Transcript Development of clinical policy & protocols

Development of clinical policy &
protocols
Dr Emily Finch, Clinical Director,
SLAM,
MSc Addiction Studies November 2013
Learning objectives
• To know key UK sources of national clinical
guidance in substance misuse
• To understand the key processes involved in
writing a guideline
• To know the advantages and disadvantages of
using protocols to define provide
interventions.
MSc Addiction Studies November 2013
Definitions
• Guideline is a statement by which to determine a course of action.
A guideline aims to streamline particular processes according to a
set routine or sound practice. By definition, following a guideline is
never mandatory. Guidelines are not binding and are not enforced
• Medical guideline (also called a clinical guideline, clinical protocol
or clinical practice guideline) is a document with the aim of guiding
decisions and criteria regarding diagnosis, management, and
treatment in specific areas of healthcare.
• Protocol can be defined as a plan for a course of medical treatment
which usually includes a treatment plan, summarized consensus
statements and addresses practical issues.
• An alternative definition of a protocol can be as a set of rules
followed by providers such as nurses. Often considered to be
stricter than a guideline, and to carry more weight with the law, but
there is no hard evidence to support this view and the terms are
usually used interchangeably.
MSc Addiction Studies November 2013
Definitions in practice
• Often no clear distinction between a guideline
and a protocol.
• Guidelines are often national or regional or
apply to a particular professional group. They
usually apply to a wide area of clinical practice
• Protocols commonly apply to a single clinical
service or local area and are usually more
detailed.
MSc Addiction Studies November 2013
NICE (National Institute for Health
and Clinical Excellence)
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Set up in 1999 to reduce variation in the availability and quality of NHS treatments
and care
Produces evidence-based guidance and other products
Resolve uncertainty about which medicines, treatments, procedures and devices
represent the best quality care and which offer the best value for money for the
NHS.
It uses quality of life measures as its main outcome with a strong emphasis on cost
effectiveness.
NICE is a Special Health Authority - an Arms Length Body funded by the
Department of Health.
Public health guidance for local authorities, the NHS and all those with a remit for
improving people's health in the public, private, community and voluntary sectors.
Most of its work applies to England and Wales only.
Guidance developed by an independent committee of experts including clinicians,
patients, carers and health economists.
A Citizens Council provides NICE with the public's perspective on what are often
challenging social and moral issues raised by NICE guidance.
MSc Addiction Studies November 2013
Types of NICE Guidance
• Clinical guidelines make recommendations to the NHS on treating
and caring for people with specific diseases and conditions (Pilling
et al 2011).
• For example the addiction guidelines were written by the National
Collaboration centre on Mental Health (a partnership of the Royal
College of Psychiatrist and the British psychological Society) and
overseen by a guidelines development group.
• NICE technology appraisals use a different process and make
recommendations on when and how new and existing medicines
and treatments should be used in the NHS.
• NICE public health guidance makes recommendations to the NHS,
local authorities and other organisations in the public, private,
voluntary and community sectors on how to improve people's
health and prevent illness and disease.
MSc Addiction Studies November 2013
NICE guidelines in Addiction (available
at www.nice.org.uk)
Clinical Guidelines
• Drug misuse: psychosocial interventions
(CG51)
• Drug misuse: opioid detoxification (CG52)
• Alcohol-use disorders: physical complications
(CG100)
• Alcohol dependence and harmful alcohol use
(CG115)
• Psychosis with coexisting substance misuse
(CG120)
Technology appraisals
• Drug misuse - naltrexone (TA115)
• Drug misuse - methadone and
buprenorphine (TA114)
• Smoking cessation - varenicline (TA123)
Public Health guidance
• Workplace interventions to promote smoking
cessation (PH5)
• Smoking cessation services (PH10)
• Preventing the uptake of smoking by children
and young people (PH14)
• Quitting smoking in pregnancy and following
childbirth (PH26)
• Smokeless tobacco cessation - South Asian
communities (PH39)
• Needle and syringe programmes (PH18)
• Interventions to reduce substance misuse
among vulnerable young people (PH4)
• Alcohol-use disorders - preventing harmful
drinking (PH24)
Quality standards
• Alcohol dependence and harmful alcohol use
(QS11)
• Substance Misuse (in development)
MSc Addiction Studies November 2013
Department of Health Clinical
Guidelines
• Produced since 1984 by the Department of Health (in conjunction
with the Scottish Government, the Welsh assembly government
and the department of health, social services and public safety in
Northern Ireland)
• Guidelines on the clinical management of drug misuse and
dependence.
• They are known as the “orange guidelines”
• Revised in 1991, 1999 and most recently in 2007.
• Aim to summarise the best possible evidence and clinical consensus
for treatment for substance misuse patients and provide guidance
for clinical staff.
• Incorporate NICE but cover a broad range of interventions including
pharmacological and psychosocial interventions.
• Do not aim to provide rigid protocols.
MSc Addiction Studies November 2013
SMMGP (Substance Management in
General Practice)
• SMMGP is a network to support general practitioners
and other primary health practitioners who work with
substance misuse in the UK.
• Guidance for the use of substitute prescribing in the
treatment of opioid dependence in primary care (2012)
• Guidance on Prescribing Benzodiazepines to Drug
Users in Primary Care (2005)
• Guidance for Working with Cocaine & Crack Users in
Primary Care (2004)
• Their website (www.smmgp.org.uk) is a useful source
of guidelines and protocols from other organisations in
the UK and internationally.
