PART I: GENERAL
SECTION 1 General Principles
Effort must be made towards improving the maternity care and gynaecological practice as much as possible. Adverse outcomes occurring in maternity care are often avoidable and may be due to reasons such as poor recognition of obstetric emergencies, failure to recognise problems at the correct time, failure to seek input from the seniors, poor communication, etc. Obstetricians are also likely to confront numerous ethical challenges in clinical practice. It is also important for all doctors to be well acquainted with the practice of evidence-based medicine, which combines clinical expertise and external scientific evidence. All these important principles of clinical practice, which keep patient safety paramount, are typically followed in the UK healthcare system. These have been discussed in details in this chapter.
ETHICAL PRACTICE OF MEDICINE
‘I will use treatments for the benefit of the ill in accordance with my ability and my judgement, but from what is to their harm and injustice I will keep them’.
—Hippocratic Oath
Oaths, codes and guidelines for the ethical practice of medicine date back to the Hippocratic Oath of the 4th century bc. Though this oath was largely forgotten at the time of its composition, it achieved a place of prominence in the 18th and 19th centuries as a result of renewed interest in the field of medical ethics. The ‘Hippocratic Oath’ is the most durable medical oath of Western civilisation, which graduating medical students swear to at most of the medical schools in the world. Other oaths commonly sworn to by new physicians include the ‘Declaration of Geneva’ [an updated form of the Hippocratic oath formulated by the World Medical Association (WMA), Ferney-Voltaire, France].1 The origins of the Hippocratic oath presently remain unclear, although most historians agree that the oath's name, ‘Hippocrates’, was not based on the name of its author. Most historians think that the oath originated from a cult of Greek physicians, who were followers of Pythagoras.2 Alternatively, many researchers also believe that ‘the Hippocratic oath’ was created by physician-priests of the cult of Asclepius in ancient Greece. The main ethical principles set forth by the Hippocratic oath include beneficence (action that is done for the benefit of others), non-maleficence (doing no harm), confidentiality and prohibition of abortion, euthanasia and sexual relations with patients.3
In the early 19th century, some work in the area of medical ethics was done by Sir Thomas Percival.4 The American Medical Association (AMA) was formed in 1847, which led to the resurgence of interest in the area of medical ethics.5 However, the surgeons were excluded from this code of ethics. The American College of Surgeons (ACS), Chicago, Illinois, by Dr Miles F Porter, formed in 1913 had set some of the earliest ethics guidelines for the surgeons.6,7
The WMA made efforts towards the modernisation of the Hippocratic oath, following the conclusion of World War II.8 This issue was raised during the trial of Nazi doctors, who had experimented with Jewish prisoners in concentration camps at the time of World War II. After the conviction of the Nazi physicians, the War Crimes Tribunal had put forth 10 principles relevant to human experimentation, known as the ‘Nuremberg Code’.9 The Nuremberg code included the concepts of informed consent, societal good and volunteerism as the foundation for biomedical research. The Nuremberg code emphasises the following principles:10 the voluntary consent of the human subject is absolutely essential before involving a person in biomedical research; the person involved should have legal capacity to give consent and should be given free power of making an appropriate choice. There should not be any element of force, fraud, deceit, duress or other concealed form of constraint or coercion involved in taking consent.11 In order to enable the patient to make an enlightened decision, the patient or research subject must be explained in details about the nature, duration and purpose of the procedure or research; the method and means by which it is to be conducted and the inconveniences, complications and the hazards of the procedure and the likely effects upon the health.
During the coming years, approximately eight more declarations of ethics were published by various international organisations. The first ones were the Declaration of Geneva by the WMA and the International Code of Medical Ethics, 4which were published in 1948.12 The Declaration of Helsinki, published in 1964, reemphasised the principle of informed consent for volunteers in biomedical research.
Ethical Principles for Medical Research and Practice
The ethical principles for medical research and practice as highlighted by the Belmont report for the protection of human subjects in the biomedical and behavioural research are given in the following text:13
Respect for the Patients (Autonomy)
Autonomy refers to the patient's right to choose or refuse treatment. The doctors must show respect for their patients and research subjects by treating them as autonomous individuals and obtaining informed consent before undertaking surgical procedures or any medical or surgical procedure related to research. In the practice of obstetrics and gynaecology, the doctor needs to develop respect for the patient as an individual as well as a woman.
Beneficence
Beneficence refers to the action which is done for the benefit of others. This is based on the principle of ‘avoiding any harm’. ‘Doing no harm’ is termed as non-maleficence. The doctors need to favour those procedures and treatments, which are likely to benefit the patients and avoid unnecessary harm.
Justice
The doctor should be fair in the process of selecting subjects or the patients. They should be treated fairly in the distribution of benefits and burden.
Ethical Confidentiality
Trust is the foundation of a physician−patient relationship. This is based on the fact that the patient has the right to privacy, which must be always respected. Patients may disclose their private information to the doctor. This is especially the case in the gynaecological practice, where the patients share sensitive information related to intimacy and sexuality with their doctors. Confidentiality, therefore, forms an important aspect of a successful therapeutic relationship. According to the code of ethics of AMA (1957), ‘A physician may not reveal the confidences entrusted to him in the course of medical attendance or the deficiencies he may observe in the character of patients, unless he is required to do so by the law or unless it becomes absolutely necessary to protect the welfare of the individual or the community’.14 The parameters within which the breach of confidentiality would be justified are still controversial. Reporting of sexually transmitted diseases (STDs), which may pose to be a serious risk to the public health, may be permitted in some US states. In gynaecological practice, a variety of complex and difficult situations may arise, where the doctor is faced with the dilemma of whether or not to maintain patient confidentiality. For example, when a woman seeks a medical termination of pregnancy (MTP) or sterilisation and requests confidentiality from her partner, the doctor may be faced with a dilemma. In most cases, obligation to patient confidentiality predominates.
Before undertaking any gynaecological surgery or obstetric procedure, it is important for the obstetrician gynaecologist to take informed consent from the patient. Nowadays, the informed consent is required for all operative procedures. The process involves counselling the patient about the various available surgical options so that the patient can select the best surgical procedure out of the various available options. In practice, the informed consent involves informing the patient about the diagnosis, degree of certainty regarding the diagnosis, the surgery that would be recommended in that case and possible alternatives along with their expected outcomes, risks and benefits. The patient outcome, if no therapy is administered, must also be explained to the patient. The consent should be taken well in advance of surgery in a comfortable setting. The patient must be given adequate time to absorb the information, ask any questions if she feels so and then to make an informed decision. Effective communication between the patient and the surgeon is of utmost importance, while counselling the patient regarding various available treatment options. The surgeon may make use of written material (self-explanatory patient leaflets), visual aids (models), websites, etc., to explain the procedure to the patients. The patients must also be informed about the advantages, disadvantages, success and failure rates and complications of the various procedures. The patient must be counselled even regarding the rare complications that are serious and may affect the individual's life. The patient should be given adequate time to interpret and absorb the information presented to her before making the final decision. At no point must it be taken for granted that the patient would be herself able to understand the general risks of surgery, e.g., anaesthetic complications.
Elements of Informed Consent
The informed consent requires the following pieces of information: nature of the procedure, rationale of doing the procedure, advantages and disadvantages of doing the procedure and availability of alternatives. If the surgeon encounters an additional pathology at the time of surgery in addition to one for which the informed consent was taken, then the surgeon must first finish the planned surgery and discuss the condition later with the patient. The exception to this rule is the discovery of a life-threatening pathology in which case the surgeon can legally perform surgery in the patient for that condition. The elements of informed consent are as follows:14
- Disclosure of information: The patients must be explained about their diagnosis and also briefed about the various available treatment options, including no treatment and various medical, surgical and alternative therapies. The risks and benefits of each modality need to be explained in sufficient details so that a reasonable adult patient can understand the situation and make an informed choice.
- Voluntariness: While making a decision, the patient must be free of coercion or constraints and must be able to choose freely. The patient should be mentally competent to be able to make a choice and there must be no evidence of limitation in her ability to understand the information. She must be in a condition to act independently on the basis of information that has been disclosed.
- Validation: A written consent form must be given to the patient, which must be duly signed by her. Consent must be taken for each procedure, which is going to be performed even if they are being performed in a single setting. If an additional pathology is discovered at the time of surgery, the surgeon can legally operate on it, only if the condition is life-threatening. On the other hand, if the condition is not life-threatening, then the surgeon must finish the planned surgery and discuss the condition later with the patient. There are four exceptions to the informed consent:15
- Emergency situations: If the relatives are unavailable, the patient is unconscious and is suffering from an emergency life-threatening condition.
- Intentional relinquishing by the patient: Waiver may be given by the patient in case of research projects or exploratory laparotomy.
