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ith education being one of the four pillars of advanced

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clinical practice, ACPs can often find themselves involved

in teaching junior colleagues. Having a basic understanding of how learning happens and how teaching can support this process can assist healthcare professionals in creating an effective educational environment.

Constructive alignment

Constructive alignment is the process of ensuring that an educational encounter or programme achieves that which it intends to. It does this by encouraging educators to consider three key areas.

•

First, the intended learning outcomes (ILOs) should be set. These should help the learner and educator to be clear on what they are expected to achieve from the session and should utilise verbs to help learners know what action they need to take for successful completion (e.g. ‘explain’, ‘demonstrate’ or ‘describe’).

•

Second, the teaching activities should be planned with consideration of how they will help learners to achieve the ILOs. Educators should consider how the format of the activity contributes to the overall aims of the session. For example, is the session best as a one- to- one, small group or larger session? Should it be teacher led or student centred? What should the session cover?

•

Finally, the educator should consider how to assess successful completion of the session. For this, they should refer to the verbs

used in the ILOs to ensure that the expectations match the reality. By using constructive alignment to provide the link between learning and assessment, learners are empowered to understand the expectation upon them from an educational encounter, therefore having the opportunity to actively demonstrate the depth of their knowledge, not merely answer simple questions (see Bloom’s taxonomy of learning– Figure47.1).

Ensuring learning is appropriate

The primary purpose of education is to ensure that learners develop in their knowledge, skills and understanding of a specific subject area or task. For this reason, it is essential that educators ensure that the expected level of attainment is appropriate to the student’s stage of learning and competence.

The comfort model describes the importance of ensuring that a teaching encounter provides learners with an adequate level of stretch to encourage their development without the contents or expectations being so excessive that learning is hindered by panic. Likewise, the model suggests that teaching mediums should be planned so that learning is sufficient to ensure that students do not remain in an area where they are already comfortable in their knowledge base.

Vygotsky’s model of the sociocultural theory of human learning describes learning as a social process and the origination of human intelligence in society or culture (Figure47.2). The major theme of Vygotsky’s theoretical framework is that social interaction plays a fundamental role in the development of cognition. Vygotsky believed everything is learned on two levels: first, through interaction with others, and then integrated into the individual’s mental structure. Every function in the person’s cultural development appears twice: first, on the social level, and later, on the individual level; first, between people (interpsychological) and then inside the person (intrapsychological). This applies equally to voluntary attention, to logical memory and to the formation of concepts. All the higher functions originate as actual relationships between individuals.

A second aspect of Vygotsky’s theory is the idea that the potential for cognitive development is limited to a ‘zone of proximal development’ (ZPD). This ‘zone’ is the area of exploration for which

the student is cognitively prepared but requires help and social interaction to fully develop. A teacher or more experienced peer can provide the learner with ‘scaffolding’ to support the student’s evolving understanding of knowledge domains or development of complex skills. Collaborative learning, discourse, modelling and scaffolding are strategies for supporting the intellectual knowledge and skills of learners and facilitating intentional learning.

Experiential learning andconstructivism

Kolb’s learning cycle (Figure47.3) demonstrates the process that learners take in gaining new knowledge and skills and is particularly pertinent to healthcare education due to the benefits of experiential learning and reflection in skills acquisition and its prominence within the simulated learning environment. Kolb’s experiential learning theory works on two levels: a fouring and four separate learning styles. Much of Kolb’s theory is concerned with the learner’s internal cognitive essence of Kolb’s theory is a description of the learning process, which is defined as a fourlearning cycle begins at any one of these four stages, but the following is the sequence most often suggested for the learning process.

1 Concrete experience: the learning process begins with the

learner actively carrying out an experience/activity.

2 Reflective observation: following the Concrete Experience

stage, the learner consciously reflects on that experience.

3 Abstract conceptualisation: the learner attempts to understand

the general principles under the experience, trying to conceptualise a theory, model or hypothesis of what is observed.

4 Active experimentation: the learner trys to determine how to

test a model, theory and/or plan for new experiences, probably

with different behaviours. The cycle consists of four areas which allow learners to skill or participate in an experience followed by the opportunity to reflect upon their performance. Following their reflection, they can consider the new concepts which they have observed and begin to use these within practice, hence beginning the cycle anew. This cycle suggests that learners are always looking to develop and improve their skills, and as such it can be beneficial for educators to view it as a spiral rather than a circle, whereby the learner never returns to the start of the cycle but relearning process from a more advanced starting point, thus deepening their knowledge in a manner that allows new learning to be constructed upon previously gained knowledge.

