clinical audit process

2009 UHBristol Clinical Audit Team – Version 3 Page 1 of 7
The aim of this ‘How To’ guide is to provide advice on how to involve patients, service users and carers in
the clinical audit process. The Healthcare Quality Improvement Partnership (HQIP) state that the
involvement and engagement of patients, service users and carers in clinical audit is vital and is a marker of
high quality audit. If you are thinking about involving patients, service users and/or carers in your project it
is important that you discuss this with your divisional Clinical Audit Facilitator at the planning stage. Aspects
of this guide are discussed in more detail in:
How To: Set an Audit Sample and Design your Data Collection & Data Collection Form.
How To: Apply Ethics to Clinical Audit
Clinical audit must include patients. They,
as well as clinicians, are the true
professionals in illness
. The doctor may be
highly qualified to diagnose and give
treatment. However, only the patients truly
know the pain, physical and psychological,
and the stress of their illness. The patient’s
voice is so valuable as part of the audit”.
The engagement agenda within the NHS is seen to
enhance the quality of healthcare services by ensuring
that they are oriented, planned and delivered to meet
patient needs and interests. In particular involving
patients in clinical audit provides a mechanism by which
NHS organisations can show that what is being measured
actually matters to patients.
The Department of Health has published a range of
guidance and legislation that places the engagement
agenda at the heart of improving quality within the NHS.
This documentation is aimed at ensuring that patient
involvement is incorporated into the way in which NHS
organisations make decisions and improve services. Key
Department of Health documents are:
Iain Thomas, MINAP representative, Member
of the SW London Cardiac and Stroke Network
HQIP, Patient & Public Engagement (PPE), PPE
in Clinical Audit 2009
Patient and Public Involvement in the New NHS (1999) – This document places involvement at the
centre of NHS policy stating that health organisations ‘need to work with patients, service users, their
carers and local communities to develop ways of improving health and making services and care
responsive to individuals’ and local communities’ needs’.
Patient and Public Involvement Forums (PPIFs) (2003) – A PPIF was established as an independent
statutory body for each NHS trust and PCT in England. The aim of the PPIFs was to improve the quality of
NHS services by representing the views and experiences of patients, their carers and families, through
monitoring and reviewing NHS delivery, seeking the views of the public about those services and making
recommendations to the NHS accordingly.
NHS Act, 2006 – Section 242 of the Act, states that all NHS organisations have a duty to involve by
ensuring that arrangements are in place so that the ‘persons to whom those services are being or may
be provided are, directly or through representatives, involved in and consulted on the planning of the
provision of those services, the development and consideration of proposals for changes in the way
those services are provided, and decisions to be made by that body affecting the operation of those
Health and Social Care Act (2007) and Local Involvement Networks (LINks) – The Act reiterated that
patient and public engagement should be part of the “core business” of every NHS organisation and
How To: Involve Patients, Service Users &
Carers in Clinical Audit

