The NICE experience Christine Baldwin Division 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 “to develop a guideline on appropriate methods of feeding patients who: 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

The process (1) Proposal National Collaborating Centre for Acute Care (NCCAC) Scope stakeholders

The process (2) Guideline Development Group: Clinicians GP Dietitians (2) Speech & Language Therapist Nurses Patient Groups pharmacists

Development of clinical questions The process (3) Development of clinical questions

Clinical questions P atients I ntervention C omparison O utcomes 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 www.nice.org.uk 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) NOTES FOR PRESENTERS The guideline is available in a number of formats. You can download them from the NICE website or order hard copies of the quick reference guide or information for the public by calling the NHS Response Line on 0870 1555 455. Please refer to the accompanying implementation advice for the policy context and useful links. 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 malnutrition Interventions

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 Formal Consensus Techniques (but lack of time) Potential benefits of nutrition support may be better addressed by non-RCT techniques (but NICE lack the resources) Formal Consensus Techniques (but lack of time) NICE recognized our problems and allowed some Guidance based on first principles

Nutritional screening Inpatients Outpatients Residents of care homes Attendees of GP surgeries should all be screened for risk of malnutrition (D (GPP))

Grading of evidence A B C D D (GPP) meta-analysis or good quality RCT extrapolated 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 risk of malnutrition (D (GPP))

Screening Two most important features: linked to effective treatment pathway leads to beneficial outcome

Implications (1) Numbers of: hospital inpatients (n=11,157) hospital outpatients (n=10,823) community

Implications (2) Who will carry out screening? Need adequate numbers of dietitians Who will raise awareness?  referrals available to see patients provide training

Implications (3) Research recommendation: Would a screening programme for all patients impact on clinical outcomes (LOS, QOL, complications), compared with no screening?

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)

Nutritional supplements Dietary advice + nutritional supplements The debate Dietary advice vs Nutritional supplements vs Dietary advice + nutritional supplements

Implications (1) Can dietitians see all the patients that need intervention? Which intervention? develop policies training to ensure consistency

Implications (2) Research recommendation: Benefits to patients at nutritional risk offered sip feeds vs dietary counselling: survival complication rate LOS QOL cost

Consider enteral tube feeding (ETF): if patient malnourished/at risk of malnutrition despite the use of oral interventions and has a functional and accessible gastrointestinal tract use the most appropriate route of access and mode of delivery NOTES FOR PRESENTERS For the purposes of this guideline, enteral tube feeding refers to the delivery of a nutritionally complete feed (containing protein or amino acids, carbohydrate with or without fibre, fat, water, minerals and vitamins) directly into the gut via a tube. The tube is usually placed into the stomach, duodenum or jejunum via either the nose, mouth or the direct percutaneous route. Enteral tube feeding is not exclusive and can be used in combination with oral and/or parenteral nutrition. Patients receiving enteral tube feeding should be reviewed regularly to enable re-instigation of oral nutrition when appropriate. Most enteral feeding tubes are introduced at the bedside but some are placed surgically, at endoscopy or using radiological techniques, and some are inserted in the community. Enteral tube feeding should be considered for patients who are malnourished or at risk of malnourishment, who can’t be fed orally and who have a working and accessible gut. Whenever possible the patient should be aware of why this form of nutrition support is necessary, how it will be given, for how long, and the potential risks involved. There may be considerable ethical difficulties in deciding if it is in a patient’s best interests to start a tube feed. stop when the patient is established on adequate oral intake from normal food surgical patients may have different needs

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 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 Challenge and opportunity for dietitians

Acknowledgements Joanna Prickett Dietitian, All members of the Guideline Development Group North Bristol NHS Trust