Surgical patients present with disorders resulting from inherited abnormalities, environmental factors or combinations in varying proportions. These are summarised in Box 1.1, as a useful ‘first principles’ framework or aide-mémoire upon which to construct a differential diagnosis. This is useful when clinical features do not immediately point to a diagnosis. This approach is known as the ‘surgical sieve’; however, it is not a substitute for logical thought based on the clinical findings.

Box 1.1 The surgical sieve

When considering the causes of a particular condition, it may be helpful to run through the range of causes listed here. This should only be a first step and not a substitute for thought. This approach gives no indication of the likely severity, frequency or importance of the cause.

Congenital

• Genetic

• Environmental influences in utero

Acquired

• Trauma—accidents in the home, at work or during leisure activities, personal violence, road traffic collisions

• Inflammation—physical or immunological mechanisms

• Infection—viral, bacterial, fungal, protozoal, parasitic

• Neoplasia—benign, premalignant or malignant

• Vascular—ischaemia, infarction, reperfusion syndrome, aneurysms, venous insufficiency

• Degenerative—osteoporosis, glaucoma, osteoarthritis, rectal prolapse

• Metabolic disorders—gallstones, urinary tract stones

• Endocrine disorders and therapy—thyroid function abnormalities, Cushing’s syndrome, phaeochromocytoma

• Other abnormalities of tissue growth—hyperplasia, hypertrophy and cyst formation

• Iatrogenic disorders—damage or injury resulting from the action of a doctor or other health care worker; may be misadventure, negligence or, more commonly, system failure

• Drugs, toxins, diet, exercise and environment

— Prescription drugs—toxic effects of powerful drugs, maladministration, idiosyncratic reactions, drug interactions

— Smoking—atherosclerosis, cancers, peptic ulcer

— Alcohol abuse—personal violence, traffic collisions

— Substance abuse—accidents, injection site problems

— ‘Western diet’—obesity, atherosclerosis, cancers

— Lack of exercise—obesity, osteoporosis, aches and pains

— Venomous snakes, spiders, scorpions and other creatures—local and systemic toxicity

— Atmospheric pollution—pulmonary problems

• Psychogenic—Munchausen syndrome leading to repeated operations, problems of indigent living, ingestion of foreign bodies, self-harm

• Disorders of function—diverticular disease, some swallowing disorders

Congenital conditions

The term congenital defines a condition present at birth, as a result of genetic changes and/or environmental influences in utero such as ischaemia, incomplete development or maternal ingestion of drugs such as thalidomide. Congenital abnormalities of surgical interest range from minor cosmetic deformities such as skin tags through to potentially fatal conditions such as congenital heart defects, urethral valves and gut atresias.

Congenital abnormalities become manifest any time between conception and old age, although most are evident at birth or in early childhood. Some are diagnosed antenatally, for example, fetal gut atresias with grossly excessive amniotic fluid (polyhydramnios). There are expanding specialist areas involving intrauterine or fetal surgery, for example, for urinary tract obstruction. During infancy, conditions such as congenital hypertrophic pyloric stenosis come to light. In childhood, incompletely descended testis may become evident. Finally, some disorders may present at any stage. For example, a patent processus vaginalis may predispose to an inguinal hernia even into late middle age.

Whilst many congenital abnormalities give rise to disease by direct anatomical effects, others cause disease by disrupting function, with the underlying disorder revealed only on investigation. For example, ureteric abnormalities allowing urinary reflux predispose to recurrent kidney infections.

Acquired conditions

Acquired surgical disorders result from trauma or disease or from the body’s response to them, or else present as an effect or side-effect of treatment. For example, bladder outlet obstruction may result from prostatic hypertrophy, from fibrosis after gonococcal urethritis or from damage inflicted during urethral instrumentation. The classification detailed here is a framework, but conditions may fit more than one heading, and the mechanism behind some disorders is still poorly understood.

Trauma: Tissue trauma, literally injury, includes damage inflicted by any physical means, i.e. mechanical, thermal, chemical or electrical mechanisms or ionising radiation. Common usage tends to imply blunt or penetrating mechanical injury, caused by accidents in industry or in the home, road traffic collisions, fights, firearm and missile injuries or natural disasters such as floods and earthquakes. Damage varies with the causative agent, and the visible injuries may not indicate the extent of deep tissue damage.

Inflammation: Many surgical disorders result from inflammatory processes, most often stemming from infection. However, inflammation also results from physical irritation, particularly by chemical agents, e.g. gastric acid/pepsin in peptic ulcer disease or pancreatic enzymes in acute pancreatitis.

Inflammation may also result from immunological processes such as in ulcerative colitis and Crohn’s disease. Autoimmunity, where an immune response is directed at the body’s constituents, is recognised in a growing number of surgical diseases such as Hashimoto’s thyroiditis and rheumatoid disease.

Infection: Primary infections presenting to surgeons include abscesses and cellulitis, primary joint infections and tonsillitis. Typhoid may cause caecal perforation, and abdominal tuberculosis may be discovered at laparotomy. Amoebiasis can cause ulcerative colitis-like effects. Preventing and treating infection is an important factor in surgical emergencies such as acute appendicitis or bowel perforation. Despite the rational use of prophylactic and therapeutic antibiotics, postoperative infection remains a common complication of surgery.

Neoplasia: Certain benign tumours such as lipomas are common and are excised mainly for cosmetic reasons. Less commonly, benign tumours cause mechanical problems such as obstruction of a hollow viscus or surface blood loss, e.g. gastrointestinal stromal tumours (GIST). Benign endocrine tumours may need removal because of excess hormone secretion (see Endocrine disorders later). Finally, benign tumours may be clinically indistinguishable from malignant tumours and are removed or biopsied to obtain a diagnosis.

