nutrition support for adults oral nutrition support ...1.1. the need for guidelines in nutrition...

National Collaborating Centrefor Acute Care

Nutrition Support for AdultsOral Nutrition Support, Enteral TubeFeeding and Parenteral Nutrition

METHODS, EVIDENCE & GUIDANCE

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3. Organisation of Nutrition Support inhospital and the community 563.1. Introduction 563.2. Nutrition support in the community 563.3. Nutrition support in Hospital 563.4. Methods 583.5. Clinical evidence 583.6. Cost effectiveness evidence 603.7. Conclusion 603.8. Recommendations for clinical practice 613.9. Research recommendations 62

4. Screening for malnutrition and the riskof malnutrition in hospital and the community 634.1. Nutritional assessment 634.2. Why and how to screen 634.3. Methods 644.4. Studies considered for this review 654.5. Clinical evidence 654.6. Cost-effectiveness evidence 654.7. Consensus development methods 664.8. Impact of nutritional assessment on

the patient 684.9. Recommendations for clinical practice 694.10. Research recommendations 69

5. Indications for nutrition support 705.1. Introduction 705.2. Methodology 705.3. Appropriate Nutrition Support and

ethical/legal issues 715.4. Rationale for recommendations 725.4.1 Recommendations for clinical practice 725.5. Algorithms 74 - 76

6. What to give in hospital and the community 77

6.1. Background 776.2. General Principles 776.3. Calculating requirements 78

NUTRITION SUPPORT IN ADULTS4

Contents

Guideline Development Group membership and acknowledgments 6

Stakeholder Involvement 8

Abbreviations 10

Glossary of Terms 12

1. Introduction and methods 27

1.1. The need for guidelines in nutrition support 27

1.2. What is a guideline? 281.3. Remit of the guideline 281.4. What the guideline covers 291.5. What the guideline does not cover 291.6. Who the guideline is for 301.7. Who developed the guideline? 301.8. Methodology 301.9. Hierarchy of clinical evidence 331.10. Health economics methods 331.11. Forming and grading the recommendations 351.12. Specific problems with evidence relating

to the development of nutrition support guidelines 36

1.13. Patient-centred care 371.14. Summary of the recommendations 371.14.3 Research recommendations 51

2. Malnutrition and the principles of nutrition support 53

2.1. Introduction 532.2. The causes of malnutrition 532.3. The effects of malnutrition 542.4. The prevalence of malnutrition 542.5. Principles underlying intervention 55

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6.4. Concerns with prescribing levels 796.5. Recommendations for clinical practice 806.6. Re-feeding Problems 806.7. Recommendations for research 83

7. Monitoring of nutrition support inhospital and the community 847.1. Introduction 847.2. Methods 847.3. Recommendations for clinical practice 857.4. Research Recommendations 90

8. Oral Nutrition Support in hospital and the community 91

8.1. Introduction 918.2. Oral nutritional support versus standard

care in malnourished patients 918.3. Dietary advice versus standard care 968.4. Oral nutritional supplements versus

dietary advice 978.5. Recommendations for clinical practice 988.6. Oral nutrition support in surgical patients 988.7. Recommendations for clinical practice 1038.8. Oral nutrition support in pancreatitis patients 1038.9. Oral multivitamin and mineral

supplementation in malnourished patients 1038.10. Nutrition support in patients with dysphagia1068.11. Recommendations for clinical practice 1088.12. Research recommendations 108

9. Enteral tube feeding in hospital and the community 110

9.1. Introduction 1109.2. General Indications for Enteral Tube Feeding1109.3. Recommendations for clinical practice 1119.4. Enteral tube feeding versus standard care 1119.5. Recommendations for clinical practice 1159.6. Enteral tube feeding routes of access 1159.7. Recommendations for clinical practice 1179.8. Percutaneous Endoscopic Gastrostomy

(PEG) versus Nasogastric (NG) Feeding 1179.9 Recommendations for clinical practice 1199.10. Commencing enteral tube feeding after

insertion of a percutaneous endoscopicgastrostomy 119

9.11. Recommendations for clinical practice 1199.12. Types of enteral feeds 1199.13. Mode of delivering Enteral Tube Feeding 1219.14. Recommendations for clinical practice 1229.15. Motility Agents 1229.16. Recommendations for clinical practice 1239.17. Complications of enteral tube feeding 1239.18. Recommendations for clinical practice 1249.19. Research recommendations 124

10. Parenteral nutrition in hospital and the community 125

10.1. Introduction 12510.2. PN versus no PN 12510.2.3Elective PN in surgical patients 12710.3. Recommendations for clinical practice 12810.4. Parenteral versus enteral tube feeding 12910.5. Recommendations for clinical practice 13210.6. Venous access for PN 13210.7. Recommendations for clinical practice 13410.8. Peripheral PN versus central PN 13410.9. PN via a tunnelled catheter versus

PN via a non-tunnelled catheter 13610.10. Tailored PN preparations versus

standard PN preparations 13710.11. Recommendations for clinical practice 13710.12. Delivery of PN cyclically versus continuously 13810.13. Recommendations for clinical practice 13910.14. Complications from PN 13910.15. Recommendations for clinical practice 14010.16. Research recommendations 140

11. Supporting patients in the community 141

11.1 Home enteral tube feeding 14111.2 Recommendations for clinical practice 14111.3 Home parenteral nutrition 14211.4 Recommendations for clinical practice 14211.5 Working in partnership with patients,

families and carers 14311.6 Recommendations for clinical practice 14611.7 Research recommendations 146

12. Audit criteria 147

12. Bibliography 153

CONTENTS 5

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Abbreviations

aaaa Amino acid

AAPPRR Acute phase reaction

AASSPPEENN American Society for Parenteral and Enteral Nutrition

BBAAPPEENN British Association for Parenteral and Enteral Nutrition

BBDDAA British Dietetic Association

BBMMII Body Mass Index

CCEEAA Cost-effectiveness analysis

CCII Confidence interval

CCOO22 Carbon dioxide

CCOOPPDD Chronic obstructive pulmonary disorder

CCVVAA Cerebrovascular disease

CCUUAA Cost-utility analysis

CCVVCC Central venous catheter

DDEEAALLEE Declining Exponential Approximation of Life Expectancy

DDHH Department of Health

EENN Enteral nutrition

EESSPPEENN European Society of Parenteral and Enteral Nutrition

(European Society for Clinical Nutrition and Metabolism)

EETTFF Enteral tube feeding

GGDDGG Guideline Development Group

GGII Gastrointestinal

GGPP General Practitioner

GGPPPP Good practice point

GGRRAADDEE Guidelines Recommendations Assessment Development Evaluation

GGRRPP Guideline Review Panel (formerly known as the Guidelines Advisory Committee, from which Designated Committee Members were selected)

HHEETTFF Home enteral tube feeding

HHIIVV Human Immunodeficiency Virus

HHPPNN Home parenteral nutrition

HHRRQQLL Health Related Quality of Life

HHTTAA Health technology assessment

HHTTBBSS Health Technology Board for Scotland

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ABBREVIATIONS 11

IICCEERR Incremental cost-effectiveness ratio

IIPP Inpatient

IIVV Intravenous

LLOOSS Length of Stay

LLYY Life-year

MMAACC Mid arm circumference

MMAAMMCC Mid arm muscle circumference

MMDDTT Multidisciplinary team

MMNNAA Mini Nutritional Assessment

MMNNAA--SSFF Mini Nutritional Assessment-Short Form

MMNNDD Motor neuron disease

MMRRCC Medical Research Council

MMSS Multiple sclerosis

‘‘MMUUSSTT’’ ‘Malnutrition Universal Screening Tool’

NNCCCC National Collaborating Centre

NNCCCC--AACC National Collaborating Centre for Acute Care

NNCCEEPPOODD National Confidential Enquiry into Patient Outcome and Death

NNDD Nasoduodenal

NNGG Nasogastric

NNHHSS National Health Service

NNII Nutrition intake

NNIICCEE National Institute for Health and Clinical Excellence (formerly National Institute for Health and Clinical Excellence)

NNJJ Nasojejunal

NNNNTT Number needed to treat

OO22 Oxygen

OONNSS Oral Nutritional Supplement

PPEEGG Percutaneous endoscopic gastrostomy

PPEEJJ Percutaneous endoscopic jejunostomy

PPIICCCC Peripherally inserted central catheters

PPIICCOO Framework incorporating patients, interventions, comparisons, outcomes

PPIIUU Patient Involvement Unit (formerly known as the National Guidelines and Audit Patient Involvement Unit)

PPNN Parenteral nutrition

PPPPIIPP Patient and Public Involvement Programme

QQAALLYY Quality-adjusted life year

RRCCTT Randomised controlled trial

RRDDAA Recommended Dietary Allowance

RRQQ Respiratory quotient

SSIIGGNN Scottish Intercollegiate Guidelines Network

SSRR Systematic review

TTPPNN Total parenteral nutrition

TTSSFF Tricep skinfold

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Glossary of TermsAmended from a glossary produced by the Patient Involvement Unit, NICE.

AAbbssoolluuttee rriisskk rreedduuccttiioonn ((RRiisskk ddiiffffeerreennccee)) The difference in event rates between two groups (one subtracted from the other)in a comparative study.

