How do we know we are doing a good job?

There was no systematic mechanism for monitoring the clinical performance of healthcare professionals or of hospitals. For the future there must be effective systems within hospitals to ensure that clinical performance is monitored. There must also be a system of independent external surveillance to review patterns of performance over time and to identify good and failing performance. (www.bristol-inquiry.org.uk/)

The audit cycle

Audit is a form of quality improvement that aims to improve clinical care by critically examining existing practice and identifying any areas for concern. The necessary steps involve:

What’s the difference between audit, service evaluation and research?

Unlike research, audit by definition is not designed to obtain new evidence but rather compares actual performance with some agreed level of quality standards. The findings may be unique to the individual hospital or health care system and not generalisable to other situations. Its aim is to improve health care delivery rather than identify new risk factors or new interventions that work. It is concerned with the appropriate implementation of evidence or consensus based guidelines rather than their development. It usually uses existing data rather than collecting new data though the process of extracting that data may be similar to that used in research. Service evaluation can be considered even one stage earlier than audit as its primary purpose is simply to measure what and how services are actually delivered without reference to any specific quality standard as in audit. Both audit and research, however, may have ethical implications (see below) though usually audit and service evaluation do not require formal ethical review by a research ethics committee. Appendix 14.1 highlights the differences between research, audit and service evaluation.

Figure 14.1 Cross-sectional statistical process control chart showing the control of phosphate level in patients on renal replacement therapy across different renal units in the United Kingdom. The x-axis indicates whether the unit is large or small and the graph shows different confidence intervals so one can infer the probability that the result may have occurred by chance. There are four high performing units and one low performing unit outside the 99.9% confidence limits.

Source: taken from Hodsman A, Ben-Shlomo Y, Roderick P et al. (2011) The ‘centre effect’ in nephrology: what do differences between nephrology centres tell us about clinical performance in patient management? Nephron Clin Pract 119: c10–c17. Reproduced with permission from S. Karger AG Basel.

Ethical issues

Research ethics can be defined as the sustained analysis of motives of, procedures for and social effects of biomedical research (Murphy, 2004, p. 1). Any clinical, biomedical, epidemiological or social-science research which involves direct contact with NHS patients or healthy participants should be undertaken in accordance with commonly agreed standards of good ethical practice. The Declaration of Helsinki, first written in 1963 by the World Medical Association, lays down a set of ethical principles for medical research. The fundamental and widely accepted ethical principles can be broadly classified as:

• Beneficence (to do good)
  
• Nonmaleficence (first, do no harm)
  
• Autonomy (individual’s right to choose)
  
• Justice (fairness and equality)
  
• Truthfulness (informed consent, confidentiality)

Historical events, such as the Nuremberg Trials (Nazi doctors experimented on prisoners under the pretext of medical research) and the Tuskegee syphilis study (where African-American men with syphilis were never asked for consent and had penicillin knowingly withheld after its introduction so that doctors could study the natural history of the disease), led to the need for a statement of ethical issues in research, such as the Declaration of Helsinki, and for arrangements for the ethical review of proposed research in order to protect the research participants and promote high-quality research.

For research involving patients of the United Kingdom National Health Service (NHS), their tissue or their data, ethical review and favourable ethical opinion is sought prospectively from an NHS Research Ethics Committee. Research undertaken by academic staff or students involving participants outside of the NHS should be reviewed by ethical committees within the host Higher Education Institution. Ethical review must occur before any research related activity takes place. Other developed countries have different but equivalent bodies such as Institutional Review Boards (IRBs) in the United States or Independent Ethics Committees. Ethics committees must not only consider key ethical aspects of the research but also its validity; poor quality research can be unethical because it may have no benefit in terms of new knowledge whilst have some risk for the participants. It may also put future participants at harm if the research is misleading (for example the scare concerning MMR vaccination and risk of autism leading to a decline in population vaccination rates)

Ethical issues in Randomised Controlled Trials (RCTs)

All research studies raise ethical issues, such as participant confidentiality. However RCTs involve more difficult issues than observational studies, because they mean that the choice of treatment is not made by patients and clinicians but is instead devolved to a process of random allocation. This means that a patient in an RCT may receive a new untested treatment, or not be able to choose a new active treatment if allocated to the placebo group.