Malignant tumours may present with signs and symptoms from the primary, the effects of metastases (‘secondaries’) and sometimes, systemic effects such as cachexia. Malignant tumours are responsible for a large part of the general surgical workload.

Vascular disorders: A tissue or organ becomes ischaemic when its arterial blood supply is impaired; infarction occurs when cell life cannot be sustained. Atherosclerosis progressively narrows arteries often resulting in chronic ischaemia, causing symptoms such as angina pectoris or intermittent claudication. It also predisposes to acute-on-chronic ischaemia when diseased vessels finally occlude. Other common causes of acute arterial insufficiency are thrombosis, embolism and trauma. Arterial embolism causes acute ischaemia of limbs, intestine or brain; emboli often originate in the heart. If blood supply is restored after a period of ischaemia, further damage can ensue as a result of reperfusion syndrome.

When a portion of bowel becomes strangulated, the initial mechanism of tissue damage is venous obstruction and this progresses to arterial ischaemia and infarction.

An aneurysm is an abnormal dilatation of an artery resulting from degeneration of connective tissue. This may rupture, thrombose or generate emboli.

Chronic venous insufficiency in the lower limb causing local venous hypertension is responsible for the majority of chronic leg ulcers in the West.

Degenerative disorders: This is an inhomogeneous group of conditions characterised by deterioration of body tissues as life progresses. In the musculoskeletal system, osteoporosis decreases bone density and impairs its structural integrity, making fragility fractures more likely. Spinal disc and facet joint degeneration is common, causing back pain and disability, and osteoarthritis is widely prevalent in later life: the almost universal musculoskeletal aches and pains are probably caused by degeneration of muscle, tendon, joint and bone.

Other degenerative disorders include age-related retinal macular degeneration, glaucoma, the inherited disorder retinitis pigmentosa, and certain neurological disorders (Alzheimer’s, Huntington’s and Parkinson’s disease, bulbar palsy). Atherosclerosis and aneurysmal arterial diseases are often non-specifically labelled degenerative.

Metabolic disorders: Metabolic disorders may be responsible for stones in the gall bladder (e.g. haemolytic diseases causing pigment stones) or in the urinary tract (e.g. hypercalciuria and hyperuricaemia causing calcium and uric acid stones, respectively). Hypercholesterolaemia is a major factor in atherosclerosis and hypertriglyceridaemia is a rare cause of acute pancreatitis.

Endocrine disorders and hormonal therapy: Hypersecretion of hormones, as in thyrotoxicosis and hyperparathyroidism, may require surgical removal or reduction of glandular tissue. Endocrine tumours, benign and malignant, may present with metabolic abnormalities such as hypercalcaemia caused by a parathyroid adenoma, Cushing’s syndrome resulting from an adrenal adenoma or episodic hypertension caused by a phaeochromocytoma.

Diabetes mellitus, particularly when poorly controlled, causes a range of complications of surgical importance, e.g. diabetic foot problems, retinopathy and cataract formation, as well as predisposing to atherosclerosis.

Hormone replacement therapy in postmenopausal women brings mixed benefits: it slows osteoporosis and reduces colorectal cancer risk whilst slightly increasing risk of breast and endometrial cancer. There is also evidence of an increased rate of thromboembolism, as with higher oestrogen-containing oral contraceptive pills.

Other abnormalities of tissue growth: Growth disturbances such as hyperplasia (increase in number of cells) and hypertrophy (increase in size of cells) may cause surgical problems, in particular benign prostatic hyperplasia, fibroadenosis of the breast and thyroid enlargement (goitre).

In surgery, the term cyst imprecisely describes a mass which appears to contain fluid because of characteristic fluctuance and transilluminability. A cyst is defined as a closed sac with a distinct lining membrane that develops abnormally in the body. A variety of pathological processes produce cysts. Most are benign but some cysts may have malignant change in the wall.

Iatrogenic disorders: Iatrogenic damage or injury results from the action of a doctor or other health care worker. It may be an unfortunate outcome of an adequately performed investigation or operation, e.g. perforated colon during colonoscopy or pneumothorax from attempted aspiration of a breast cyst. These are termed surgical misadventure. However, if the damage results from a patently wrong procedure, e.g. amputation of the wrong leg or removal of the wrong kidney, then negligence is likely to be proven. Such wrong site surgery is easily avoided by preoperative site marking. Other potentially negligent actions include retained surgical swabs after laparotomy, or vascular trauma during central venous line insertion. Complications of bowel surgery such as anastomotic leakage may result from poorly performed surgery but can occur in expert hands; only audited results can demonstrate whether the surgeon is proficient. Wrong drugs or doses are usually iatrogenic. It is unusual for iatrogenic problems to be due simply to one person’s failure. More often it is a system failure, with inadequate checks and balances in the system.

Drugs, toxins and diet: Problems with prescribed drugs include unavoidable toxic effects of certain chemotherapeutic agents, e.g. neutropenia, and the side-effects of drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) causing duodenal perforation, or codeine phosphate causing constipation. Drug allergy, idiosyncrasy or anaphylaxis may result from individual responses to almost any drug, and interactions between drugs cause adverse effects; in this respect warfarin is a prime culprit. Maladministration of drugs may also cause problems with, for example, the wrong drug given for intrathecal chemotherapy causing paralysis.

In many countries, venomous creatures such as spiders, snakes or scorpions cause toxic and sometimes fatal harm.

