Quality of life in SARCOPENIA. Dr. C. Beaudart Department of Public Health, Epidemiology and Health Economics, University of Liège, Belgium

Transcription

1 Quality of life in SARCOPENIA Dr. C. Beaudart Department of Public Health, Epidemiology and Health Economics, University of Liège, Belgium 1

2 Background v Proms / Quality of life: Patient Reported Outomes (PROMS) : health outcome directly reported by the patient who experienced it Quality of life (OMS) : individuals' perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns Health care is essentially a humanistic transaction where the patient's well-being is a primary aim Quality of life = secondary/main evaluation criteria (RCTs)? Differentbypopulations (different Assessed questionnaires (genericages, vs specific) Specific to one disease, one symptom or Generic questionnaires Specific questionnaires different stages of diseases, etc.) one population Allow comparisons between populations/ diseases Less comparisons between populations Less sensitive to change More sensitive to change Quality of Life in Sarcopenia Charlotte Beaudart 2

3 Background v Sarcopenia: Progressive and generalized loss of muscle mass and muscle function (muscle strength and/or physical performance) ICD-10-CM code Prevalence of 1-29% in community-dwelling population; % in hospitalized population1 v Definition : no worldwide consensus v EWGSOP : Quality of Life in Sarcopenia Charlotte Beaudart 3

4 Background Outcomes of sarcopenia v 17 prospective studies included in a RS and MA: 12 reported mortality as outcome 6 reported functional decline as outcome ½ study found a significant association with sarcopenia (+ low BMD) 2 reported length of hospitalization as outcome 2/2 studies found a significant association with sarcopenia 2 reported fractures as outcome OR of 3,03 (95% CI 1,80-5,12) 2 reported falls as outcome OR of 3,6 (95% CI 2,96-4,37) ½ study found a significant association with sarcopenia 1 reported incidence of hospitalization Quality of Life in Sarcopenia Charlotte Beaudart 1/1 reported a significant association with sarcopenia 4

5 Background v SF-36 Generi c Quality of life and muscle strength Hertfordshire study, UK, 2987 individuals Low muscle strength is associated with a lower quality of life in men/women (adjusted on age, physical activity level, BMI and comorbidities) Sayer et al Age and Ageing 2006; 35: Quality of Life in Sarcopenia Charlotte Beaudart 5

6 Background v Quality of life and muscle mass Farmington, USA, 337 individuals Correlation low muscle mass/low quality of life (general health status) Quality of Life in Sarcopenia Charlotte Beaudart 6

7 Background v Quality of life and SARCOPENIA Heterogeneous results All Generic quality of life questionnaires Not always suitable to detect subtle effects of a specific condition on QoL 7 Quality of Life in Sarcopenia Charlotte Beaudart

8 Background Necessary to have a specific tool to assess the impact of sarcopenia on QoL. The aim of this study was to develop and validate a sarcopenia specific QoL questionnaire, called SarQoL (Sarcopenia Quality of Life), and designed for community-dwelling elderly subjects aged 65 years and older. Quality of Life in Sarcopenia Charlotte Beaudart 8

9 Development Development of the SarQoL - Methods Language : French Experts : 3 geriatricians (SG, JP, YR), 3 rheumatologists expert in the field of bone and muscle (EB, JYR, RR), 1 physiotherapist and Professor in BioGerontology & Geriatric Rehabilitation (IB), 1 physiotherapist and Professor of Epidemiology & Geriatric Rehabilitation (OB), 1 linguist expert in the French language (JVB), 2 experts in methodology of questionnaires (MJ, PI) and, at last, one statistician (ND) Subjects : Quality of Life in Sarcopenia Charlotte Beaudart 9

10 Development Charlotte Beaudart University of Liège Ivan Bautmans Vrije Universiteit Brussel Emmanuel Biver Geneva University Hospitals Jean Petermans CHU Liège Jean-Yves Reginster University of Liège, Belgium Fanny Buckinx University of Liège René Rizzoli Geneva University Hospitals Olivier Bruyère University of Liège Sophie Gillain CHU Liège SarQoL questionnaire Charlotte Beaudart Yves Rolland CHU Toulouse 10

11 Development Step 1. Item generation Exhaustive review of the literature Interview of 5 subjects with sarcopenia, in a face-to-face discussion Feedback of experts who had received a semi-structured questionnaire The list of items was discussed with the experts in a meeting to reformulate some of them, delete or subdivide others and, finally organize them into domains of dysfunction. Step 2. Item reduction To select the most pertinent items to include in the final questionnaire 21 sarcopenic subjects and experts graded the relevance of each item on a 4-point 11 Likert scale ranging from 1.innot relevant Charlotte to 4. extremely relevant Quality of Life Sarcopenia Beaudart

