Evidence-based medicine

Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. Evidence-based medicine combines the individual doctor’s expertise and the best available external evidence when making decisions about the patient’s healthcare.

Evidence-based medicine is a lifelong process which involves:

Evidence-based medicine has the following advantages:

External evidence includes research from basic medical sciences, patient-centred clinical research, randomized trials and meta-analyses. Patient-centred clinical research looks at the accuracy and appropriateness of diagnostic tests, the use of prognostic indicators and the effectiveness and safety of treatments. External clinical evidence may invalidate previously accepted tests and treatments, replacing them with new ones that are more accurate, effective and safe. Without the current best evidence, surgical practice risks becoming out of date, to the detriment of patient care.

Evidence may be available from individual randomized trials or via meta-analysis of several trials such as those published in the Cochrane Database of Systematic Reviews.

Clinical governance in surgical practice

Clinical governance is – a framework through which healthcare organizations are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish.

The purpose of clinical governance is to ensure a systematic approach to maintaining and improving the quality of patient care. It embodies three main areas:

Clinical governance covers organizational systems and processes for monitoring and improving services including:

Effective clinical governance addresses those structures, systems and processes that ensure quality and accountability thus ensuring proper management of an organization’s operations and delivery of service in an open and transparent setting. In so doing, it ensures continual improvement of patient care with a commitment to quality and the prevention of clinical errors.

Clinical audit

Clinical audit is a continuous cycle of quality improvement that seeks to improve patient care and service delivery through systematic review of care against explicit criteria and the implementation of change. The clinical audit process is known as the audit cycle. This involves observation of existing practice, the setting of standards, comparison between observed and set standards, implementation of change and re-audit of clinical practice (Fig. 1.1). The main components of the audit cycle are:

Figure 1.1 The audit cycle.

Benefits of undertaking clinical audit:

Clinical audit is used to compare current practice with evidence of good practice. It basically asks the question, ‘are we actually doing what we think we are doing?’. Clinical audit can:

When considering topics to audit, the following may be a useful guide; high-risk practice, cost-effectiveness, patient concerns, local concerns, conforming to international guidelines, new treatments or procedures.

Types of audit vary from basic clinical audit, e.g. morbidity/mortality, to national audit, e.g. National Confidential Enquiry into Patient Outcome and Death (NCEPOD). Whatever the subject audited, the following are essential requirements:

How does audit differ from research?

Consent

Informed consent is required for all invasive procedures. Consent should be obtained by the person who is actually going to carry out the procedure or certainly by somebody who is suitably trained and qualified and has sufficient knowledge of the proposed treatment. It is probably best that consent for major procedures is obtained either by the consultant or with the consultant present. It is good practice that consent should be obtained for any procedure that can have a complication.

For consent to be valid, the patient must have the capacity to:

Consent should be informed, i.e. the patient should be given the full information about:

Consent must be voluntary, i.e. not the result of coercion by medical staff, relatives or friends.

Minors between the ages of 16 and 18 are presumed to have capacity to consent in English law. If a doctor feels that a child under 16 has the intelligence and maturity to comprehend the risks and benefits of an intervention (Gillick competence), the patient may consent against parental wishes. Children under 16 who are not Gillick competent may not withhold or give consent; parents must act on their behalf. Patients over 16 with fluctuating capacity (e.g. under the influence of drugs affecting mental state) should be given the opportunity to consent when lucid, if their medical condition can wait until then. Otherwise, doctors may consent on their behalf.

Consent may be verbal or written. Consent forms provide some evidence that the process of consent has taken place, but are not themselves legal documents that prove that consent is valid.

Risks of operation may be general or specific to the operation. The general risks include the risks of anaesthesia and the risks of any operation, e.g. haemorrhage, wound infection, deep vein thrombosis. Examples of specific complications are recurrence after inguinal hernia repair, recurrent laryngeal nerve palsy after thyroid surgery, facial nerve palsy after superficial parotidectomy.

It is generally accepted that complications should be explained to the patient when they arise at a rate of 1% or greater. However, any devastating complication which may occur and has an incidence of less than 1% should be explained to the patient, e.g. paraplegia after aortic cross clamping.