Cigarette smoking is the biggest single preventable cause of death and disability in developed countries. Cigarette smoke is highly addictive and contains an array of carcinogens in the tar, the vasoconstrictors nicotine, and carbon monoxide that binds preferentially to haemoglobin. Not surprisingly, smoking is a powerful factor in a huge range of diseases including cardiovascular disorders of heart, limbs and brain, dysplasias and cancers of lung, mouth and larynx, respiratory disorders such as pneumonias, chronic obstructive pulmonary disease (COPD) and emphysema via small airways inflammation, stillbirth and peptic ulcer disease. Smoking compounds the atherogenic effects of diabetes and is also strongly associated with premature skin ageing. Environmental pollution adversely affects health: for example, micro-fine particles produced by diesel engines cause pulmonary inflammation.

Alcohol and substance abuse may have a surgical dimension: alcohol can lead to personal violence or road traffic collisions; cannabis smoke is carcinogenic and causes dysplasias and premalignant lesions of the oral mucosa as well as contributing to mental health problems. Misdirected injection of opioids and other drugs may cause abscesses, false aneurysms and even arterial occlusion.

The so-called ‘Western diet’, rich in fat and calories and low in vegetables, fruit and fibre, is linked with a range of diseases including colorectal and breast cancers, obesity, dyslipidaemias, diabetes and hypertension. This is particularly so when combined with a lack of exercise. Dietary fibre protects against colorectal adenomas and carcinomas as well as diverticular disease.

Psychogenic disorders: Psychogenic disorders are not often a source of surgical disease but Munchausen syndrome patients may present with abdominal pain and become subjects of repeated laparotomies, psychiatric patients living rough may suffer from exposure and frostbite, and others may repeatedly cause self-harm or swallow foreign bodies, even such items as razor blades or safety pins.

Disorders of function: A range of common disorders are defined by the functional abnormalities they cause, although their pathogenesis often remains ill understood. The gastrointestinal tract is particularly susceptible, with conditions such as idiopathic constipation, irritable bowel syndrome and diverticular disease.

Medical ethics and confidentiality

The term medical ethics refers to the universal principles upon which medical decisions should be based, and governs the beliefs and actions that influence the day to day judgements of doctors. Whilst benevolence should govern all medical practice, other factors such as self-interest, money, the distribution of resources and individual technical skills are important motivating factors.

To some extent, the practice of surgery is influenced by the need for self-protection but in trying to avoid litigation, a surgeon may over-treat or over-investigate in ways that are unnecessary and may even be unethical. A degree of self-interest is inevitable but the guiding principle should be that the patient’s interests are paramount. Desirable attributes in a surgeon are listed in Box 1.2.

Box 1.2 Desirable attributes in a surgeon

After Professor George Youngson, Emeritus Prof. of Paediatric Surgery, University of Aberdeen.

• Technical knowledge and clinical experience

• Listening and communication skills with patients, secretary, colleagues and managers

• Qualities of leadership and the ability to work in a team

• Personal attributes—kindness and empathy

• The ability to make reasoned judgements and decisions under pressure, often with incomplete information

• Situation awareness—the ability to collect and synthesise information rapidly

• Problem solving ability—often in situations not previously encountered

• Insight into one’s own practice and a willingness to change plans or behaviours if shown to be incorrect. Being prepared to listen and to learn from constructive criticism

• Organisation and planning ability to cope effectively with a heavy workload

• Professional integrity and honesty

• A genuine desire to continue learning and professional development

• Reliability in fulfilling responsibilities and commitments

• The ability to recognise one’s own values and principles and understand how they differ from others

Surgeons generally aspire to practise their craft in line with the principles of the Hippocratic Oath. This originated from the Greek School of Medicine around 500 BC and its essence is as follows:

• Doctors must be instructed and then registered to protect the public from amateurs and charlatans

• Medicine is for the benefit of patients, and doctors must avoid doing anything known to cause harm

• Euthanasia and abortion are prohibited

• Operations and procedures must be performed only by practitioners with appropriate expertise

• Doctors must maintain proper professional relationships with their patients and treatment choices should not be governed by motives of profit or favour

• Doctors should not take advantage of their professional relationships with their patients

• Medical confidentiality must be respected (see below)

Confidentiality: Patients allow the NHS to gather sensitive information about their health and personal matters as part of seeking treatment. They do this in confidence and legitimately expect staff will respect this trust.

In the UK, patient information is held under legal and ethical obligations of confidentiality. This information must not be used or disclosed in a way that might identify a patient without their consent. Caldicott Guardians are senior staff in the NHS and social services appointed to protect patient information locally. The doctor’s duty of confidence is a legal obligation derived from case law and is a requirement in professional codes of conduct. Even if a patient is unconscious, the duty of confidence is not diminished.

Whilst cases are often discussed over lunch and elsewhere with colleagues, this should not be done in a public place. When patients are discussed at meetings, identification data should be concealed and written notes about patients should not be left lying around or taken from the hospital except using official channels, for example, during patient transfer.

Do not resuscitate (DNR) orders: A DNR order on a patient’s file means that doctors are not required to resuscitate a patient if their heart stops. It is designed to prevent unnecessary suffering and potential side-effects such as pain, broken ribs, ruptured spleen or brain damage. The British Medical Association and the Royal College of Nursing say that DNR orders can be issued only after discussion with patients or family, difficult though this may be. Decisions should not be made by junior doctors alone but in consultation with seniors. The most difficult cases are those involving patients who know they are going to die and are suffering pain or other severe symptoms but who could live for months.