MSc Addiction Studies November 2013
Other sources
• British association for psychopharmacolgy
(2004, 2012) Evidence and consensus based.
• Public Health England
• Medical Royal Colleges
• Any organisation with authority and
competence to produce guidelines
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Categories of evidence and strength of
recommendations (adapted from Shekelle et all 1999)
Categories of evidence for causal relationships and
treatment
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Ia: evidence from meta-analysis of randomised
controlled trials
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Ib: evidence from at least one randomised
controlled trial
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IIa: evidence from at least one controlled study
without randomisation
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IIb: evidence from at least one other type of quasiexperimental study
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III: evidence from non-experimental descriptive
studies, such as comparative studies, correlation
studies and case-control studies
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IV: evidence from expert committee reports or
opinions and/or clinical experience of respected
authorities
Proposed categories of evidence for observational
relationships
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I: evidence from large representative population
samples
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II: evidence from small, well-designed, but not
necessarily representative samples
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III: evidence from non-representative surveys, case
reports
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IV: evidence from expert committee reports or
opinions and/or clinical experience of respected
authorities
Strength of recommendation
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A: directly based on category I evidence
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B: directly based on category II evidence or
extrapolated recommendation from category I
evidence
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C: directly based on category III evidence or
extrapolated recommendation from category I or II
evidence
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D: directly based on category IV evidence or
extrapolated recommendation from category I, II or
III evidence
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S: Standard of care
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Guideline status
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NICE clinical guidelines - not subject to a mandatory requirement regarding
funding. Health departments in England and Wales may choose to issue advice the
NHS on their implementation.
NICE public health guidance - not subject to a mandatory requirement regarding
funding but again the NHS, local authorities and the wider public, private and
voluntary community sectors in England should take it into account.
Technology appraisals - NHS is required to provide funding and resources for
medicines and treatments recommended within three months from the date of
publication of each technology appraisal.
Other guidelines – no formal status
Professional bodies will take account of the use of guidelines when judging
whether a clinician is fulfilling adequate standards of care. E.g Department of
Health guidelines on clinical management.
Commissioning standards and contract performance measures will also take
national guidelines into account when they are defined.
Care Quality Commission (CQC) will use national guidelines to develop inspection
standards.
Usually important to follow national guidelines or clear reasons why not
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Developing a guideline
• Defining a subject area
Important and relevant one, prioritisation, judging benefit,
variation in national practice, evidence available , consensus
possible
• Judging evidence
?randomised controlled trials, viewed as a hierarchy, clinical
consensus at the bottom. State explicitly.
Can use systematic review for finding and reviewing evidence.
Many areas of clinical care, especially in addiction, has not or could
not be subject to rigorous trials. Consensus evidence from experts
in the valuable
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Developing a guideline
• Defining a guideline process
Groups of experts , range of backgrounds, different theoretical back
grounds, service users and carers involved. Group make
recommendations. Cost effectiveness evidence. Clinical outcomes
• Developing recommendations
Simple and understandable . Strength of the evidence which led to the
recommendation. Seek to improve practice and there fore be aspirational
but not so much so that they cannot be implemented. Externally peer
reviewed.
• Dissemination
Service providers, individual clinicians and commissioners need to be
informed about the recommendations. Academic journals, professional
bodies, national and specialist press, conferences, integration into training
and CPD programmes and working with providers and commissioners .
MSc Addiction Studies November 2013
Why have protocols
• Pros
Standardise practice
Gives staff confidence
Ensure evidence based practice
Quality improvement cycles as result in changes in practice
• Cons
Have to be followed
Need to train staff
Less individualised practice ? Less patient centred.
Less creative staff
MSc Addiction Studies November 2013
Developing a protocol
• Often at service or agency level and allows national evidence based
guidance to be translated into local practice.
• Team managers or doctors. They may be written by an individual but need
to be reviewed by a group
• Can use primary evidence but do not need to as they can be written from
available national guidance.
• Relevant and needed. used frequently.
• “Fit” with other protocols often come as a group e.g. protocols for
prescribing a series of drugs. May or may not be detailed. An example
would be developing protocols for prescribing in a primary care service
without consulting local GPs.
• Only apply to a proportion of patients. Consider an “80% rule” by which
the protocol is likely to apply to 80% of patients only. Define by which
process the protocol is breached (such as the patient seeing a senior
member of staff or having a supervisor’s approval).
Effective implementation
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Tailored to a particular protocol and also on an assessment of the likely barriers.
e.g the example of the referral protocol above the predicted staff mistrust of other
agencies could be dealt with by staff having joint sessions on how the day
programme functions.
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A range of implementation tools can be effective.
Convincing key individuals
Peer pressure and modeling
Providing educational materials and meetings both internally and externally
Mass media campaigns in the appropriate circumstances.
Performance management including providing rewards for compliance and setting
goals and behavioral contracts.
Specific individual goal setting within supervision and regular review
Finally grading the change into manageable tasks and improving time
management may induce change
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Audit to evaluate implementation
Barriers to implementation
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Insufficient financial resources,
Staff with inappropriate skills
Insufficient equipment
Disagreement with the desired practice
individual attitude factors.
• Limits to the ability of the staff to manage too
much information and change at once.