- The patient is mentally incompetent, i.e., the patient has been declared mentally unsound to be able to understand and take decisions appropriately. In this case, the court takes the responsibility for the patient.
- Therapeutic privilege: In case the patient is unconscious or is in the state of confusion and there are no relatives, the physician can act in the patient's benefit without taking her consent.
Surgical Competence as a Moral Commitment
Competence of the surgeon is a moral commitment towards the patient, especially if the surgeon wants to undertake a new procedure. It is essential that the surgeon has been appropriately trained in the clinical sciences and surgical techniques, especially before any new procedure is introduced into clinical medicine.
PATIENT COMMUNICATION AND COUNSELLING
In order to communicate effectively, the surgeon needs to develop the art and skill of listening. The surgeon must tell the patient regarding what will be done to her body at the time of surgery and what are the consequences surgery can have on her life post-operatively.16 When the patient expresses her feelings, this results in the revelation of her knowledge, fears and biases. The surgeon can help her cope up with them by supplementing her knowledge with the appropriate explanations regarding the anatomy and physiology of her body parts. The usual pre-operative, operative and post-operative routines must also be described in detail. The surgeon must also explain the patient about various physical sensations (pain, discomfort, inability to walk, etc.), bandages, incisions, catheters, tubing and medications. The patient's own role in her convalescence and recovery must also be defined. The most common complications, which are likely to occur as a result of surgery, must be explained to the patient. Before undergoing surgery, the woman may feel lonely, frightened and sick. It is the duty of the surgeon to make her feel more relaxed, calm and peaceful, by allaying all her fears and anxieties. The therapeutic laying on of the surgeon's hands over the patient's shoulders or head may work wonders at time. A healing touch can often comfort the distressed patient when the words may not prove to be adequate.
In the multicultural society, it is important for the clinician to comprehend if there is any cultural issue which is influencing her decision. For example, some women may have regional or cultural concerns regarding being examined by a male gynaecologist.
The patient's family is an important part of her support system. If the patient so desires, the surgeon must involve the patient's family in the decision-making process. They should be provided with an adequate amount of information, reassurance, support and attention. If the patient requests the presence of family members, they should be allowed wherever feasible. The surgeon's contact details must be available to the patient, in case she wants to contact him or her for further clarification or information.
Verbal Communication
Verbal communication with the patient must be based on the following parameters:
- The doctor must use the vocabulary which the patient understands.
- The doctor must provide appropriate amount of information to the patient, neither too less nor too much that results in information overload. One of the most difficult questions for the clinicians to answer is ‘how much is too much?’ The problem is further aggravated due to perceptions regarding litigations.
- The clinicians should make sure that they properly greet the patient before they start taking the history.
- The doctor must ensure that the patient is at ease, by using an appropriate body posture and facial expression. Besides the patient−doctor communication, the surgeon also needs to pay attention towards the doctor−doctor and doctor−nurse communication, all of which are equally important.
Non-verbal Communication
Besides the verbal communication, there are certain non-verbal components of communication that may be perceived by the patients and may reflect the doctor's attitude towards them. This may include the way the doctor greets the patient, their facial expression, their posture, etc.
These include maintaining the patient's records and sending letters to other healthcare professionals.
Clinical Records
Well-maintained clinical records help in maintaining communication with other professionals and in the protection of the patients. They may serve to protect against the future medicolegal litigations. Poor quality records are likely to confuse other healthcare professionals, thereby endangering the patient's life. Records must be either typed or written in legible handwriting. Preferably, these records must be dated, timed and signed. Concise information must be presented in these records. The physician must not try to present any information, which is not based on evidence. A multidisciplinary team approach must also be practiced and other clinicians may be involved, if the gynaecologist feels the requirement.
Communication with an Angry or Complaining Patient
Observation of good communication principles as described previously may help in addressing an angry or a complaining patient. At all times, the doctor must try to remain as calm and patient as possible.
Patient Counselling
The surgeon can help prepare the patient psychologically, by providing counselling in form of reassurance, information and any other form of support to help her deal with the emotional distress related to gynaecological surgery. The patient is likely to react to surgery in the same way she had reacted to the stressful events in her life. Once the surgeon has come to know about this, while counselling the patient, he or she can start the psychological preparation of the patient. Psychological preparation for surgery is supposed to be effective by reducing the negative impact of surgery on the quality of life, pain, medication use, behavioural recovery and physiological function. The surgeon should be with the patient at the time of administering anaesthesia. Psychosexual rehabilitation may be important after gynaecological surgery to help restore her sexual function, sexual identity, body image and self-esteem. Common emotional responses to surgery or medical treatment are described next.
Insecurity
Feelings of insecurity and vulnerability are common among women undergoing surgery. The surgeon can diminish these feelings by ensuring the patient that the surgery is likely to improve the quality of life by providing improvement in the various parameters, such as relief of pain, removal of cancer, improvement in the quality of life, restoration of fertility, etc. If the patient is convinced that she would be better than she is before surgery, she is likely to trust and believe her surgeon and feel less insecure.
Anxiety or Fear
The patient faces fear of unknown at the time of hospitalisation. Proper information about the surgery and recovery process would help allay this fear and anxiety. The surgeon is also responsible to ensure that the rest of the hospital staff involved in the surgery also behaves positively with the patient. There is also fear regarding the loss of economic competence for an uncertain length of time. This may be especially important if the patient is the only earning member of the family.
Regression and Dependency
People who are ill or who undergo surgery tend to regress into a more dependent state. It may be difficult for the family to deal with a woman, who is no longer self-sufficient or is emotionally unstable. This can lead to anger and frustration on part of the relatives and friends. The prospects of surgery as well as feelings of non-health are likely to contribute to emotional fragility, including the feelings of sadness, depression, tearfulness and irritability.
Grief and Depression
Grief is a normal, natural reaction to illness or loss of any kind. Grief is essential for emotional healing. By recognising the various stages of grief, the surgeon is able to help the patient understand, regarding what is happening to her.
Post-surgical depression is also a common finding in patients who have undergone surgery. She may experience the feelings of helplessness, hopelessness and worthlessness. Other symptoms of depression may include midnight depression, insomnia, nightmares, loss of appetite or excessive eating, lethargy, difficulty in making decisions, psychosomatic symptoms and fatigue.
Clinical governance can be described as a systematic approach for sustaining and improving the quality of patient care within the National Health System (NHS).17 The seven pillars of clinical governance are as follows:
- Clinical effectiveness and the practice of evidence-based medicine
- Risk management
- Clinical audit
- Education, training and continuing professional development
- Patient and public involvement (PPI)
- Staffing and staff management
- Use of information technology.
Each of these elements has been described in detail in the following text. Accountability and transparency or openness are the two essential components outlining the framework of clinical governance. Accountability is based on five core principles: responsibility, explainability, accuracy, auditability and fairness. Transparency or openness is important because it is believed that poor performance and practice often flourishes behind closed doors.
Clinical effectiveness implies that everything which is done is designed in such a way so as to achieve the best patient outcomes. It can be defined as ‘doing the right thing to the right person at the right time in the right place’. This basically employs adopting an evidence-based approach for managing the patients.
Practice of evidence-based medicine is an approach to medical practice, which aims at integrating individual clinical expertise with the best available external clinical evidence from systematic research in form of well-designed and conducted research trials. The term ‘evidence-based medicine’ was coined by Guyatt in 1991. The coined term subsequently appeared in 1991 in the editorial of the American College of Physicians (ACP) Journal Club.18 However, its roots go much further back. Evidence-based medicine incorporates a broad range of topics, from clinical epidemiology to biomedical informatics to evidence-based guidelines.
Evidence-based medicine involves the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. On the other hand, clinical expertise implies the proficiency and judgement that the individual clinicians acquire through clinical experience and clinical practice. Evidence-based medicine is a guide only and we should not assume that all patients should be treated similarly according to the results of clinical trials. It is used to make decisions about the care of individual patients. Each patient is an individual, and the clinician must remember this while initiating treatment. All types of clinical trials are included in the practice of evidence-based medicine. However, the methods must be critically appraised in order to assess the validity of the evidence. Objective measurements of disease outcome eliminate bias, are more scientific relative to subjective measures and are therefore applicable to the practice of evidence-based medicine. The strongest degree of evidence coming from meta-analysis, systemic reviews and randomised controlled trials (RCTs) can yield the strongest recommendations, whereas evidence in the form of case-control trials can yield only weak recommendations. Often, an RCT will be conducted to assess the benefits or risks associated with a new, expensive treatment. Though RCTs reveal a strong degree of evidence, they are not the only trials that contribute to evidence-based medicine. Prospective trials, observational and cross-sectional studies, all provide vital information that guides the process of daily decision-making.19 The grading criteria for various levels of evidence are described in Table 1.1 and Figure 1.1.