AAbbssttrraacctt Summary of a study, which may be published alone or as an introduction to a fullscientific paper.

AAccuuttee PPhhaassee RReessppoonnssee ((AAPPRR)) A group of physiologic processes occurring soon after the onset of infection,trauma, inflammatory processes, and some malignant conditions. The mostprominent change is a dramatic increase of acute phase proteins, especially C-reactive protein, in the serum. Also seen are fever, increased vascular permeability,

and a variety of metabolic and pathologic changes2.

AAddjjuussttmmeenntt A statistical procedure in which the effects of differences in composition of thepopulations being compared (or treatment given at the same time) have beenminimised by statistical methods.

AAllggoorriitthhmm ((iinn gguuiiddeelliinneess)) A flow chart of the clinical decision pathway described in the guideline, wheredecision points are represented with boxes, linked with arrows.

AAllllooccaattiioonn ccoonncceeaallmmeenntt The process used to prevent advance knowledge of group assignment in a RCT.The allocation process should be impervious to any influence by the individualmaking the allocation, by being administered by someone who is not responsiblefor recruiting participants.

AAnncciillllaarriieess The equipment and consumables required for enteral and parenteral nutrition.

AApppplliiccaabbiilliittyy The degree to which the results of an observation, study or review are likely tohold true in a particular clinical practice setting.

AApppprraaiissaall ooff GGuuiiddeelliinneess,, RReesseeaarrcchh aanndd An international collaboration of researchers and policy makers whose aim is toimprove the quality and effectiveness of clinical practice guidelines(http://www.agreecollaboration.org). The AGREE instrument, developed by thegroup, is designed to assess the quality of clinical guidelines.

AApppprraaiissaall CCoommmmiitttteeee A standing advisory committee of the Institute. Its members are drawn from theNHS, patient/carer organisations, relevant academic disciplines and thepharmaceutical and medical devices industries.

AArrmm ((ooff aa cclliinniiccaall ssttuuddyy)) Sub-section of individuals within a study who receive one particular intervention,for example placebo arm.

AAsssseessssmmeenntt pprroottooccooll Written instructions for the conduct and analysis of the assessment of a technology.


EEvvaalluuaattiioonn ((AAGGRREEEE))

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AAsssseessssmmeenntt RReeppoorrtt In technology appraisals, a critical review of the clinical and cost effectiveness ofa health technology/technologies. It is prepared by the Assessment Group. Toprepare the report, the Assessment Group carries out a review of the publishedliterature and the submissions from manufacturers and sponsors.

AAssssoocciiaattiioonn Statistical relationship between two or more events, characteristics or othervariables. The relationship may or may not be causal.

AAuuddiitt See ‘Clinical audit’.

AAuuddiitt ttrraaiill Records of action to assess practice against standards. Also a record of actions,for example changes to a draft guideline so that reasons can be apparent to athird party.

BBaasseelliinnee The initial set of measurements at the beginning of a study (after run-in periodwhere applicable), with which subsequent results are compared.

BBiiaass Influences on a study that can lead to invalid conclusions about a treatment orintervention. Bias in research can make a treatment look better or worse than itreally is. Bias can even make it look as if the treatment works when it actuallydoesn’t. Bias can occur by chance or as a result of systematic errors in the designand execution of a study. Bias can occur at different stages in the researchprocess, e.g. in the collection, analysis, interpretation, publication or review ofresearch data.

BBlliinnddiinngg ((mmaasskkiinngg)) Keeping the study participants, caregivers, researchers and outcome assessors unawareabout the interventions to which the participants have been allocated in a study

BBooddyy MMaassss IInnddeexx A measure of body weight relative to height used to determine whether peopleare underweight, at a healthy weight, over weight or obese.

BBoolluuss//iinntteerrmmiitttteenntt ffeeeeddiinngg The administration of a feed through an enteral tube delivered as a single portionover a short period of time.

CCaappiittaall ccoossttss Costs of purchasing major capital assets (usually land, buildings or equipment).Capital costs represent investments at one point in time.

CCaarree hhoommeess This refers to residential and nursing care.

CCaarreerr ((ccaarreeggiivveerr)) Someone other than a health professional who is involved in caring for a personwith a medical condition.

CCaassee--ccoonnttrrooll ssttuuddyy Comparative observational study in which the investigator selects individuals whohave experienced an event (for example, developed a disease) and others whohave not (controls), and then collects data to determine previous exposure to apossible cause

CCaassee rreeppoorrtt ((oorr ccaassee ssttuuddyy)) Detailed report on one patient (or case), usually covering the course of thatperson’s disease and their response to treatment.

CCaassee sseerriieess Report of a number of cases of a given disease, usually covering the course of the disease and the response to treatment. There is no comparison (control) groupof patients.

GLOSSARY 13

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CCllaassssiiffiiccaattiioonn ooff rreeccoommmmeennddaattiioonnss A code (such as A, B, C, D) given to a guideline recommendation, indicating thestrength of the evidence supporting that recommendation.

CClliinniiccaall aauuddiitt A quality improvement process that seeks to improve patient care and outcomesthrough systematic review of care against explicit criteria and the implementationof change.

CClliinniiccaall eeffffiiccaaccyy The extent to which an intervention is active when studied under controlledresearch conditions.

CClliinniiccaall eeffffeeccttiivveenneessss The extent to which an intervention produces an overall health benefit in routineclinical practice.

CClliinniiccaall iimmppaacctt The effect that a guideline recommendation is likely to have on the treatment ortreatment outcomes, of the target population.

CClliinniiccaall qquueessttiioonn In guideline development, this term refers to the questions about treatment and carethat are formulated to guide the development of evidence-based recommendations.

CClliinniicciiaann A healthcare professional providing direct patient care, for example doctor, nurseor physiotherapist.

CClluusstteerr A closely grouped series of events or cases of a disease or other related healthphenomena with well-defined distribution patterns, in relation to time or place orboth. Alternatively, a grouped unit for randomisation.

CCoocchhrraannee LLiibbrraarryy A regularly updated electronic collection of evidence-based medicine databases,including the Cochrane Database of Systematic Reviews.

CCoocchhrraannee RReevviieeww A systematic review of the evidence from randomised controlled trials relating toa particular health problem or healthcare intervention, produced by the CochraneCollaboration. Available electronically as part of the Cochrane Library.

CCoohhoorrtt ssttuuddyy A retrospective or prospective follow-up study. Groups of individuals to befollowed up are defined on the basis of presence or absence of exposure to asuspected risk factor or intervention. A cohort study can be comparative, in whichcase two or more groups are selected on the basis of differences in their exposureto the agent of interest.

CCoommbbiinneedd mmooddaalliittyy Use of different treatments in combination (for example surgery, chemotherapyand radiotherapy used together).

CCoommmmeennttaattoorr Organisations that engage in the appraisal process but that are not asked toprepare a submission dossier, and that receive the Final Appraisal Determination(FAD) for information only, without right of appeal. These organisations aremanufacturers of comparator technologies, NHS Quality Improvement Scotland;the relevant National Collaborating Centre; other related research groups andother groups where appropriate.

CCoommmmeennttss ttaabbllee Table compiled by NICE to show all the comments and responses generated aspart of the consultation process.

CCoommmmeerrcciiaall iinn ccoonnffiiddeennccee See ‘In confidence’


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CCoommmmuunniittyy This may refer to care homes (including residential care and nursing care),domiciliary care (also known as ‘home’ care) and primary care.

CCoo--mmoorrbbiiddiittyy Co-existence of more than one disease or an additional disease (other than thatbeing studied or treated) in an individual.

CCoommppaarraabbiilliittyy Similarity of the groups in characteristics likely to affect the study results (such ashealth status or age).

CCoommpplliiaannccee The extent to which a person adheres to the health advice agreed with healthcareprofessionals. May also be referred to as ‘adherence’.

CCoonnffeerreennccee pprroocceeeeddiinnggss Compilation of papers presented at a conference.

CCoonnffiiddeennccee iinntteerrvvaall ((CCII)) A range of values for an unknown population parameter with a stated ‘confidence’(conventionally 95%) that it contains the true value. The interval is calculated fromsample data, and generally straddles the sample estimate. The ‘confidence’ valuemeans that if the method used to calculate the interval is repeated many times, thenthat proportion of intervals will actually contain the true value.

CCoonnffoouunnddiinngg In a study, confounding occurs when the effect of an intervention on an outcomeis distorted as a result of an association between the population or interventionor outcome and another factor (the ‘confounding variable’) that can influence theoutcome independently of the intervention under study.

CCoonnsseennssuuss mmeetthhooddss Techniques that aim to reach an agreement on a particular issue. Formalconsensus methods include Delphi and nominal group techniques, and consensusdevelopment conferences. In the development of clinical guidelines, consensusmethods may be used where there is a lack of strong research evidence on aparticular topic. Expert consensus methods will aim to reach agreement betweenexperts in a particular field.

CCoonnssuullttaattiioonn The process that allows stakeholders and individuals to comment on initialversions of NICE guidance and other documents so their views can be taken intoaccount when producing the final version.