Guidelines for when a DNR may be issued::

• If a patient’s condition is such that resuscitation is unlikely to succeed

• If a mentally competent patient has consistently stated or recorded they do not want to be resuscitated

• If an advance notice or living will says the patient does not want to be resuscitated

• If successful resuscitation would not be in the patient’s best interest because it would lead to a very poor quality of life

In the UK, NHS Trust Hospitals must agree explicit resuscitation policies that respect patients’ rights and are readily available to patients, families and carers; policies must be regularly monitored.

Communication

With patients

Doctor–patient relationships are best learnt by following good examples in the clinic and ward in an apprenticeship model. Patients are vulnerable, often with unpleasant symptoms and usually with little understanding of anatomy, physiology or pathology. They rarely understand the likely progress of a disease or its treatment and may have been conditioned by the media to expect miracle cures or to believe that the latest technology is what they need. Patients take in only about 10% of what is said during a consultation, but this can be improved in the right setting and with reinforcement. Important messages need to be given in comfortable surroundings, without giving the impression the doctor is in a rush, perhaps with family present and with a nurse who can later ensure messages have been understood.

Doctors are in a privileged position, able to make decisions on a patient’s behalf that can have dramatic effects on their life and that of their family. Patients these days generally wish to know more about their condition, but can then take greater responsibility for it than in the old days of the paternalistic doctor. Thus an effective doctor–patient relationship involves not only taking an accurate history but also intelligent listening to discover what patients know, or think they know, about their health and likely treatments, and responding to their concerns in ways they can understand. A good interview also involves imagining ‘the third eye’, how both sides of the consultation might appear to an observer. Patients frequently complain, with good reason, that they ‘don’t know what is going on’. They pick up bits of information that may be inaccurate, so doctors should anticipate what they should explain to patients and families and give information in a timely fashion.

During the process of diagnosis and treatment, there is often uncertainty and incomplete information, so it is valuable to explain at intervals the stage reached, both to the patient and, with the patient’s permission, to relatives. Where there are different treatment options, a balanced view of the alternatives should be given, perhaps with some statistics, but when the doctor has reason to prefer one approach, this should be explained too, and then the patient can make a considered choice. It can be easy to persuade patients to undergo treatment—after all, you are the expert in their eyes—but trust, respect and empathy teach that patients may wish to reflect at leisure. Except in emergencies, patients should be able to go away and consider options rather than have to sign a consent form just before treatment. They may even wish to take a second opinion if choices are uncertain or potentially life-changing; this should be welcomed rather than discouraged. By helping patients understand their condition, their self-management will be more effective. Similarly, key factors such as diet or smoking habits can be discussed in an atmosphere of trust with more hope of success.

Palliative care: Sometimes cure is not possible. Then quality of life may become the goal, with palliative treatment being offered. Patients generally want to know what will happen, including their mode of dying. Whilst this can be hard to predict, they need to know their symptoms, particularly pain, will be managed effectively and that they will be looked after. Experience teaches it is usually impossible to say with accuracy when a patient will die except a few days before it will happen, so it is unwise to predict life span except in general terms.

Breaking bad news: All doctors in clinical practice experience the need to break bad news, such as an unfavourable outcome, unsatisfactory care, a cancer diagnosis or a poor prognosis. It is an event doctors tend to remember and a moment in the patient or relative’s life they will never forget.

Ideally, bad news should be conveyed by the most senior member of the team but in reality, bad things often happen at night, often in the A&E department, and the most junior doctor is the one on the spot. Discuss what is to be said with your seniors even under these circumstances wherever possible. The following general points apply:

• Bad news is private. Find a quiet space, preferably an office with chairs (you don’t need a desk)

• Avoid hiding behind jargon: ‘the metastatic nature of the neoplasm makes it inoperable’ is useless. ‘I’m sorry to say that the cancer has spread and an operation won’t help’ is better

• Give time and space; turn off pagers and phones if possible

• Don’t be defensive and don’t be afraid to express regret

• Avoid filling the silence of grief with continuous chatter

• Allow time for questions. If you don’t know the answer, say so and try to find out

• Always offer another meeting, ideally with the head of the team

• Many patients/families will wish to discuss what has been imparted with their family doctor, so it is vital that you get all information to the GP before that visit

Communicating with colleagues

Communicating with colleagues involves speaking, both face to face and on the telephone (Box 1.3), and writing (handwriting, dictating, typing, emailing) patient notes, information letters to patient or family practitioners, e.g. after an outpatient consultation, referral letters, discharge summaries, reports and presentations for local or larger-scale medical meetings. All of these need to be honest, accurate and timely, particularly when communicating patient information. Remember, recipients are entitled to rely on what you have written in their later treatment of a patient. Also, any written information may be called in evidence in a court of law should something go wrong later. Patient notes must never be altered later, although rarely, amendments may be added provided they are signed and dated.

Box 1.3 Effective telephone consultation and handover

When you need to consult a consultant or colleague by telephone about a patient, particularly during unsocial hours, you must clarify details yourself before phoning. Think through the case, pinpointing key elements listed below:

• On phoning, state your name and status (on-call SpR for instance) and say at the outset what you think you want—whether advice or for the consultant to come in

• Summarise the case succinctly, visualising how your description appears to the listener

• When did the problem start (day, time)?

• What circumstances necessitated the patient coming to hospital?

• What was the patient’s state on arrival (conscious/unconscious; wounds or bleeding; level of pain; resuscitation status)?

• Did you examine the patient and establish the signs or were they reported to you?

• Is there any relevant past history?

• What has progress been since arrival?

• What investigations have been ordered and what results do you have so far?

• Are any other specialists involved, e.g. plastics or orthopaedics?

