The NICE experience
Christine BaldwinDivision of Medicine, Imperial College London
& The Royal Marsden Hospitals, London
PEN Group Annual Conference, London, August 2006
Structure
• Process
• Type of evidence
• Implications for dietitians
The need for this guideline
• Malnutrition is common
• Nutritional provision in hospital and community may be inadequate
• Provision of nutritional support requires complex decisions
• Wide variation in nutritional care standards
Topic nomination
• are still capable of deriving some of their nutritional requirements by conventional feeding and/or
• have difficulty swallowing
including the use of nutritional supplements and enteral and parenteral feeding methods”
DoH and Welsh Assembly
“to develop a guideline on appropriate methods of feeding patients who:
The process (1)
• Proposal
• National Collaborating Centre for Acute Care (NCCAC)
• Scopestakeholders
The process (2)
Guideline Development Group:
• Clinicians • GP• Dietitians (2)• Speech & Language Therapist• Nurses• Patient Groups• pharmacists
The process (3)
Development of clinical questions
Clinical questions
• P atients– Malnourished patients
• I ntervention– More food or nutritional supplement
• C omparison– No intervention
• O utcomes– mortality
Process (4)
• Literature search
• Review of papers
• Extraction of data on identified outcomes
Process (5)
• Development of guidelines from evidence base
• 1st consultation
• 2nd consultation
• Final guideline produced
Stakeholder comments
Stakeholder comments
The guideline
• Quick reference guide (a summary)
• NICE guideline (all of the recommendations)
• Full guideline (all of the evidence and rationale)
• Information for the public (a plain English version)
www.nice.org.uk
Changing clinical practice
• Department of Health has asked NHS organisations to work towards implementing the guidelines
• Compliance will be monitored by the Healthcare Commission
• NICE guidelines are based on the best available evidence
Aims of the guideline
• Authoritative evidence-based guidelines on nutritional support :
– ‘Who? – When? – What? – How ?’
excluding children and immunonutrition
Valid evidence
• Systematic review of multiple randomised controlled trials (RCTs)
• Large RCTs
• Non-randomised, case-control studies
• Non-experimental studies from more than one centre
• Opinions based on clinical evidence
Problems of evidence (1)
• Study design
• Which studies are included
• Heterogeneity
• Study quality
Definition of malnutritionInterventions
Problems of evidence (2)
Wanted: volunteers for randomized,
placebo controlled trial
No evidence available
NICE found no RCTs with the introduction of screening as the intervention that then looked at either change in process or clinical measures as outcomes.
NICE argument:
Even if evidence proves that nutrition support is effective, it does not necessarily follow that screening for malnourishment is of benefit
Potential Solutions
• Potential benefits of nutrition support may be better addressed by non-RCT techniques (but NICE lack the resources)
NICE recognized our problems and allowed some Guidance based on
first principles
• Formal Consensus Techniques (but lack of time)
Nutritional screening
• Inpatients
• Outpatients
• Residents of care homes
• Attendees of GP surgeries
should all be screened for riskof malnutrition (D (GPP))
Grading of evidence
A meta-analysis or good quality RCT
Bextrapolated evidence from good quality RCTs or meta-analysis of cohort studies
C
D
D (GPP) good practice point
Recommendations
• 77 recommendations
• 10 priorities for implementation
• 5 research recommendations
• Grade A = 8• Grade B = 9• Grade D (GPP) = 60
Key priorities for implementation
• 10 recommendations:
– Screening (3)– Identification (2)– Nutritional support (1)– Education (4)
Nutritional screening
• Inpatients
• Outpatients
• Residents of care homes
• Attendees of GP surgeries
should all be screened for riskof malnutrition (D (GPP))
Screening
Two most important features:
• linked to effective treatment pathway
• leads to beneficial outcome
Numbers of:
• hospital inpatients (n=11,157)• hospital outpatients (n=10,823)• community
Implications (1)
Implications (2)
• Who will carry out screening?
• Need adequate numbers of dietitians
• Who will raise awareness?
• referrals• available to see patients• provide training
Research recommendation:
Would a screening programme for all patients impact on clinical outcomes (LOS, QOL, complications), compared with no screening?
Implications (3)
Education
“Screening for malnutrition and the risk of malnutrition should be carried out by healthcare professionals with appropriate skills and training” to enable accurate data collection
(D (GPP))
Implications (1)
• Staff training:
• Clear procedures
• medical staff• nursing staff• management
Implications (2)
Research recommendation:
“Further research is needed to ascertain whether an educational intervention … for all healthcare professionals … would have an affect on patient care [LOS, QOL, complications], compared to no formal education.”
Oral nutritional intervention
“Healthcare professionals should consider oral nutrition support to improve nutritional intake for people who can swallow safely and are malnourished or at risk of malnutrition.” (A)
The debate
Nutritional supplements
Dietary advice
Dietary advice + nutritional supplements
vs
vs
Implications (1)
• Can dietitians see all the patients that need intervention?
• Which intervention?
• develop policies• training to ensure consistency
Research recommendation:
Benefits to patients at nutritional risk offered sip feeds vs dietary counselling:
Implications (2)
•survival•complication rate•LOS•QOL •cost
Consider enteral tube feeding (ETF):
and
use the most appropriate route of accessand mode of delivery
stop when the patient is established on adequateoral intake from normal food
surgical patients may have different needs
has a functional and accessible gastrointestinal tract
if patient malnourished/at risk of malnutritiondespite the use of oral interventions
Enteral feeding
“Healthcare professionals should consider enteral tube feeding in people who are malnourished or at risk of malnutrition, respectively, and have:
(D (GPP))
• inadequate or unsafe oral intake, and • a functional, accessible gastrointestinal tract ”
Elective enteral feeding
No evidence of clinical benefits
“Enteral tube feeding should not be given to people unless they are malnourished or at risk of malnutrition and have; inadequate or unsafe oral intake and a functional, accessible gastrointestinal tract, or they are taking part in a clinical trial.” (A)
Surgical patients:early post-op ETF
ETF vs nil by mouth
“General surgical patients should not have [ETF] within 48 hours post-surgery ...” (A)
• 23 RCTs: combined results do notdo not support the use of early ETF
Are they NICE guidelines?
Not perfect BUT they do raise the profile of nutritional care and oblige organizations to take it seriously.
Challenge and opportunity for dietitians
Summary
Acknowledgements
• Joanna Prickett Dietitian,
• All members of the Guideline Development Group
North Bristol NHS Trust