This concept can be utilised effectively by advanced clinical practitioners (ACPs) looking to provide an effective learning experience through the concept of a spiral curriculum. This means that when learners are attending a study programme or learning skills, areas of learning should be continuously revisited to provide reinforcement and development of more complex levels of understanding and competence. For example, if a trainee ACP is learning line insertion in the intensive care unit (ICU), they may begin with a straightforward insertion, whereby the supervisor controls the ultrasound and obtains the initial puncture. With time, the spiral curriculum would allow the learner to improve their understanding and ability by taking on more complex components of the procedure or attempting cannulation of more difficult vessels, with the supervisor continuing to revisit areas of prior learning to reinforce and build upon the learner’s ability.

This process of students building on their existing knowledge to enable ongoing learning is known as constructivism. Constructivist pedagogy redefines the roles and intertheir teachers through the creation of a nurturing environment.

stage continuum cycle. The four- stage

stage cycle of learn-

processes. The

practise a

employs the

relationships of students and

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Part 6Advanced clinical practice education

Simulated learning anddecision- making theories

Table48.1 Considerations when planning touse SBE asan education tool. Source: Forrest K, McKimm J, Edgar S (2013) Essential Simulation in Clinical

Education. Wiley, Chichester.

✓ Key points

•

Simulation has a long history with its development closely tied to technological advances in computer and materials science

•

Simulation is now recognised as adding value to training and education and enabling practice of a range of skills and competencies in a safe environment

•

Many countries and regions have established simulation centres, although these are inequitably distributed around the world

•

Simulation- based education enables the delivery of a continuum of learning throughout a doctor’s career

•

More research is needed to determine the impact of simulation training on improving health outcomes

✓ Key points

•

Simulation- based training is needed due to changes in healthcare organisations, patient safety issues and challenges with clinical training

•

Simulation- based training appears to be an appropriate learning technique for the training of clinical and non- technical skills

•

It enables deliberate and repetitive practice and encourages structured feedback

•

Simulation- based training is educationally effective and can complement clinical training, but needs to be embedded and integrated into curricula, not a bolt- on

•

Skills learned in the simulated environment are transferable to the real clinical environment

✓ Key points

•

Understanding learning theories helps instructors design, run and evaluate effective simulation- based training

•

The context of simulation- based learning contributes significantly to creating, recognising and using learning opportunities

•

Different theoretical aspects apply to different practical teaching and learning strategies

•

The starting point is always to define the required learning outcomes and learners’ needs, then design the simulation session to include activities to help learners achieve the outcomes

•

Building in time for ongoing feedback and debriefing is essential to optimise learning

•

High fidelity is not necessarily vital as long as participants are willing to suspend their disbelief

✓ Key points

•

Non- technical skills (NTS) are the cognitive and social skills used by experienced professionals to deliver a high- quality and safe clinical performance

•

Scenario- based simulation training provides the optimal environment in which to explore and highlight NTS

•

When using simulation for teaching NTS, scenarios must include learning objectives in the NTS domain and be designed accordingly

•

Embedding NTS into scenario design will enhance the learning and development gained by healthcare professionals from engagement with simulated practice

•

Crew resource management key points provide an excellent platform to begin focusing on generic non- technical aspects of performance in scenario design

ISTUDY

imulation- based education (SBE) is used to replicate clinical

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practice settings and scenarios, in order that clinicians and

learners can carry out tasks of varying complexity in a safe and supported environment and improve their learning. Students have the opportunity to put into practice skills they have learnt, in a realistic setting, and then afterwards take part in structured debriefing of the simulation in order that they, and other participants, can learn from what has taken place. This moves us on from the historical ‘see one, do one, teach one’ educational method used in healthcare settings in the past.

There are a number of considerations when planning to use SBE as an education tool. Table48.1 explores these in more depth in addition to this chapter.

Why use simulation- based education?