• Finally, indicate again what you want the consultant to do

Hospital doctors work in teams where it is important to know one’s responsibilities and those of everybody else, and to understand when to call for help in good time. Changes in a patient’s condition usually need to be passed on to other team members. If you have made a mistake, admit it early and do everything you can to mitigate it.

With diminishing junior doctors’ hours, it is vital to have structured handover of patients to the incoming team at the end of shifts and at weekends and holidays, including especially details of ill patients and those with complex management problems and any agreed plans for them.

Communication via the clinical record: Reduced junior hospital doctors’ hours make it imperative to keep the written records for every patient up to date, including management plans and what to do if predictable changes occur. Date and legibly sign each entry giving your name in capitals and grade, record important test results and write instructions for antibiotic and DVT prophylaxis. In high operative risk patients, seniors should document discussions before surgery. After operation, write or type an operation note with clear postoperative instructions so these are immediately available to recovery and ward staff.

Document details of any discussions with patient and relatives—particularly about poor prognosis or withdrawal of active treatment and who has been told about this or about a diagnosis of malignancy. Regarding a discharge summary, ensure all investigation results have been checked and the diagnosis and future plans have been recorded and send it immediately on discharge. If the patient died, record the cause of death in the notes as it is written on the certificate and inform the family doctor.

Evidence-based medicine and guidelines

History: Evidence-based medicine (EBM) as now understood really began when Professor Archie Cochrane, a Scottish epidemiologist, published his book Effectiveness and Efficiency: Random Reflections on Health Services in 1972 and continued with his later advocacy of its principles. EBM has gradually gained political support and acceptance within the medical profession. EBM calls into question the traditional belief that ‘we’ve always based our practice on science’. Cochrane’s work has been recognised by the proliferation of Cochrane Centres and the international Cochrane Collaboration, all devoted to meticulously evaluating evidence and promoting its use.

The aim of evidence-based medicine (EBM) is to apply best scientific evidence to clinical decision making. It relies on critical assessment of published evidence about risks and benefits of treatments (or lack of treatment) and of diagnostic tests. Only between 50% and 80% of the volume of medical treatments are evidence based, with better evidence available for more common treatments. Statements by medical experts are seen as the least valid form of evidence, but evidence-based practice is not relevant where imponderables such as quality of life judgements are involved. Evidence-based guidelines (EBG) have an appeal to health economists, policymakers and managers as they help to measure performance and perhaps justify rationing or centralising resources.

Austin Bradford Hill, the grandfather of modern medical research, who was fundamental in discovering the link between smoking and lung cancer, produced a set of guidelines, as given in Box 1.4, for assessing causality, i.e. the relationship between an exposure and an outcome, and these remain the foundation of evidence-based medicine today.

Box 1.4 Guidelines for assessing the relationship between an exposure and an outcome

• A strong and consistent association, specific to the problem being studied

• The supposed cause must come before the possible effect

• There should ideally be a biological gradient or dose-response effect

• The association should be consistent with what is already known or at least not completely at odds with it

• It should be biologically plausible

Cherry-picking the evidence versus systematic review: Cherry-picking is a dubious means of reinforcing what you already believe, the very opposite of systematic review. It involves relying only on published work that supports your view and finding reasons to ignore what goes against it. The solution is a process of systematic review as conducted by the Cochrane Collaboration. Their methodologies were largely established at McMaster University. The term EBM first appeared in 1992 and now journals devoted to the subject include the BMJ’s Clinical Evidence, the Journal of Evidence-Based Healthcare and Evidence Based Health Policy, all co-founded by Anna Donald, an Australian pioneer.

Evidence-based medicine encourages clinicians to integrate valid and useful scientific evidence into their clinical expertise. Using systematic reviews, meta-analyses, risk-benefit analyses and randomised controlled trials (RCTs), EBM aims that health professionals make ‘conscientious, explicit, and judicious use of current best evidence’ in everyday practice. Systematic review of published research studies is a very important method of evaluating treatments. An explicit search strategy is used finding relevant data, both published and raw and unpublished. The methodological quality of each study is evaluated, ideally blind to the results. Alternative treatments are compared, and then a critical, weighted summary is given. This thorough sifting of information often reveals large knowledge gaps and sometimes grossly flawed ‘best practices’; it has saved numerous lives without undertaking new research studies. Muir Gray has commented ‘advances will be made through clean, clear information’.

The Cochrane Collaboration is perhaps the best known, most rigorous and respected organisation providing systematic reviews. Once the best evidence has been assessed, treatment is rated as ‘likely to be beneficial’, ‘likely to be harmful’, or ‘evidence did not indicate benefit or harm’. A 2007 analysis of 1016 systematic reviews from all 50 Cochrane Collaboration Review Groups found 44% of the interventions beneficial, 7% harmful and 49% where the evidence did not support benefit or harm. 96% recommended further research.

When it comes to new or radical ideas, well-trained experts using clinical common sense should be able to make rational judgements about what is likely to be true; the more unlikely the claims for a new treatment, the higher must be the standard of proper evidence.

Longitudinal or cohort studies: For predicting prognosis, the highest level of evidence is a systemic review of inception cohort studies, i.e. groups of patients assembled near the onset of the disorder. These groups are followed over years to determine how variables such as smoking habits, exercise, occupation and geography may affect outcome. Prospective studies take years to perform but are valued more than retrospective studies which are more likely to generate bias.

Ranking the quality of evidence (Box 1.5): The strongest evidence for therapeutic interventions is by systematic review of randomised, double- or triple-blind, placebo-controlled trials with allocation concealment and complete follow-up, in a homogeneous patient population and medical condition. In contrast, patient testimonials, case reports, and even expert opinion have lesser value because of the placebo effect, biases inherent in observation and reporting, and personal and institutional biases.