Traditionally, surgical practice had been experiential and based on the contemporary understanding of basic mechanisms of disease. Surgery was considered as an art and was largely based on experience. There was a change in this trend with the emergence of ‘evidence-based medicine’ in the 1980s. There is no doubt that the use of evidence-based medicine has been beneficial, but over-reliance on RCTs and the scientific evidence may not prove to be useful for providing individualised medical care to the patients. There has been a continuing debate between the practice of ‘experience’ and ‘evidence-based medicine’, while providing care to the patients.
The ethical principles, which must be kept in a surgeon's mind before administering treatment to any patient, include the following: the interests of their patients must always be paramount; any recommendation to a patient must be supported by the best available evidence; before implementing any new intervention or procedure, it must have been properly compared with the currently accepted method(s).
Steps of Evidence-based Medicine
The practice of evidence-based medicine comprises the following steps:
- Asking the right question
- Searching for best evidence
- Appraising the evidence for its validity
- Acting on the basis of findings associated with evidence
- Evaluating the clinical practice and efficacy of the above steps through the process of audit.
8Asking the right question: In order to define the clinical problem, the correct question must be asked from the patient. The question should be as clear and focussed as possible, in terms of the four elements described by the abbreviation PICO (patient, intervention, comparison and outcome) and summarised in Table 1.2.
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For comparison regarding a specific intervention or a treatment strategy, the best quality evidence is available from the RCTs. On the other hand, for comparison related to the exposure to a particular risk factor, cohort studies, which are followed up for a specified period of time, provide the best evidence. Therefore, in case of cohort studies, the abbreviation can be modified as PECOT (patient, exposure, comparison, outcome and time).
Searching for evidence: Finding the evidence to the focussed question may require an extensive search. As previously mentioned, the best quality evidence comes from the RCTs. Evidence can be searched from many databases, where the published research studies are indexed. There are several large databases that include citations of published studies. One of the larger ones is PubMed20 or Medline, produced by the US Library of Medicine, which contains over 23 million articles. These may comprise different types of studies including case reports, observational studies, RCTs, systematic reviews, etc. Several other online databases are also available for search. Excerpta Medica data BASE (EMBASE) is a biomedical and pharmacological database of published literature, indexing primarily European studies. This has been designed to support information managers and pharmacovigilance specialists in conforming to the regulatory requirements of a licensed drug. Research studies pertaining to nursing or midwifery can be obtained from databases such as Midwives Information & Resource Service [(MIDIRS), (midwifery digest)], British Nursing Index (BNI) and Current Index to Nursing and Allied Health Literature (CINAHL). Research studies pertaining to psychological literature may be obtained from psycLIT (a CD-ROM version of psychological abstracts) or psycINFO. PsycLIT was merged into the PsycINFO online database in 2000. It contains research studies from not only the field of psychology, but also the fields of sociology, linguistics, medicine, law, psychiatry and anthropology. PROSPERO (International Prospective Register of Systematic Reviews) is another open-access international database of prospectively registered systemic reviews in health and social care. The best resource for the high-quality systemic reviews is the Cochrane library (ISSN 1465–1858), which has a collection of six databases containing different types of high-quality independent evidence. This information is likely to enable healthcare professionals in an evidence-based decision-making process. It also has a seventh database which provides information about Cochrane groups. These seven databases are as follows:
- Cochrane Database of Systemic Reviews (CDSR): This is the leading resource for systematic reviews in healthcare. The CDSR includes Cochrane Reviews (the systematic reviews) and protocols for Cochrane Reviews as well as editorials.
- Cochrane Central Register of Controlled Trials (CENTRAL): This is a source of randomised and quasi-randomised controlled trials.
- Cochrane Methodology Register (CMR): This register comprises a bibliography of publications which report on methods used while conducting controlled trials.
- Database of Abstracts of Reviews of Effects (DARE): This is a database containing abstracts of systematic reviews which have been quality-assessed. DARE complements the CDSR by assessing the quality and summarising reviews, which have not yet been carried out by Cochrane.
- Health Technology Assessment (HTA) Database: This includes UK and international health technology assessments (studies of the medical, social, ethical and economic implications of healthcare interventions). The aim of the HTA database is the development of the quality and cost-effectiveness of healthcare services.
- NHS Economic Evaluation Database (EED): This database assists decision-makers by systematically identifying economic evaluations from around the world. It not only appraises their quality, but also highlights their relative strengths and weaknesses.
- About The Cochrane Collaboration Database: This database contains information related to various Cochrane groups within Cochrane.
The DARE and HTA database are available on the websites www.tripdatabase.com and www.york.ac.uk. There are two online databases pertaining to the international guidelines: (1) AHRQ (Agency for Healthcare Research and Quality) National Guidelines Clearinghouse and (2) Guidelines International 9Network Library. In the UK, the national guidelines pertaining to obstetrics and gynaecology are produced by the following societies:
- Scottish Intercollegiate Guidelines Network (SIGN)
- National Institute for Health and Care Excellence (NICE)
- Royal College of Obstetricians and Gynaecologists (RCOG).
Appraising the evidence for its validity: It is important to critically appraise the available evidence for its validity because different types of studies reported in the literature are likely to have different strengths and weaknesses. The clinician needs to decide if a particular research study would be clinically significant for their patients. A particular research study can be critically appraised by asking the following questions:
- Is the study valid [i.e. are the results of the study reliable and what kind of research study (study methodology) was carried out]?
- What are the results of the study?
- Would the results of the study help the clinicians in looking after their patients?
Generally, larger studies are preferred over the smaller ones because the results of larger studies are less likely to be due to chance. A systematic review of the RCTs is the most important component in the practice of evidence-based medicine.21 Clinical guidelines are usually based on systematic reviews. A systematic review is a type of literature review, which collects and critically analyses multiple research studies. These mainly include RCTs. However, at times, there also may be observational studies. The method of systematic review must be clear, specific and well-structured. It must include the clearly defined PICO questions. An extensive search of literature must be carried out followed by the critical appraisal of the studies located after searching with a specific criterion. Finally, these research studies must be analysed using appropriate methods. Data from each of these individual studies may be pooled and statistically analysed using a technique known as the meta-analysis.
While systematic reviews and meta-analyses are essential for summarising the evidence related to efficacy and safety of healthcare interventions, the clarity and transparency of these studies at times may be suboptimal. In order to improve the system for reporting and conduct of the systematic reviews and meta-analysis, the quality of reporting of meta-analysis (QUOROM) statement was published in 1999. Since then, there has been publication of several statements for improving the standards for primary and secondary research, such as preferred reporting items for systematic reviews and meta-analyses (PRISMA), Consolidated Standards of Reporting Trials (CONSORT), The Standards for Reporting of Diagnostic Accuracy (STARD) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE).22–25
Acting on the basis of findings associated with evidence: Decisions related to treatment must be based on the results of the appraised evidence after considering both the benefits and harms of treatment and helping the patient make a choice, i.e. the shared decision-making process.
Audit: Evaluation of the clinical practice and efficacy of the previous steps: Audit has been described in detail later in the text.
Different Types of Trials or Research Studies in Clinical Practice
Double-blind trials: A double-blind study refers to a type of research study in which neither the study participants nor the person giving the treatment knows which treatment a particular subject is receiving. This helps in alleviating potential bias through randomisation of patients to the drug or placebo without either the doctor or the patient knowing which agent is being used. In this way, both the researchers and the study participants are ‘blind’ to which subject is receiving what type of treatment during the study. This method helps the researchers to get more accurate results from their research. Double blinding allows researchers to ‘control’ a study for the psychological effects that sometimes help people feel better, simply because they expect to feel better when they receive a medication. Placebo-controlled studies are most appropriately undertaken in a double-blind fashion with both the observer and the patient blinded to treatment. Although one might think that placebo has no effect, in fact, there may well be a huge placebo (psychological) effect. Placebo studies are undertaken in patients with cancer, particularly to establish the palliative value of drugs or the effectiveness of a new treatment where none exists. As a variation of this theme, patients can be randomised to receive either the new drug or an established therapy.
Single-blind trial: This is a single-blind study where the patient does not know which arm of therapy they are receiving. However, the investigator does have this information. For example, a study is undertaken assessing the effects of a cholesterol-lowering agent on cardiovascular disease. Patients are randomised by the investigators to receive either the drug or the placebo. However, the patients are unaware regarding the kind of treatment they would receive.
Randomised controlled trials: RCTs form the heart of evidence-based medicine because these trials help in evaluating the effectiveness of a particular therapeutic method and are likely to be associated with least bias. A typical RCT involves the following steps (Fig. 1.2):
- Enrolment of the subjects who meet the eligibility criteria into the study
- Random allocation of the subjects into the treatment and control groups
- Administration of the treatment to the ‘treatment group’ while no treatment or placebo is administered to the ‘control group’
- Follow-up of both the groups
- Analysis of the results.