CCoonnssuulltteeee An organisation that accepts an invitation to participate in the appraisal. Consulteescan participate in the consultation on the draft scope, the Assessment Report and theAppraisal Consultation Document; consultee organisations representing patient/carersand professionals can nominate clinical specialists and patient experts to present theirpersonal views to the Appraisal Committee, AND are given the opportunity to appealagainst the Final Appraisal Determination (FAD).

CCOONNSSOORRTT ssttaatteemmeenntt Recommendations for improving the reporting of randomised controlled trials injournals. A flow diagram and checklist allow readers to understand the conduct ofthe study and assess the validity of the results.

CCoonnttrrooll ggrroouupp A group of patients recruited into a study that receives no treatment, a treatmentof known effect, or a placebo (dummy treatment) - in order to provide acomparison for a group receiving an experimental treatment, such as a new drug.

GLOSSARY 15

((CCoonnssoolliiddaatteedd rreeppoorrttiinngg ooff cclliinniiccaall ttrriiaallss))

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CCoonnttrroolllleedd cclliinniiccaall ttrriiaall ((CCCCTT)) A study testing a specific drug or other treatment involving two (or more) groups ofpatients with the same disease. One (the experimental group) receives the treatmentthat is being tested, and the other (the comparison or control group) receives analternative treatment, a placebo (dummy treatment) or no treatment. The two groupsare followed up to compare differences in outcomes to see how effective theexperimental treatment was. A CCT where patients are randomly allocated totreatment and comparison groups is called a randomised controlled trial.

CCoosstt bbeenneeffiitt aannaallyyssiiss A type of economic evaluation where both costs and benefits of healthcaretreatment are measured in the same monetary units. If benefits exceed costs, theevaluation would recommend providing the treatment.

CCoosstt--ccoonnsseeqquueenncceess aannaallyyssiiss ((CCCCAA)) A type of economic evaluation where various health outcomes are reported inaddition to cost for each intervention, but there is no overall measure of health gain.

CCoosstt--eeffffeeccttiivveenneessss aannaallyyssiiss ((CCEEAA)) An economic study design in which consequences of different interventions aremeasured using a single outcome, usually in ‘natural’ units (for example, life-yearsgained, deaths avoided, heart attacks avoided, cases detected). Alternativeinterventions are then compared in terms of cost per unit of effectiveness.

CCoosstt--eeffffeeccttiivveenneessss mmooddeell An explicit mathematical framework, which is used to represent clinical decisionproblems and incorporate evidence from a variety of sources in order to estimatethe costs and health outcomes.

CCoosstt--uuttiilliittyy aannaallyyssiiss ((CCUUAA)) A form of cost-effectiveness analysis in which the units of effectiveness arequality-adjusted life-years (QALYs).

CCoonntteenntt eexxppeerrtt An individual with skills or knowledge relating to the subject being investigated.

CCrriitteerriioonn ((iinn aauuddiitt)) An explicit statement that defines the appropriateness of healthcare decisions,services and outcomes, and that can be measured.

CCrroossss--sseeccttiioonnaall ssttuuddyy The observation of a defined set of people at a single point in time or time period– a snapshot. (This type of study contrasts with a longitudinal study which followsa set of people over a period of time).

DDeecciissiioonn aannaallyyssiiss A systematic way of reaching decisions, based on evidence from research. Thisevidence is translated into probabilities, and then into diagrams or decision treeswhich direct the clinician through a succession of possible scenarios, actions and outcomes.

DDeecciissiioonn aannaallyyttiicc tteecchhnniiqquueess A way of reaching decisions, based on evidence from research. This evidence istranslated into probabilities, and then into diagrams or decision trees that directthe clinician through a succession of possible scenarios, actions and outcomes.

DDeecciissiioonn pprroobblleemm A clear specification of the interventions, patient populations and outcomemeasures and perspective adopted in an evaluation, with an explicit justification,relating these to the decision which the analysis is to inform.

DDiieettaarryy aaddvviiccee The provision of instructions on modifying food intake to improve nutritional intake.


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DDiissccoouunnttiinngg Costs and perhaps benefits incurred today have a higher value than costs andbenefits occurring in the future. Discounting health benefits reflects individualpreference for benefits to be experienced in the present rather than the future.Discounting costs reflects individual preference for costs to be experienced in thefuture rather than the present.

DDoommiinnaannccee An intervention is said to be dominated if there is an alternative intervention thatis both less costly and more effective.

DDoossaaggee The prescribed amount of a drug to be taken, including the size and timing of the doses.

DDoouubbllee bblliinndd ssttuuddyy A study in which neither the subject (patient) nor the observer(investigator/clinician) is aware of which treatment or intervention the subject isreceiving. The purpose of blinding is to protect against bias.

DDrroopp--oouutt A participant who withdraws from a clinical trial before the end.

DDyysspphhaaggiiaa Any impairment of eating, drinking and swallowing.

EEccoonnoommiicc eevvaalluuaattiioonn Comparative analysis of alternative health strategies (interventions orprogrammes) in terms of both their costs and consequences.

EEffffiiccaaccyy See ‘Clinical efficacy’.

EEffffeecctt ((aass iinn eeffffeecctt mmeeaassuurree,, ttrreeaattmmeenntt The observed association between interventions and outcomes or a statistic tosummarise the strength of the observed association.

EEffffeeccttiivveenneessss See ‘Clinical effectiveness’.

EElleeccttiivvee Name for clinical procedures that are regarded as advantageous to the patientbut not urgent.

EElleeccttrroollyytteess Anions and cations in the blood, tissue fluids and cells e.g. sodium, potassiumand chlorine.

EEnntteerraall nnuuttrriittiioonn see enteral tube feeding

EEnntteerraall ttuubbee ffeeeeddiinngg Nutrition support directly into the gut via a tube (the term as used in theseguidelines does not include oral intake).

EEppiiddeemmiioollooggiiccaall ssttuuddyy The study of a disease within a population, defining its incidence and prevalenceand examining the roles of external influences (for example, infection, diet) andinterventions

EEvviiddeennccee Information on which a decision or guidance is based. Evidence is obtained froma range of sources including randomised controlled trials, observational studies,expert opinion (of clinical professionals and/or patients).

EEvviiddeennccee ttaabbllee A table summarising the results of a collection of studies which, taken together,represent the evidence supporting a particular recommendation or series ofrecommendations in a guideline.

GLOSSARY 17

eeffffeecctt,, eessttiimmaattee ooff eeffffeecctt,, eeffffeecctt ssiizzee))

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EExxcclluussiioonn ccrriitteerriiaa ((lliitteerraattuurree rreevviieeww)) Explicit standards used to decide which studies should be excluded fromconsideration as potential sources of evidence.

EExxcclluussiioonn ccrriitteerriiaa ((cclliinniiccaall ssttuuddyy)) Criteria that define who is not eligible to participate in a clinical study.

EExxppeerrtt ccoonnsseennssuuss See ‘Consensus methods’.

EExxtteennddeedd ddoommiinnaannccee If Option A is both more clinically effective than Option B and has a lower costper unit of effect, when both are compared with a do-nothing alternative thenOption A is said to have extended dominance over Option B. Option A istherefore more efficient and should be preferred, other things remaining equal.

EExxttrraappoollaattiioonn In data analysis, predicting the value of a parameter outside the range ofobserved values.

FFaacciilliittaattoorr An individual whose function is to promote the effective functioning of thegroup.

FFooccuuss ggrroouupp A qualitative research technique. It is a method of group interview or discussionof between 6–12 people focused around a particular issue or topic. The methodexplicitly includes and uses the group interaction to generate data.

FFoollllooww uupp Observation over a period of time of an individual, group or initially definedpopulation whose appropriate characteristics have been assessed in order toobserve changes in health status or health-related variables.

GGaanntttt CChhaarrtt A project planning tool showing the timing of tasks within a project. Dates runfrom left to right and each task is represented by a horizontal bar, the left end ofwhich marks the expected beginning of the task and the right end of whichmarks the planned completion date.

GGaassttrroojjeejjuunnoossttoommyy ttuubbee Enteral tube inserted through the abdominal wall which passes through thestomach into the jejunum for the purpose of nutrition support.

GGaassttrroossttoommyy Enteral tube inserted through the abdominal wall into the stomach for thepurpose of nutrition support.

GGeenneerraalliissaabbiilliittyy The extent to which the results of a study based on measurement in a particularpatient population and/or a specific context hold true for another populationand/or in a different context. In this instance, this is the degree to which theguideline recommendation is applicable across both geographical and contextualsettings. For instance, guidelines that suggest substituting one form of labour foranother should acknowledge that these costs might vary across the country.

GGeenneerriicc nnaammee The general non-proprietary name of a drug or device.

GGoolldd ssttaannddaarrdd A method, procedure or measurement that is widely accepted as being the bestavailable.

GGooooddnneessss--ooff--ffiitt How well a statistical model or distribution compares with the observed data.

GGoooodd PPrraaccttiiccee PPooiinnttss Recommended good practice based on the clinical experience of the GuidelineDevelopment Group.


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GGrraaddiinngg eevviiddeennccee A code given to a study or other evidence, indicating the quality andgeneralisability of the research. The highest grade evidence will usually beobtained from randomised controlled trials.

GGrreeyy lliitteerraattuurree Reports that are unpublished or have limited distribution, and are not included inthe common bibliographic retrieval systems.

HHaarrmmss Adverse effects of an intervention.

