of bood or bood products in reation to an endoscopic procedure a Court order shoud be sought. 9 What are the responsibiities of the endoscopist in respect of sedation? 9.1 In giving advice to patients about the procedure it is necessary to expain how best to minimise discomfort. The patient shoud be offered the choice to have sedation or not. 9.2 If sedation is to be used it is important to advise patients of specia precautions to be taken after eaving the hospita with respect to the consumption of acoho, the driving of vehices and the operation of machinery. Patients must be advised to avoid potentiay dangerous activities for 24 hours. This advice shoud be given in written form as we as verbay. Most endoscopic procedures of the gastro-intestina tract are carried out under simpe sedation using drugs which depress the centra nervous system but aow the patient to respond to command throughout the period of sedation. The technique shoud carry a margin of safety sufficient to avoid unintended oss of consciousness. If the eve of sedation exceeds these imits then probems such as depression of vita centres and aspiration become ikey. 11 The aw and defence organisations are sedom, if ever, prepared to defend an operator/anaesthetist who has an accident with sedation. It is usua for an experienced endoscopist to take responsibiity for sedating the patient as we as undertaking the procedure but it shoud be a minima requirement that a second appropriatey-trained person is present throughout the procedure. Such a person may be a nurse who is quaified as an endoscopy assistant and who is capabe of monitoring the cinica condition of the patient throughout the procedure. Shoud the occasion arise he or she must be capabe of assisting the doctor in the case of an emergency. If intravenous access is used to administer drugs the neede shoud be eft in pace unti recovery is compete What shoud be done if the patient withdraws consent haf-way through the procedure? 10.1 Amost aways withdrawa of consent comes from a strugging patient who is under the infuence of drugs. The endoscopist then has the responsibiity of doing what he considers to be in the patient s best interests. For exampe if a stone is about to be reeased from the ower end of the common bie duct then, after a pause for expanation and perhaps further sedation, the best course of action may be to continue.

13 Guideines for Informed Consent for Endoscopy Procedures If the patient is strugging and the procedure is ikey to take more than an extra few minutes then it is prudent to withdraw the endoscope, aow the patient time to recover and then to discuss with him/her how best to proceed. For exampe, the endoscopic procedure coud be performed at a ater date under a genera anaesthetic, or an aternative investigation such contrast radiography may be considered more appropriate. 11 Figures for compication rates for different endoscopic procedures It is ikey that many tertiary centres of exceence wi have ower compication rates for therapeutic endoscopy than some smaer units. Where possibe it is best to quote compication rates for the unit where the procedure is to be performed. Endpiece This paper deas soey with informed consent which is ony one of the items of information needed by patients before they undergo an endoscopic procedure (Appendix C). In an audit of 16 out of 18 Endoscopy units in Northern region it was found that adequate written information about risks; about procedures for consent; and about aftercare was provided to patients in ony four instances. Re-assessment of the quaity of information given in pamphets, after advice had been given, satisfied the standards of audit in ony 12 of the 18 units. 13 Thus in the country as a whoe it seems ikey that many endoscopists fai in their duty to patients to provide adequate information. (Appendix D). As a resut they eave themseves open to unnecessary and painfu itigation. It is prudent to remember the aphorism provided by an experienced barrister deaing in this area who said, Peope who are taked to sedom sue. 6 Acknowedgements The Working Party is gratefu to Professor Duncan Coin-Jones, Professor John Lennard-Jones and Ms N Davies QC for hepfu advice during the many drafts of this document. REFERENCES 1. ASGE. Review of endoscopic caims. In: Risk management: An information resources manua. American Society of Gastroenteroogy, Neae G. Reducing risks in gastro-enteroogica practice. Gut 1998; 42: NHS Management Executive, A guide to consent for examination and treatment 4. Seeking Patient s Consent: the ethica considerations. Genera Medica Counci Be G.D., McCoy R.F., Charton, J.E., Campbe D., Dent N.A., Gear M.W.L., Logan R.F.A. Recommendations for Standards of sedation and patient monitoring during gastrointestina endoscopy. Gut 1991; 32: Davies N. Medico-ega issues in endoscopy. In: Rory McCoy, ed. Quaity contro in endoscopy. Springer Verag 1991, pp Periera S.P., Hussaini S.H., Wikinson M.L. Informed consent for upper gastrointestina endoscopy. Gut 1995; 37: UKCC Guideines for professiona practice: para 23. United Kingdom Centra Counci for Nursing, Midwifery and Heath Visiting. 9. Posta consent for upper gastrointestina endoscopy. Shepherd H.A., Spencer Austin T., Hancock B., Angin J., Hewett D.J. Copies obtainabe from Dr H Shepherd, Roya Hampshire County Hospita, Romsey Road, Winchester, Hampshire, SO22 5DG

