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Editor,—The phrase “informed consent” falls so readily from the pen that it is easy to forget that two distinct processes are involved: firstly, providing appropriate information and then obtaining consent from the patient. In attempting to combine these two steps, Shepherd and colleagues () remove some of the patients' essential safeguards. As Neale (OpenUrl) points out in his gentle and thoughtful comment, “written information . . . is undoubtedly useful but it does not replace the over-riding need for doctors to speak with their patients . . .”.
Neither the paper nor the commentary cite the GMC advice1although they are quoted extensively in the British Society of Gastroenterology guideline on informed consent for endoscopy procedures.2 Particularly relevant is this: “obtaining informed consent cannot be an isolated event. It involves a continuing dialogue between you and your patients . . . you should give . . . the patient time to ask questions”.
However carefully prepared, a booklet cannot be appropriate for every patient and every circumstance. Pressing patients to “sign consent” in advance of meeting any endoscopy staff is to deprive them of the opportunity to ask questions or seek reassurance. “If you are the doctor . . . undertaking an investigation it is your responsibility to discuss it with the patient …”2although the job may be delegated to an appropriate person.
Giving information by post is desirable: requesting signed consent by that route is not.
Editor,—Shepherd and colleagues () offer a timely and thoughtful contribution to the increasingly loud debate within trusts about informed consent. As well as endoscopy, their example is relevant to other services offering invasive open access procedures, especially radiology. Their booklet addresses three problems: (i) that information regarding proposed procedures should be given in circumstances in which patients could not be perceived to be under duress to give consent; (ii) that the information is given, albeit indirectly, by one who is trained to perform the procedure; and (iii) that an explanation is given regarding risks as well as benefits, as is often not the case at present.
Neale's commentary (OpenUrlCrossRefPubMedWeb of Science) is, as one would expect, in many ways equally perceptive but he fails to take account of an essential aspect of open access services. As he makes clear, such a process of informing consent cannot address the problem of informing choice among available options as the information arrives through the post with an appointment for a particular procedure. However desirable it may be that such a choice should be an integral element of informing consent, the nature of an open access service dictates that the decision regarding the choice of the procedure must have been taken prior to the referral having been made. This raises two further issues: (1) how to ensure that appropriate judgement is used to decide the choice of the procedure; and (2) how to assess an acceptable level of risk for open access procedures in general and for the particular individual to whom a procedure is offered.
Neale's example of ERCP, although not generally an open access procedure, serves to focus thinking about these unanswered questions but does not diminish the contribution of Shepherd and colleagues in enhancing the quality of information given to patients. The ratio of manpower to demand means that, for the foreseeable future, much as endoscopists may wish “to speak with their patients about options for further action” prior to offering procedures, attempting to do so in every case would impose unacceptable delays in their management.
Editor,—The booklet for consent has been designed and implemented as a practical way of addressing all of the issues that surround seeking patient's consent for open access procedures. We feel it pays due regard to recommendations of the British Society of Gastroenterology and the GMC but differs in that it is the first practical approach to dealing with high volume outpatient endoscopy services. As Dr Bruce points out in his very supportive letter, the decision that endoscopy is required has usually already been made by the patient discussing the matter with the general practitioner.
The postal questionnaire and informed consent document makes clear provision for the patient who has any doubt or concern not to sign the paper but to attend the endoscopy department with the expectation of having further explanation by an informed individual. We suggest that this approach is still better than what can only best be described as a huge range of consenting procedures that operate in various endoscopy units throughout the country. We must accept that patient consent obtained within a few minutes of the patient being endoscoped is a practice that can no longer be tolerated as consent is always open to challenge. Neale, in his commentary, we think misses the point between obtaining informed consent in a practicable, reasonable, and legal way for the procedure which is about to be performed by introducing the concept of discussing alternatives. Most endoscopists would surely agree that by the time the patient has arrived for endoscopy in the outpatient sector, particularly on the open access service, it is inappropriate to start discussing whether alternative and other modalities of investigation are appropriate. This should have happened during the patient's consultation with the general practitioner.
It was foreseen many years ago that once an open access endoscopy service was made available it would become a high volume service, which can leave both endoscopists and patients vulnerable. Protocols for endoscopy have helped in patient selection but they are not always available. We think it must be regarded as a minimum standard of care that the consent obtained for these procedures is as informed as it can possibly be made, within the practicalities surrounding the delivery of service. Furthermore, we suggest that this booklet is the first to openly address this problem and that, judging by the response the authorship has had, many other colleagues throughout the country agree with our approach.
Editor,—Thank you for allowing me to see the correspondence regarding “informed consent”. Dr Bennett states that writing to inform a patient of what is involved in “open access” gastrointestinal endoscopy (including risks and benefits) is desirable but requesting patients to “sign consent” at home is not. He cites GMC advice that “..obtaining informed consent cannot be an isolated event. It involves continuing dialogue between you and your patients... you should give... the patient time to ask questions.” In contrast, Dr Bruce states that “The ratio of manpower to demand (for gastrointestinal endoscopy) means that much as endoscopists may wish to speak with their patients about ...(this) would impose unacceptable delays in management.”
In writing a commentary on informed consent I did not attempt to resolve these differences. As was stated in the BSG guidelines on informed consent,2-1 “In busy clinical practice it is not possible to satisfy NHS guidelines meticulously and lawyers recognise the difficulties... Each unit must develop a code of practice suitable to its mode of operation... The law takes the view that the responsibility for obtaining informed consent lies with the endoscopist who is to perform the procedure...” But as the GMC concedes, “Where this is not practicable you may delegate (this responsibility)... to a person (who) is suitably trained and qualified; has sufficient knowledge...and understands the risks...”
The difficulty with open access endoscopy lies in the shared responsibility. The GP has assessed the patient and usually remains responsible for the patient's care. I assume that consultant gastroenterologists who offer open access endoscopy instruct participating GPs carefully regarding indications, alternatives, risks, and potential benefits, thereby delegating responsibility. And as Shepherd and colleagues () make clear, patients are not “pressed” to sign the consent form at home; they have the option not to sign until they have discussed the procedure with the endoscopist. Moreover, if the BSG guidelines are followed “... a qualified nurse should check the level of understanding and provide further explanation... and the endoscopist should deal with any last minute questions”.
Meanwhile, the value of open access endoscopy remains a subject for debate.2-2 It has been suggested that a one stop dyspepsia clinic is a preferable means of practice.2-3 Such practice overcomes the problem of gastroenterologists “not speaking with patients about options”.