HHeeaalltthh eeccoonnoommiiccss The study of the allocation of scarce resources among alternative healthcaretreatments. Health economists are concerned with both increasing the averagelevel of health in the population and improving the distribution of health.

HHeeaalltthh rreellaatteedd qquuaalliittyy ooff lliiffee A combination of an individual’s physical, mental and social well-being; notmerely the absence of disease.

HHeeaalltthh tteecchhnnoollooggyy Any method used by those working in health services to promote health, preventand treat disease, and improve rehabilitation and long-term care. Technologies inthis context are not confined to new drugs or pieces of sophisticated equipment.

HHeetteerrooggeenneeiittyy Or lack of homogeneity. The term is used in meta-analyses and systematic reviewswhen the results or estimates of effects of treatment from separate studies seem to bevery different – in terms of the size of treatment effects or even to the extent thatsome indicate beneficial and others suggest adverse treatment effects. Such resultsmay occur as a result of differences between studies in terms of the patientpopulations, outcome measures, definition of variables or duration of follow-up.

HHoommee eenntteerraall ttuubbee ffeeeeddiinngg The practice of enteral tube feeding in the community.

HHoommee ppaarreenntteerraall NNuuttrriittiioonn The practice of parenteral nutrition in the community.

HHoommooggeenneeiittyy This means that the results of studies included in a systematic review or meta-analysis are similar and there is no evidence of heterogeneity. Results are usuallyregarded as homogeneous when differences between studies could reasonably beexpected to occur by chance.

HHyyppootthheessiiss A supposition made as a starting point for further investigation.

IImmpplleemmeennttaattiioonn Introducing the use of the guidance recommendations in practice.

IInn ccoonnffiiddeennccee mmaatteerriiaall Information (for example, the findings of a research project) defined as‘confidential’ as its public disclosure could have an impact on the commercialinterests of a particular company or the academic interests of a research orprofessional organisation.

IInncclluussiioonn ccrriitteerriiaa ((lliitteerraattuurree rreevviieeww)) Explicit criteria used to decide which studies should be considered as potentialsources of evidence.

IInnccrreemmeennttaall aannaallyyssiiss The comparison of the costs and effects of one intervention compared with thenext best alternative.

IInnccrreemmeennttaall ccoosstt eeffffeeccttiivveenneessss rraattiioo ((IICCEERR)) The difference in the mean costs in the population of interest divided by thedifferences in the mean outcomes in the population of interest.

GLOSSARY 19

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IInnddeexx In epidemiology and related sciences, this word usually means a rating scale, forexample, a set of numbers derived from a series of observations of specifiedvariables. Examples include the various health status indices, and scoring systemsfor severity or stage of cancer.

IInnddiiccaattiioonn ((ssppeecciiffiicc)) The defined use of a technology as licensed by the Medicines and Healthcareproducts Regulatory Agency (MHRA).

IInntteennttiioonn--ttoo--ttrreeaatt aannaallyyssiiss ((IITTTT aannaallyyssiiss)) An analysis of the results of a clinical study in which the data are analysed for allstudy participants as if they had remained in the group to which they wererandomised, regardless of whether or not they remained in the study until theend, crossed over to another treatment or received an alternative intervention

IInntteerrmmeeddiiaattee oouuttccoommeess Outcomes that are related to the outcome of interest but may be more easilyassessed within the context of a clinical study: for example, blood pressurereduction is related to the risk of a stroke.

IInntteerrnnaall vvaalliiddiittyy The degree to which the results of a study are likely to approximate the ‘truth’ forthe participants recruited in a study (that is, are the results free of bias?). It refersto the integrity of the design and is a prerequisite for applicability (externalvalidity) of a study’s findings. See ‘External validity’.

IInntteerrvveennttiioonn Healthcare action intended to benefit the patient, for example, drug treatment,surgical procedure, psychological therapy.

JJeejjuunnoossttoommyy Enteral tube inserted through the abdominal wall directly into the jejunum forthe purpose of nutrition support.

LLeennggtthh ooff ssttaayy The total number of days a participant stays in hospital.

LLiicceennccee See ‘Product licence’.

LLiiffee yyeeaarr A measure of health outcome which shows the number of years of remaining lifeexpectancy.

LLiiffee--yyeeaarrss ggaaiinneedd Average years of life gained per person as a result of the intervention.

LLoonnggiittuuddiinnaall ssttuuddyy A study of the same group of people at more than one point in time. (This type ofstudy contrasts with a cross sectional study which observes a defined set ofpeople at a single point in time).

LLuummeenn Cavity or channel within a tube

MMaallnnuuttrriittiioonn A state of nutrition in which a deficiency of energy, protein and/or othernutrients causes measurable adverse effects on tissue/body form, composition,

function or clinical outcome94 (in these guidelines we do not use the term tocover excess nutrient provision). For the purposes of this guideline we haveconsidered that malnutrition is likely to be significant if a person has a

BMI 10% within the previous 3-6

months, or a BMI5% within theprevious 3-6 months.


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MMaallnnuuttrriittiioonn,, aatt rriisskk has eaten little or nothing for more than 5 days and/or is likely to eat little ornothing for the next 5 days or longer

MMeeddiicciinneess aanndd HHeeaalltthhccaarree PPrroodduuccttss The Executive Agency of the Department of Health protecting and promotingpublic health and patient safety by ensuring that medicines, healthcare productsand medical equipment meet appropriate standards of safety, quality,performance and effectiveness, and are used safely.

MMeettaa--aannaallyyssiiss Results from a collection of independent studies (investigating the sametreatment) are pooled, using statistical techniques to synthesise their findingsinto a single estimate of a treatment effect. Where studies are not compatible e.g.because of differences in the study populations or in the outcomes measured, itmay be inappropriate or even misleading to statistically pool results in this way.See also Systematic review & Heterogeneity.

MMoottiilliittyy aaggeenntt A medication used to aid the movement of food from the stomach into theintestine.

NNaassoodduuooddeennaall ((ttuubbee)) ffeeeeddiinngg Nutrition support provided via a tube inserted via the nose, oesophagus andstomach into the duodenum.

NNaassooggaassttrriicc ((ttuubbee)) ffeeeeddiinngg Nutrition support provided through a tube inserted through the nose via theoesophagus into the stomach.

NNaassoojjeejjuunnaall ((ttuubbee)) ffeeeeddiinngg Nutrition support provided through a tube inserted through the nose via theoesophagus, stomach and duodenum into the jejunum.

NNIICCEE TTeecchhnnoollooggyy AApppprraaiissaallss Recommendations on the use of new and existing medicines and othertreatments within the NHS in England and Wales, such as: medicines (forexample, drugs), medical devices (for example, hearing aids and inhalers),diagnostic techniques (tests used to identify diseases), surgical procedures (forexample, repair of hernias), health promotion activities (for example, patienteducation models for diabetes).

NNoonn--eexxppeerriimmeennttaall ssttuuddyy A study based on subjects selected on the basis of their availability, with noattempt having been made to avoid problems of bias.

NNuummbbeerr nneeeeddeedd ttoo ttrreeaatt ((NNNNTT)) The number of patients that who on average must be treated to prevent a singleoccurrence of the outcome of interest.

NNuuttrriittiioonn aasssseessssmmeenntt A comprehensive evaluation to define nutrition status, including medical history,dietary history, physical examination, anthropometric measurements andlaboratory data, by a health professional with skills and tanning in nutrition andnutrition support. For example dietitian, nutrition nurse.

NNuuttrriittiioonn ssccrreeeenniinngg A rapid, simple and general procedure used by nursing, medical or other staff,often at first contact with the patient, to detect those who have significantnutritional problems or significant risks of such problems, in order that clearguidelines for action can be implemented, e.g. simple dietary measures or referral

for expert help94.

GLOSSARY 21

RReegguullaattoorryy AAggeennccyy ((MMHHRRAA))

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NNuuttrriittiioonn ssuuppppoorrtt The provision of nutrients and any necessary adjunctive therapeutic agents topatients orally and/or enterally by administration into the stomach or intestineand/or by intravenous infusion (parenterally) for the purpose of improving ormaintaining a patient’s nutrition status’

NNuuttrriittiioonn SSuuppppoorrtt TTeeaamm A multidisciplinary team with dietetic, nursing, pharmacy and medical expertiseto provide safe nutrition support.

OObbsseerrvvaattiioonnaall ssttuuddyy Retrospective or prospective study in which the investigator observes the naturalcourse of events with or without control groups; for example, cohort studies andcase–control studies.

OOllddeerr ppeeooppllee People over the age of 65 years.

OOppeerraattiinngg ccoossttss Ongoing costs of carrying out an intervention, excluding capital costs.

OOrraall NNuuttrriittiioonnaall SSuupppplleemmeenntt A product for use in oral nutrition support given with the aim to increasenutritional intake.

OOrraall nnuuttrriittiioonn ssuuppppoorrtt The modification of food and fluid by: fortifying food with protein, carbohydrateand/or fat plus minerals and vitamins; the provision snacks and/or oralnutritional supplements as extra nutrition to regular meals, changing mealpatterns or the provision of dietary advice to patients on how to increase overallnutrition intake by the above.

