Health Related Quality of Life: Cancer cachexia. Professor Graeme D. Smith Editor Journal of Clinical Nursing CMU,Taiwan August 2017
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1 Health Related Quality of Life: Cancer cachexia Professor Graeme D. Smith Editor Journal of Clinical Nursing CMU,Taiwan August 2017
2 Overview to lecture Introduction/Scotland Patient related outcome measures (PROM s) Health related quality of life HRQoL) measures Psychometrics Cancer cachexia Assessment of cancer cachexia Nursing/healthcare implications
3 Cancer cachexia
4 Davidson C & Smith GD (2005) Cachexia and its management. Cancer Nursing Practice (March suppl.) Cancer cachexia
5 Editor JCN
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7 Scotland Edinburgh Napier University
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12 The meaning of QoL is difficult to define: Quality of Life: Definition the possession of the resources necessary to the satisfaction of individual needs, wants and desires, participation in activities enabling personal development and selfactualisation and comparison between oneself and others Shin and Johnson, 1978
13 What is quality of life?
14 World Health Organization: Definition of Health (1948) "a state of complete physical, mental, and social well-being, and not merely the absence of disease and infirmity".
15 Health Related Quality of Life Definition: The functional impact of an illness and its consequent therapy upon the patient, as perceived by the patient. Shipper et al. (1990)
16 Health related quality of life: Historical Perspective 1940 s Equated with goodness of life 1960 s socio-economic status (i.e. unemployment) 1970 s subjective issues (i.e. family life, health) 1975 Term QoL appears in Index Medicus s onwards Development of Medical and Nursing indicators
17 The nature of research evidence Patient evidence Clinical evidence High quality patient care (Relevant, effective, acceptable, appropriate) Economic evidence Acknowledgement: Dr Sophie Staniszewska, RCN Research Institute, University of Warwick
18 Patient voice evidence
19 Cancer cachexia: Quality of Life Patient reported outcomes measures (PRMO) measure of patients health Health related quality of life (HRQoL) a PROM concerned with health aspects of patient Important in cancer cachexia survival in inappropriate form of assessment Need for HRQoL tools in cancer cachexia
20 Patient reported outcome measures: PROMs HRQoL Utility Symptoms Satisfaction Behaviour Utilization
21 What is a PROM? Patient-reported outcomes measure (PROM) represent the patient s report of a health condition and its treatment (Acquadro et al. Value in Health 2003;5: ) Any report coming directly from patients (i.e., study subjects) about a health condition and its treatment (FDA Draft PRO Guidance)
22 Health Outcomes: different perspectives Clinical Perspective Patient Perspective Subjective health status Health related quality of life Satisfaction Societal Perspective Utilization Cost
23 The value of patient evidence What insights does patient evidence offer us? Personal impact of living with a condition and experience of care People s preferences and values Outcomes that patients want from treatment or care Impact of treatment or care on outcome, symptoms, physical and social functioning, quality of life Risks, benefits and acceptability of a treatment or service Equality issues and considerations for specific sub-groups
24 Health Related Quality of Life: Beware of questionnaire copyright
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26 Psychometrics: key references Bannigan, K. and Watson, R (2009), Reliability and validity in a nutshell. Journal of Clinical Nursing, 18: DeVon HA, Block ME, Ernst DM et al. (2007) A Psychometric Toolbox for Testing Validity and Reliability. Journal of Nursing Scholarship (2 nd Quarter):
27 Psychometrics: HRQoL Psychometrics What evidence is there that subjective judgements form a sound basis for measuring health? Can subjective data be more than just a crude approximation of health? Do HRQoL measures merely affix numbers to quantitative subjective judgements? Psychometrics describe the science of assigning numerical scores to subjective judgements
28 Evaluation HRQoL: Psychometrics Psychometric assessment involves evaluation of the following: Validity Reliability Sensitivity Specificity Before achieving acceptance as a valid diagnostic tool or evaluative yardstick in disease assessment psychometric testing must be undertaken.
29 Quality of HRQoL: Psychometrics Validity Extent to which a tool measure what it is intend to A quantitative assessment of how well an index measures the phenomenon of interest Criterion Validity Comparison of a new index vs. the gold standard Discriminant validity Extent to which scores of a measurement distinguish between individuals that should differ (in health). Content Validity Measures the degree to which the index measures the full spectrum of problems caused by a specific disease
30 Quality of HRQoL measures: Psychometrics Concurrent Validity Validity indicated by comparing scores on a measurement with those obtained by applying alternative, similar measures at same time. Construct Validity Used when there is no criterion to evaluate the validity of a measure against. i.e. compares a new index with a hypothesis Convergent validity The extent to which two or more instruments that claim to measure the same topic agree with each other.
31 Quality of HRQoL measures: Reliability Reliability Consistency of an index when re-administered under similar conditions on separate occasions The reliability of an instrument is the degree of consistency with which the instrument measures the attribute in question Reliability refers to the stability of a measurement Will it give the same results on separate occasions
32 Quality of HRQoL measures: psychometrics Sensitivity Ability of a measurement tool identify those who have a condition % of all cases with a condition who are detected by the measure Specificity Ability of a measrue to correctly identify those who do NOT have a condition The word specificity refers to how narrowly a test is targeted i.e. does it only identify people with a specific disease?
33 Quality of HRQoL measures Analogue of an Archer: An archer must learn to hit the centre of the target. Then he/she must be able to hit the centre consistently=good archer. Validity and reliability of HRQoL can be thought of in a similar way.
34 HRQoL measurement scales: Psychometrics
35 What Health Outcomes are Important? What we want to know. How much the intervention improves health people involved? What outcomes/factors should we be looking at? Types of Outcome.. Cure? Progression-free? Improved measurement? (e.g. pain management) Reduction of risk? (e.g. malnutrition) Improved quality of life? Tools to measure health related quality of life (HRQoL) were developed and are available in a wide range of areas of health
36 Types of Health Measurement Tool In an attempt to capture health a number of tools have been designed: Generic (preference based) compared across diseases? Comparable across different diseases SF-36 Disease Specific measures changes within a particular disease or area. Limited can only calculate within a disease QLQ CA30 Add-on disease add on to a generic tool. (EQ-5D add-on) 36
37 Examples of HRQoL Measures Generic (disease non-specific) EQ-5D EuroQol 5 Dimension SF-6D and SF-36 Short-Form Disease Specific EORTC QLQ-C30 -European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-CAX24 Cancer cachexia Add-On Tools EQ-5D+C add on for cognitive factors 37
38 Describing Health State Using EQ-5D Mobility I have no problems in walking about I have some problems in walking about I am confined to bed Self-care I have no problems with self care I have some problems washing or dressing myself I am unable to wash or dress myself Usual activities (e.g. work, study, housework, family or leisure activities) I have no problems with performing my usual activities I have some problems with performing my usual activities I am unable to perform my usual activities Pain/discomfort I have no pain or discomfort I have moderate pain or discomfort I have extreme pain or discomfort Anxiety/depression I am not anxious or depressed I am moderately anxious or depressed I am extremely anxious or depressed
39 EQ-5D VAS
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41 Valuing Health States Using EQ-5D EQ-5D defines 243 possible states: Values of states elicited from UK general population (n=3,395) Has been developed in different countries for that specific population Mean values can be used in economic evaluations Values elicited using time trade-off QUALY so 1year in perfect health = 2 years in 0.5 health Now a version for children language has changed: anxious/depressed sad/worried/unhappy Work/housework school/playing/sports
42 Measuring health related quality of life Using HRQoL measures in clinical setting: 1. Prioritise problems 2. Facilitate communication 3. Screen for potential problems 4. Identify preferences 5. Monitor changes/ Responses to treatment 6. Train new staff 7. Clinical audit 8. Clinical governance Higginson & Carr (2001) Carr AJ and J Higginson I J (2001)Measuring quality of life: Are quality of life measures patient centred? BMJ,322(7298):
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44 Cancer cachexia: Quality of Life
45 Cancer cachexia: Quality of Life Most widely used HRQoL scales in oncology: 1. FACT-G Functional Assessment of Cancer Therapy (FACT-G) AND 2. EORTC-QLQC30 European Organization for Treatment of Cancer Quality of Life Questionnaire
46 Cancer cachexia: Quality of Life
47 QLQ EORTC 30
48 QLQ EORTC 30 Five Multi-item scales: 1. physical 2. role 3. social 4. emotional 5. cognitive functioning Nine single items: 1. pain 2. fatigue 3. financial impact 4. appetite loss, 5. nausea/vomiting 6. diarrhoea, 7. constipation, 8. sleep disturbance 9. quality of life
49 Critique of cancer tools Inadequacy of current tools Most relevant & important HRQOL issues not covered by EORTC QLQ C30 or FACT G FAACT methodological flaws in development & fails to address social impact Specifically Measure HRQoL in Cancer cachexia?