14 12 Guideines for Informed Consent for Endoscopy Procedures 10. UKCC Guideines for professiona practice: paras 26-9 United Kingdom Centra Counci for Nursing, Midwifery and Heath Visiting. 11. Quine M.A., Be G.D., McCoy R.F., Charton J.E., Devin H.B., Hopkins A. Prospective audit of upper gastrointestina endoscopy in two regions of Engand: safety, staffing and sedation methods. Gut 1995; 36; Poswio D.E. Medico-ega aspects of sedation. In: Rory McCoy, ed. Quaity contro in endoscopy. Springer Verag 1991, pp Tanner A.R., Wison C.W. Improving information given to patients before endoscopy: a regiona audit. Quaity in Heath Care 1994; 2:

15 Guideines for Informed Consent for Endoscopy Procedures 13 APPENDIX A An exampe of a patient information eafet on PEG tube insertion*. HAVING A GASTROSTOMY (PEG) Genera Expanations Those ooking after you are concerned that you are not receiving enough nourishment because you have difficuty in eating. We are asking your agreement to introduce a sma tube into your stomach through the skin and between the nave and the breast bone. By pacing a tube through the skin and underying tissues in this way it is possibe to avoid the need for a tube which passes through your mouth or nose. Liquid nourishment can be introduced through the tube severa times a day to repace or suppement what you take by mouth so that your body wi receive a norma amount of food each day. Between the times when the fuid is introduced, the tube can be cosed so that it cannot be seen beneath your cothes and visitors need not know that it is there. It is ikey that you wi need to receive nourishment every day through this tube for at east severa weeks. What you Shoud Expect Before the Procedure A doctor wi expain what is going to be done and wi ask you to sign a consent form. This is to ensure that you understand the procedure and its impications. If you have any questions or worries do not be afraid to ask. Passage of an Instrument and Tube Through Your Mouth You wi be asked to remove fase teeth and spectaces. Then you wi be made comfortabe on the bed resting on your eft side. A nurse wi stay with you throughout. The doctor wi give you an injection to make you fee seepy and reaxed. To keep your mouth open a pastic mouthguard wi be put between your teeth. A fexibe instrument, thinner than your itte finger with a bright ight on the end, wi now be genty introduced into your mouth over the back of your tongue and down into the stomach. Some air wi be passed through the instrument to distend the stomach and aow the doctor a cear view. Later this instrument with the ight wi be removed quicky and easiy. It wi be repaced by a soft pastic tube which wi be drawn over your tongue and down into the stomach. Passage of a Neede and Tube Through the Skin of the Abdomen A oca anaesthetic injection wi be given at a point in the skin of the upper abdomen. A neede and sma tube wi then be introduced at this point through the skin and into the stomach. You may fee a sense of painess pressure whie this is done.

16 14 Guideines for Informed Consent for Endoscopy Procedures After the Procedure The insertion of the tube takes about haf an hour. It is quite ikey that the back of your throat wi fee sighty sore for the rest of the day. You may aso fee a itte boated if some of the air remains in your stomach. Both these discomforts wi pass and wi usuay need no medication. Feeding Fuid wi first be introduced through the tube on the foowing day. Over the next 3-4 days a regime of feeding wi be estabished and the reevant peope wi earn how to manage the feeding system. It shoud then be possibe for you to receive nourishment through the tube every day for as ong as it is needed. Care of the Tube You or those ooking after you wi need to keep cean the point at which the tube passes through the skin. Once the tissues have heaed it is possibe for the tube to be repaced if necessary. Potentia Probems There may be a sight risk to crowned teeth or denta bridgework, and you shoud te the doctor if you have either of these. Occasionay, a probem arises because the tube, or the instrument used to introduce it, damages the stomach or eads to a eak of stomach contents. These unusua compications can require specia treatment incuding an operation. An infection can occur at the point where the tube passes through the skin and an antibiotic may be given to reduce this risk or treat any infection that occurs. * the committee are gratefu to Professor John Lennard-Jones for kindy preparing this exampe eafet.