OOrrooggaassttrriicc ((ttuubbee)) ffeeeeddiinngg Nutrition support provided by a tube inserted through the mouth via theoesophagus into the stomach

OOppppoorrttuunniittyy ccoosstt The opportunity cost of investing in a healthcare intervention is the otherhealthcare programmes that are displaced by its introduction. This may be bestmeasured by the health benefits that could have been achieved had the moneybeen spent on the next best alternative healthcare intervention.

OOuuttccoommee Measure of the possible results that may stem from exposure to a preventive ortherapeutic intervention. Outcome measures may be intermediate endpoints orthey can be final endpoints. See ‘Intermediate outcome’.

PP vvaalluuee The probability that an observed difference could have occurred by chance,assuming that there is in fact no underlying difference between the means of theobservations. If the probability is less than 1 in 20, the P value is less than 0.05;a result with a P value of less than 0.05 is conventionally considered to be‘statistically significant’.

PPaalllliiaattiivvee ccaarree Active holistic care of patients with advanced progressive illness, focusing on themanagement of pain and other symptoms and provision of psychological, socialand spiritual support. The goal of palliative care is the achievement of the best

quality of life for patients and their families.378

PPaarreenntteerraall nnuuttrriittiioonn The provision of nutrition support through intravenous administration of nutrientssuch as amino acids, glucose, fat, electrolytes, vitamins and trace elements.


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PPeerriiooppeerraattiivvee The period from admission through surgery until discharge, encompassing pre-operative and post-operative periods. Studies included in this guideline for surgicalpatients sometimes start or end their intervention outside this period. However, theyalways include nutrition support during some of the perioperative phase.

PPeeeerr rreevviieeww A process where research is scrutinised by experts that have not been involved inthe design or execution of the studies.

PPiilloott ssttuuddyy A small scale ‘test’ of the research instrument. For example, testing out (piloting)a new questionnaire with people who are similar to the population of the study,in order to highlight any problems or areas of concern, which can then beaddressed before the full scale study begins.

PPllaacceebboo An inactive and physically identical medication or procedure used as acomparator in controlled clinical trials.

PPllaacceebboo eeffffeecctt A beneficial (or adverse) effect produced by a placebo and not due to anyproperty of the placebo itself.

PPoowweerr See ‘Statistical power’.

PPrriimmaarryy ccaarree Healthcare delivered to patients outside hospitals. Primary care covers a range ofservices provided by GPs, nurses and other healthcare professionals, dentists,pharmacists and opticians.

PPrriimmaarryy rreesseeaarrcchh Study generating original data rather than analysing data from existing studies(which is called secondary research).

PPrroodduucctt lliicceennccee An authorisation from the MHRA to market a medicinal product.

PPrrooggnnoossiiss A probable course or outcome of a disease. Prognostic factors are patient ordisease characteristics that influence the course. Good prognosis is associatedwith low rate of undesirable outcomes; poor prognosis is associated with a highrate of undesirable outcomes.

PPrroopprriieettaarryy nnaammee The brand name given by the manufacturer to a drug or device it produces.

PPrroossppeeccttiivvee ssttuuddyy A study in which people are entered into the research and then followed up overa period of time with future events recorded as they happen. This contrasts withstudies that are retrospective.

QQuuaalliittaattiivvee rreesseeaarrcchh Research concerned with subjective outcomes relating to social, emotional andexperiential phenomena in health and social care.

QQuuaalliittyy aaddjjuusstteedd lliiffee yyeeaarrss ((QQAALLYYSS)) An index of survival that is adjusted to account for the patient’s quality of lifeduring this time. QALYs have the advantage of incorporating changes in bothquantity (longevity/mortality) and quality (morbidity, psychological, functional,social and other factors) of life. Used to measure benefits in cost-utility analysis.

QQuuaalliittyy ooff lliiffee See ‘Health related quality of life’

GLOSSARY 23

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QQuuaannttiittaattiivvee rreesseeaarrcchh Research that generates numerical data or data that can be converted intonumbers, for example clinical trials or the national Census which counts peopleand households.

QQuuiicckk RReeffeerreennccee GGuuiiddee An abridged version of NICE guidance, which presents the key priorities forimplementation and summarises the recommendations for the core clinical audience.

RRaannddoomm aallllooccaattiioonn oorr RRaannddoommiissaattiioonn Allocation of participants in a research study to two or more alternative groups usinga chance procedure, such as computer-generated random numbers. This approach isused in an attempt to ensure there is an even distribution of participants withdifferent characteristics between groups and thus reduce sources of bias.

RRaannddoommiisseedd ccoonnttrroolllleedd ttrriiaall ((RRCCTT)) A comparative study in which participants are randomly allocated to interventionand control groups and followed up to examine differences in outcomes betweenthe groups.

RRaappiidd uuppddaattee Review of existing guidance carried out sooner than originally planned becausenew data have become available.

RReeffeerreennccee ssttaannddaarrdd ((oorr ggoolldd ssttaannddaarrdd)) An agreed standard, for example for a test or treatment, against which otherinterventions can be compared.

RReellaattiivvee rriisskk ((RRRR)) The number of times more likely or less likely an event is to happen in one groupcompared with another (calculated as the risk of the event in group A/the risk ofthe event in group B).

RReelliiaabbiilliittyy//rreeppeeaattaabbiilliittyy The degree of agreement exhibited when a measurement is repeated underidentical conditions. Reliability refers to the degree to which the results obtainedby a measurement procedure can be replicated.

RReemmiitt The brief given by the Department of Health and Welsh Assembly Government atthe beginning of the guideline development process. This defines core areas ofcare that the guideline needs to address.

RReesseeaarrcchh EEtthhiiccss CCoommmmiitttteeee An independent committee that scrutinises proposals for research to ensure theyare ethically acceptable.

RReessoouurrccee iimmpplliiccaattiioonn The likely impact in terms of finance, workforce or other NHS resources.

RReettrroossppeeccttiivvee ssttuuddyy A retrospective study deals with the present/ past and does not involve studyingfuture events. This contrasts with studies that are prospective.

RReevviieeww ooff tthhee lliitteerraattuurree An article that summarises the evidence contained in a number of differentindividual studies and draws conclusions about their findings. It may or may notbe systematically researched and developed.

SSeeccoonnddaarryy bbeenneeffiittss Benefits resulting from a treatment in addition to the primary, intended outcome.

SSeeccoonnddaarryy ccaarree Care provided in hospitals.

SSeelleeccttiioonn bbiiaass ((aallssoo aallllooccaattiioonn bbiiaass)) A systematic bias in selecting participants for study groups, so that the groupshave differences in prognosis and/or therapeutic sensitivities at baseline.Randomisation (with concealed allocation) of patients protects against this bias.


((ffoorr aa gguuiiddeelliinnee oorr aapppprraaiissaall))

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SSeelleeccttiioonn ccrriitteerriiaa Explicit standards used by guideline development groups to decide which studiesshould be included and excluded from consideration as potential sources ofevidence.

SSeennssiittiivviittyy aannaallyyssiiss A means of representing uncertainty in the results of economic evaluations.Uncertainty may arise from missing data, imprecise estimates or methodologicalcontroversy. Sensitivity analysis also allows for exploring the generalisability ofresults to other settings. The analysis is repeated using different assumptions toexamine the effect on the results. One-way simple sensitivity analysis (univariateanalysis): each parameter is varied individually in order to isolate theconsequences of each parameter on the results of the study. Multi-way simplesensitivity analysis (scenario analysis): two or more parameters are varied at thesame time and the overall effect on the results is evaluated. Threshold sensitivityanalysis: the critical value of parameters above or below which the conclusions ofthe study will change are identified. Probabilistic sensitivity analysis: probabilitydistributions are assigned to the uncertain parameters and are incorporated intoevaluation models based on decision analytical techniques (for example, MonteCarlo simulation).

SSeerrvviiccee ddeelliivveerryy gguuiiddaannccee Recommendations on service delivery primarily aimed at health servicecommissioners. Service delivery guidance focuses on the broad configuration andprovision of clinical services and addresses only those interventions that are likelyto have implications for the configuration of services.

SSppeecciiaalliisseedd nnuuttrriittiioonn ssuuppppoorrtt

SSppeecciiffiicciittyy ((ooff aa tteesstt)) The proportion of individuals classified as negative by the gold (or reference)standard, who are correctly identified by the study test.

SSttaannddaarrdd ccaarree The situation in which a patient is given no supplementary nutrition support butstill eats meals and snacks as appropriate for their clinical status and usualpractice.

SSttaannddaarrddiisseedd PPaarreenntteerraall NNuuttrriittiioonn Admixtures containing fixed formulations of nutrients, such as amino acids,glucose, fat emulsion and electrolytes in a single sterile container system.Additions of other nutrients such as vitamins and trace elements and occasionallysupplemental electrolytes are required to ensure complete admixtures areadministered.

SSttaakkeehhoollddeerr Those with an interest in the use of a technology under appraisal or a guidelineunder development. Stakeholders include manufacturers, sponsors, healthcareprofessionals, and patient and carer groups.

SSttaattiissttiiccaall ppoowweerr The ability to demonstrate an association when one exists. Power is related tosample size; the larger the sample size, the greater the power and the lower therisk that a possible association could be missed.

