Dr. Elizabeth WeekesDepartment of Nutrition & DieteticsGuy’s & St. Thomas’ NHS Foundation TrustLondon

Dietetic intervention in the Dietetic intervention in the management of COPD –management of COPD –effects on patient-centred effects on patient-centred outcomesoutcomes

Outcome measures in nutrition researchOutcome measures in nutrition research

Dietary intake (energy & protein)

Weight change

Body composition (especially fat free mass)

Muscle function (handgrip strength)

Biochemical parameters

Patient-centred outcomesPatient-centred outcomes

Quality of Life- Generic e.g. Short Form-36 (SF-36)- Disease-specific e.g. St. George’s Respiratory Questionnaire

Utilisation of healthcare resources- Hospital admissions, post-operative complications,

GP visits, drug therapy

Functional measures - Objective e.g. maximal sniff pressures- Subjective e.g. MRC dyspnoea scale, Activities of Daily

Living score- Appropriate to clinical condition

Subjective measures ofFunctional status

• Validity and reliability

• Statistical versus clinical significance

• Interpretation of score change(minimum clinically importantdifference)

• Location

• Timing

What is the evidence?What is the evidence?

Crohn’s disease (Imes at al., 1987, 1988)- ↑ incidence of remission- ↓ length of stay and time lost from work

COPD (Rogers et al., 1992)- ↑ respiratory muscle and handgrip strength- ↑ walking distances

Liver disease (Hirsch et al., 1993)- ↓ incidence of severe infections and hospitalisation

Elderly- ↓ number of falls (Gray-Donald et al., 1995)- ↑ activities of daily living (Woo et al., 1994)

Consequences of malnutrition in COPDConsequences of malnutrition in COPD

Weight loss and low body weight are associatedwith poor prognosis and increased mortality

• Increased risk of :Acute exacerbations (Connors et al., 1996)

Hospital readmission (Pouw et al., 2000)

Mechanical ventilation (Vitacca et al., 1996)

• Decreased exercise tolerance (Schols et al., 1991)

• Poor quality of life (Shoup et al., 1997)

Nutrition intervention in COPDNutrition intervention in COPD

• 16 randomised controlled trials (RCTs)

• All used proprietary nutritional supplements(5 included dietary advice/encouragement)

• Minimal effects on weight gain and respiratory muscle function (Ferreira et al., 2004)

• Research is required in dietary counselling and food manipulation (Schols & Brug , 2003)

Research questionsResearch questions

• Can six months intervention with dietary counselling and food fortification result in weight gain in outpatients with COPD?

• Is weight gain associated with measurable clinical benefit for the patient?

Study designStudy design

Baseline Month 6 Month 12

Intervention

Follow-up

M1 M3 M7 M9W2

Dietary counselling and food fortificationDietary counselling and food fortification

Intervention- Experienced dietitian- Advice tailored to clinical condition,

lifestyle and preferences etc.- Six months free supply of milk

powder for food fortification(Pluspints, Kerry Foods, Eire)

- NAGE leaflet, written advice and practical demonstrations

Control- NAGE leaflet

Outcome measuresOutcome measures

• Weight change• Body composition• Dietary intake• Health-related quality of life (QoL)• Non-elective hospital admissions• Antibiotic therapy• Perceived dyspnoea• Activities of Daily Living (ADL)• Depression score• Muscle function (skeletal and lung)

RecruitmentRecruitment

59 completed baseline assessmentIntervention n = 31

Control n = 28

50 completed 1 month assessment

37 (63 %) completed 12 month assessmentIntervention n=20

Control n = 17

40 completed 6 month assessment

Patient characteristics (n = 59)Patient characteristics (n = 59)

Intervention

N = 31

Control

N = 28

Females:Males

Age (years)

Weight (kg)

Body mass index (kg/m2)

FEV1 (% predicted)

SGRQ Total score

SF-36 General Health score

Dyspnoea score

ADL score

15:16

68.9 (47 – 89)

54.5 (7.3)

19.9 (1.4)

30.9 (12.8)

55.3 (19.9)