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How To: Involve Patients, Service Users &
Carers in Clinical Audit
replaced PPIFs with LINks. LINks are independently run by agencies or charitable groups with the aim of
giving local citizens a voice and the authority to monitor local services and hold providers to account.
High Quality Care for All: NHS Next Stage Review (2008) – Lord Darzi’s report emphasised the need for
high quality care for patients and the public and the need to work in partnership. By stating that
‘measuring and valuing what matters most to patients, the public and staff is the way in which we will
enable the NHS to make progress towards high quality care’.
World Class Commissioning (2009) – World class commissioning aims to use best practice from across
the world to help PCTs deliver better health and well-being for their population. Competency three
states that this should mean to; ‘proactively build continuous and meaningful engagement with the
public and patients to shape services and improve health’.
The NHS Constitution (2009) – The NHS Constitution pledged that patients have the right to be involved
in discussions and decisions about their healthcare, and to be given information to enable them to
do this; and the right to be involved, directly or through representatives, in the planning of healthcare
services, the development and consideration of proposals for changes in the way those services are
provided, and in decisions to be made affecting the operation of those services.
The patient’s voice is so important but do not forget the carer. There are about six million voluntary
carers, relatives and friends of all ages, in the UK
. They have more experience than a doctor of a
patient’s pain, problems and care needs. They are the unrecognised figures in dealing with patients,
their views should be brought into the open through audit”.
Sirkka Thomas, Former Health Visitor and Cardiac, Nurse, now carer for her husband
HQIP, Patient & Public Engagement (PPE), PPE in Clinical Audit 2009
HQIP states that ‘Patients need to be involved and engaged in the selection of initiatives to improve quality;
in the governance of these initiatives, such as a clinical audit; in the collection of data for the audit; as part
of the dissemination of the products to ensure, as consumers, they are provided with re-assurance and
possible choice of healthcare provider, where such a choice is realistic or possible’.
HQIP, Patient & Public Engagement (PPE), PPE in Clinical Audit 2009
Clinical audit is about improving the quality of clinical services given to patients. At UHBristol we believe that
clinical audit should be focused on what matters most to our patients, service users and their carers. For
example, if outcomes are being audited, patients should be enabled to inform us about what outcome
measures actually matter to them.
The benefits of engagement as specified below are based upon those listed by HQIP in Patient & Public
Engagement (PPE), PPE in Clinical Audit 2009.
Those who have lived with, or cared for, someone with a particular illness are “experts” in the condition.
They have
a subjective and valid view point based on actual experience about where quality could, and
should, be improved.
Through participation and engagement patients and service users can enhance clinical audit by
achieving services better focused on their needs.
A patient’s or service user’s direct experience of care gives them a different perspective about
ways to improve the quality of a service compared to a clinician. Patients might make different
choices about which aspects of care should be included as standards to be measured through the
clinical audit process.
A patient can address the concerns they have raised by assisting with the development of the
action plan. The patient’s perspective will provide staff with a clearer picture about what changes

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How To: Involve Patients, Service Users &
Carers in Clinical Audit
are needed and help to ensure that services are being provided in the way people want to see
Clinical audit results can provide patients and the public with more knowledge about the quality of care
in a particular healthcare setting; enabling them to make more informed choices about where they
obtain treatment. Public reporting should raise public confidence in the NHS as it boosts trust and
satisfaction. Involvement in clinical audit should also provide patients with a deeper insight into care
that is provided. However, it is important to remember that the communication of audit results should
be done in such a way to ensure it is accessible to the public and easy to understand, i.e. written simply
whereby the data and conclusions are easy to understand.
Being involved in improving the quality of care through the clinical audit process can bring health
benefits to patients; feeling satisfaction after having influenced their care, being listened to, and from
the social interaction and engagement that this offers.
As a direct result of listening to local people and developing clinical audits that are responsive to local
needs patients and the public should feel a greater ownership of their local health services.
Patient involvement will give clinical audit insight into the preferences of patients as to suitable
indicators of the quality of care provided. It will further assist in the identification of what is needed to
maintain and improve care in the future.
In 1969, Sherry Arnstein developed her ladder of
participation to provide a framework of participation. The
ladder illustrates the different levels at which a patient/
service user may wish to become involved and the level of
involvement an organisation has reached.
The ladder is a useful visual tool and has been frequently
adapted. Models commonly show information, consultation
and partnership. In terms of clinical audit this might mean:
Information – Informing patients of the results of a
clinical audit. This is the lowest level of engagement.
Consultation – Sending out a patient survey. This is often mistaken as a high level of involvement but is
usually placed in the middle of the ladder and considered lower than engaging or partnering the patient.
Partnership – Joint working between clinicians and patients, service users and careers to develop a
clinical audit project from the very beginning, participating throughout the process and with potential
for some clinical audit projects being patient-led. This is the highest level of engagement.
The table below illustrates HQIP’s ‘Criteria and Indicators of Best Practice in Clinical Audit’. HQIP believe that
a key element in achieving good quality clinical audit is through patient representation and participation.
HQIP have adapted the NHS Centre for Involvement’s (NCI) set of six organisational standards and included
additional criteria in order to give more in depth guidance for specific engagement in clinical audit.