Subjects with a particular condition, who meet the inclusion criteria for entry into the trial, are randomly allocated to either receive treatment or some form of control (either no treatment or the current, ‘gold standard’ treatment). 10A computer programme is used for randomising the data in different participating centres. Various participating centres are also linked with telephone services to request the randomisation procedure. Wherever possible, double blinding should be performed. The outcome of interest is measured to evaluate if one group experiences any benefit over the others. The main advantage of the RCT is the concealment of the treatment allocation and thus minimisation of the selection bias and low chances of confounding. These studies are, however, time-consuming and expensive. Also, there can be an appreciable loss to follow-up if the infrastructure is not in place to ensure good data collection.
Parameters which decide the validity of these studies include the following: Random allocation of the subjects into the treatment and control groups, group selection in a way that the characteristics (age, parity, sample size, etc.) of both the groups should be similar, and equal treatment of both the groups and inclusion of all the patients while analysis of results and formulation of conclusion.
Case-control study: This is a study comparing the characteristics of subjects selected on the basis of their disease status. A case-control study compares two groups of people: those with the disease or condition under study (cases) and a very similar group of people who do not have the disease or condition (controls). While the cohort study can be visualised as a prospective study, following subjects forward through time, case-control study is a retrospective study. This study involves the recruitment of cases (subjects with the disease) and a group of control (subjects without the disease), both of which are looked back through time to compare their exposures to evaluate if any of the exposure appears to relate to the disease development. Case-control studies are relatively cheap in comparison with the cohort studies and can be used to investigate a number of different exposures simultaneously. The main difficulty associated with this type of study is the selection of the control group. Also, these studies can be often associated with considerable problems related to the selection bias and observer or recall bias. These studies differ from the cohort studies regarding the fact that cohort studies are not good at investigating rare exposures as a large number of subjects need to be recruited to obtain enough evidence of the exposure. Moreover, case-control studies cannot be used for making estimates of disease incidence and are not very helpful in investigating the series of events resulting in the disease diagnosis. Presence of confounding factors can also pose further problems.
Cross-sectional studies: In these studies, the data are collected from a sample of subjects at a given point of time and comparisons are made between the variables to investigate the extent of disease of interest or to assess which exposures may be linked with the disease. These studies represent a snapshot in time and therefore the prevalence is generally the main outcome measure. Moreover, no information is obtained on the disease incidence over time.
Open study: Open study is a type of study in which both the researchers and the participants know which treatment is being administered. For example, a study compares the effect of low-molecular-weight heparin versus aspirin in the prevention of deep vein thrombosis (DVT) amongst post-operative gynaecological patients. Patients are randomised by the study coordinator to receive treatment as either a tablet or injection. This study assessing DVT post-operatively is an open study as patients and investigators will know which treatment they are receiving as it is either an injection or a tablet. If, however, they wished to create a double-blind study then patients could be randomised to receive injection plus placebo tablet or aspirin plus placebo injection.
Cohort studies: Cohort studies or longitudinal studies involve the follow-up of individuals. Subjects are recruited into cohort studies and followed up over time to assess the incidence of a particular disease. In case of a disease that has already been diagnosed, disease progression can be assessed. A cohort study is prospective in the sense that the individuals who are exposed and non-exposed to a putative risk factor are followed up over a defined period of time and the disease experience of the exposed group at the end of follow-up is compared with that of the non-exposed group. Cohort studies are more important than the cross-sectional studies because they provide far more information on the incidence of events. These studies also allow temporal assessments to be made regarding whether the exposure preceded the outcomes of interest or not. A cohort study may also be historical (retrospective or non-concurrent). Cohort studies are, however, not useful at investigating rare studies. They are frequently used when the disease is common and the effects of various exposures are not well understood.
Meta-analysis: Analysis of data from published literature is termed as meta-analysis. Meta-analysis is a common way of assessing the effect of treatment or the potential risks of treatment by reviewing and assessing all the data published in the medical literature. Many of the guidelines are published through meta-analysis.
Over recent years, there has been a growing appreciation that a small but significant proportion of patients may experience adverse events, as a result of an error on the part of the healthcare workers, e.g., errors in the route of administration or dosage of medicines by the nurses. Sometimes, these events may prove to be serious or even life-threatening. Over the past few decades, there has been an increasing trend towards application of principles of risk management in healthcare organisations. Since small errors can result in particularly disastrous and costly adverse outcomes in both obstetrics and gynaecology, it is appropriate to review clinical risk management issues. Risk management involves the ways in which these errors can be identified, analysed and subsequently reduced. It involves examining the various procedures, right from the beginning until their end. The various incidents and accidents are analysed to prevent their occurrence. This is based on the principle that simple system errors can result in some of the most devastating mistakes. The concept of risk management is based on the following strategies:26
- Identification, characterisation and assessment of potential threats
- Assessment of the vulnerability of critical assets to specific threats
- Determining the risk: This involves assessment of the expected consequences of specific types of attacks on various assets
- Identifying ways to reduce those risks
- Prioritising risk reduction measures.
An educational and supportive environment, rather than a blame culture, helps in encouraging the reporting of adverse incidents. This encourages the staff to learn from the adverse outcomes. Reduction in the adverse events, which occur in healthcare institutions, helps in improving the overall quality of patient care. Within the NHS, risk is managed best within a framework, called RADICAL (Raise Awareness, Design for safety, Involvement of users, Collection and Analysis of safety data, and Learning from patient safety incidents) framework, which incorporates all elements of clinical governance. The RADICAL framework for risk management in the healthcare system is described in Flowchart 1.1.27
Process of Risk Management
The process of risk management involves the following steps: risk identification, compilation of a risk register, and risk analysis and risk control.
Flowchart 1.1: The RADICAL framework for the management of risk in health care.27*Set of training procedures for use in environments where human error can have overwhelming effects.
Risk identification: There must be formal processes for identifying anything that might interfere with the delivery of safe, good-quality maternity services. If something goes wrong, the clinicians can identify the risk by looking back at the series of events to identify the things that went wrong. Risks could also be identified through internal or external sources. Internal sources for identifying risk refer to risk assessment conducted in all clinical (wards, clinics, theatre, delivery suite, day assessment unit, etc.) as well as non-clinical areas (secretarial office, canteen, etc.). Risk assessment can also be obtained through reporting of incidents, record of complaints and claims, and consultation with the staff in form of workshops, surveys, interviews, clinical audit, etc. External sources identify the risk at the national level and include national confidential enquiries, Clinical Negligence Scheme for Trusts (CNST) standards, RCOG guidelines, NICE guidelines, protocols and visitation, National Patient Safety Agency Alerts (NPSA), post-graduate dean's specialty site visits and Care Quality Commission (CQC). Each maternity as well as gynaecology unit should have a trigger list for reporting of incidents (Tables 1.3 and 1.4). Staff must be encouraged to complete incident forms for these various triggers. To optimise the reporting of incidents, an organisation should have a 12culture wherein staff should be aware and motivated about reporting of adverse events. They should be aware that they would be listened to and not blamed for the adverse event. In fact, they should be provided with an accurate feedback because feedback drives motivation, which would eventually help in improvement.
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Compilation of a risk register: The risks identified through the processes described above should be entered in the risk registers, which should be preferably maintained in the clinical area of each maternity and gynaecology unit. Examples of various risks, which could be included in a gynaecology risk register, may include the risks identified in the care pathways for management of gynaecological emergencies, etc. However, risk registers are not merely limited to clinical issues. Non-clinical issues such as those related to breakdown of building, heating system, etc., can also be noted in the risk register. Once the risk is identified, it is graded within a standard matrix described in Table 1.5. In this matrix, the risk is scored in two ways. The first one is the seriousness or consequences of risk (from being a negligible event to a catastrophic event, which can result in multiple fatalities). Levels of severity are locally defined, taking into account the extent of harm caused to the patient and the organisation. The second score reflects the probability of the occurrence of an event (from being impossible to occur to occurring certainly). Both these scores are multiplied to reach a risk score, which helps to quantify the level of risk. Within this matrix, a risk with a score of 20 or higher is usually considered to represent an unacceptable risk. Residual risks exceeding a preset threshold are entered into a departmental or a directorate register. Significant risks from that register are then in turn mentioned in a hospital or trust-wide risk register. Ideally, a risk register should be in an electronic format. A risk register is not a static document; it must be continually reviewed. It is modified as older risks are treated or new ones appear. Steps must be taken for reduction of risk either by reducing the frequency of its occurrence or by reducing its severity.
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Risk analysis: Once the risks have been identified, they are noted in the risk register, following which they are assigned a risk score as previously described (Table 1.5). This helps in identifying the risks or incidents that require in-depth investigation or those that require immediate action for correction.
