Dietetic intervention in the management of COPD – effects on patient-centred outcomes Dr. Elizabeth Weekes Department of Nutrition & Dietetics Guy’s & St. Thomas’ NHS Foundation Trust London

Outcome measures in nutrition research Dietary intake (energy & protein) Weight change Body composition (especially fat free mass) Muscle function (handgrip strength) Biochemical parameters

Patient-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 of Functional status Validity and reliability Statistical versus clinical significance Interpretation of score change (minimum clinically important difference) Location Timing

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 COPD Weight loss and low body weight are associated with 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 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 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 design Month 12 Baseline Month 6 M7 M9 M1 M3 W2 Intervention Follow-up

Dietary 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 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)

Recruitment 59 completed baseline assessment Intervention n = 31 Control n = 28 50 completed 1 month assessment 40 completed 6 month assessment 37 (63 %) completed 12 month assessment Intervention n=20 Control n = 17

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)

Weight change (kg)

Change in mid arm muscle circumference (cm)

Change in sum of four skinfolds (mm)

Change in SGRQ Activity score

Change in SGRQ Impacts score

Change in SGRQ Total score

Short 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 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 %) 1 (5 %) 4 (24 %) 9 (53 %) 5 (29 %) 7 (41 %) - 0.16 0.63 0.01

Antibiotic 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 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 function No differences between the groups in:- - Handgrip strength (skeletal muscle) Maximal mouth pressures (respiratory muscles) Sniff pressures (diaphragm)

Conclusions 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 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?