Box 1.5 How Cochrane Centres evaluate evidence

Note that the hierarchy of evidence relates to the strength of the literature and not necessarily to its clinical importance.

1 Strength of evidence

a. Level of evidence: i.e. is the evidence a true measure of the benefit of an intervention? In descending order of reliability:

— Cochrane (or equivalent quality) systematic reviews of all relevant randomised controlled trials

— At least one well-conducted randomised controlled trial

— A non-randomised trial assigning participants to a treatment group alternately or by date or time of arrival, for example

— Non-randomised studies where a control group ran concurrently with an intervention group

— Non-randomised studies where intervention effects are compared with historical data

— Single case studies

— Opinion of experienced experts—‘conventional wisdom’

b. Quality of evidence: determined by how well the study methods minimise bias

c. Statistical precision: the degree of certainty about whether a measured effect truly exists

2 Size of effect

For clinically relevant benefits or harms, how far away is the outcome of the intervention from ‘no apparent effect’?

3 Relevance of the evidence

How appropriate is the outcome for the health care problem studied, and how useful is it for measuring the benefits (or harms) of the treatment? To which groups or subgroups of patients may the results apply?

4 The likely range of the true effect

Studies that are well designed and carried out can show unreliable results because of chance. Confidence interval (CI) describes the likely range of the true effect. For example, a study may show that 40% (95% CI 30% to 50%) of people appear to be helped by a treatment; we can thus be 95% certain the true effect lies between 30% and 50%.

A series of classifications of the strength of different types of evidence have been fashioned, grading them according to their freedom from biases that plague medical research; all are based around the same descending hierarchy:

• Systematic reviews of randomised controlled trials (RCTs)

• Individual RCTs

• Controlled observational studies—cohort and case control studies

• Uncontrolled observational studies and case reports

• Established practice and expert opinion (not to be confused with personal experience, sometimes dubbed eminence-based medicine). Expert opinion may be the best guide in the absence of good research evidence

Other classifications of quality of evidence: For a review of classifications of evidence, see:

http://www.patient.co.uk/doctor/Different-Levels-of-Evidence-%28Critical-Reading%29.htm

For a detailed discussion of the quality of evidence for different purposes, see:

www.nice.org.uk/niceMedia/docs/grading_evidence.pdf

Quality and limitations of clinical trials: Trials must now be registered in advance: the Declaration of Helsinki 2008 requires that every clinical trial be registered in a publicly accessible database before recruitment of the first subject. The International Committee of Medical Journal Editors refuses to publish clinical trial results if the trial was not recorded in this way. This should eliminate the bias inherent in the failure to publish negative trials.

In 1993, 30 medical journal editors, clinical trialists, epidemiologists and methodologists met in Ottawa to develop a new scale to assess the quality of randomised controlled trial (RCT) reports. This eventually resulted in the Consolidated Standards of Reporting Trials (CONSORT) Statement, published in 1996 and now largely adhered to by respected medical journals (http://www.consort-statement.org/home/). Cochrane adheres to similar standards and employs software ‘RevMan’ to help reviewers evaluate published studies.

Resources

• Cochrane Library: http://www.thecochranelibrary.com/view/0/index.html

• UK National Institute for Health and Clinical Excellence (NICE): http://www.nice.org.uk/

• NHS search engine for Evidence in Health and Social Care (from NICE): https://www.evidence.nhs.uk/

Guidelines: Clinical guidelines, practice policies, protocols and codes of practice are locally or more widely published mechanisms aimed at harmonising processes of care using best practice. Some are produced by surgical societies such as the Association of Surgeons of GB &I (ASGBI). Guidelines should be just that—providing a structure rather than absolute ways to proceed in every case; they may be varied if clinical conditions dictate. Guidelines should have an evidence basis or be of proven clinical effectiveness and need regular review as evidence accumulates. Local guidelines are a natural outcome of clinical audit studies (see p. 13 below).

Keeping up to date: continuing medical education

Clinicians are quite properly expected to keep up with current developments and to demonstrate this to be revalidated. Surgical knowledge and wisdom can be acquired by reading, from seniors in clinic and on ward rounds, by discussion at local and regional meetings and by attending courses. Meetings may include journal clubs, case presentations, reviews of specific topics, and presentation of research or audit projects. Broad national update meetings are valuable and in the UK, include the ASGBI and speciality meetings such as the Vascular Society and the British Orthopaedic Association. Meetings are a forum for trainees to present their work, learn from other presentations and find out what is current from colleagues. Surgeons in the UK are required to keep a log-book record of their educational activities to demonstrate their continued learning and this document forms part of regular appraisal and revalidation.

Consent to treatment

Treatment against a patient’s will is only rarely justifiable. Clearing the airways of someone about to choke to death who is irrational because of impaired consciousness can easily be justified on the grounds that the patient would have wanted it if fully rational. UK common law holds that an adult of sound mind has the right to determine what is done with his body and a surgeon who performs an operation without consent commits an assault in the eyes of the law.

When is consent necessary?: Ideally, medical treatment should not proceed without first obtaining the patient’s consent. Consent may be expressed, or it may be implied, as when a patient presents for examination and acquiesces in the suggested procedure. Expressed permission can be based on an oral or a written agreement. Most invasive investigations (such as upper GI endoscopy or arteriography) and any surgical operation should be preceded by written consent, ideally well in advance to give the patient time to think it over. If oral consent alone has been obtained, then a note should be made in the patient’s record.