13The incident must be investigated using Reason's organisational ‘Swiss cheese’ model of accident causation (Fig. 1.3). This model illustrates that there are many layers of defence between the hazards to accidents. Alignment of flaws in each of the layers allows the accident to occur. This model has been adopted by the NPSA and used as the ‘fishbone tool’ for root cause analysis. Fishbone diagrams (Fig. 1.4) are often used by the NPSA for identifying the contributory factors.28 It helps to categorise the potential sources of defects or the root causes. Various components of a fishbone are as follows:
- Head of the fish: Effect or the outcome
- Horizontal branches: Causes (various causes can be divided into non-service processes such as methods, materials, people, equipment, technique, environment and service processes such as policy, procedures, plan and people)
- Sub-branches: Reasons.
Risk control: Following the appropriate analysis of risk, measures must be put in place for controlling these risks. Selection of the appropriate treatment plan is dependent on the risk rating. Lessons learned from the identification and treatment of risk should be shared with the healthcare professionals in other parts of the hospital or trust through several routes such as multidisciplinary team meetings, ward meetings, safety alerts, newsletters, intranet and educational meetings. Both the NPSA and the RCOG have communication channels which can be used for this purpose.
Definition
Audit is the process of quality improvement of the healthcare services, thereby improving the overall quality of life. It aims at improving the patient care and outcome by assessing, evaluating and improving the care of the patients. This is achieved through the systematic review of care against set criteria. Based on the findings of the review, the changes are identified and implemented. Where indicated, the identified changes are implemented at an individual, team or service level. Further monitoring is implemented to confirm if these changes result in an improvement towards the delivery of healthcare services. The difference between audit and research has been described in Table 1.6.
Fig. 1.4: Fishbone diagram for root cause analysis.28
A typical audit cycle is described in Figure 1.5 and comprises the following steps:
- Initial needs assessment: The audit cycle comprises an initial needs assessment where the requirements of the department or section or individual are determined and the actual audit itself is determined.
- Identification of standards: Then what is to be audited is decided upon; it is important to identify the standards against which the audit will be compared. These can be national standards or clinical guidelines determined by the national bodies or comparisons can even be made within the department.
- Data collection: Once the standards are set, data collection is undertaken, with selection of retrospective or prospective data followed by data analysis.
- Recommendations: The results can then be presented, compared to the standards and from this, recommendations for improvements or implementation of changes are made.
- Re-audit: Finally, to assess how effectively these recommendations have been implemented, a re-audit is suggested in the future.
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Education, Training and Continuing Professional Development
Management of the patient must function as a part of an efficient multidisciplinary team. The most important factor behind the success of this team is the experience, education and training of the various team members. This sometimes may be difficult to be acquired because the obstetric emergencies are a rare occurrence. This experience and training may be best gained through stimulation and practice. According to the fourth report of the Confidential Enquiry into Maternal Deaths and Morbidity from the MBRRACE-UK collaboration which was published at the end of 2017, nearly 50% of the maternal deaths could have been prevented.29 The Confidential Enquiries into Stillbirths and Deaths in Infancy (CESDI) have also identified substandard care as a major contributor to foetal and neonatal mortality.30,31 Substandard care in obstetrics and gynaecology adds immensely to the NHS expenditure because maternity claims are responsible for the highest value litigation complaints reported to the NHS Litigation Authority (NHSLA). The most important causes of the maternity claims have been mistakes in the interpretation of foetal heart, mistakes in the management of labour, prevention of cerebral palsy, etc. This further highlights the importance of training, education and continuing professional development in the speciality of obstetrics and gynaecology.
Stimulation Training
This involves the use of stimulation models for training in obstetrics including bony pelvis and advanced full-body birthing simulators having accurate anatomy and functionality to facilitate multiprofessional obstetric training of birth management, e.g., SimMom, Noelle, and PRactical Obstetric Multi-Professional Training (PROMPT) birth stimulator. Simple part-task trainers can be used for teaching specific obstetric skills, e.g., instrumental delivery, manoeuvres for shoulder dystocia, and manoeuvres for breech delivery. Hybrid stimulation, which involves the use of simple part-task trainers in combination with full-body birthing simulators, is also used. Computer-based virtual reality simulation models, which provide both kinaesthetic and visual feedback to the trainers, are also available.
Simple and advanced simulation models can be used for teaching advanced obstetric skills within the structured simulation-based training courses. One such structured simulation-based training course, the Advanced Life Support in Obstetrics (ALSO) course, was introduced in the US in 1991.32 This was followed by the Managing Obstetric Emergencies and Trauma (MOET) course in 1998.33 This course aimed at teaching advanced skills to the obstetricians and anaesthetists. Both these courses resulted in a significant improvement in obstetric emergency management. PROMP course has been developed in the UK to provide practical training to the obstetricians, midwives and the anaesthetists.34 Other obstetric emergency courses, which have been described, include Multidisciplinary Obstetric Simulated Emergency Scenarios (MOSES) and Training in Obstetric Emergency Scenarios (TOES).35,36 Training programmes should be specifically focused towards the development of specific clinical skills [e.g. management of eclampsia, shoulder dystocia, cord prolapse, post-partum haemorrhage (PPH), and conducting instrumental deliveries], communication skills, team working and awareness of an individual's role within the team. Some of the important features of Stimulation-Based 15Medical Education (SBME) include the following:37
- Active participation of all team members: These training programmes must aim at the training of all staff within the maternity and gynaecological unit including the doctors, midwives, healthcare assistants, porters, etc. Training should be provided in a non-threatening environment and as per the individual's specific role in the team. Constructive feedback must be provided to the various team members for the purpose of improvement.
- Provision of local (in-house) training: The training should be preferably provided to the staff locally within their unit This is not only likely to be less expensive, but also helps in recognition of the safety issues within the environment and helps the staff to become familiar with their working environments.
- Use of realistic simulation models: As far as possible, real-appearing simulation models (e.g. trousers with bleeding red material, demonstrating PPH, and perineum with prolapsed cord) must be used for these training programmes.
- Provision of incentives for training: Institutions should help in implementing and subsequently running a training programme by funding its cost. The NHS has schemes in which maternity hospitals having a high standard of training, guidelines and audit are rewarded with reduced insurance premiums.
- Interprofessional clinical training with an integrated team approach: Training should be provided to the various members of the team in accordance with their specific roles in the team so that they function as a part of the multidisciplinary team. People are likely to make fewer errors when they work as part of an integrated team.
- Multiprofessional ‘fire-drill’ training: According to the recommendations by the RCOG and the Royal College of Midwives in their report, ‘Safer Childbirth: Minimum Standards for the Organisation and Delivery of Care in Labour’, there is a requirement for regular multiprofessional ‘fire-drill’ training in the management of labour ward emergencies such as cord prolapse, vaginal breech delivery, shoulder dystocia, antepartum haemorrhage, and severe PPH.38
- Provision of evidence-based training: Training should be based on the practice of evidence-based medicine.
- Evaluation of the training programme: The training programme must be formally evaluated to assess its effectiveness.
Levels of Training
Kirkpatrick has described four levels for evaluating the efficacy of training programmes (Table 1.7).39,40
Patient and Public Involvement
Patient and public involvement ensures that the healthcare services meet the patient's requirements. Feedback provided by the patients and the public is used for improving the healthcare services. Both the patients and their carers are involved in the development of the services and monitoring of the treatment outcomes.
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Staffing and Staff Management
This involves appropriate recruitment and management of staff. It also involves adequate monitoring of their performance. Underperformance needs to be identified and addressed. Staff retention must be encouraged by motivating and developing the staff. Good working conditions need to be provided to the staff.
Using Clinical Information and Information Technology
- Clinical information and information technology need to be used to ensure the following: Patient data must be accurate and up to date.
- Confidentiality of the patient data must be respected.
- Complete use of the data must be made to measure quality of outcomes (especially through audits).
- Development of services to cater towards the local requirements.
Teaching
An interaction between teachers and learners or trainees in a clinical workplace is crucial to medical education. There are several teaching methods followed in the NHS for different situations. Several teaching methods require few minutes whereas others demand few months. Demonstration as well as observation of the learner must be followed by proper evaluation and feedback as the learners of today are the specialists of tomorrow. Various teaching methods followed in the NHS are described in Box 1.1 and each of them would now be described next in details.41 Each teaching method is associated with a different amount of student retention (Fig. 1.6).
Lecture
Lecture is an educational talk to an audience and is the teaching method with which most clinicians are comfortable. Lecture has been described as ‘a process by which the notes of a teacher become the notes of the student without passing through the minds of either’.
Though lectures can be considered as one of the most commonly used method of teaching, the major drawback of a lecture is minimal participation by learners. Lecture is mainly 16associated with general or superficial learning where there is minimal participation or interaction by the trainees. Also, this is the method associated with minimum retention of the facts by the audience. However, lectures can sometimes serve as an important method of teaching in the following situations:
- The lecturer is a world authority on a subject.