Medical error is currently the 14th leading cause of death in the world, and in the UK we harm approximately one in 20 of our patients through, often avoidable, human errors. Medication errors in England alone account for 1700lives and £98 billion in costs to the NHS, as over 237million medication errors are made per year. A number of human factors, including decision making, situational awareness, communication and teamworking, can be observed. These are then discussed in the debrief using a technique of ‘advocacy with enquiry’, exploring why learners feel the way the way do, how decisions were made, and how they felt they behaved. This gives learners the opportunity to undertake stressful, complex or rarely seen scenarios, so that when a similar experience occurs in clinical practice, they feel better prepared for it.

How touse simulation- based education

Any simulation should be designed with a set of learning objectives. These objectives may be mapped to a curriculum, a highlighted learning need within clinical practice or to look at specific elements of behaviour, such as decision making, for example. A number of factors then need to be considered in the planning, as evidence shows that poorly designed simulation can have negative impacts on learners.

Once the learning objectives have been set, scenario design can be undertaken. There are a number of different factors to consider, such as the use of technology or manikins, through to whether or not to use simulated patients (SPs), who may be specially trained actors or members of faculty who undertake the role of the patient within the scenario. Plans need to be made for what may happen throughout the scenario. For example, what will the patient’s physiological observations do if an intervention is made by the learner? You may also want to use a ‘plant’ within

your scenario– a member of faculty who is there to ensure the scenario plays out to the learning objectives and can interact with the learner and steer them in a certain way.

However your scenario is designed, it is important to ensure realism where possible. The learner should always be there in their own role, not asking an ACP to play the part of a consultant, for example. To add to this realism, it is useful to ask learners to attend in their own work clothing, so they feel immersed in the situation. Any tasks undertaken or tests requested should be done in real time and results then fed back appropriately.

When planning your scenario, it is important to ensure you have ‘escape plans’ in place in case the learner behaves differently from how you would have expected, as stopping the scenario may have a detrimental effect on learning.

The debrief should then take place immediately after the scenario, with the learner, facilitator and any observers. It may also be useful for learning to have some input from simulated patients, if used, as they can provide insight into how they felt the learner behaved and how the communication was. The time ratio of scenario to debrief should be 1:2, so a 10- minute simulation will need a 20takes place. Those debriefing a simulation should have had appropriate training as, as with the simulation itself, poor debriefing can have a negative impact on learners.

minute debrief. This is where the majority of learning

Decision making insimulation

One of the things that can be closely examined during simulation scenarios is the learner’s ability to make decisions, and how this was done. An element which commonly has an impact on a clinician’s ability to make a decision is stress, as stress can limit the use of shortlongStress is unfortunately commonplace in modernbut we get very little training in how to deal with it.

Stress inoculation testing (SIT) is well documented to work in the training of military, athletes and emergency response teams. We can use simulation to replicate stressful scenarios in clinical practice, ranging from cardiac arrest resuscitation to working with unco- operative colleagues, adding in time pressures and distractions. In doing so, we can examine how the stress of these situations affects the learner, and then later in the debrief look at how these factors were dealt with and, importantly how they can be overcome in future situations. Trials looking at how this training affected those dealing with stressful situations regularly in emergency healthcare settings found that using repeated stress exposure training over a period of time lead to an improvement in how clinicians were able to respond and continue despite the stress of the situation.

term cognition and affect how this interacts with

term memory to process the situation in front of them.

day healthcare

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Chapter 48Simulated learning anddecision- making theories

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Part 6Advanced clinical practice education

Integrating simulation andvirtual reality into clinical practice education

Figure49.1 ASPiH Standards for Simulation- based Education in Healthcare. Source: https://ebsltd.wpengine.com/wp- content/

uploads/2017/07/pamphlet.pdf

Figure49.2 Schematic illustration of virtual reality, merged reality and augmented reality. Source: Parida K etal. (2021)/John

Wiley & Sons

ISTUDY

imulation can be used to replicate clinical scenarios without

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exposing patients to risk. There is limited evidence for the

use of simulation in advanced practice education but studies have also shown that the use of best practice in simulationeducation at curriculum design level improves learning.

based

Standards forsimulation- based education

The Association for Simulated Practice in Healthcare (ASPiH) has a framework of standards which describes the attributes required to design and deliver simulation intended to provide quality assurance to providers, regulators, healthcare professionals and governing bodies. By following the ASPiH standards framework, simulation providers can ensure they are using evidence- based practice under four themes.