Patients or their representatives
are involved in the clinical audit if
The patient group to whom the
clinical audit standards apply is
clearly defined.
The clinical audit standards take
full account of patient priorities
and patient-defined outcomes.
For example, the clinical audit
incorporates Patient Related
Outcome Measures (PROMS).
Patients/carers are recognised
as key stakeholders in the
clinical audit process.
If appropriate and feasible,
patient representatives and
relevant patient organisations

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How To: Involve Patients, Service Users &
Carers in Clinical Audit

are involved in clinical audit
governance, treated as
stakeholders, and where
appropriate, in all stages of the
clinical audit cycle as equal
members of the clinical audit
Patients who are members of
the clinical audit team are fully
informed about what is
expected from them in terms of
participation, commitment and
Not all patients and/or patient
organisations will be members
of the clinical audit team but, as
relevant stakeholders, should
still be kept informed and
If required, patients who are
members of the clinical audit
team are given basic clinical
audit training to enable them to
contribute effectively to the
clinical audit process.
Patients are kept informed
throughout the clinical audit
process about timescales,
progress, results and actions.
All communications should use
plain English avoiding the use of
jargon and acronyms.

Patients, service users and carers should not be involved in a clinical audit project simply as a tick box
exercise. At the outset of your project it is important to consider whether or not involvement will add value
to your project design.
Most commonly involvement in clinical audit is achieved through a survey; this is likely to be a questionnaire
asking for details about what happened to the patient or service user. Surveys should only ask for
information that cannot be collected from another source and that is related to processes or the outcomes
of care i.e. were standards of best practice being met. For instance, were they given the correct patient
information leaflet?
Asking patients about their satisfaction with our services and/or their ideas for improvement is a valid and
important aspect of patient involvement, but tends to sit outside the clinical audit cycle of measuring
against standards.
Surveys are not the only means by which patients, service users and carers can be involved in clinical audit
projects and programmes. Consider the following:
Information can be made available locally to staff members, patients, service users and carers on planned
clinical audit projects, current projects and completed projects. A summary can be provided outlining each
clinical audit topic, the background, aims, objectives and standards; and in the case of completed projects a
summary of the results and any actions implemented can also be included. This can be achieved via
newsletters, leaflets or via posters located on the ward/ hospital notice boards.
If individuals have taken part in a survey it is good practice to offer to send them a copy of the finalised