A doctor may proceed without consent if the patient’s balance of mind is disturbed or if the patient is incapable of giving consent because of unconsciousness. The same principles apply if the patient is a minor, but it is sensible to seek consent from responsible relatives or to check with colleagues that the planned action is in the patient’s best interest. Opinions should be recorded in the notes before action is taken.

The unconscious patient: Under the necessity principle, a surgeon is justified in treating a patient without expressed consent if what he seeks to protect is more valuable than the wrongful act, i.e. treating without consent, provided there is no objection to treatment. Treatment must be no more extensive than is essential and procedures not needed for the patient’s survival must not be performed. For example, a diseased testis could be removed during a hernia repair but sterilising a patient during a Caesarean section without consent constitutes assault.

Ambiguous wording on consent forms requiring a patient to agree to any operation the surgeon considers necessary is regarded by the courts as completely worthless. For this reason a model consent form was produced by the NHS Executive in 1990 to be used throughout the health services.

Practical aspects of consent for treatment: In British law, there is no such thing as informed consent. Surgeons like to feel they obtain informed consent after explaining to the patient in non-technical language the nature, purpose and risks of the proposed investigation or treatment, together with alternatives and the likely outcome of treatment. The patient must be capable of understanding the explanation and if this is not the case then informed consent has not been obtained. It follows that consent cannot be obtained from patients who are unconscious or of unsound mind.

Obtaining consent (Box 1.6): Consent should be obtained by a doctor sufficiently knowledgeable to explain the treatment, any alternatives, the likely outcome and any significant risks. Sometimes trained nurses obtain a first stage consent which is confirmed by a doctor later.

Box 1.6 The informed consent process

The informed consent process should include:

• A description of the procedure or operation and anaesthetic

• Why the procedure is recommended and the risks and benefits

• The degree of severity and likelihood of complications

• Treatment alternatives with related risks and benefits

• Probable consequences of declining the recommended or alternative therapies

• Name of doctor conducting the procedure and the anaesthetic

• Other doctors performing tasks related to the procedure

The types and level of risk that have to be discussed are not well defined, but a risk of complication or potential failure to treat the condition of 5–10% should certainly be discussed. Operation-specific or disease-specific risks must be explained (e.g. facial nerve damage in parotid surgery, hypoparathyroidism following thyroid surgery) and the discussion detailed in the records. General risks such as DVT or pneumonia are not usually discussed but this does place doubt on whether such consent is truly informed.

Discussion prior to consent should occur in an unhurried manner, giving the patient time to absorb the information, to question the doctor obtaining consent and to indicate treatments he does not want. The patient may wish to discuss aspects of what is proposed with family or friends before consenting. In patients incapable of giving consent it is customary to obtain consent from a near relative. Whilst not essential in law, this represents good practice.

Most patients do not read the forms they sign before undergoing treatment; more than half do not understand them; and only a quarter of forms include all the data needed to make an informed decision. The US Department of Veteran’s Affairs has adopted an electronic informed-consent software program with a digital pad to sign, with details stored in their medical record. The program, known as iMedConsent, includes a library of anatomical diagrams and explanations at easy reading level for 2000+ procedures in 30+ specialties. The process was initially slow to perform but soon became quick. Patients having elective procedures could now gain all the information they needed in advance and it was easy to check they had understood it. The main disadvantage is that these privately produced programs are expensive.

Consent in children: Consent can be obtained from children aged 16 and over and occasionally in those under 16. It is always sensible to liaise with parents wherever possible in young people aged 17 and 18. In the absence of parents, another relative or person ‘in loco parentis’ can give consent for children.

For children in care, the local authority usually has full parental rights and the director of social services or deputy needs to sign the consent form. If the child is in voluntary care, the parents still act as guardians and their consent should be obtained.

Jehovah’s Witnesses: Adult Jehovah’s Witnesses usually refuse blood or blood product transfusion even in an extreme emergency because of their interpretation of part of the Bible. If permission to transfuse is withheld then blood should not be given. Failure to respect the patient’s wish may result in an accusation of battery. The moral dilemma of allowing a patient to die when blood transfusion is likely to prevent death is uncomfortable but the law is clear. General advice is that a surgeon cannot refuse to treat simply because the patient imposes conditions on that treatment, although it may be possible to transfer the patient to a compliant surgeon’s care. In these circumstances, it is wise to interview the patient in the presence of a witness and explain the risks. The discussion should be noted and the witness should sign the hospital record.

In children of Jehovah’s Witnesses the position is different. If a blood or blood product transfusion is needed to save the life of a child or to prevent harm, the transfusion can be given and defended in law by claiming that the decision was taken in the best interests of the child. If parental consent is withheld and there is ample time, the child can be made a ward of court, but this is not essential to obtain consent. If the decision to give blood is made, a second medical opinion confirming the need should be obtained if time allows. It is important to realise that a child subjected to transfusion against parental wishes may be rejected by the parents.

Clinical governance and clinical audit

Clinical governance is a systematic approach to preserving and advancing the quality of patient care within a health system. Since the 1970s, there has been a growing realisation that looking critically at the way we run our clinical practice and then taking active steps to move ahead is much more effective than simply following time-honoured practices or even opening new avenues of research. In the UK, this movement is now universal but with varying degrees of success. Clinical governance starts with the mindset that the quality of care matters; it embodies a range of activities described here and elsewhere in this chapter. See also NHS Scotland clinical governance: http://www.clinicalgovernance.scot.nhs.uk/section1/introduction.asp.

Management attitude to quality of care: Health service managers have to keep quality of care high on their long list of priorities and facilitate clinicians’ initiatives.