SSyynntthheessiiss ooff eevviiddeennccee A generic term to describe methods used for summarising (comparing andcontrasting) evidence into a clinically meaningful conclusion in order to answer adefined clinical question. This can include systematic review (with or withoutmeta-analysis), qualitative and narrative summaries.

GLOSSARY 25

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SSyysstteemmaattiicc rreevviieeww Research that summarises the evidence on a clearly formulated questionaccording to a pre-defined protocol using systematic and explicit methods toidentify, select and appraise relevant studies, and to extract, collate and reporttheir findings. It may or may not use statistical meta-analysis.

SSyysstteemmiicc IInnffllaammmmaattoorryy RReessppoonnssee A systemic inflammatory response to at least two criteria leukocytosis, fever,tachycardia, and tachypnea.

TTeecchhnniiccaall LLeeaadd Appraisals team member who has responsibility for the technical aspects of theappraisal including liaising with the Assessment Group, scoping the appraisal,preparing drafts of consultation documents and advising the AppraisalCommittee on technical aspects of the appraisal. There may be more than oneTechnical Lead for an appraisal.

TTeecchhnnoollooggyy aasssseessssmmeenntt The process of evaluating the clinical, economic and other evidence relating touse of a technology in order to formulate guidance on its most efficient use.

TTeesstt--aanndd--ttrreeaatt ssttrraatteeggyy Testing all individuals presenting with suspected of having a condition, andtreating only those with a particular test result.

TTiimmee hhoorriizzoonn The time span used in the NICE appraisal which reflects the period over whichthe main differences between interventions in health effects and use ofhealthcare resources are expected to be experienced, and taking into account thelimitations of supportive evidence.

TTrreeaattmmeenntt aallllooccaattiioonn Assigning a participant to a particular arm of the trial.

TTrreeaattmmeenntt ooppttiioonnss The choices of intervention available.

UUttiilliittyy A measure of the strength of an individual’s preference for a specific health statein relation to alternative health states. The utility scale assigns numerical valueson a scale from 0 (death) to 1 (optimal or ‘perfect’ health). Health states can beconsidered worse than death and thus have a negative value.


SSyynnddrroommee ((SSIIRRSS))

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11..11 TThhee nneeeedd ffoorr gguuiiddeelliinneess iinn nnuuttrriittiioonn ssuuppppoorrtt

Malnutrition is a state in which a deficiency ofenergy, protein and/or other nutrients causesmeasurable adverse effects on tissue/body form,

composition, function or clinical outcome 94 (inthese guidelines we do not use the term to coverexcess nutrient provision). It is both a cause anda consequence of ill-health and is common in theUK. Since malnutrition increases a patient’svulnerability to ill-health, providing nutritionsupport to patients with malnutrition shouldimprove outcomes but decisions on the mosteffective and safe means to do so are complex.Currently, knowledge of the causes, effects andtreatment of malnutrition amongst UK healthprofessionals is poor. Guidelines are thereforeneeded to emphasise the following:

1. Malnutrition is common - many people whoare unwell in hospital or the community, arelikely to eat and drink less than they need. Thisimpairment of food and fluid intake may beshort-lived as part of an acute illness, orprolonged if there are chronic medical or socialproblems. If impaired food intake persists foreven a few days, a patient can becomemalnourished to a degree that may impairrecovery or precipitate other medical problems.This is especially true if the patient wasmalnourished before they became unwell dueto other longstanding medical or psycho-socialproblems, or a generally poor diet. Tocompound any disease related reduction infood intake, many patients also have no helpwith obtaining or preparing meals when theyare ill at home, while those in hospital mayhave further problems relating to poorstandards of catering, inappropriate or

interrupted meal times, incorrect foodconsistencies, and inappropriate eating aidsand/or staff to help them eat and drink for

themselves. The ‘Better Hospital Food’248 and

the ‘Protected Mealtimes’249 plans are welcomegovernment initiatives which try to improve theprovision of hospital meals and snacks.

2. Malnutrition increases vulnerability to ill-health - The consequences of malnutritioninclude vulnerability to infections, delayedwound healing, impaired function of heartand lungs, muscle weakness and

depression353. As a consequence people whoare malnourished consult their generalpractitioners (GPs) more frequently, go tohospital more often for longer periods, andhave higher complication and mortality ratesfor similar conditions. If poor dietary intakepersists for weeks, the resulting malnutritionmay be life-threatening in itself.

3. Decisions on providing nutrition support arecomplex - Although it is clear that clinicaloutcomes in malnourished groups are poorcompared to the better nourished (e.g.malnourished surgical patients havecomplication rates 2-3 times higher than theirbetter nourished counterparts), the indicationsfor active nutrition support using dietarysupplementation, enteral tube feeding orparenteral nutrition are debatable. Whenindividuals are unable or unlikely to meet themajority of their nutrient needs for prolongedperiods (e.g. patients with dysphagia orintestinal failure) the need for appropriatesupport is necessary unless there are concernsaround ethical issues. However, if nutritionalintake is closer to meeting a patient’s needs or

INTRODUCTION AND METHODS 27

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the likely period of impaired intake isuncertain, decisions on providing nutritionsupport and the best means to do so are moredifficult with multiple criteria for choosingoral, enteral or parenteral modalities whichvary with both individual patient needs andthe clinical expertise available to ensure thatany intervention can be undertaken safely.

4. Understanding of malnutrition and nutritionsupport amongst many healthcareprofessionals is poor – The many difficultiesrelating to the need and best mode ofnutrition support are compounded by a lack ofknowledge about malnutrition and itstreatment amongst many healthcareprofessionals. There has been little emphasison nutrition education in eitherundergraduate medical or nursing courses.This has led to poor recognition of bothnutritional risks and the dangers of poorlymanaged nutrition support. Along with thelack of agreed national guidelines, this hasalso led to wide variation in nutritional care

standards. Heyland et al 151 highlighted thedifference between evidence in nutritionalhealthcare and practice when stating that:

‘Approximately 30-40% of patients do notreceive care according to present scientificevidence and about 20-25% of care is notneeded or is potentially harmful’.

The objective of these guidelines is therefore toimprove the practice of nutrition support byproviding guidance to assist all healthcareprofessionals to correctly identify patients inhospital or the community who requirenutritional intervention, and to help themchoose and deliver the most appropriate form ofnutrition support at the appropriate time. Assuch, they are in keeping with other recentpublications highlighting the importance ofgood nutritional care e.g. the Department of

Health’s Essence of Care document82, the WelshAssembly Government’s Fundamentals of

Care370 and the Royal College of Physicians’report ‘Nutrition and patients: a doctor’s

responsibility’297. They are also about improving

people’s quality of life by making them feelbetter through adequate nutrition, and theyhave been developed with a significantcontribution from patient representatives.

11..22 WWhhaatt iiss aa gguuiiddeelliinnee??

Guidelines are recommendations for the care ofindividuals in specific clinical conditions orcircumstances – from prevention and self-carethough primary and secondary care to morespecialised services. Clinical guidelines are basedon the best available evidence, and are producedto assist healthcare professionals and patientsmake informed choices about appropriatehealthcare. While guidelines assist the practice ofhealthcare professionals, they do not replace theirknowledge and skills.

Clinical guidelines for the NHS in England andWales are produced as a response to a request fromthe Department of Health and the Welsh AssemblyGovernment. They select topics for guidelinedevelopment and before deciding whether to refer aparticular topic to the National Institute for Healthand Clinical Excellence (NICE) they consult with therelevant patient bodies, professional organisationsand companies. Once a topic is referred, NICE thencommissions one of seven National CollaboratingCentres to produce a guideline. The CollaboratingCentres are independent of government andcomprise partnerships between a variety ofacademic institutions, health profession bodies and patient groups.

11..33 RReemmiitt ooff tthhee gguuiiddeelliinnee

The following remit was received from theDepartment of Health and National Assembly forWales in as part of NICE’s 7th wave programmeof work:“To prepare a guideline on appropriate methodsof feeding people whoare still capable of deriving at least some of theirnutritional requirements by conventional feedingand/orhave difficulty in swallowingincluding the use of nutritional supplements andenteral and parenteral nutrition methods.”

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11..44 WWhhaatt tthhee gguuiiddeelliinnee ccoovveerrss

These guidelines cover most aspects of nutritionsupport in adult patients (>18 years) who areeither malnourished or are at ‘risk’ of malnutrition.In some cases specific guidance related topatients in specific care settings or with specificdiseases has been provided but in general theguidance is applicable to patients whatever theirsetting (hospital or community) or disease. Theguideline therefore includes:

• Information on the prevalence of malnutritionand the benefits of good nutrition

• Guidance on the appropriate forums for theorganisation of nutrition support in all settings

• Guidance on who should be screened formalnutrition and when, along with the criteriafor consideration when assessing patients’nutritional status.

• The general indications for nutrition supporttogether with ethical and legal considerationsthat may arise.

• Guidance on the process and specialconsiderations required to prescribe nutritionsupport and details information on theimportant parameters to monitor for patientsreceiving nutrition support.

• Detailed guidance on the administration oforal, enteral and parenteral nutritionincluding; the appropriate types of access forenteral and parenteral nutrition and theoptimum mode of delivering these.

• Specific guidance on the management ofproviding nutrition support to patients withdysphagia

• Issues to consider for patients receivingenteral and parenteral nutrition support in thecommunity

• Issues arising for patients and their carers.

