BACKGROUND Standards for good practice in clinical risk management issued by the Clinical Negligence Scheme for Trusts indicate that “appropriate information is provided to patients on the risks and benefits of proposed treatment, and of the alternatives available before a signature on a consent form is sought”.
AIMS To investigate the practicability and patient acceptability of a postal information and consent booklet for patients undergoing outpatient gastroscopy.
METHODS Information about gastroscopy procedure, personalised appointment details, and a carbonised consent form were compiled into a single booklet. This was mailed to patients well in advance of their endoscopic procedure. Patient satisfaction for this new process was assessed by questionnaire.
RESULTS 275 patients received a patient information booklet. Of these, 150 (54.5%) returned the consent form by post when they confirmed their attendance; 141 (94%) had signed the form, and the other nine requested further information. Of the remaining 125 booklets sent out, 115 (92%) forms were brought back on the day of the investigation having been previously signed. The remaining 10 (8%) required further information before signing the form. An audit of 168 patients was used to test reaction to the booklet and the idea of filling in the form before coming to hospital; 155 patients (92.2%) reported the information given in the booklet to be “very useful”, and all reported it to be “clear and understandable”.
CONCLUSION A specifically designed patient information booklet with integral consent form is accepted by patients, and improves the level of understanding prior to the investigation being carried out.
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When referred by their general practitioner to an open access endoscopy service, patients will not have been seen by a gastroenterologist prior to their investigation. The information given to patients about the procedure by their own doctors is likely therefore to be varied in depth and content. Furthermore, some patients will sign consent forms without asking for additional information, especially when they have already gone to the trouble of attending the hospital. The busy clinical environment may well inhibit questions and certainly does not permit much time for deliberation. Consent given in these circumstances has been questioned by senior legal opinion and may be defective if it is not based on sufficient information.
The National Health Service Litigation Authority, through the Clinical Negligence Scheme for Trusts (CNST), seeks to raise standards in the areas of communication with patients, and in gaining informed consent to treatment. The CNST has recently published a manual of 11 principal standards which member Trusts are exhorted to meet in order to achieve a reduction in subscriptions.1
Standard 7 states that “appropriate information is provided to patients on the risks and benefits of proposed treatment, and of the alternatives available before a signature on a consent form is sought”. The rationale for this flows from the observation that “complaint or litigation is less likely to follow if patients understand to what they are consenting”. The Standard then goes on to demand that:
consent forms conform to National Health Service Executive Guidelines on content and design;
there is patient information available showing the risks and benefits of proposed procedures; and
there is a policy guideline stating that consent for elective procedures is to be obtained by a person capable of performing the procedure.
English case law relating to informed consent to treatment provides that there must be prior consultation or discussion. Where this does not take place, the patient, as a matter of law, may be held as not to have consented to treatment.2 In practice, however, recent cases which have come to trial have dealt with alleged failure to disclose risks inherent in the treatment, rather than failure to consult the patient. Medical practitioners may be held negligent if they fall below the standard of care practised by a responsible body of medical opinion in drawing their patient's attention to the risks inherent in a given procedure. This is the application of the so called Bolam test to the counselling of patients.3
This approach is a pragmatic one which distinguishes English practice from other countries such as the United States. Judges here have tended to uphold a standard of care based on a responsible body of medical practice over the right of the individual patient to know of all risks.2
As a result, there is no clear guidance as to the level of risk which requires specific mention to patients. Indeed, clinical judgement may indicate that a risk discussed with one patient, may properly be considered inappropriate to mention with another in the same circumstances. For this reason judges in the landmark Sidaway case avoided laying down any specific quantification of risk, relying instead on the professional judgement of doctors and the capabilities of the particular patient concerned.4
Taking the CNST standard together with the legal principles into account, it might be suggested that all patients coming for endoscopy should have a prior consultation with a fully trained endoscopist 24 hours before being scheduled for investigation.5 This, however, is extremely expensive in terms of skilled resource, and would have the undesirable effect of reducing the availability of a heavily used service, thereby disadvantaging other patients with an urgent need. The British Society of Gastroenterology has stated that such a standard is impossible to achieve.