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How To: Involve Patients, Service Users &
Carers in Clinical Audit
Information can be obtained from patients, service users, carers or members of the public via the following
1. An area of concern raised by way of a complaint or via the Patient, Advice & Liaison Service (PALS) can
be investigated using clinical audit.
2. A topic of concern highlighted via a focus group can be investigated using clinical audit.
3. Self-completed questionnaires – Questionnaires can be completed at the end of an episode of care.
4. Structured one-to-one interviews – Interviews can be face-to-face or via the telephone. The interviewer
asks a number of pre-determined questions and allocates the answers to one of a pre-determined set of
possible responses.
Links can be developed with existing groups in order to give patients, service users and/or carers an
opportunity to comment on your local clinical audit programme.
Joint working between clinicians and patients, service users and careers can ensure that a partnership
approach to clinical audit is instigated from the very beginning of a clinical audit process and continued
throughout. There should also be some scope for some clinical audit projects to be patient-led.
Partnership working can be achieved through the involvement of patient, service user and/or carer
representative(s) on your clinical audit committee or the clinical audit project team. This way, you could get
direct input into:
Identifying and prioritising topics.
Designing projects.
Setting process standards and key outcome measures.
Collecting data.
Analysing and interpreting results.
Disseminating findings.
Agreeing and monitoring action plans.
One or two patients are not representative of all patients.
Patients will not understand clinical audit.
There are too many problems about confidentiality.
None of these problems are insurmountable. One or two patients on a committee may not be
representative of all patients, but is this a good enough reason not to do it? After all, are the clinicians on
your committee representative of all clinicians? Patients can be given basic training in audit. They can sign
confidentiality undertakings. The real issues are about motivation, time and resources.
Try to find people who are used to committee/ project work. You could consult with patient
organisations to help identify appropriate representatives.
Try to ensure that the patients you involve have links to wider networks, for wider consultation.
Do not select a current or former patient of a clinician who sits on your committee. This is unfair to both
Be clear about why you have involved patients and what you are hoping that they will contribute.
Be clear about expectations.
Provide training as appropriate.
Ensure you can pay travel and carer costs.
Schedule meetings at convenient times for patients.
Think about physical access to meeting rooms.
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How To: Involve Patients, Service Users &
Carers in Clinical Audit
Avoid jargon.
All structured surveys, staff or patient, administered by post, in hospital, or via a one-to-one interview, are
subject to approval by the Questionnaire, Interview and Survey (QIS) Group. The contact details for the QIS
group are listed at the end of this guide. The QIS group offers advice on survey design and is responsible for
monitoring all survey activity at the Trust. Please contact Paul Lewis, the Patient Involvement Facilitator for
advice on structured surveys/ questionnaires. If you require advice on unstructured interviews and focus
groups, this should be discussed directly with Tony Watkin, the Trust’s Public Involvement Project Lead. The
contact details for Paul Lewis and Tony Watkin are listed at the end of this guide. Formal Research projects
are subject to approval by a Research Ethics Committee (REC) and therefore do not require QIS approval.
In essence, the engagement of patients and public, both nationally and locally in clinical audit needs to
Engagement in the strategic direction of clinical audit.
Consultation in respect of standards to be audited.
Active participation in collection and analysis of clinical audit data.
Engaging the public in communication activity about clinical audit, partly as patients or potential
patients of treatment, and also through involvement in governance.
To achieve this, involvement needs to underpin the whole conception of clinical audit, from beginning to
end. It needs to be integral to the whole project.
The UHBristol Clinical Audit website is available [online] via:
Contact details for the UHBristol Clinical Audit Team are available from the Clinical Audit Central
Office or [online] via:
The full range of UHBristol ‘How To’ guides are available [online] via:
A copy of the UHBristol Proposal Form, Presentation Template, Report Template, Summary Form,
and Action Form
are available [online] via:
The UHBristol Clinical Audit Central Office can be contacted on tel. (0117) 342 3614 or e-mail:
[email protected]
Clinical Audit Training Workshops can be booked through the Clinical Audit Central Office.
For advice on Clinical Effectiveness, including how to write guidelines, contact James Osborne, Clinical
Effectiveness Co-ordinator, tel. (0117) 928 3827 or e-mail: [email protected]

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How To: Involve Patients, Service Users &
Carers in Clinical Audit
For advice on Patient Involvement, including designing structured surveys and questionnaires
contact Paul Lewis, Patient Involvement Facilitator, tel. (0117) 928 3638 or e-mail:
[email protected]
For advice on Patient Involvement, including unstructured surveys and focus groups contact Tony
Watkin, Public Involvement Lead, tel. (0117 928 3729 or e-mail: [email protected]
Surveys MUST be approved by the Trust’s Questionnaire, Interview and Survey (QIS) Group.
Proposals should be submitted to Paul Lewis using the QIS proposal form. The proposal form is
available [online] via
A copy of the UHBristol Covering Letter template is available [online] via the internal intranet site
For advice on research projects contact the Research & Development Department, tel. (0117) 342
0233 or e-mail: r&[email protected]
For advice on literature reviews contact the Learning Resource Centre, tel. 0117 342 0105 or e-mail:
[email protected]
The Sample Size Calculator is available [online] via: