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