The use of a postal consent form coupled with an information booklet was therefore investigated as a way of reconciling the individual patient's need to be informed and to consent without being exposed to undue pressure, with the need to investigate as many patients as possible within the shortest time.
Subjects and methods
In total, 275 patients referred to the open access service for an upper gastrointestinal endoscopy were surveyed.
An information booklet was written by the consultant gastroenterologist and nursing staff. This draft document was submitted to the communications manager (a trained journalist) for subediting.6 Colleagues in the legal department reviewed the document and revised text where appropriate, so that this booklet became a valid document for obtaining consent which conforms to NHS Management Executive (NHSE) guidelines.7
The booklet was then professionally printed. It incorporated a consent form which was detachable, and self carbonating so that patients could return the top copy and confirm the appointment which had been given. The text of the booklet explained the process of endoscopy, the options regarding sedation and the drugs used, the risks of endoscopy and sedation, the personnel they were likely to encounter and why, and finally the recovery process and procedures relevant to their discharge. Patients who signed the consent form were acknowledging that they were content to proceed with the planned gastroscopy, but this did not ultimately affect their right to change their mind later. To personalise the document, clinic staff wrote in the patient's name and appointment time on the first page of the booklet.
After treatment patients were asked to complete a short questionnaire to indicate their reactions to the booklet and the consent form.
Table 1 summarises the results. Of the 275 booklets sent out, a high proportion (96.8%) had been signed, either having been posted or returned by hand on the day of the endoscopy. In all 150 (54.5%) booklets were returned by post having been signed prior to endoscopy. Of the remaining 125 booklets, 115 were brought back on the day of the gastroscopy having been signed prior to coming to hospital. Nineteen patients (6.9%) wished to ask for further information and subsequently signed the consent in the endoscopy department, at least 30 minutes before the procedure. Every patient sent a booklet subsequently attended for gastroscopy.
To test whether or not these results represented true satisfaction the patient questionnaire was administered (table 2). The results indicate that 96.8% of patients were content to sign their forms at home but only 56.6% posted them back to the unit.
Pereira et al have previously shown that the standard consent form administered immediately prior to endoscopy in hospital was read by only half of the patients attending their service.8 Furthermore, doctors tend naturally to write in a style normally associated with medical journals rather than, for example, a tabloid newspaper.9
The atmosphere of a busy department just prior to undergoing an unknown procedure is not the best environment in which take in new and complex information. In such circumstances it is easy to remain passive and go with the flow. Morgan et al divided patients into two groups, information seekers and information avoiders on the basis of coping behaviour. Those who sought information would be expected to ask further questions. If the information given was compatible with their coping behaviour there would be less anxiety than expected and time spent in recovery would be reduced.10
Physicians working in a clinical environment are endowed with considerable authority. The balance of power between professionals and patients is heavily skewed. Taking all these factors together patients are placed at a significant disadvantage.
These results indicate a strong preference for the decision to be taken at a distance from the hospital in familiar circumstances. Satisfying this need requires a well written information booklet which describes the investigation, and prepares the patient for what is to happen. The booklet also describes the common indications for undertaking the procedure and mentions both the common risks involved, and the potential benefits.
The proportion of consent forms returned prior to the investigation being carried out may be increased by supplying prepaid envelopes with the booklets. These results show the system to be popular with patients, and the endoscopy unit staff report that it saves them time, although that benefit has not been measured objectively.
Full text of the booklet is available on theGut website: www.gutjnl.com
YOUR INFORMATION BOOKLET
ROYAL HAMPSHIRE COUNTY HOSPITAL
TELEPHONE: (01962) 825058
An appointment for your Colonoscopy has beenarranged: on ______________________ at ___________
Please telephone the Endoscopy Department on (01962) 825058 if this is not convenient.