50 Cancer cachexia
51 Cancer cachexia: Quality of Life Definition Cancer cachexia is a multi-facted syndrome Defined by on-going loss of skeletal muscle mass (with or without loss of fat mass) Cannot be reversed by conventional nutritional support Leads to progressive functional impairment
52 Cancer cachexia: Quality of Life
53 Cancer cachexia: Quality of Life
54 Cancer cachexia: Quality of Life Cachexia has a profound negative effect on: Treatment Survival Clinical burden Psychosocial factors Health related quality of life No standard of care or approved drugs
55 Cancer cachexia: Quality of Life
56 Cancer Cachexia: Quality of Life EPCRC guidelines
57 Cancer cachexia: Quality of Life EPCRC diagnostic criteria
58 Cancer cachexia: Quality of Life
59 Cancer cachexia: Treatment
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61 Cachexia: Quality of Life
62 Cachexia: Quality of Life
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64 Cachexia: Quality of Life FAACT
65 Cachexia: Quality of Life G8 Screening Tool
66 Cachexia: Quality of Life MNA Short form
67 Cancer cachexia: Quality of Life Malnutrition Screening Tool (MST)
68 Cancer cachexia: Quality of Life Malnutrition Screening Tool (MST)
69 Cancer cachexia: Quality of Life Edmonton Symptoms Assessment System
70 Cancer cachexia: Quality of Life Patient-generated subjective global status
71 Cancer cachexia: Quality of Life Nutrition impact symptoms
72 Cancer Cachexia: Quality of Life FAACT
73 Cachexia: Quality of Life FAACT
74 Cancer cachexia: Quality of Life Key reference: Wheelwright SJ et al. (2017) Development of the EORTC QLQ-CAX24: A questionnaire for cancer patients with cachexia. Journal of Pain and Symptom Management Vol. 53 No. 2 pp
75 Cancer cachexia: Quality of Life No standard of care or approved drugs Cachexia common problem for cancer patient Incidence of cachexia in cancer 50-80% Accounts for 20% of cancer deaths
76 Impact of cancer cachexia
77 Cancer cachexia: Quality of Life Methods for development of EORTC QLQ-CAX24 Approved by EORTC Quality of Life group Supplement the EORTC QLQ-C30 Involved several European countries Coordinated UK (University of Southampton) Ethical & research governance approval in each country Four distinct phases (Phases 1-4)
78 Cancer cachexia: Quality of Life Methods for development of EORTC QLQ-CAX24 Phase One: HRQoL in cachexia generated interviews with patients & HCP s Supplemented with literature search Phase Two: HRQoL issues reviewed and revised Questionnaire items formulated
79 Cancer cachexia: Quality of Life Methods for development of EORTC QLQ-CAX24 Phase Three: Questionnaire items are pilot tested face/content validity & acceptability Provisional version of QLQ-CAX developed Phase Four: New questionnaire field tested Still to be reported by EORTC QLG
80 Cancer cachexia: Quality of Life Methods for development of EORTC QLQ-CAX24 Eligibility criteria for participants: Confirmed cancer diagnosis Consensus definition of cancer cachexia Over the age of eighteen years old Able to participate in interview Able to complete self-report questionnaire
81 Cancer cachexia: Quality of Life Phase two: Results Patient comments lead to inclusion 2 items: too tired to eat being in too much pain to eat Thirteen items removed Result of decision rules from module guidelines Total items to be considered Phase 3 = 44
82 Cachexia: Quality of Life Phase Three: Results Total 110 patients were recruited Wording changed Have you worried that your weight might lose your independence? Have you worried about becoming more dependent on others? Item Have you felt hungry?- removed as ambiguous Appetite loss covered by QLQ-C30
83 Cachexia: Quality of Life Examples deleted (20 items) No hunger (scoring ambiguity) Changeable appetite Thinks a lot about food and eating Uncomfortable with sexual intimacy Lack of support from HCP s Worried about weight loss
84 Cancer cachexia: Quality of Life Provisional module has 24 items EORTC QLQ-CAX-24 Five multi-item sub-scales proposed Food aversion Eating and weight loss worry Eating difficulties Loss of control Physical decline
85 Cancer cachexia: avoiding food
86 Cancer cachexia: Quality of Life Example of sub-scale: Food aversion Taste change Texture of food unpleasant Putting off eating by food smells Putting off eating by quantity Feeling too full to eat (Cronbach s alpha 0.72)
87 Cancer cachexia: Quality of Life Example of sub-scale: Eating difficulties Willing but not able to eat Difficulty drinking Difficulty swallowing (Cronbach s alpha 0.62)
88 Cachexia CAX-24: Quality of Life
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90 Summary: Cachexia CAX-24 The EORTC QLQ-CAX24 provides an: Relevant tool for cancer cachexia Acceptable with cancer cachexia patients Applicable for assessment of cancer cachexia Suitable for clinical practice (research) Provide evidence of patient perceived benefit
91 Cancer cachexia: nursing assessment
92 Cachexia: Quality of Life references Bennani-Baiti N et al., What is cancer anorexia-cachexia syndrome? A historical perspective. J R Coll Physicians Edinb 2009;39: Fearon KC et al.,understanding the mechanisms and treatment options in cancer cachexia. Nat Rev Clin Oncol 2013;10:90 9. Vaughan VC et al., Cancer cachexia: impact, mechanisms and emerging treatments. J Cachexia Sarcopenia Muscle 2013;4: Fearon KC et al., Definition and classification of cancer cachexia: an international consensus. Lancet Oncol 2011;12: Tan BH, Fearon KC., Cachexia: prevalence and impact in medicine. Curr Opin Clin Nutr Metab Care 2008;11: Fearon KC et al., Cancer cachexia: mediators, signaling, and metabolic pathways. Cell Metab 2012;16: Dodson S, et al., Muscle wasting in cancer cachexia: clinical implications, diagnosis, and emerging treatment strategies. Annu Rev Med 2011;62:
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