4Patient-centred outcomes Quality of LifeGeneric e.g. Short Form-36 (SF-36)Disease-specific e.g. St. George’s Respiratory QuestionnaireUtilisation of healthcare resourcesHospital admissions, post-operative complications,GP visits, drug therapyFunctional measuresObjective e.g. maximal sniff pressuresSubjective e.g. MRC dyspnoea scale, Activities of Daily Living scoreAppropriate to clinical condition
5Subjective measures of Functional status Validity and reliabilityStatistical versus clinicalsignificanceInterpretation of score change(minimum clinically importantdifference)LocationTiming
6What is the evidence? Crohn’s disease (Imes at al., 1987, 1988) - ↑ incidence of remission- ↓ length of stay and time lost from workCOPD (Rogers et al., 1992)- ↑ respiratory muscle and handgrip strength- ↑ walking distancesLiver disease (Hirsch et al., 1993)- ↓ incidence of severe infections and hospitalisationElderly- ↓ number of falls (Gray-Donald et al., 1995)- ↑ activities of daily living (Woo et al., 1994)
7Consequences of malnutrition in COPD Weight loss and low body weight are associatedwith poor prognosis and increased mortalityIncreased 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)
8Nutrition 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)
9Research questionsCan 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?
11Dietary counselling and food fortification Intervention- Experienced dietitian- Advice tailored to clinical condition,lifestyle and preferences etc.- Six months free supply of milkpowder for food fortification(Pluspints, Kerry Foods, Eire)NAGE leaflet, written adviceand practical demonstrationsControl- NAGE leaflet
12Outcome measures Weight change Body composition Dietary intake Health-related quality of life (QoL)Non-elective hospital admissionsAntibiotic therapyPerceived dyspnoeaActivities of Daily Living (ADL)Depression scoreMuscle function (skeletal and lung)
13Recruitment 59 completed baseline assessment Intervention n = 31Control n = 2850 completed 1 month assessment40 completed 6 month assessment37 (63 %) completed 12 month assessmentIntervention n=20Control n = 17
21Short Form-36 scoreSignificant correlation between weight change and health change scorePatients who reported improved health gained 3.8 (+ 6.7) kg body weight over 12 monthsPatients who reported no change or a deterioration in health lost 1.6 (+ 2.8) kg body weight over 12 monthsp = 0.005
22Non-elective hospital admissions Interventionn = 20Controln = 17pYear prior to studyYear of the studyMonths 1 to 6Months 7 to 128 (40 %)6 (30 %)1 (5 %)4 (24 %)9 (53 %)5 (29 %)7 (41 %)-0.160.630.01
24Subjective functional measures Dyspnoea score - Significant difference between the groups at 6 (but not 12) monthsActivities of daily living score – Significant difference between the groups at 6 and 12 monthsDepression score – Significant difference between the groups at 12 months
25Objective measures of muscle function No differences between the groups in:-- Handgrip strength (skeletal muscle)Maximal mouth pressures (respiratory muscles)Sniff pressures (diaphragm)
26Conclusions Clinical benefits for the intervention group:- - non-elective hospital admissions- antibiotic therapy (ABX)- quality of life (QoL)- activities of daily living (ADL)- perceived dyspnoeaBenefits in QoL, ADL, non-elective hospital admissions and ABX persisted for at least six months after the intervention ceasedNo differences in disease severity, skeletal or lung muscle function
27Future researchMore 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 programmesIn the absence of improvements in muscle function, what are the mechanisms of action on QoL and ADL?