You have been advised by your GP or Hospital Doctor to have an investigation known as an Endoscopy.
The procedure you will be having is called a Colonoscopy. This is an examination of your large bowel (colon). It will be performed using a flexible endoscope whilst you are sedated. The investigation will be carried out by a trained doctor.
This booklet has been written to enable you to make an informed decision in relation to consenting to the investigation. At the back of this booklet is your consent form, once you have read and understood all the information, including the possibility of complications, and you agree to undergo the investigation, please sign and date the consent form and send it to the Endoscopy Department, at least one week prior to your appointment. You will notice that the consent form is carbonised, allowing you to keep a copy for your records, please fill it in while it is still attached to this booklet.
The consent form is a legal document, therefore if there is anything you do not understand or wish to discuss further do not sign the form, but please still indicate your decision by ticking the appropriate box on the consent form and returning the top copy to the Endoscopy Department at least one week prior to your appointment.
If you are unable to keep your appointment, please notify the Department as soon as possible, this will enable the staff to give your appointment to someone else and they will be able to arrange another date and time for you. Please bring this booklet with you when you attend.
The word Endoscopy is derived from two Greek words; "Endo" which means within and "scope" which means to look, therefore Endoscopy simply means to look within.
WHAT DOES ENDOSCOPY MEAN?
You have been advised to undergo this investigation of your large bowel to help your doctor find the cause for your symptoms, thereby facilitating treatment, and if necessary to decide on further investigations.
WHY DO I NEED TO HAVE AN ENDOSCOPY?
There are many reasons for this investigation including:- anemia, bleeding from the back passage (Rectum), diagnosing the extent of some inflammatory bowel diseases, and assessing the clinical importance of abnormalities found on X-Ray.
This is an investigation looking at the inside of your large bowel (colon), using a flexible endoscope which is connected to a television system. Within each scope is an illumination channel which enables light to be directed onto the lining of your colon, and another which relays images back, via a processor, onto a television screen. This enables the Doctor to have a clear view and to check whether or not disease or inflammation is present.
SO WHAT IS A COLONOSCOPY?
During the investigation the Doctor may need to take some samples from the lining of your colon for analysis, this is painless.. A video recording or photographs can be taken for record and documentary purposes.
Sometimes the Endoscopist may encounter a problem which can be effectively treated at the same time. In such cases, unless you indicate otherwise, discretion to treat the problem will be assumed.
PREPARING FOR THE INVESTIGATION
The large bowel, which normally contains faeces, must be very clean to ensure safe, clear views. You will need to be on a low fibre diet, considerably increase your fluid intake for two days prior to the examination. A diet sheet is included with this booklet. If you are on iron tablets or stool bulking agents (e.g. Fybogel, Regulan, Proctofibe) you must stop these upon receipt of this booklet. Twenty-four hours before your examination you should take clear fluids only (no food) e.g. glucose drinks, Bovril, tea and coffee with sugar.
On the day prior to the examination you will need to take the laxative sent to you to clear out the bowel, clear instructions will be sent with this, if you have any queries do not hesitate to contact the Endoscopy Unit and someone will assist you.
Your routine medication should be taken, if you're appointment is in the afternoon, all medication should be taken by 8 a.m. that same day. If you are a diabetic controlled on insulin or medication and have been given a late appointment, please notify the Endoscopy Department as soon as possible and an earlier appointment will be arranged. Do not take your insulin or diabetic tablets or have breakfast on the morning of your test, but please bring your insulin or diabetic tablets with you.
WHAT ABOUT MY MEDICATION?
This will depend on how quickly you recover from the sedation and how busy the Department is. You should expect to be in the Department for at least three hours. The Department also looks after emergencies and these often take priority over our outpatient list.
HOW LONG WILL I BE IN HOSPITAL?
When you arrive in the Department, you will be greeted by a trained member of staff will ask you a few questions, one of which concerns your arrangements for getting home. As you are having sedation you will not be allowed to drive or use public transport, so you must arrange for a family member of friend to collect you.