Before one can undertake an RCT, the health professionals treating the patients must be uncertain about whether the treatments being evaluated are better, worse or the same as any existing treatment or a placebo. This is called clinical equipoise. If there is existing evidence that a new treatment is superior then clinicians should not participate. However, in reality, most clinicians will have some preference or ‘hunch’ that one treatment is better than another, but they will need to suspend these views to conduct an RCT to provide clear evidence. Often, RCT results are different from clinicians’ hunches. For example a recent large RCT of a drug that inhibits the cholesteryl ester transfer protein (CETP) and raises HDL-cholesterol, associated with a reduced risk of heart disease, actually found an increased risk of cardiovascular events. Despite improving HDL-cholesterol, it was unclear why patients on active treatment had a higher mortality rate though the drug did unexpectedly raise the participants’ blood pressure (Barter et al., ).

As described in more detail below patients must give informed consent to participate in an RCT and must understand that the treatment they receive will be determined by chance through randomisation. If one of the treatments is a placebo group then the patients must know this. They should not be coerced to take part or given financial incentive other than any expenses that arise from participation. Even if they consent to participate, they are entitled to withdraw from the study at any time and this should in no way compromise their future treatment. For informed consent to be ethically valid the investigator must disclose all risks and benefits and the participant must be competent to understand this. Independent research ethics committee must review and approve studies before they are undertaken.

One special aspect of RCTs is the use of ‘sham’ procedures to maintain blinding. In a drug trial it is usually straightforward to create an identical looking placebo so that participants cannot tell whether they are taking the active or placebo medication. This is more complex for nonmedical interventions, especially surgical interventions. In this case a sham procedure may be used though this may have risk in itself. For example, a RCT of foetal nigral transplantation for Parkinson’s disease randomised patients to the insertion of aborted material using stereotactic surgery. The placebo group underwent the same procedure and had partial burr holes made in the skull but no needle or foetal material was inserted (Olanow et al., ).

Ethical issues in observational studies

Observational studies are usually less problematic and of lower risk as the researchers simply measure characteristics of the participants using questionnaires, tissue, imaging or physiological measures. One issue that may arise in such studies is opportunistic identification of clinical abnormalities and it is good practice to have an explicit protocol for how these will be handled as well as obtaining consent from the participants as to whether they would wish to have this information feedback to them and/or their general practitioners. For example many epidemiological studies will measure blood pressure and there are clear evidence-based guidelines on what constitutes a level worthy of treatment if it is sustained over several readings or over a 24-hour period. However, studies of MRI brain imaging in the elderly will find a high prevalence of asymptomatic brain infarcts (around 18% in subjects between 75 and 97 years in the Rotterdam study). In this case it is less clear that feeding back abnormal results is helpful as it may cause participant anxiety without necessarily any improvement in health care (Vernooij et al., ).

Informed consent

Informed consent is at the heart of ethical research. Most studies involving individuals must have appropriate arrangements for obtaining consent from potential research participants. Informed consent must be:

• voluntary and freely given;
  
• fully informed;
  
• recorded in writing or some other means if there are literacy issues.

Potential participants should be given a written information sheet and informed consent form, which has received approval from a relevant research ethics committee. The written information sheet should contain the following elements: why they have been selected, what is the purpose of the research, what will happen to them if they agree, any risks or benefits, how their information will be kept confidential, what if something goes wrong, how to find out further information.

Obtaining informed consent should be seen as a process of communication and discussion between researcher and participant. The researcher has a duty to ensure the participant truly understands what is being asked of them, and that they are willing to voluntarily give full, informed consent. Researchers should be very careful not to coerce the participant or to emphasise the potential benefits, nor attempt to minimise the risks or disadvantages of participation. Coercion may be implicit rather than explicit if the recruiting clinician has a long standing relationship with the patient who may find it hard to refuse the invitation. Participants have the right to ask questions of the researcher, and be given reasonable time to consider their decision to participate before confirming their willingness to participate both verbally and in writing. All participants must have given informed consent before any aspect of the research starts.

Vulnerable groups (children and incapacitated adults)

Children

Informed consent must be obtained from the child’s parent (or legal guardian) as appropriate. When parental consent is obtained, the assent (voluntary agreement) of the child should also be sought by researchers, as appropriate to the child’s age and level of understanding. A full explanation of the research must be given to the parent (or legal guardian) of the child, in accordance with the principles described earlier, including the provision of written information and opportunity for questions and time for consideration. The parent (or legal guardian) may then give informed consent for the child to participate in the study.