The degree of information to be conferred to a patient continues to evolve through debate in English law. Consent issues challenged by a claimant are tested in English law against the elements of negligence. Rulings have been led by legal precedent. In Sidaway vs. Bethlem Royal Hospital (1985), a patient undergoing cervical cord decompression was not warned against a 1–2% risk of spinal cord injury, which she subsequently suffered. Although she claimed she would not have undergone surgery if she had been warned, a responsible body of surgical opinion would also not have warned a patient of the risk and therefore, the court ruled for the doctor of the basis of the Bolam test.

Since then, in Chester vs. Afshar (2004), surgery for back pain resulted in cauda equina syndrome, the possibility of which the patient was not informed prior to surgery. The judges ruled that failure to inform had violated her right to choose. She may, however, have still opted for this surgery, therefore it is debated that it is difficult to establish causation if the failure to inform may not have changed the outcome, i.e. the patients choice for surgery.

Any move away from Bolam towards a Bolitho-style ruling by the English courts has not yet led to a deviation from the ‘prudent doctor test’ where it is a matter of clinical judgement by the doctor as to the degree of information to be given to the patient. However, in an Australian case (Rogers vs. Whitaker, 1992), a patient underwent surgery to her blind right eye but suffered a 1:14 000 complication of sympathetic ophthalmia leading to blindness in her functional left eye. She successfully claimed, as the court ruled that the doctor had failed to answer her questions with proper care and skill, and if the risk had been disclosed, the plaintiff would not have had the operation. This approach to disclosure of all relevant information is called the ‘prudent patient test’.

Medico-legal issues

When a patient pursues a claim of negligence against an individual or trust, they must establish three elements:

Breach of duty has historically been tested against the Bolam principle (Bolam vs. Friern Hospital Management Committee 1957), where the doctor is not guilty if he has acted in accordance with a practice accepted as proper and responsible by a responsible body of medical men skilled in that particular art. Although there may be a body of professional opinion opposing the view, as long as it can be considered acceptable practice to a group of doctors of similar standing, then the action may not form a breach of duty.

More recently, the case of Bolitho vs. City & Hackney Health Authority (1997) led to the House of Lords deciding that if professional opinion called in support of a defence case was not capable of withstanding logical analysis, then the court would be entitled to hold that the body of opinion was not reasonable or responsible. This means that a court can overrule a body of professionals supporting a defendant through the Bolam principle, if it feels that their argument does not follow logical reasoning.

With the exception of minors, patients have 3 years from the time of injury, or recovery from mental illness if present at the time of injury, to bring a case to court. There can therefore be a considerable time lag prior to representation in court. It is therefore vital to maintain high standards of thorough and contemporaneous note-keeping.

Civil Procedure Rules require a Letter of Claim to be sent to the defendant, and a response drawn. Particulars of Claim and Negligence then are prepared by the plaintiff, which are defended with any statements as a formal defence. If the case is to proceed, then the Court will hear expert opinions on each area of disagreement. If no agreement is formed, the case will go to trial.

Compensation may be awarded by the courts as ‘general’ damages for pain and suffering and ‘special’ damages for actual amounts such as claim expenses, need for care, loss of income, etc.

Breaking bad news

Breaking bad news to patients and their relatives is almost a daily occurrence. Most medical schools provide tutorials on ‘breaking bad news’ as part of the course and much experience may be obtained in role-play in such tutorials. However, there is no substitute for the real thing and it is appropriate for a medical student to sit in when bad news is actually being broken to relatives or patients. A doctor who is explaining the bad news should always check with the patient or the relatives that it is appropriate for a medical student to be present at the time. It is understandable that some patients’ relatives may find this obtrusive.