17 Guideines for Informed Consent for Endoscopy Procedures 15 APPENDIX B An exampe of a possibe consent form. Endoscopy Consent Form I... of hereby consent (or hereby consent to the submission of my chid/ward) to undergo endoscopy, the nature and purpose of which have been expained to me by Dr I have understood the information that has been given/tod to me about the procedure. I have been given the opportunity to ask questions. I aso give consent for any necessary biopsies, photographs or X-rays to be taken. Warning 1. * For gastroscopy, diitation/stent insertion in the oesophagus, PEG tube and any other endoscopic procedure. I understand that a endoscopic procedures carry a very sma risk of haemorrhage or perforation of the gut, foowing which surgery may be necessary. Other rare compications incude aspiration pneumonia and a reaction to the IV sedative drugs used to sedate me. Upper gastrointestina endoscopies may invove a sight risk to crowned teeth or denta bridgework. 2. * For Coonoscopy and Fexibe Sigmoidoscopy I understand that these examinations carry a sma risk of damage to the ining of the arge bowe which may need to be repaired by means of surgica operation. The risk of perforation or beeding is increased if it is necessary to treat poyps with hot biopsy forceps or a poypectomy snare. 3. * For ERCP I understand that ERCP is an endoscopic procedure that may damage the bie duct or produce either choangitis (infection in the bie duct) or infammation of the pancreas. If a sphincterotomy is necessary then the risk of haemorrhage or perforation is increased. If a stent is inserted through an area of narrowing in the bie duct or pancreas to reieve jaundice, again choangitis and pancreatitis may occasionay occur. I understand that the stent may need to be repaced from time to time. * Deete where necessary Date:. Signed:.. (Patient) I confirm that I have expained to the patient the nature and purpose of the endoscopic procedure. Date:. Signed:.. (Medica Practitioner)

18 16 Guideines for Informed Consent for Endoscopy Procedures APPENDIX C Suggested stye and items that shoud be incuded in any information sheet provided for patients undergoing endoscopic procedures Specific items may need omission or different emphasis depending on the intended audience - Out patient, Day case or In patient Different pamphets wi be needed for upper gastrointestina endoscopy, coonoscopy, ERCP and certain therapeutic procedures 1. Information shoud be cear, informa and understandabe to the ay person, avoiding the use of jargon. (Pain Engish). 2. There shoud be cear directions for finding the endoscopy unit. 3. There shoud be a contact teephone number for the endoscopy unit. 4. There shoud be accurate and unambiguous statements regarding fasting or bowe preparation. 5. There shoud be information on the taking of reguar medications (or a request to contact the endoscopy unit if in any doubt). 6. Instructions for diabetic patients shoud be incuded (perhaps just a request to contact the unit). 7. Procedura risks shoud be ceary itemised. This might incude minor probems such as a sore throat but MUST incude substantive risks associated with therapeutic endoscopy where reevant. 8. For upper gastrointestina endoscopy, a discussion of sedation and non-sedation with throat spray shoud be incuded. 9. Consent procedures shoud be expained. Some units may opt to undertake this task in a cinic setting, others may send the consent forms with the information sheets, but asking for them to be signed when they arrive at the unit after discussion with the endoscopist or nurse practitioner. 10. Emphasise the vaue and avaiabiity of spoken carification for the patient when they attend the endoscopy unit. 11. Care after the procedure, incuding side effects, shoud be described. 12. Do s and Don ts on going home shoud be stated. 13. Information on getting the resut of the endoscopy shoud be stated. This may be the Genera Practitioner, a referring consutant or a member of the endoscopy staff. If this is uncear, it can be very frustrating for the patient. 14. Foow up arrangements shoud be stated where appicabe. 15. A statement asking for vauabes to be eft at home shoud be incuded.

19 Guideines for Informed Consent for Endoscopy Procedures 17 APPENDIX D Suggested Audit Standards For Consent And Patient Information 1. Information eafets are in Pain Engish. 2. Information eafets for Out patients and/or Day case patients incude ALL the information points outined in Appendix C. 3. A patients have access to the reevant information and give informed consent (see 5). 4. The correct consent procedures are used for a patients who are unabe to give informed consent themseves. (This can be a particuar probem for patients requiring PEG insertion). 5. A patient survey is undertaken at east once a year to ensure: - information is appropriate and understood - informed consent was given from the patient s perspective - opportunities for verba carification worked. 6. The procedura risks for your own unit are known and accuratey stated in the information sheets. Quaity Issues Quaity Assurance Are minima standards for information avaiabiity and consent procedures achieved? Monitoring of patient compaints and compiments regarding the endoscopic service can hep to identify areas for improvement. Quaity Monitoring The audit suggestions above can contribute to this, especiay 5. Quaity Contro Are critica events such as serious compications and apses in consent procedures identified, monitored and minimised by rigorous review? Quaity Improvement No unit wi be abe to meet a the outined criteria but mechanisms shoud be put in pace to achieve an idea situation over time with the constant drive to improve procedura performance both technicay and from the patient s perspective. Cinica Risk Management These standards shoud be seen as a critica eement of Risk Management in endoscopic practice. Other issues woud incude ensuring appropriate indications for a endoscopic procedures and monitoring technica competence incuding compications. We pan that this guideine wi be revised from time to time. Comments or suggestions for use in subsequent editions shoud be sent to: The Cinica Services and Standards Committee, British Society of Gastroenteroogy, 3 St Andrews Pace, Regent's Park, London NW1 4LB.