The child should also be given information about the research. This will be age-appropriate and offered according to the child’s level of understanding. Often the use of visual aids or cartoons can explain basic information for young children. Verbal assent should be sought from the child, and recorded in the research notes, as well as the child’s medical record (for clinical trials). Older children may wish to sign a consent form. For children over the age of 16 this would constitute legally valid consent.

Written information provided to children should be written in age-appropriate language that the child could understand. Different versions of the research information should therefore be produced for different age ranges e.g. under 5s, 6–12 year olds, 13–15 year olds and over 16.

Incapacitated adults

Incapacitated adults do not have mental capacity to make decisions for themselves. This may be because of unconsciousness, mental illness, or other causes, to the extent that the person does not have sufficient understanding or ability to make or communicate responsible decisions. Special arrangements exist to ensure the interests of incapacitated adults recruited into research studies are protected. For investigational medicinal product (drug) trials, or trials of medical devices in England, Wales and Northern Ireland the provisions for inclusion of incapacitated adults are laid down in the Medicines for Human Use (Clinical Trials) Regulations 2004 and as amended. In Scotland, these regulations and also the Adults with Incapacity (Scotland) Act 2004 (regulations 4 to 16 and Parts 3 and 5 of Schedule 1) will also apply. Such requirements are considered suitable for other types of clinical research.

When considering a patient who is unable to consent for themselves for suitability for a trial, the decision on whether to consent to, or refuse, participation in a trial will be taken by a legal representative who is independent of the research team and should act on the basis of the person’s presumed wishes. The type and hierarchy of legal representative who should be approached to give informed consent on behalf of an incapacitated adult prior to inclusion of the subject in the trial is given in Table 14.1 (note that arrangements for Scotland are slightly different).

Table 14.1 Type and hierarchy of legal representative who can give informed consent on behalf of an incapacitated adult prior to inclusion of the subject in the trial.

The appropriate legal representative should be provided with an approved Legal Representative Information Sheet and Legal Representative Informed Consent Form to document the consent process.

The consent given by the legal representative remains valid in law even if the patient recovers capacity. However, at this point, the patient should be informed about the trial and asked to decide whether or not they should continue in the trial, and consent to continue should be sought.

Research governance

Research governance can be defined as the broad range of regulations, principles and standards of good practice that exist to achieve, and continuously improve, research quality across all aspects of health care in the UK and worldwide. In the UK, the Department of Health published the first Research Governance Framework for Health and Social Care in 2001, and this was updated in 2005 and sets out to:

• safeguard participants in research;
  
• protect researchers/investigators (by providing a clear framework to work within);
  
• enhance ethical and scientific quality;
  
• minimise risk;
  
• monitor practice and performance;
  
• promote good practice and ensure lessons are learned.

Research governance includes research that is concerned with the protection and promotion of public health, undertaken in or by the Department of Health, its non-Departmental Public Bodies and the NHS, or within social care agencies. It includes clinical and nonclinical research; and any research undertaken by industry, charities, research councils and universities within the health and social care systems. Everyone who undertakes health-care research (research involving individuals, their tissue or their data) therefore has responsibilities for research governance. This includes lead researchers, research nurses, students undertaking research, as well as NHS organisations where research takes place and universities who may employ or supervise researchers or act as sponsor organisations.

Research governance should be considered at all stages of the research, from the initial development and design of the research project, through it’s set-up, conduct, analysis and reporting. Researchers need to ensure that:

• day to day responsibility for elements of each research project is clearly stated;
  
• research follows the agreed protocol;
  
• research participants receive the appropriate care while participating in the research;
  
• data protection, integrity and confidentiality of all records is intact;
  
• reporting adverse incidents or suspected misconduct is undertaken.

Research governance approval is required from any NHS Trust before the research can take place on their premises, or access patients, their tissue or their data. All research documents such as research protocol, participant information sheets and informed consent forms, details of NHS Research Ethics Committee approval, researcher CV are submitted for governance checks. Current systems for multi-centre research review the research governance compliance at a nominated lead NHS Trust, and local information only is submitted to the local NHS Trusts. The Integrated Research Application System (www.myresearchproject.org.uk) is used for submission of research information to NHS Research Ethics Committees as well as NHS research governance approval.

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