The first theme is faculty, guaranteeing that those delivering are appropriately trained to a high standard in education and simulation, and that subject matter experts oversee simulation programmes. This also includes ensuring that faculty are trained in debriefing and highlights the need to ensure a safe learning environment is maintained for learners. The second theme of technical personnel calls for simulation technicians to be registered with the Science Council.

Theme three is activity. This prescribes the mapping of simulation to curricula or learning needs analysis undertaken in clinical practice. The activity theme also recommends regular review of programmes and oversight by appropriate faculty to ensure content and relevance is maintained. The fourth and final theme, resources, recognises the need for appropriate training environments. This also links in with the Department of Health Technology Enhanced Learning (TEL) framework out a clear vision for the use of TEL across health and social care to produce improved patient outcomes, safety and experience.

(Figure49.1). This framework is

which sets

Curriculum design

When developing simulations as part of a curriculum, it is important to have an established set of learning outcomes. Learning objectives should be achievable and set at an appropriate level for the learners. For simulation to be effective, the skills needed within the scenario should have already been taught to the candidates. There should also be consideration of how human factors will be incorporated into the scenario, such as teamworking, communication and decision making. The learners should be aware of the learning outcomes or the focus of the

scenario, for example conflict resolution, prior to the scenario starting so that they are aware of what is being measured.

Virtual reality (VR) inhealthcare education

The use of simulation in healthcare education has grown exponentially in the last decade, in particular the use of VR. VR is one of a number of technology(Figure49.2). VR uses software to create immersive simulated environments which can range from a fully equipped clinical environment to the cytoplasm within a human cell. A large body of evidence supports VR simulation in all industries and more recently healthcare. VR helps to promote knowledge acquisition and skill acquisition combined and as such has been shown to be effective in ensuring patient safety during high- stakes clinical scenarios such as complex surgery or timeplethora of evidence to support the notion that VR can significantly improve learner performance, particularly in fields such as aviation, leading to reduction in potentially harmful mistakes being caused as a result of human error.

The environment created by VR is largely computer generated, with the more complex technologies requiring highcomputing equipment to run the software. The computergenerated environment offered by VR has classically been viewed as offering limited interaction between the user and the simulated environment, unlike merged reality technologies. However, developments in technologies specifically aimed at healthcare education have seen platforms such as OMS Medical, developed by Oxford Medical Simulation, fully integrating artificial intelligence capabilities within their software to drive patient behaviours. This allows the user to communicate, examine and treat a variety of patients presented to them. The integrated adaptive patient physiology and pharmaceutical modelling also give intuitive feedback on treatment decisions.

Although there is evidence to support the use of VR in healthcare education, there has been a call for greater standardisation of how to use immersive technologies in healthcare training and education. In the absence of national guidance, facilitators are encouraged to follow similar principles to ASPiH, particularly in terms of curriculum development, setting robust learning objectives, providing appropriate training for facilitators and applying the same evidence- based debriefing principles that should be applied to other simulation activities.

enhanced teaching modalities available

critical emergency scenarios. There is a

spec

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Chapter 49Integrating simulation andvirtual reality into clinical practice education

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Part 6Advanced clinical practice education

The advanced practitioner asclinical educator andsupervisor

Figure50.1 The relationship of assessment strategies to educational hierarchical models. Source: Adapted from

Work-based assessment

Simulation

Knowledge-

based

assessment

Assessment Type

Figure50.2 Pendleton’s feedback model. Source: Chowdhury RR, Kalu,

G.(2004) Learning to give feedback in medical education. Obstetrician & Gynaecologist, 6, 243–247/John Wiley & Sons

Self-assessment by learner to acknowledge what was done well

What was done well reinforced by facilitator group

Creating Does

Evaluating

Analysing

Applying

Understanding

Remembering

Bloom’s Taxonomy

Shows How

Knows How

Knows

Miller’s Hierarchy

Figure50.3 ALOBA principles. Source: Chowdhury RR, Kalu, G.(2004)

Learning to give feedback in medical education. Obstetrician & Gynaecologist, 6, 243–247/ John Wiley & Sons

Learner reflects and acknowledges areas he needs help with

Tasks/goals that need to be achieved – identified

Ta sk assumes a learning exercise for learner and facilitator

DOPS, portfolios,

Mini-CEX, CBD

OSCEs

VIVA, Written

Assessment tools

15,16

exams

MCQs

Skills used to achieve successful outcomes discussed

Self-assessment by learner–what could have been done better – analyses alternative skills

Facilitator/group suggests alternative skills if necessary

Learner feedback to the facilitator – content of feedback and skills

Facilitator praises achievements, introduces theories

Learner and facilitator suggest skills to achieve outcome

Rehearsal of skills used to achieve outcome

Facilitator summarises skills to achieve outcome

ISTUDY

s a registered healthcare professional, the advanced clinical

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practitioner’s (ACP) ongoing responsibilities for supporting

and mentoring junior and undergraduate healthcare col-

leagues are well documented.