- Learners are at a comparatively early stage in their career.
- There is a limited amount of time for training the trainees.
Brainstorming
It is a spontaneous group discussion, which helps trigger ideas and generates ways of solving a problem. A clinical teacher can use brainstorming to promote clinical and critical thinking in trainees who are at a relatively early stage in their career. A teacher may start by introducing an idea or a clinical question to a certain group of trainees. The trainees are then asked to share their own viewpoints, ideas and thoughts pertaining to that question.
Delphi Technique
The Delphi technique is used for developing group consensus about problems where there is no or insufficient definite evidence. This method is used for estimating or forecasting. In this method, a facilitator and an expert panel is selected. Each member of the panel is known as an expert or a judge and is provided with a questionnaire, which they have to answer. However, the individual responses are kept anonymous, which can be considered as a characteristic feature of Delphi technique. The results are then analysed and feedback provided to the panel of experts by the facilitator. Multiple such rounds can take place (Fig. 1.7).42 Characteristic features of this technique include, anonymity of the responses by the experts, statistical representation of the study results, feedback of the group answers, flexibility of the experts and expert's contribution to the group. This technique can be used for obtaining consensus about tackling clinical problems, clinical education and formulation and use of clinical guidelines.
Fig. 1.7: Scheme for the Delphi technique.42
Direct Observation of Procedural Skills (DOPS)
DOPS is a supervised learning event (SLE) tool which is used for observing the interaction of a trainee with a patient while performing a practical procedure. This technique comprises three steps:
- Observation of the procedure by the teacher
- Demonstration of the correct way of doing the procedure to the trainee and deciding whether the procedure performed by him or her was adequate or inadequate
- In case the procedure was inadequately performed by the trainee, he or she is informed why it was inadequate and how it could have been done in a better manner.
The 1-minute Preceptor
It is a quick five-step process which creates a structure for teaching in a clinical environment, e.g., a ward round. For this teaching technique to be successful, there must be a strong rapport between the teacher and the learner. The five steps of the 1-minute preceptor are as follows:
- Commitment: There is commitment on part of the trainees and they answer the questions which the teacher asks them about the patient. The learner sees the patient and decides upon a diagnosis and/or the treatment strategy.
- Justification: The trainee justifies why they came to that decision. The teacher will accept or reject what the trainee has said.
- Application: The lessons learnt from the above patient are applied by the trainees to other situations and other women.
- Positive reinforcement: The teacher explains to the trainees what they did well. This is likely to increase their confidence.
- Correction of mistakes: The teacher should then gently tell the trainees their mistakes or what they did not say correctly. This should be specific and not vague.
Also known as instructional coaching, peer mentoring or lesson study, peer coaching is a confidential and non-evaluative method of teaching through which two or more colleagues work together for professional development, expansion, refinement and building new skills; sharing ideas; teaching one another; conducting classroom research; and/or solving problems in the workplace. Teachers or trainers involved in peer coaching should share successful practices and suggestions and/or learn collaboratively and professionally.
Problem-based Learning
In this method of teaching, trainees are given a problem or a case to discuss. This can be described as a type of self-directed learning (Fig. 1.8), where learners are encouraged to identify the learning objective and research for clinical, psychological, social, ethical, professional and public health aspects of the particular problem.
Schema Activation
A schema can be defined as a representation of a plan in the form of a model. From a philosophical perspective, a schema is a conception of what is common to all members of a class. In this technique, the teachers activate the recall of basic facts and concepts, which they feel that the trainees may be knowing or had learnt previously. This knowledge is essential to all members in the group. For example, before teaching about genitourinary prolapse, the teacher may ask the students to recall their knowledge related to the anatomy of pelvic floor.
Schema Refinement
Schema refinement is a useful method for teaching more advanced learners. In this technique, the learners are encouraged to apply basic concepts, clarify their understanding and solve clinical problems through the application of that knowledge, e.g., asking the students to recall their knowledge pertaining to anatomy, physiology and endocrinology before teaching them about amenorrhoea. The next step would be asking the students to solve clinical problems pertaining to the cause of amenorrhoea [whether amenorrhoea is due to Turner syndrome or androgen sensitivity syndrome or polycystic ovary syndrome (PCOS)] by application of that knowledge.
Simplified Procedural Hierarchy
In this method, the teacher or the trainer demonstrates step by step a specific technique or the procedure to the learner or trainee. The characteristic feature of this teaching method is that there is no requirement for assessment, evaluation, testing or giving feedback to the trainee.
Complex Procedural Hierarchy
In this method of teaching, a hierarchy is involved which progresses over numerous encounters, spanning over a significant time period. As the first step, the consultant may ask a trainee to assist him or her in surgery so that the trainee gets to observe the steps of the surgical technique involved. After assisting several such operations, the consultant would then ask the trainee to describe the operation in order to ascertain that he or she has grasped the steps, techniques and use of instruments that are essential for the patient's safety. As the next step, the consultant then assists the trainee in performing the surgical procedure. The teacher may initially ask the trainee to perform a few steps of the procedure, moving on to performing the entire procedure independently. As the next step, if the consultant, based on his or her evaluation and feedback, feels that the trainee has become capable of carrying out that particular surgery independently, he or she is then asked to carry out the operation while being assisted by another trainee. However, the consultant would be immediately available, if required. As the final step, the trainee would become capable of training other junior trainees to help them do the surgical procedure independently.
Snowballing
This method of teaching is used when the teacher is unsure about the current level of knowledge or the skills 18of the learners. The teacher starts by discussing the basics of the topic. However, as soon as it becomes obvious that the knowledge base of the learners is high, the discussion is allowed to snowball, i.e., increase in the intensity and importance.
Goldfish Bowl
The goldfish bowl is a tool for analysing and improving group discussion. In this technique, one group of learners sits in a circle in the middle. This can be considered as the fish bowl. A second group of students sit or stand in a circle around them. The people in the inner group are involved in performing a task undertaking a role-play (e.g. breaking bad news) (Fig. 1.9). The task is set up and moderated by the facilitator. This technique is likely to be more useful when the students have had a few minutes to prepare the ideas and questions in advance. To enable this, the facilitator prepares a series of cards beforehand containing criteria for the outer group to focus on. Each student in the outer circle picks one of these cards and makes notes on those criteria during the discussion. When the students in the inner circle have finished their task, a discussion occurs between the students of the outer circle based on the criteria mentioned in their cards.
Workplace-based Assessments
Workplace-based assessments (WPBAs) are used for evaluating the trainee's progression through the speciality training programme. The aim of WPBAs is to ensure whether teaching and learning has been effective or not. It identifies the strengths and weaknesses of the trainees. WPBAs are of two types:
- Formative assessments
- Summative assessments.
Formative Assessment
Formative assessment helps in keeping track of a student's progress through the particular course of learning. It is based on dialogue between the tutor and the student and involves the teacher providing assessment and feedback to the student regarding his or her progress. Formative assessment, however, is not used for pass or fail decisions. Formative encounters are referred to as ‘supervised learning events’. Different types of formative assessments are described in Table 1.8.
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Summative Assessment
Summative assessment usually takes place at the end of the course and is designed to find out whether the student has met the objectives of the course or not. This type of assessment is used for pass or fail decision. All the three parts of the MRCOG exam are a type of summative assessment. Summative encounters are referred to as ‘assessments of performance’ (AoPs). Different types of summative assessments are described in Table 1.8.
Case-based discussion: Case-based discussion (CbD) is a type of formative assessment, which involves case discussion between trainee and trainer. In this method, the trainee provides direct feedback about the case under discussion to the teacher. This way the teacher can assess the following skills in a trainee:
- Clinical decision-making
- Knowledge
- Application of knowledge.
Mini clinical evaluation exercise: The mini clinical evaluation exercise (mini-CEX) is another workplace-based formative assessment tool. Each mini CEX should take around 20 minutes. This formative assessment tool helps in assessing the trainee's cognitive skills. For example, in a clinic, a group of trainees may be asked to assess the patient: take his or her history, perform a clinical examination, devise a management plan, etc. The trainer should provide feedback to the trainee immediately after the assessment. Trainers use the mini-CEX to directly assess trainees in the following skills:
- History-taking
- Clinical examination
- Formulating management plans
- Communicating with patients
- Professional and interpersonal skills.
Objective Structured Assessment of Technical Skills (OSATS): OSATS is one of the workplace-based assessment tools commonly used in obstetrics and gynaecology training in the NHS. This tool is beneficial for assessment of skills, such as diagnostic as well as operative laparoscopy and hysteroscopy, foetal blood sampling, manual removal of placenta, opening and closing the abdomen, operative vaginal delivery, caesarean section, perineal repair and uterine evacuation.