WHAT HAPPENS WHEN I ARRIVE?
If someone is going to collect you, the nurse will need to know if they are planning to stay with you or if they are planning to go into town, back to work or home. The nurse will need to be given this person's telephone number so that she can contact them when you are ready to go home.
You will be shown to your special trolley and, once you have undressed and put on a hospital gown, your blood pressure and heart rate will be recorded, and should you suffer from breathing problems, a recording of your oxygen levels will be taken. If you are diabetic, your blood glucose level will be recorded. The nurse is very aware that you may be worried and anxious so do not be afraid to ask any questions, the staff will want you to be as relaxed as possible for the investigation and will not mind answering any questions. Prior to your investigation, you will see the Gastronenterology Specialist Nurse Practitioner who is an experienced and senior nurse, she will need to ask you some questions regarding your medical condition and any surgery or illness you have had in the past, to ensure that you are fit to undergo the investigation. She will also explain the procedure to you. If you have not already done so, you will be asked to sign your consent form at this point. She will insert a small needle into the back of your hand, which will be used to administer the sedation. Prior to the investigation you will be given the opportunity to ask the Doctor any further questions.
This will be administered via the needle in your hand or arm. It will make you quite drowsy but not unconscious. You will be in a state called co-operative sedation. This means that, although drowsy, you will still hear what is said to you and will therefore be able to carry out simple instructions during the investigation, you will be relaxed and able to breathe quite normally during the procedure. Whilst you are sedated we will monitor your breathing and heart rate, so any changes will be quickly noted and dealt with accordingly. For this reason small probe on your finger is connected to a pulse oximeter which measures your oxygen levels and heart rate during the procedure. Sedation has an amnesic effect, the chances therefore of you remembering anything about the investigation are unlikely.
PLEASE NOTE: If you decide to have sedation you will not be allowed to drive, operate heavy machinery or sign any legal documents for 24 hours following the procedure.
Whilst on your trolley you will be transferred into the Procedure Room where the doctor and nurses will introduce themselves and you will have the opportunity to ask any further questions. Nurses will be with you at all times and you will be asked to lie on your left side. The sedation will be administered to and will be a mixture of two drugs usually Pethidine and Valium. In order to monitor your heart rate and breathing the nurse looking after you will clip the probe onto one of your fingers.
The Endoscopy involves manoeuvring the videoscope around the length of your large bowel (colon). There are some bends that naturally occur in the bowel and regrettably negotiating those may be uncomfortable for a short period of time.
Air is gently pressed into the bowel during the procedure to facilitate the examination. Most of this air is taken out as the scope is removed. Samples may need to be taken from the lining of the bowel, also, if any polyps are found they can be removed quite painlessly using a special wire loop device.
RISKSColonoscopy is known as an invasive procedure and therefore carries risks/complications. These are rare.
The major ones being bleeding from and perforation of the bowel wall. Disturbances of your heart rate and breathing can also occur. Should any of these occur you will be admitted into hospital. You might require surgery to repair any damage.
The procedure takes approximately 20 minutes after which time you will return to the recovery area and your condition will be monitored by the recovery room staff.
AFTER THE PROCEDURE
You will be allowed to rest for as long as it is necessary. Your blood pressure and heart rate will be recorded and, if you are diabetic, you blood glucose will be monitored. Should you have underlying breathing difficulties or if you oxygen levels were low during the procedure, we will continue to monitor your breathing. Once you have recovered from the initial effects of the sedation (which normally takes 30 - 60 minutes), you will be offered a hot drink and a snack.
Before you leave the Department, the nurse or doctor will explain the diagnosis and any medication or further investigations required. She will also let you know if the doctor wishes to see you again in the Out-Patient Department. Due to the sedation having an amnesic effect, it is a good idea to have a member of your family or a friend with you when you are given this information.
If you require medication you will be able to collect your prescription from the Hospital Pharmacy Department, so please remember to bring some money with you for the prescription charge.