34.7 (23.0)

3 (1 – 5)

15 (7 – 18)

14:14

69.2 (46 – 85)

53.5 (8.5)

19.5 (1.9)

32.7 (14.6)

62.0 (16.7)

29.5 (21.6)

4 (1 – 5)

11 (8 – 18)

-4

-3

-2

-1

0

1

2

3

4

5

Time (months)

Wei

ght c

hang

e (k

g)

InterventionControl

3 6 9 12

Weight change (kg)Weight change (kg)

-1.2

-1

-0.8

-0.6

-0.4

-0.2

0

0.2

0.4

0.6

0.8

Intervention

Control

Time (months)3 6 9 12

MA

MC

ch

ang

e (c

m)

Change in mid arm muscle circumference (cm)Change in mid arm muscle circumference (cm)

-6

-4

-2

0

2

4

6

8

10

12

S4SF

change (

mm

)

Intervention

Control

Time (months)

3 6 9 12

Change in sum of four skinfolds (mm)Change in sum of four skinfolds (mm)

-15

-10

-5

0

5

10

Ch

ang

e in

SG

RQ

Act

ivit

y sc

ore

Intervention

Control

6 months(n = 37)

12 months(n = 35)

Change in SGRQ Activity scoreChange in SGRQ Activity score

-20

-15

-10

-5

0

5

10

15

Ch

ang

e in

SG

RQ

Imp

acts

sco

re

Intervention

Control

6 months(n = 37)

12 months(n = 34)

Change in SGRQ Impacts scoreChange in SGRQ Impacts score

-15

-10

-5

0

5

10

Ch

ang

e in

SG

RQ

Tot

al s

core

Intervention

Control

6 months(n = 37)

12 months(n = 34)

Change in SGRQ Total scoreChange in SGRQ Total score

Short Form-36 scoreShort Form-36 score

Significant correlation between weight change and health change score

Patients who reported improved health gained 3.8 (+ 6.7) kg body weight over 12 months

Patients who reported no change or a deterioration in health lost 1.6 (+ 2.8) kg body weight over 12 months

p = 0.005

Non-elective hospital admissionsNon-elective hospital admissions

Intervention

n = 20

Control

n = 17

p

Year prior to study

Year of the study

Months 1 to 6

Months 7 to 12

8 (40 %)

6 (30 %)

6 (30 %)

1 (5 %)

4 (24 %)

9 (53 %)

5 (29 %)

7 (41 %)

-

0.16

0.63

0.01

Antibiotic therapyAntibiotic therapy

Patients prescribed antibiotics (ABX)

Intervention n = 13 (65 %)

Control n = 15 (88 %)

p = 0.10

Prescribed ABX - 1.2 (+ 4.5) kg

Not prescribed ABX + 4.0 (+ 7.8) kg

P = 0.03

Subjective functional measuresSubjective functional measures

Dyspnoea score - Significant difference between the groups at 6 (but not 12) months

Activities of daily living score – Significant difference between the groups at 6 and 12 months

Depression score – Significant difference between the groups at 12 months

Objective measures of muscle functionObjective measures of muscle function

• No differences between the groups in:-

- Handgrip strength (skeletal muscle)

- Maximal mouth pressures (respiratory muscles)

- Sniff pressures (diaphragm)

ConclusionsConclusions

• Clinical benefits for the intervention group:-- non-elective hospital admissions- antibiotic therapy (ABX)- quality of life (QoL)- activities of daily living (ADL)- perceived dyspnoea

• Benefits in QoL, ADL, non-elective hospital admissions and ABX persisted for at least six months after the intervention ceased

• No differences in disease severity, skeletal or lung muscle function

Future researchFuture research

More research is needed on the effects of nutrition intervention on patient-centred outcomes (dietary counselling, food fortification, oral nutritional supplements, tube feeding or parenteral nutrition)

Nutritional intervention may be more effective in sedentary patients in combination with other therapies e.g. pulmonary rehabilitation programmes

In the absence of improvements in muscle function, what are the mechanisms of action on QoL and ADL?