Education and training of clinical staff: Thorough and well-rounded teaching in medical and nursing school, including anatomy and surgery, is the starting point. Training posts then need to offer a wide range of experience in an apprenticeship model, including step-by-step learning of procedures to back up continuing medical education as well as specific courses such as Advanced Trauma Life Support (ATLS). During training, good behaviours, attitudes and judgement can be acquired (see attributes of a good surgeon earlier). All clinicians need to remain open-minded to change and remember it is their professional duty to remain up to date.

Clinical audit: Clinical audit reviews clinical performance against agreed standards, refining clinical practice and then re-auditing—a cyclical process of improving quality.

Clinical effectiveness: Clinical effectiveness studies evaluate the extent to which an intervention works, its efficiency, safety, appropriateness and value for money. Studies of this type can be instructive and worthwhile for trainees to undertake.

Research and development: Professional practice can change in the light of good research evidence, provided it can be implemented effectively. Evidence-based medicine involves critical appraisal of the literature and development of evidence-based guidelines, protocols and implementation strategies from research.

Clinical performance: Poor performance and poor practice often thrive behind closed doors but can be revealed by a local climate of openness; this also demonstrates the organisation meets the needs of its population. In surgery, trouble may come to light through morbidity and mortality meetings, clinical audit, via patient complaints or by ‘whistle blowing’, and these should provide the motor for change. Critical incident meetings, for example, can thoroughly examine particular adverse events and recommend change.

Nationally in the UK, the National Patient Safety Agency (http://www.npsa.nhs.uk/) ‘informs, supports and influences healthcare organisations and individuals’ by handling patient safety incidents, by running national independent Confidential Enquiries (NCEPOD in surgery and anaesthesia), by encouraging ethical research, and by developing and implementing safety recommendations, advice and strategies. Through the National Clinical Assessment Service (http://www.ncas.npsa.nhs.uk/), it endeavours to solve concerns about the performance of health practitioners short of referral to the General Medical Council.

Risk management: This is a prospective process to identify hazards that could cause harm, decide who might be harmed and how, then evaluate the risks and decide on precautions. Risks in a health service include: risks to patients, risks to practitioners and risks to the organisation itself. Recognising in advance where particular risks lie is the first step to minimising those risks. Areas of potentially high risk include:

The elderly: surgeons deal with an increasingly elderly population. The likelihood of co-morbid disease is higher, although chronological age by itself is less important than biological age

Emergency surgery: this carries a higher risk of complications and death than elective surgery. Patients may be more physiologically disrupted or not fully resuscitated, intervention may be required out-of-hours when the ideal mix of staff is not available; investigations such as CT scanning may also not be available

Day surgery: preoperative assessment can preselect patients for day surgery and minimise risk

Critically ill patients: these patients need optimising before surgery, often with shared care with a senior anaesthetist, physician or other specialist. More preoperative investigations and resuscitation may be needed, perhaps in an ICU or HDU. The initial surgical approach may become a damage limitation exercise with more realistic expectations about outcome

Operative risk assessment: the American Association of Anaesthesiologists (ASA) grade scheme gives anaesthetist and surgeon a subjective idea of how sick the patient is and the likely outcome.

Information management: Information management is vital to facilitate good, effective and economical practice. For example, high quality and available patient notes, systems for ordering laboratory and imaging tests and receiving results, accurate and prompt discharge summaries, easy outpatient booking, good feedback to family practitioners and reliable A&E systems. Hand-written methods have been employed for many years, with recent attempts to employ computers to streamline processes. These have been successful in countries such as Denmark, but in the UK, system design has largely been driven by computer companies rather than clinicians, so systems are often unfriendly and ineffective. However, the use of individual smart cards for patients to hold their own records, and easily portable devices such as the iPad hold promise for the future, provided clinicians take sufficient interest in their development.

Surgical (clinical) audit:

‘Research is concerned with discovering the right thing to do; audit with ensuring that it is done right.’ Richard Smith BMJ

There is a tendency to be over-optimistic or even defensive about one’s own practice. Yet patients, referring doctors, medical defence organisations (who defend the professional reputations of members when their clinical performance is called into question) and those paying for health care (governments and their agents and private insurers) are entitled to know that the quality of care provided in a given unit is up to standard. Examining morbidity and mortality at regular meetings within a unit (‘significant event’ reviews) are important but suffer from inherent weaknesses such as defensiveness, incomplete data and rivalry. These meetings usually fail to address overarching problems such as wound infection rates or aspects of care from the patient’s point of view, such as delayed treatment, off-hand consultations, poor pain control and failure to give explanations. It is well established that medical errors are generally more likely to be due to a system failure than an individual error and system errors are unlikely to be discovered by these morbidity and mortality meetings.

Clinical audit is a means by which clinicians can be collectively accountable for the care they provide and demonstrate its quality to outsiders. It requires a mechanism for scrutiny of each other’s work in a non-threatening and constructive manner or else it would not function. In brief, a group of clinicians examines a topic of concern and agrees in advance what are acceptable standards of practice or outcomes, ideally based on published norms. In other words, they establish and sign up to a set of standards for indicator based audit. The process embodies specific objectives, accepting peer review and being committed to change should weaknesses be revealed.

Once a topic is agreed, an audit cycle can begin with a pilot project on a small number of subjects, perhaps 20. A questionnaire is designed which ideally is capable of being completed retrospectively by non-clinical staff from hospital notes. With the pilot results, methods are refined and a larger scale project undertaken. Results are analysed by the group and necessary changes, and how these should be implemented, agreed. This is the most thorny aspect of clinical audit and the most difficult to achieve. Once the necessary changes have been implemented, the same audit needs to be repeated after a defined interval (completing the audit cycle) to bring the process up to a quality assurance mechanism.