Consent for direct access endoscopy

Many patients undergoing upper gastrointestinal endoscopy or colonoscopy have the procedure performed by a doctor they have not previously consulted. Some studies have shown that a higher proportion of so-called direct or open access patients do not have a valid indication for the procedure, as compared with patients who have had a prior consultation with a gastroenterologist.¹

But direct access endoscopy facilitates the patient's journey by avoiding the consultation appointment with its inevitable costs and time delays. But does this mean that patients undergoing direct access endoscopy are less well-informed as to the nature of the procedure and the potential risks and benefits? How does one ensure that these patients are able to provide genuine informed consent to having these invasive procedures? The issues are particularly relevant for patients undergoing colonoscopy who will undergo their bowel preparation procedure before meeting the endoscopist for the first time and where there will therefore be a greater reluctance to delay the procedure even if some issues emerge at the time of being asked to sign the form of consent. In this issue Serajasingham et al.² report a study as to the adequacy of consent in patients undergoing direct access colonoscopy.

Endoscopy is generally very safe and in many situations there should be little difficulty in referring doctors to identify suitable patients for whom the procedure is indicated. For the small number of patients where the endoscopic examination reveals pathology that requires a more risky therapeutic procedure, the procedure should be re-scheduled as a separate procedure after the patient has had an opportunity to have the particular intervention fully explained. So it would appear that direct access endoscopy can be appropriate. It is, however, essential that patients receive appropriate information on the procedure from both the referring doctor and the endoscopist well before attending for their endoscopy. If not, the patient will later be able to claim that the risks of the procedure had not been adequately disclosed to them.

Many patients who are scheduled for direct access endoscopy have had previous endoscopies and been recalled as part of surveillance programs for Barrett's esophagus or colonic neoplasia. These patients are often less concerned about the procedure, having had one or more previously. But time will have passed since the last examination, and with it new comorbidities may have developed. There needs to be a robust process to ensure that such comorbidities and new contraindications are identified prior to the endoscopy appointment. The patient can then be warned of risks that have increased since their earlier procedure.

Providing the information that will allow for informed consent is never a one-step process, nor can it fail to take into account the needs of the patient – their indication for the examination, their comorbidities and medications, language needs, educational background, and their anxieties. For patients undergoing colonoscopy, in particular, they need to understand all the details of the bowel preparation procedure. These issues all need to be considered in planning a direct access endoscopy program.

By far the most popular and practical procedure used is to provide an information brochure; many gastroenterology and endoscopy associations have produced such model brochures to assist endoscopists and their patients. Alternative or additional techniques using DVDs, videos,³ or interactive multimedia presentations,⁴ have been reported and these have been shown to be well received by patients. However, they need to do more than just explain the nature of the endoscopic examination and its potential complications. The possible contraindications to direct access endoscopy, what symptoms to be alert for after the procedure and what to do should they occur, the limitations of the procedure and what drugs (such as anticoagulants) that might influence the safety of sedation and endoscopy all need to be covered in the brochure.

The information brochure for open-access endoscopy should also offer the patient the opportunity to make a consultation appointment with the endoscopist prior to the procedure, should they have concerns that need discussion. It is clear from the report from Serajasingham et al.² that patients do find such brochures useful – indeed, they are the most important source of information they receive. Such brochures therefore need to be carefully written to ensure that they cover all the issues, are worded so that patients from a wide range of educational backgrounds will understand – but not so long that they will not be read fully! This is not easily achieved.

In addition to patients receiving a brochure or other educational material, there is also an option to offer a pre-admission clinic visit where experienced endoscopy nurses have the opportunity to check the suitability of the patient, go over all the relevant information, and ensure that the patient and their family have suitable levels of understanding. This can also be done by telephone to save the patient from having to travel a significant distance. Such a pre-admission visit or call also provides an opportunity to complete (and have the patient sign) a check list that covers the steps that have been taken and the fact that the patient has received the brochures that explain the procedure (as well as the financial arrangements!). In our private gastroenterology group practice, we have found that it takes about 20 min for an experienced nurse to interview each patient in the pre-admission clinic, and to ensure an appropriate level of understanding so as to obtain informed consent and ensure optimal patient safety.

The final step in the consent process is the completion and signing of the written consent form. While the legislative requirements governing this vary from jurisdiction to jurisdiction, for direct access endoscopy patients it should be the endoscopist who witnesses the patient signing the form. This will provide the opportunity for the endoscopist to greet and briefly assess the patient's suitability and, most importantly, assure himself or herself that the patient does understand the nature of the procedure and enquire if the patient has any further questions. Most particularly, the endoscopist must answer any questions carefully and patiently, as a small number of patients will only be satisfied by reassuring themselves that they have confidence in the person performing the invasive procedure by such direct contact. To allow the pressure of the endoscopy facility routine to short-cut this communication is to invite real difficulties if any problems are encountered. Serajasingham et al.² found a small percentage of patients were dissatisfied with the direct access process despite careful planning of the service, and that there were no demographic characteristics to identify these patients.

The success (and safety) of a direct access endoscopy program will depend on the endoscopy facility and endoscopists ensuring that they pay close and ongoing attention to ensure that all the above matters are canvassed, as summarized in Table 1.