OSATS can be either formative or summative:
- Formative OSATS (SLEs) gives trainees the opportunity to practise and receive feedback for a given procedure.
- Summative OSATS (assessments of performance) allows trainees to demonstrate whether or not they are competent in performing a procedure.
Objective structured clinical examination (OSCE): OSCE is a summative assessment tool for the assessment of the cognitive, affective and psychomotor domains. This is useful in assessing interpersonal skills, attitudes and practical skills.
Checklists are often used in OSCEs to assess performance skills. Rating scales can also be used in OSCEs.
Appraisal-assisted Learning
An appraisal reviews the trainee's personal, educational and job-related goals and achievements. It works to maximise the effectiveness of a good training programme. It is confidential 19and designed to assist the trainee's progress in his or her career pathway.
- All trainees have to participate in the appraisal process on a regular basis. A good appraisal involves working together with an appraiser on a planned programme for development over a realistic period of time.
- The appraiser should be monitoring the trainee's progress informally to adjust the programme of learning. The appraiser must provide encouragement to the appraisee as the targets are met. Positive feedback should be provided for enabling the appraisees develop confidence in their abilities.
- Appraisal and assessment are often confused but they are different processes. Appraisal assists learning informally with the help of the following:
- Encouraging open informal dialogue
- Establishing learning goals
- Addressing concerns supportively
- Guiding the appraisee throughout the year.
On the other hand, assessment formally tests whether learning has been achieved or not.
LEGAL RIGHTS OF WOMAN, UNBORN AND NEWBORN CHILDREN
Unborn babies have little by way of legal rights. Although the human foetus is worthy of respect, according to law it does not have any right prior to birth.43 With the increasing use of foetal imaging in clinical practice, the foetus is commonly being regarded as a separate patient with unique rights. According to law, if the woman is legally competent, her wishes must be respected. She should not be treated any different from other competent adults. A pregnant woman cannot be made to have treatment unless she gives her consent for it, e.g., caesarean section, even if this means that her baby will die or come to serious harm. However, this may sound harsh and may not always be accepted by the clinicians taking caring for that particular patient. As a result, problems may sometimes arise with the doctors taking legal help. This has led to a grey zone and there have been cases where the decision of a competent woman regarding the management of her pregnancy and labour may not always be respected.
Sometimes, a woman's decision or behaviour may threaten the survival of an otherwise healthy foetus. According to law, the clinician needs to respect the decision of a competent woman, even if it results in her death or death of an otherwise viable foetus. Similarly, a competent refusal by the pregnant patient of the treatment designed to save the life of her foetus (and/or herself) must be respected. In particular, a mother cannot be made to put herself at risk or through unpleasant or unwanted procedures just for the benefit of the child.
On the other hand, the interests of the foetus and the embryo are not completely ignored by the law. The embryo or foetus can be offered benefit without breaching the rights of others, particularly the mother. Once a child is born, it acquires the same rights as others. Children are entitled to sue for the damage they had sustained during the prenatal period. However, this does not imply that the foetus has rights before birth.
Refusal of the parents to give consent for treatment of their newborn child is dealt with in the ‘Department of Health’ document. The key feature is that clinicians and parents may not always agree on what is best for a child. Usually, if parents refuse treatment for their child, then treatment will not go ahead. However, if the clinicians and their colleagues believe that it is crucial for the child to have the treatment in question, e.g., if they think that the child would die or suffer serious permanent injury without the treatment, then the courts can be asked to decide what would be best in the child's interests. Applications to court can be made at short notice, if necessary. If the emergency is such that there is no time to apply to court, any doubts should be resolved in favour of the preservation of life.
The main aim of this act is to provide a legal framework for making decisions on behalf of those adults who lack the capacity for making a particular decision by themselves.44 Every possible step to confirm capacity must be taken before deciding that someone lacks capacity. If there is doubt about whether the patients have capacity or not, the health professional must get an expert opinion from a consultant psychiatrist or psychologist having a background in dealing with patients having learning difficulties. If following assessment, there remains a serious doubt about the patient's competence, legal advice must be sought.
The legalities in such cases are wrapped up in the Mental Capacity Act 2005. A court order will be usually required to provide treatment in these cases. The court would normally expect to make a ‘one-off’ decision relating to a particular treatment for an individual lacking capacity. If the court foresees that further decisions may be needed, it can appoint a ‘Deputy’ to act on behalf of an individual who lacks capacity. The Deputy will have lasting power to make decisions on the patient's behalf over all matters, including medical care. In an emergency situation, treatment can be provided without a court order. However, in these cases, it is sensible to get a second opinion to confirm that it is an emergency and that urgent treatment is necessary. In these cases, relatives and carers are not able to give consent. However, the health professional in charge can use ‘consent form 4’ from the Department of Health to authorise the investigation or treatment. The health professional must be acting only in the best interest of the patient by consulting the relatives, carers, etc., and the Trust's legal department. A second opinion should also be obtained from a colleague. There are a number of serious situations that must be referred to the Court for their judgement. For example, if it was felt that a young woman (who lacks capacity) would be incapable of rearing a child, the parents might wish her to be sterilised. The courts view removal of fertility as extremely serious. Any decision of this kind would have to come from the Court and it would be illegal for the health professional to use the consent form 4. 20However, in case of an adult woman who lacks capacity to give consent or withholds consent to treatment, it is alright for the health professional to carry out hysterectomy for dealing with menorrhagia by using the consent form 4 if he or she is able to demonstrate that they are acting in the patient's best interest even though the procedure would render the woman infertile. The Mental Capacity Act 2005 also extends ‘powers of attorney’ to cover medical matters. ‘Power of attorney’ implies that individuals give someone else the legal power to make decisions on their behalf. For example, old persons may realise that their brain is beginning to fail. The ‘power of attorney’ may be given to their children, but it could also be given to a trusted friend or lawyer. An individual can arrange for someone to have ‘lasting power of attorney’ in the event of his or her losing capacity.
Training in obstetrics: Several studies evaluating the effectiveness of skills training for dealing with obstetric emergencies have presented with conflicting results.45,46 Though various training methods in obstetrics and gynaecology have been developed, described and evaluated, further well-designed RCTs for evaluation of training in obstetrics are urgently required.
- The Simulation and Fire-drill Evaluation (SaFE) study, a large RCT commissioned by the Department of Health comprised 140 individuals (95 midwives and 45 doctors) who were randomly recruited from six hospitals across the southwest of England. The study evaluated the methods of multiprofessional obstetric emergency training. The results of the study showed that practical, multiprofessional, obstetric emergency training is likely to increase the knowledge of midwives and doctors regarding the management of obstetric emergencies.47
- A systematic review of literature by Ameh et al. has demonstrated that short competency-based training in emergency obstetric care is likely to result in a significant improvement in the knowledge and skills of healthcare providers.48 It is also likely to bring about significant improvement in the health outcomes in clinical practice.
KEY FEATURES
- Principles of medical ethics include: autonomy (patient's right to refuse or choose treatment); beneficence (acting in the patient's best interests); non-maleficence (doing no harm) and justice (fairness and equality in distribution of scarce health resources).
- Taking informed consent from the patients prior to an obstetric or gynaecological procedure ensures that the patient's autonomy is respected.
- Clinicians are responsible for maintaining their medical and surgical competence.
- The patient's confidentiality must be protected at each stage. It can be overridden only under exceptional circumstances.
- Attempts by the law to enforce clinical decisions upon a pregnant woman are against the basic legal principles and must be best resisted.
- Simulation-based training of maternity staff in obstetric emergencies appears to be the most effective strategy to help reduce the rate of complications in obstetrics and gynaecology practice.
- Various methods of teaching and assessment of the obstetricians and gynaecologists in training in the UK are likely to improve the quality of health care.
REFERENCES
- Kumar A. Hippocratic Oath, 21st Century. Indian J Surg. 2010;72(2):171–5. DOI: 10.1007/s12262-010-0045-0
- Jotterand F. The Hippocratic oath and contemporary medicine: dialectic between past ideals and present reality? J Med Philos. 2005;30(1):107–28. DOI: 10.1080/03605310590907084.