For more detailed information please see the fullscope of this guideline Appendix One: scope..

11..55 WWhhaatt tthhee gguuiiddeelliinnee ddooeess nnoott ccoovveerr

The guideline does not provide guidance on:

• The provision of normal food and drinks

• Patients requiring specific specialisttherapeutic or maintenance nutrition regimensin the context of diseases such as inbornerrors of metabolism, diabetes and chronicrenal or liver failure.

• Pregnant women, since the nutritionaldemands on the mother and baby requirespecialist considerations

• Patients with eating disorders. This is covered

in the NICE guideline on eating disorders244.

• People who are obese. This will be covered bythe NICE obesity guidelines expected to bepublished in 2007.

• Primary prevention of malnutrition in healthyindividuals in the general population.

• Children and adolescents under the age of 18 years.

• The guideline also provides norecommendations on:

• The suitability of individually named oralsupplements or enteral and parenteralnutrition solutions.

• The use of novel substrates such as glutamineor arginine (we are aware that there is someevidence suggesting potential benefit fromthe use of these substrates and believe thatthis should be addressed by NICE in theformat of a health technology assessment).

• Types of tubing and receptacles used forenteral and parenteral nutrition support.

• The management of infections and infectioncontrol related to enteral and parenteralnutrition support although reference is madeto the existing NICE guidance on InfectionControl where appropriate.

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11..66 WWhhoo tthhee gguuiiddeelliinnee iiss ffoorr

This guideline does not include recommendationscovering every detail of nutrition support. Insteadthey seek to ensure that all healthcare professionalsconsider every patient’s nutritional status and thelength of time the patient has or will have aninadequate food intake, whatever the disease stateor care setting. They are therefore relevant to allhealthcare professionals who come into contact withpatients, as well as to the patients themselves andtheir carers. It is also expected that the guideline willalso be of value to those involved in clinicalgovernance in both primary and secondary care tohelp ensure that arrangements are in place toidentify, treat and audit malnutrition and the use ofnutrition support within their organisations.

11..77 WWhhoo ddeevveellooppeedd tthhee gguuiiddeelliinnee??

A multidisciplinary Guideline Development Group(GDG) comprising professional group members andconsumer representatives of the main stakeholdersdeveloped this guideline (see Guideline DevelopmentGroup Membership and acknowledgements).

The National Institute for Health and ClinicalExcellence funds the National Collaborating Centrefor Acute Care and thus supported the developmentof this guideline. The GDG was convened by theNational Collaborating Centre for Acute Care (NCC-AC) and chaired by Dr Mike Stroud in accordancewith guidance from the National Institute for Healthand Clinical Excellence (NICE).

The Group met every 6-8 weeks during thedevelopment of the guideline. At the start of theguideline development process all GDG members’interests were recorded on a standard declarationform that covered consultancies, fee-paid work,share-holdings, fellowships and support from thehealthcare industry. At all subsequent GDGmeetings, members declared arising conflicts ofinterest which were recorded.

Staff from the NCC-AC provided methodologicalsupport and guidance for the development process.They undertook systematic searches, retrieval andappraisal of the evidence and drafted the guideline.The Glossary to the guideline contains definitions ofterms used by staff and the GDG.

11..88 MMeetthhooddoollooggyy

11..88..11 OOuuttlliinnee ooff mmeetthhooddss uusseedd

The guideline was commissioned by NICE. Theguideline development process involved several stepsand was developed in accordance with the guidelinedevelopment process outlined in Guidelinedevelopment methods: information for National

Collaborating Centres and guideline developers245 .

11..88..22 DDeevveellooppmmeenntt ooff cclliinniiccaall qquueessttiioonnss

The Guideline Development Group proposed a listof clinical questions (Appendix Two) related to theinitiation and administration of oral, enteral andparenteral nutrition support. With the exception ofthe nutrition screening, monitoring and refeedingsyndrome questions, the remaining questions weredeveloped to investigate the benefit of one type ormode of intervention with another.

11..88..33 TTyyppeess ooff ssttuuddyy iinntteerrvveennttiioonnss

The Guideline Development Group agreed on thedefinition of terms and the inclusion and exclusioncriteria for oral, enteral and parenteral interventions.These were included in the search strategies andconsidered throughout the process of systematicreviewing.

11..88..44 TTyyppeess ooff ssttuuddyy ppooppuullaattiioonn

The search strategies were not restricted tospecific patient/population groups since the GDGwished to determine the likely benefit or risks ofnutrition support to all patient groups. Papers onchildren, pregnant mothers and people witheating disorders were excluded since they wereout of the scope of this guideline.)

11..88..55 TTyyppeess ooff oouuttccoommeess

The Guideline Development Group requested thatall outcomes should be recorded, with theexception of biochemical outcomes which werenot clearly associated with clinical benefit (forexample changes in nitrogen balance or plasmaprotein concentrations).

11..88..66 TTyyppeess ooff ssttuuddiieess

Study design was restricted to systematic reviews,meta-analyses of randomised controlled trials andrandomised controlled trials. No other study designs


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were considered because of the potential biasassociated with observational study designs. Also, the wide inclusion criteria agreed forpopulations, interventions and outcomes would havemade the task of including observational studiesin the systematic reviews too great for the resources available.

11..88..77 LLiitteerraattuurree sseeaarrcchh

A literature review was conducted to identify andsynthesise relevant evidence from the publishedliterature. Three main search strategies weredeveloped for oral, enteral and parenteral nutritioninterventions. Four other search strategies weredeveloped for nutritional screening, monitoring,dysphagia and patient issues.

Search filters to identify systematic reviews (SRs) andrandomised controlled trials (RCTs) were applied tothe search strategies. No language restrictions wereapplied to the search; however, foreign languagepapers were not requested or reviewed.

The following databases were included in theliterature search:

• The Cochrane Library up to 2005 (Issue 1)

• Medline (Dialog Datastar) 1966-2005 (week)

• Embase (Dialog Datastar) 1980-2005 (week)

• Cinahl (Dialog Datastar) 1982-2005

• Allied & Complementary Medicine (DialogDatastar) 1985-2005

• British Nursing Index (Dialog Datastar) 1994-2005

Although literature searching was started in 2003update searches were run for each search toensure all reviews included literature up to thesame cut-off date. Therefore, each database was

searched from its start date up to 3rd March2005. Papers identified after this date were notconsidered, with the exception of the draft BAPENreport on ‘The cost of malnutrition in the UK andthe economic case for the use of oral supplements

(ONS) in adults’91, which the GDG had beenanticipating but which was received shortly afterthe cut-off date. Search strategies can be foundin Appendix Three.

There was no systematic attempt to search for allthe ‘grey literature’ (conferences, abstracts, thesesand unpublished literature). We searched forguidelines and reports from relevant websites,including the following listed below. Bibliographiesof identified reports and guidelines were alsochecked to identify relevant literature.

• National Institute for Health and ClinicalExcellence (NICE) (www.nice.org.uk)

• National electronic Library for Health (NeLH)(http://www.nelh.nhs.uk/)

• National Institutes of Health ConsensusDevelopment Program (consensus.nih.gov)

• New Zealand Guidelines Development Group(NZGG) (http://www.nzgg.org.nz/)

• Scottish Intercollegiate Guideline Network(SIGN) (www.sign.ac.uk)

• US National Guideline Clearing House(www.guidelines.gov)

• Web sites of relevant members of theGuidelines International Network(http://www.g-i-n.net/)

• Google (www.google.com)

11..88..88 SSttuuddyy sseelleeccttiioonn

One reviewer independently scanned the titlesand abstracts of the literature searches. Fullpublications were obtained for any studiesconsidered relevant or where there wasinsufficient information from the title andabstract to make a decision.

11..88..99 DDaattaa eexxttrraaccttiioonn aanndd qquuaalliittyy aasssseessssmmeenntt

A team of reviewers individually applied theinclusion/exclusion criteria to determine allpotentially relevant studies. The reviewers alsoassessed the quality of eligible studies byreferring to the SIGN quality checklists forsystematic reviews/meta-analyses andrandomised control trials. Of all the relevantstudies data on the type of population,intervention, comparator and outcomes wassummarised onto evidence tables (AppendixFour). In the instances where there was missing


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data we did not attempt to contact the authorsbecause of limited resources.

11..88..1100 MMeettaa--aannaallyyssiiss

For some of our results we were able to produce ameta-analysis using Review Manager version 4.2,the software used by the Cochrane Collaboration.For some studies we approximated the meanlength of stay using the median and estimatedthe standard deviation as a weighted mean of thestandard deviations of the other studies.

11..88..1111 AAbbsseennccee ooff lliitteerraattuurree

The recommendations in this guideline have beensystematically developed with as much scientificrigour as possible. However for a number of theclinical questions there was an absence of RCTevidence either because the clinical questions didnot lend themselves to controlled trials andsystematic reviewing, or for which there were toofew trials identified to make substantiverecommendations. Invariably, we needed to useadditional approaches such as surveys orinformal/formal consensus development to assistwith some areas of the guidance. Below is adescription of the areas of the guideline thatrequired additional approaches in addition tosystematic searching and reviewing of RCTs.