1–3

However, there is the extended privilege of supporting ACP and junior medical colleagues in their educational and professional journey. Alongside involvement in teaching (see Chapter47), the skills of the educational supervisor should also include effective assessment, feedback and communication.

What is workplace- based assessment?

Workplace- based assessments cover evaluation of more than technical skills, allowing learners to develop their abilities in situational awareness, communication and teamwork. Bloom’s tax-

(Figure50.1) provides a useful tool to help educators to

onomy understand the progression of learners’ cognition from basic factual recall through to the ability to evaluate and consider their

technical abilities within a changing, patient- centred envi-

nonronment. Indeed, evidence has shown that when students excel in their understanding and application of knowledge within exam settings, they have a stronger basis on which to achieve the higher levels of Bloom’s hierarchy within work-

based practice.

Bloom’s taxonomy should be considered alongside the work

of Miller a supporting framework for assessment. As with Bloom,

(see Figure50.1) who similarly proposed a pyramid as

progression up the hierarchy comes from continued development from a basic recall of information to being deemed an expert. Miller notes that achievement at a higher level also implies that the learner has achieved the lower levels of attainment; therefore, a learner who has successfully completed a work- based assessment and achieved the level of ‘do’ would be assumed to have the prerequisite level of competence that would otherwise need to be assessed in knowledge-

based forms of assessment. It can therefore be argued that the highest level of Miller’s pyramid should reflect what the learner does in practice using assessment tools including DOPS, miniCEX and case-

based discussions, rather than in simulated settings such as in the OSCE environment, in order to provide an understanding of their established practice.

Feedback

It is believed that workplace- based assessments on their own have limited effect on the performance of learners, with the biggest drivers in improvement being the coaching and feedback received rather than the preparatory work or assessments themselves.

Feedback is the process whereby someone, usually an assessor, provides their perspective on the performance of someone else in order to improve their abilities. This process is often learner centred, allowing them to interpret information intended to empower them to evaluate and enhance their future performance and as such, learners should play a vital role within the provision of feedback. Indeed, studies have demonstrated that feedback is most effective when learners are motivated to receive it and empowered to act upon it, and when feedback is timely, addresses a specific task and is sufficiently objective to give the learner the means to act upon it.

8,9

Ende’s guidelines foreffective feedback

Ende established a set of clinical principles for providing effective feedback, fective and is often confused with the process of evaluation,

believing that feedback can otherwise be inef-

meaning that mistakes do not get rectified and clinical competence is not achieved. Although these guidelines offer good advice, it could be argued that they fall short of providing an explicit structure for the facilitation of feedback. Despite this, when used with a defined structure, they can help both assessors and learners to engage in constructive feedback processes, helping to enforce the learning process by ensuring it is specific and non-

Box 50.1 Feedback. Source: Chowdhury RR, Kalu, G.(2004) Learning to give

feedback in medical education. Obstetrician & Gynaecologist, 6, 243–247/John Wiley &Sons

Feedback should be:

judgemental.

undertaken with the teacher and the trainee working as allies towards a common goal expected at a mutually agreed time and place close in time to the episode on which it is sought based on specific behaviour rather than general performance and should have been ideally observed at first hand given in small quantities and limited to remediable behaviours descriptive, non-evaluative and non-judgemental composed of subjective data, which should be labelled as such given on decisions and actions and not on one’s interpretation of the student’s motives.

Pendleton’s feedback model

Pendleton’s feedback model11 (Figure50.2) is a four- step process which allows the assessor and learner to work together immediately following an observational encounter, whereby the discussion focuses on what parts of the assessment were performed well, followed by which areas require improvement. In both cases, the learner will open the discussion by reflectingon their practice, with the assessor following in order to reinforce learning points and provide feedforward on how to improve.