- Antoniou SA, Antoniou GA, Granderath FA, Mavroforou A, Giannoukas AD, Antoniou AI. Reflections of the Hippocratic Oath in modern medicine. World J Surg. 2010;34(12):3075–9. DOI: 10.1007/s00268-010-0604-3
- Thomas Percival (1740-1804) codifier of medical ethics. JAMA. 1965;194(12):1319–20. PMID: 5321497
- Baker R, Caplan A, Emanuel LL, Latham SR. Crisis, ethics, and the American Medical Association 1847 and 1997. JAMA. 1997;278(2):163–4. DOI: 10.1001/jama.1997.03550020095046
- Hanlon CR. Ethics in surgery. J Am Coll Surg. 1998;186(1):41–9. DOI: 10.1016/s1072-7515(97)00157-9
- Tung T, Organ CH. Ethics in surgery: Historical perspective. Arch Surg. 2000;135(1):10–3. DOI: 10.1001/archsurg.135.1.10
- Thomas J. Ethical and legal issues in medical practice. Indian J Urol. 2009;25(3):335–6. DOI: 10.4103/0970-1591.56191
- Shuster E. The Nuremberg Code: Hippocratic ethics and human rights. Lancet. 1998;351(9107):974–7. DOI: 10.1016/S0140-6736(05)60641-1
- Ghooi RB. The Nuremberg Code-A critique. Perspect Clin Res. 2011;2(2):72–6. DOI: 10.4103/2229-3485.80371
- Gillon R. Defending the four principles approach as a good basis for good medical practice and therefore for good medical ethics. J Med Ethics. 2015;41(1):111–6. DOI: 10.1136/medethics-2014-102282
- Royal Australasian College of Surgeons. Code of Ethics: September 1993. Arch Surg. 1996;131(8):900–1. PMID: 8712917
- Petrini C. On the tenth anniversary of the “Universal Declaration on Bioethics and Human Rights”. Clin Ter. 2015;166(6):236–7. DOI: 10.7417/CT.2015.1893
- Muthuswamy V. Ethical issues in clinical research. Perspect Clin Res. 2013;4(1): 9–13. DOI: 10.4103/2229-3485.106369
- Royal College of Obstetricians and Gynaecologists. Obtaining valid consent. Clinical Governance Advice No. 6. London: RCOG; 2015. Online resource https://www.rcog.org.uk/en/guidelines-research-services/guidelines/clinical-governance-advice-6/.
- General Medical Council. Good Medical Practice. Manchester: RCOG; 2013. Online resource https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-medical-practice
- Scally G, Donaldson LJ. Clinical governance and the drive for quality improvement in the new NHS in England. BMJ. 1998;317(7150):61–5. DOI: 10.1136/bmj.317.7150.61
- Masic I, Miokovic M, Muhamedagic B. Evidence based medicine-new approaches and challenges. Acta Inform Med. 2008;16(4):219–25.
- Smith R, Rennie D. Evidence-based medicine-an oral history. JAMA. 2014;311(4):365–7. DOI: 10.5455/aim.2008.16.219–225
- Williamson PO, Minter C. Exploring PubMed as a reliable resource for scholarly communications services. J Med Libr Assoc. 2019;107(1):16–29. DOI: 10.5195/jmla.2019.433
- Evans I, Thornton H, Chalmers I, Glasziou P. Testing Treatments: Better Research for Better Healthcare, 2nd edition. London: Printer and Martin; 2011. PMID: 22171402
- Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009;339:b2700. DOI: 10.1136/bmj.b2700
- Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. DOI: 10.1136/bmj.c332.
- Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative: standards for reporting of diagnostic accuracy. Clin Chem. 2003;49(1):1–6. DOI: 10.1373/49.1.1
- von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. STROBE initiative. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ. 2007;335(7624):806–8. DOI: 10.1016/j.jclinepi.2007.11.008
- NHS Litigation Authority. Ten years of maternity claims: An analysis of NHS litigation authority data. London: NHSLA; 2012. Online resource https://resolution.nhs.uk/resources/ten-years-of-maternity-claims-an-analysis-of-nhs-litigation-authority-data/
- Royal College of Obstetricians and Gynaecologists. Improving patient safety: risk management for maternity and gynaecology. Clinical Governance Advice No. 2. London: RCOG; 2009. Online resource https://www.rcog.org.uk/en/guidelines-research-services/guidelines/clinical-governance-advice-2/
- National Patient Safety Agency. (2010). Root cause analysis: fishbone template. Online resource https://improvement.nhs.uk/documents/2093/cause-effect-fishbone.pdf
- Lucas DN, Bamber JH. UK Confidential enquiry into maternal deaths-still learning to save mothers' lives. Anaesthesia. 2018;73(7):407–20. DOI: 10.1111/anae.14246
- Congdon R. A new confidential enquiry. CEMD, CESDI and CEMACH. Pract Midwife. 2003;6(3):36–7. PMID: 12677842
- Rosser J. Confidential Enquiry into Stillbirths and Deaths in Infancy (CESDI). Highlights of the 6th annual report. Pract Midwife. 1999;2(9):18–9. PMID: 10723409
- Beasley JW, Damos JR, Roberts RG, Nesbitt TS. The advanced life support in obstetrics course: a national programme to enhance obstetric emergency skills and to support maternity care practice. Am J Obstet Gynecol. 2007;196(5):PE27–E28. DOI: 10.1001/archfami.3.12.1037
- Johanson RB, Menon V, Burns E, Kargramanya E, Osipov V, Israelyan M, et al. Managing obstetric emergencies and trauma (MOET) structured skills training using models and reality-based scenarios. BMC Med Educ. 2002;2(1):5. DOI: 10.1186/1472-6920-2-5
- Sibanda T, Crofts JF, Barnfield S, Siassakos D, Epee MJ, Winter C, et al. PROMPT education and development: saving mothers' and babies lives in resource-poor settings. BJOG. 2009;116(6):868–9. DOI: 10.1111/j.1471-0528.2009.02117.x
- Johannsson H, Ayida G, Sadler C. Faking it? Simulation in the training of obstetricians and gynaecologists. Curr Opin Obstet Gynecol; 2005. pp. 17557–61. DOI: 10.1097/01.gco.0000188726.45998.97
- Royal College of Obstetricians and Gynaecologists, Royal College of Midwives. The Clinical Learning Environment and Recruitment. Report of a Joint Working Party. London: RCOG Press; 2008. Online resource https://aim25.com/cats/7/10795.htm
- Ziv A, Ben-David S, Ziv M. Simulation based medical education: an opportunity to learn from errors. Med Teach. 2005;27(3):193–9.
- Royal College of Obstetricians and Gynaecologists, Royal College of Anaesthetists, Royal College of Midwives, Royal College of Paediatrics and Child Health. Safer Childbirth: Minimum Standards for the Organisation and Delivery of Care in Labour. London: RCOG Press; 2007. Online resource https://www.rcog.org.uk/en/guidelines-research-services/guidelines/safer-childbirth-minimum-standards-for-the-organisation-and-delivery-of-care-in-labour/
- Kirkpatrick D. Techniques for evaluating training program. J Am Soc Training Dev. 1959;13:21–6. Online resource https://www.scirp.org/(S(i43dyn45teexjx455qlt3d2q))/reference/ReferencesPapers.aspx?ReferenceID=1735231
- Rouse DN. Employing Kirkpatrick's evaluation framework to determine the effectiveness of health information management courses and programs. Perspect Health Inf Manag. 2011;8(Spring):1c. PMID: 21464860
- Duthie SJ, Garden AS. The teacher, the learner and the method. Obstet Gynaecol. 2010;12:273–80. https://doi.org/10.1576/toag.12.4.273.27620
- Raphael Dias de Mello P, Neide Aparecida Titonelli A. Delphi technique in dialogue with nurses on acupuncture as a proposed nursing intervention. Escola Anna Nery. 2015;19(1):174–80. Online resource https://www.scielo.br/scielo.php?pid=S1414-81452015000100174&script=sci_abstract&tlng=en
- Harrison MR. Unborn: historical perspective of the foetus as a patient. Pharos Alpha Omega Alpha Honor Med Soc. 1982;45(1):19–24. PMID: 7036194
- Office of the Public Guardian. Mental Capacity Act Code of Practice. London: TSO; 2016. Online resource https://www.gov.uk/government/publications/mental-capacity-act-code-of-practice
- Markova V, Sørensen JL, Holm C, Nørgaard A, Langhoff-Roos J. Evaluation of multi-professional obstetric skills training for postpartum hemorrhage. Acta Obstet Gynecol Scand. 2012;91(3):346–52. DOI: 10.1111/j.1600-0412.2011.01344.x
- Nielsen PE, Goldman MB, Mann S, Shapiro DE, Marcus RG, Pratt SD, et al. Effects of teamwork training on adverse outcomes and process of care in labour and delivery: a randomized controlled trial. Obstet Gynecol. 2007;109(1):48–55. DOI: 10.1097/01.AOG.0000250900.53126.c2
- Siassakos D, Crofts J, Winter C, Draycott T. Multiprofessional ‘fire-drill’ training in the labour ward. Obstet Gynaecol. 2009;11:55–60. DOI: 10.1576/toag.11.1.55.27469
- Ameh CA, Mdegela M, White S, Broek NV. The effectiveness of training in emergency obstetric care: a systematic literature review. Health Policy Plan. 2019;34(4):257–70. DOI: 10.1093/heapol/czz028