Nutritional screening: because of weaknesses inthe methodologies and designs of the studiesidentified, no firm conclusions could be made. Amodified Delphi approach for consensusdevelopment was used, consisting of two roundsof Delphi questionnaire surveys and then anominal group technique meeting. See ScreeningChapter 4.7 Consensus development methods.

Indications for oral, enteral and parenteralinterventions: the guidance could not be derivedfrom controlled trials thus the recommendationswere drafted by the technical team at the NCC-AC and modified and agreed by informalconsensus with the GDG.

Ethical and Legal issues: The brief importantcomments on the ethical and legal issues ofnutrition support contained within theseGuidelines were derived from GDG expertise andprevious expert treatises on these topics

Dysphagia: No RCT’s were found to provideguidance on options of nutrition support forpatients with Dysphagia. A specialist sub group ofspeech and language therapists’ with a specialinterest in dysyphagia was convened to developand propose suitable recommendations. Thesewere agreed by informal consensus with the GDG.

Prescription of nutrients: recommendations wereproposed by GDG members with relevantexpertise and agreed by informal consensusamong all GDG members.

Refeeding syndrome: recommendations wereformulated by members of the group based onprevious published reviews and their ownexpertise, and agreed by informal consensusamong all GDG members.

Monitoring: The GDG were sent questionnaireselectronically asking them to determine how oftencertain nutritional and biochemical parametersare and should be measured. Two GDG memberswith expertise in this area considered theoutcomes of the survey and proposed theguidance/recommendations which the GDGagreed by informal consensus.

Nutritional assessment: two GDG members withexpertise in this area proposed theguidance/recommendations to the whole GDGwho agreed on these by informal consensus.

Nutrition support teams: both randomised andnon-randomised trials were considered for thissection as some observational study designs werealso appropriate for this question.

Patients’ and carers’ views: We sent lettersrequesting evidence on patients’ and carers’ viewsof nutrition support to twenty stakeholders. A literature search was conducted to identifyrelevant evidence for any study design. The following databases were included:

• Medline (1951-2005)

• Embase (1980-2005)

• Cinahl (1982-2005)

Three sub-group meetings with patientrepresentatives on the GDG were held. Patient


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representatives were involved in the sifting of theabstracts retrieved from the literature search. A systematic reviewer summarised the evidencefrom the studies. The text was included indiscussion with patient representatives at sub-group meetings and in consultation with GDGmembers at GDG meetings.

11..99 HHiieerraarrcchhyy ooff cclliinniiccaall eevviiddeenncceeThere are many different methods of ranking theevidence and there has been considerable debateabout what system is best. A number ofinitiatives are currently under way to find aninternational consensus on the subject, but until adecision is reached on the most appropriatesystem for the NICE guidelines, the Instituteadvises the National Collaborating Centres to usethe system for evidence shown in Table 1.

TTaabbllee 11:: LLeevveellss ooff eevviiddeennccee ffoorr iinntteerrvveennttiioonn ssttuuddiieess((rreepprroodduucceedd wwiitthh ppeerrmmiissssiioonn ooff tthhee SSccoottttiisshhIInntteerrccoolllleeggiiaattee GGuuiiddeelliinneess NNeettwwoorrkk))

LLeevveell ooff eevviiddeennccee TTyyppee ooff eevviiddeennccee

1++ High-quality meta-analyses, systematic reviewsof RCTs, or RCTs with a very low risk of bias

1+ Well-conducted meta-analyses, systematicreviews of RCTs, or RCTs with a low risk of bias

1- Meta-analyses, systematic reviews of RCTs, orRCTs with a high risk of bias

2++ High-quality systematic reviews of case-controlor cohort studies

High-quality case-control or cohort studies with a very low risk of confounding, bias, orchance and a high probability that therelationship is causal

2+ Well-conducted case-control or cohort studies with a low risk of confounding, bias, orchance and a moderate probability that therelationship is causal

2- Case-control or cohort studies with a high risk of confounding bias, or chance and a significantrisk that the relationship is not causal

3 Non-analytic studies (for example, case reports,case series)

4 Expert opinion

The ranking system described above coversstudies of treatment effectiveness and is lessappropriate for studies reporting diagnostic testsof accuracy.

11..1100 HHeeaalltthh eeccoonnoommiiccss mmeetthhooddss

It is important to investigate whether healthservices are both clinically effective and cost-effective (that is, value for money). If a particulardiagnostic or treatment strategy was found to yieldlittle health gain relative to the resources used, thenit could be advantageous to re-deploy resources toother activities that yield greater health gain.

To assess the cost-effectiveness of eachrecommendation, a comprehensive systematicreview of the economic literature was conducted.In addition an original cost-effectiveness analysiswas performed for malnutrition screening.

The primary criteria applied for an intervention tobe considered cost-effective were either:

a) the intervention dominated other relevantstrategies (that is, it is both less costly interms of resource use and more clinicallyeffective compared with the other relevantalternative strategies); or

b) the intervention cost less than £20,000 perquality-adjusted life-year (QALY) gainedcompared with the next best strategy (andcompared with best supportive care).Between £20,000 and £30,000 per QALY,judgments about the acceptability of theintervention as an effective use of NHSresources have to make more explicit referenceto such factors as the degree of uncertaintysurrounding the calculation of cost-effectiveness, the innovative nature of theintervention and the particular features of thecondition and the population receiving it.

11..1100..11 LLiitteerraattuurree rreevviieeww ffoorr hheeaalltthh eeccoonnoommiiccss

We obtained published economic evidence from asystematic search of the following databases:

• Medline (Dialog Datastar) (1966-2005)

• Embase (Dialog Datastar) (1980-2005)


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• Health Economic Evaluations Database (HEED)

• NHS Economic Evaluations Database (NHS EED)

For those clinical areas we reviewed, theinformation scientists used a similar searchstrategy as used for the review of clinicalevidence. However, an economics filter was usedin the place of a systematic review orrandomised controlled trial filter. Althoughliterature searching was started in 2003 updatesearches were run for each search to ensure allreviews included literature up to the same cut-off date. Therefore, each database wassearched from its start date up to 3rd March2005. Papers identified after this date werenot considered. Search strategies can be foundin Appendix Three.

Each search strategy was designed to find anyapplied study estimating the cost or cost-effectiveness of some aspect of nutritionsupport. A health economist reviewedabstracts. Relevant references in thebibliographies of reviewed papers were alsoidentified and reviewed.

Given the diversity of economic studies, it wasnot possible to determine a general exclusioncriterion based on study quality. Hence, allstudies were included in the evidence tablesand study quality and applicability arediscussed in the review. Papers were onlyexcluded from the evidence tables and review if:

• The study did not contain any original data oncost or cost-effectiveness (i.e. it was a reviewor a clinical paper).

• The analysis was not incremental and was notdescribed adequately to allow incrementalanalysis (so studies reporting only averagecost-effectiveness ratios [the cost for onetreatment divided by the health outcome]were excluded unless they provided data toallow the calculation of incremental cost-effectiveness ratios [the change in costdivided by the change in health outcome]).Only incremental cost-effectiveness ratios caninform us about value for money.

• Cost analyses were excluded if the resultswere not presented in a way that would allowthe incremental cost per patient to beextracted or derived. The total hospital cost isdifficult to interpret unless we know howmany patients are being treated.

For one topic – nutrition support teams – it wasdecided to exclude studies which had only asingle cohort and used conjecture to assess theincremental cost. These studies were excludedsince there was other evidence that was deemedto be more rigorous – the included studies allcompared two cohorts, and one of them was arandomised controlled trial.

Included papers were reviewed by a healtheconomist. In the text, costs have beenconverted to £ sterling using the relevantpurchasing power parity for the study year. Inthe evidence tables costs are reported as givenin the paper. However, where costs were in acurrency other than pounds sterling, US dollars or euros, the results were converted topounds sterling.

Each study was categorised as one of thefollowing: cost analysis, cost-effectivenessanalysis, cost-utility analysis or costconsequences analysis (see glossary). Many ofthe studies in this review were labelled ‘costconsequences analyses’ because they presentmany different health outcomes (in addition tocost) without a single overall measure healthgain. Often these studies report complications.Where complications averted appears to be themain clinical outcome we have estimated cost-effectiveness by calculating the incrementalcost per complication averted. We did not findany ‘cost benefit analyses’ (studies that put amonetary value on health gain).

11..1100..22 CCoosstt--eeffffeeccttiivveenneessss mmooddeelllliinngg

Screening was selected for original economicanalysis because it was likely that therecommendations under consideration wouldsubstantially change clinical practice in the NHSand have important consequences for resource use.


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The details of the model are reported in chapter 4and Appendix Five: Cost-Effectiveness Analysis ofMalnutrition Screening. The following generalprinciples were adhered to:

• The GDG was consulted during theconstruction and interpretation of the model.

• The model was based on the best evidencefrom the systematic review.

• Model assumptions were reported fully andtransparently.

• The results were subject to thoroughsensitivity analysis and limitations discussed.

• Costs were calculated from a health servicesperspective.

11..1111 FFoorrmmiinngg aanndd ggrraaddiinngg tthhee rreeccoommmmeennddaattiioonnss

NICE guidel

nutrition support for adults oral nutrition support ...1.1. the need for guidelines in nutrition...

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