When we think of the nature of breaking bad news, we usually think in terms of explaining to someone that they have an inoperable condition. However, for some patients’ relatives, it is merely bad news that the patient actually requires surgery or that as a result of curative surgery, the patient, e.g. needs a permanent colostomy. Usually, however, breaking bad news involves explaining inoperable and incurable cancer and the need to face death. A problem then arises about how much the patient needs to know, and occasionally, in some cases, whether the patient actually needs to know at all. The answer to the latter is that the patient should always be told. Unless the patient is fully aware of the facts, it is difficult to deal with subsequent management, particularly explaining palliative treatment, e.g. radiotherapy or the fact that the patient requires hospice care.

Occasionally, relatives request that the patient is not told. This is not appropriate and should be explained to the relatives, particularly the fact that if the patient finds out by other means (and the patient surely will, maybe even through a careless word on a ward round), then trust is lost between patient and relative and patient and doctor. It is well recognized that most patients are told less than they would actually like to know. Occasionally, even the medical profession will rationalize reasons for not wanting to tell the patient, e.g. the patient would not want to know. In fact, most patients are intelligent and shrewd and when you actually sit down to explain the bad news to them you will realize that they have already half suspected it and many will thank you for being honest with them. Always remember that patients have many affairs that they wish to put in order, and also explaining to them honestly about life expectancy will enable them to decide if further unpleasant palliative therapy is worthwhile.

It is always difficult to know how and what to tell the patient. It is probably best not to do this on a busy ward round but to take time to go back to the bed with the nurse who is looking after the patient, sit down and take time to explain. There is a balance to explaining bad news which is somewhere between giving a long explanation skirting round the problem without actually indicating how bad the problem is and the brusque honesty approach (‘you have got incurable cancer and less then 3 months to live’). Do not leave the bedside immediately after giving bad news and worse still, do not indicate that somebody else will come back shortly and re-explain what you have already said. It is best to wait a while to give patients a chance to ask any questions. If they do not have any at the time, then indicate that you will go back later when they have had a chance to let the bad news sink in and when they may have thought of some questions that they wish to ask. It is important to allow sufficient time to talk to patients and to talk to them sensitively and also indicate that you are prepared to talk to members of the family and explain things fully to them. Some patients would be grateful if members of the family are there when bad news is broken.

Accepting terminal illness often takes time and involves a number of well-defined stages, although not all these may occur in a particular patient. These include:

It is important that every member of the team knows exactly what has been explained to the patient and also that the family doctor is aware. Over the days following the breaking of bad news, the patient and relatives may often have numerous questions and time must be taken to sit down and provide the answers.

Death and the certification of death

When you are qualified, you will be required to diagnose death. The patient is pulseless, apnoeic, and has fixed, dilated pupils. Auscultation reveals no heart sounds or breath sounds. If the patient is on a ventilator, brain death may be diagnosed even although the heart is still beating. The preconditions and the criteria for testing for brain death are explained in Chapter 18. Do not forget that after death, organs and tissue may be donated for transplantation purposes. Any solid organ and tissues may be removed from a ventilated brain-dead patient but remember that kidneys may be removed within 30 min of death and other tissues such as cornea, bone, skin and heart valves may be removed within 24 h of death.

Certification of death is important and should be carried out as soon as possible after death. This is not the same as certifying (or diagnosing) death, but is the official documentation of the patient’s cause of death that must be delivered, usually by the next of kin, to the Registrar of Births and Deaths within 5 days of the death. In practice, death certification should normally be carried out on the day after death to allow the patient’s relatives to make the funeral arrangements as soon as possible. Only a doctor who has seen the patient within 14 days prior to the death can legally fill in the certificate. In some cases, e.g. where the patient has died postoperatively, or after an emergency admission, or accident, the Coroner must be informed. If in any doubt, it is always best to ring the Coroner and discuss the case. If the Coroner decides to take the case, his department will deal with the certification of death.

Bereavement counselling

Explaining the death of loved ones to their relatives is never easy. It is best that the medical student attends a course in bereavement counselling and also, during attachments to both medical and surgical firms, accompanies the houseman or consultant who is explaining the death to relatives. The circumstances of death may cause different emotional reactions in relatives: some react with shock, others with anger and guilt, the latter being common emotions. Anger may be directed towards the deceased, other family members or the medical profession involved in the patient’s care. Support offered to the family both during the patient’s illness and at the time of the patient’s death not only helps them to cope better but may also reduce the likelihood of future problems. Religious beliefs and cultural background may influence reactions and some individuals may resort to alcohol, drugs or denial, as a way of coping with loss. In such cases, help of bereavement counsellors should be sought.