There is some criticism that Pendleton’s model can be seen as artificial and therefore prevent discussion covering certain elements such as how the learner will address their required improvements and how to approach any deficits of which the learner may be unaware, and educators should be aware of the need to address these within feedback conversations. Despite this, Pendleton’s model is widely used for structuring feedback within healthcare education, with its ease of use allowing learners and assessors to become equal partners in the feedback encounter. The agenda- led, outcome- based analysis

(ALOBA) technique

(Figure50.3) has been proposed as an

alternative.

Differential attainment andremediation

With competence having been discussed alongside taxonomy scales, clinical supervisors should be aware that on occasions a learner’s progression up the competence hierarchy to the required level of attainment may not be achieved. Reasons for this underperformance are believed to stem from numerous causes, with a failure to fail within healthcare being well documented. times learners can fail to thrive due to a multitude of institutional, social and cognitive reasons. Where underperformance has been detected, remediation should be offered using a combination of reflection and implementation of learning plans in order to allow students to explore their strengths and weaknesses in a safe environment, using resources including simulation as available.

13,14

Despite this, educators should be aware that some-

133

Chapter 50The advanced practitioner asclinical educator andsupervisor

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Advanced clinical

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practice research

Part 7

Chapters

51 Ethical and governance principles 136 52 Research design and methods 138 53 Critical appraisal skills 140

54 Audit and quality improvement sciences 142 55 From bench to bedside: integrating research into

practice

144

ISTUDY

135

136

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Part 7Advanced clinical practice research

Table51.1 De ning research

Research Service evaluation Clinical/non- financial audit Usual practice (in public health,

The attempt to derive generalisable or transferable new knowledge to answer questions with scientifically sound methods including studies that aim to generate hypotheses as well as studies that aim to test them, in addition to simply descriptive studies

Quantitative research– can be designed to test a hypothesis as in a randomised controlled trial or can simply be descriptive as in a postal survey. Qualitative research– can be used to generate a hypothesis, usually identifies/explores themes

Quantitative research– addresses clearly defined questions, aims and objectives. Qualitative research– usually has clear aims and objectives but may not establish the exact questions to be asked until research is under way

Quantitative research– may involve evaluating or comparing interventions, particularly new ones. However, some quantitative research, such as descriptive surveys, does not involve interventions. Qualitative research– seeks to understand better the perceptions and reasoning of people

Usually involves collecting data that are additional to those for routine care but may include data collected routinely. May involve treatments, samples or investigations additional to routine care. May involve data collected from interviews, focus groups and/or observation

Quantitative research– study design may involve allocating patients/service users/healthy volunteers to an intervention. Qualitative research– does not usually involve allocating participants to an intervention

May involve randomisation No randomisation No randomisation May involve randomisation but not for

Normally requires REC review but not always. Refer to http://hra- decisiontools.org.uk/ethics/ for more information

including health protection)

Designed and conducted solely to define or judge current care

Designed to answer: ‘What standard does this service achieve?’

Measures current service without reference to a standard

Involves an intervention in use only. The choice of treatment, care or services is that of the care professional and patient/service user according to guidance, professional standards and/or service user preference

Usually involves analysis of existing data but may also include administration of interview(s) or questionnaire(s)

No allocation to intervention: the care professional and patient/ service user have chosen intervention before service evaluation

Does not require REC review Does not require REC review Does not require REC review

Designed and conducted to produce information to inform delivery of best care

Designed to answer: ‘Does this service reach a predetermined standard?’

Measures against a standard Systematic, quantitative or qualitative

Usually involves analysis of existing data but may include administration of simple interview or questionnaire

No allocation to intervention: the care professional and patient/service user have chosen intervention before audit

Designed to investigate the health issues in a population in order to improve population health. Designed to investigate an outbreak or incident to help in disease control and prevention

Designed to answer: ‘What are the health issues in this population and how do we address them?’ Designed to answer: ‘What is the cause of this outbreak or incident and how do we manage it?’

methods may be used

Involves an intervention in use only. Any choice of intervention, treatment care or services is based on best public health evidence or professional consensus

May involve analysis of existing routine data supplied under licence/agreement or administration of interview or questionnaire to those in the population of interest. May also require evidence review

No allocation to intervention

treatment/care/intervention

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