Because you have had sedation, the drug remains in your blood system four about 24 hours and you may feel drowsy later on, with intermittent lapses of memory. If you live alone, try and arrange for someone to stay with you or, if possible, arrange to stay with your family or a friend for at least 12 hours, but preferably for 24 hours.
If the person collecting you has gone home, the nursing staff will telephone them when you are ready for discharge.
Please write you relative's/friend's
name and telephone number below:
LOW ROUGHAGE DIET
ROUGHAGE IS THE INDIGESTIBLE PART OF CEREALS, FRUIT AND VEGETABLES, ALSO KNOWN AS FIBRE
FOODS ALLOWEDLean tender lamb, beef, pork, chicken, turkey, offal, bacon. Lean ham, fish.
Yorkshire Pudding, pancakes. Bread sauce. Clear and pureed soups. Potato (no skins). Potato boiled and mashed. Tomato plup (no pips or skins). Fruit juices, tomato juice (if tolerated). Pastry made with white flour. White bread, white flour, Cornflakes, Rice Krispies, icing. Smooth biscuits, e.g. Marie Osborne. Spaghetti and pasta. White rice. Crisps.
Rosehip syrup, Ribena. Sugar or glucose in small amounts. Boiled sweets, toffees. Plain or milk chocolate. Shortcake, cream crackers. Water biscuits. Sponge cake, madeira cake. Ice cream, iced lollies. Plain or flavoured yoghurt. Jelly jam, jelly marmalade. Honey, syrup. Tea, coffee and fizzy drinks.
FOODS TO BE AVOIDEDWholemeal, wheatmeal, granary bread, wholemeal flour. Bran biscuits, coconut biscuits. All cereals containing bran or wholewheat, e.g. Shredded Wheat, Bran Flakes, Bran Buds, Muesli. Digestive biscuits. Ryvita, Fyking, Vita Wheat, Oat Cakes, etc.
To enable a more effective examination, we would be grateful if you would take a clear fluid diet only for the period of time stated on the attached appointment letter.
FLUIDS ALLOWEDTea (no milk). Black coffee. Water. Strained fuit juice. Strained tomato juice. Fruit squash. Soda water. Tonic water. Lemonade. Oxo, Bovril, Marmite (mixed into weak drinks with hot water). Clear soups and broths. Consomme.
IN ADDITION- You may eat clear jellies
- You may suck clear boiled sweets and clear mints
- You may add sugar or glucose to your drinks
Drinks or soups thickened with flour or other thickening agents.
FLUIDS NOT ALLOWED
w It is everyone's aim for you to be seen as soon as possible. However, the Department is very busy and your investigation may be delayed. If emergencies occur, these patients will obviously be given priority over the less urgent cases.
w Please do not bring valuables to the Hospital. The Hospital cannot accept any responsibility for the loss or damage to personal property during your time on these premises.
w Because you are having sedation, arrange for someone to collect you.
w If you are unable to keep your appointment please notify the Endoscopy Department as soon as possible.
w Have you signed your consent form or have you indicated by ticking the appropriate box that you wish to discuss the investigation further? Remember to send it back to the Endoscopy Department at least one week before your appointment.
AFTER THE PROCEDURE
If you have any problems with pain or bleeding, please contact your GP immediately, informing them that you have had an Endoscopy.
If you are unable to contact or speak to your doctor, you must go immediately to the Casualty Department. If your symptoms persist or worsen, go to Casualty.
THIS LEAFLET WAS PRODUCED BY:
Dr Hugh Shepherd FRCP MD MB BChair
* * *
Dru Bowman RMN, RGN/DIP.
Specialist Nurse Practitioner
* * *
Endoscopy Sister RGN
* * *
ROYAL HAMPSHIRE COUNTY HOSPITAL
TELEPHONE: (01962) 825058
- Abbreviations used in this paper:
- Clinical Negligence Scheme for Trusts