Approach to the patient

Most patients are quite happy to be seen and examined by medical students. Their usual attitude is: ‘Doctors have to learn, don’t they?’. Some patients, however, resent being seen by students; some understandably because they are shy and embarrassed by their condition, but others because they do not feel they should be treated as ‘guinea-pigs’. The latter are almost certainly those who in subsequent years will complain that doctors have failed to make the correct diagnosis, and one wonders exactly how they consider that medical students should learn.

Bedside manner is extremely important. It is important to establish rapport with patients so that they can trust you. Before approaching any patient on the ward, always ask the nurse in charge of the ward if you can see the patient. It may be that the patient is not well enough to be seen and examined repeatedly by students. When approaching the patient, introduce yourself with a handshake and let the patient know who you are: ‘My name is John Smith. I am a medical student. Would you mind if I talk to you and examine you?’. Always attend the ward at a sensible time and try to avoid disturbing the patients during their rest period. Always examine the patient with a colleague or a nurse present (chaperone). Do not carry out intimate examinations such as rectal or vaginal examinations except under strict supervision.

In the outpatient clinic, there will usually be notices displayed that students may be present during the consultation. Patients are told that if they do not wish to see students then they should inform the nurse in charge of the outpatient clinic. It is our practice always to ask the accompanying nurse to check with the patients whether they mind seeing students before they are brought into the consultation room. Always take plenty of time to take a history from the patient. Never rush or you may miss important points in the history. Always wash your hands both before and after examining a patient.

Taking a history

Always allow yourself plenty of time to take a full history. Develop a method of taking it, trying not to write and talk to the patient at the same time. Although as students you will not normally write the patient’s history in the notes, you should get used to recording it so that you know exactly how to record it in the notes when you become a qualified doctor. Initially you should record the following:

Make sure that you record the date of the examination. You will need this so that you can record subsequent progress.

The remainder of the history should be taken in the following order:

Examination of a lump

Examination of an ulcer

Examination

Record accurately the site and size of the ulcer. Check for colour, tenderness, increased temperature, base, edge, depth, discharge, surrounding tissues. Check the state of the local lymph nodes and carry out a general examination.

Base

Usually slough or granulation tissue. Some ulcers have a characteristic base, e.g. ischaemic ulcers often contain no granulation tissue but may contain black necrotic tissue, or tendons or bone may be seen in the base of the ulcer. Syphilitic ulcers have a classic slough that looks like a wash leather.

Edge

Classically, five types are described. These are shown in Figure 1.2 together with their usual aetiologies.

Figure 1.2 Common types of ulcer edge.

Depth

Record this accurately in millimetres.

Discharge

This may be serous, sanguineous or purulent. It may be necessary to remove slough from the base of an ulcer to accurately assess it.

Surrounding tissues

Are the surrounding tissues pink and healthy? Is the innervation normal, e.g. neuropathic ulcer associated with diabetes? Are there black satellite nodules around the ulcer, e.g. malignant melanoma?

Examine the local lymph nodes

Carry out a general examination

Classification of disease

When initially starting your surgical training, your knowledge will be limited. You will, therefore, find it difficult to reach a diagnosis. In order to do this you should go through a broad classification of the aetiology of disease as shown in Table 1.1. This is sometimes known as the ‘surgical sieve’. Ask yourself, is this lesion congenital (usually easy to decide) or is it acquired? If it is acquired, then go through the ‘sieve’ and try and decide which classification it belongs to. As you learn more pathology and more surgery, you will still find this classification suitable when trying to reach a differential diagnosis. It is a good idea when you are first learning, with every disease, lump or ulcer you meet, to sit down and go through the ‘surgical sieve’ and decide which of these groups it belongs to.

TABLE 1.1 Classification of disease (‘surgical sieve’)