12 Development Step 3. Development of the SarQoL questionnaire Focus group with experts Transcription of items into questions Determination of the layout of the questionnaire, the response format and the scoring algorithm Submission to a French linguist to ensure that it was free of any spelling or linguistic errors. Step 4. Pre-test of the SarQoL questionnaire Submitted to a sample of 20 sarcopenic patients To ensure good understandability of each question and the acceptability of the questionnaire squality formatof Life in Sarcopenia Charlotte Beaudart 12

13 Development Development of the SarQoL - Results Clinical characteristics of the population involved in the development of the questionnaire Quality of Life in Sarcopenia Charlotte Beaudart 13

14 Development SarQoL = 22 questions (55 items) Divided into 7 domains Pre-test : easy to administrate 10 minutes necessary to complete the questionnaire Score / 100 Overview of study procedures Quality of Life in Sarcopenia Charlotte Beaudart 14

15 Development 7 domains : D1 : Physical and Mental Health (8 items) Loss of arm strength, Loss of energy, Feeling old, etc. D2 : Locomotion (9 items) D4 : Functionality (14 items) Loss of flexibility Falls occurrence Climbing stairs without a banister, etc. D5 : Activities of daily living (15 items) Limitation in walking time, Fatigue, difficulty or pain during physical effort Take public transportation, Limitation in steps length, Carrying heavy objects, etc. Difficulties to walk on uneven grounds, etc. D3 : Body Composition (3 items) Physical change Loss of muscle mass, etc. D6 : Leisure activities (2 items) Change in physical activities Change in leisure activities D7 : Fears (4 items) Fear of falling Fear of getting hurt, etc. Quality of Life in Sarcopenia Charlotte Beaudart 15

16 Development Need to be validated! Quality of Life in Sarcopenia Charlotte Beaudart 16

17 Validation Validation of the questionnaire Methods Discriminative power (sarcopenic vs non-sarcopenic) : Logistic regression Internal consistency : Cronbach s α Construct validity Convergent validity : Spearman Correlation Divergent validity : Spearman Correlation Test-retest reliability (2 weeks) : ICC Floor and ceiling effects (higher than 15% considered significant) Quality of Life in Sarcopenia Charlotte Beaudart 17

18 Validation Validation of the questionnaire - Results Population 296 subjects (median age of 73.3 ( ) years) Sarcopenia diagnosed with EWGSOP algorithm (low muscle mass + low muscle strength Discriminative power Construct validity OR low physical performance) Convergent validity : Correlations ++ with some domains of the SF-36 questionnaire (functional role, vitality, general health) as well as with the EQ-5D questionnaire (utility score and usual activities) Divergent validity : correlations -- with the MMSE and the EQ-5D (pain/discomfort) Quality of Life in Sarcopenia Charlotte Beaudart 18

19 Validation Validation of the questionnaire - Results Internal consistency Global Cronbach s alpha coefficient 0.87 High level of internal consistency Testretest reliability ICC of 0.91 (95 % CI ) (interval of 2 weeks) à Floor and ceiling effects None Excellent testretest reliability The SarQoL has been shown to be valid, consistent and reliable The SarQoL can be proposed for clinical and research purposes The questionnaire still needs to be validated regarding the sensitivity to change! Quality of Life in Sarcopenia Charlotte Beaudart 19

20 Validation Validation of the questionnaire validation for other definitions Definitions based on low lean mass alone Other definitions are based on both low muscle mass and decreased performance Quality of Life in Sarcopenia Charlotte Beaudart 20

21 Validation Validation of the questionnaire validation for other definitions Quality of Life in Sarcopenia Charlotte Beaudart 21

22 Translation Translation Fr En 2 translators Synthesis of translations Version 1 Backward translation En Fr 2 translators Expert committee review Version 2 Pre-test Final version Validation of the French version Validation of the English version Population SarcoPhAge study (296 participants) EPOSA study, UK (315 participants) Discriminative 54.7 % sarcopenic vs 67.8 % non- 61,9 % sarcopenic vs ± 71,3 % non- power sarcopenic sarcopenic p<0,001 p = 0,01 Construct validity Assumption true for divergent and Assumption true for divergent and convergent validity convergent validity Internal Cronbach s alpha coefficient 0,87 Cronbach s alpha coefficient 0,88 consistency High level of internal consistency High level of internal consistency Testretest ICC of 0,91 (95 % CI 0,82 0,95) ICC of 0,95 (95% CI 0,92-0,97) reliability (interval Excellent testretest reliability Excellent testretest reliability None None of 2 weeks) Floor-ceiling effects The French and English versions of the SarQoL have been shown to be valid, consistent and reliable Sensitivity to change! Quality of Life in Sarcopenia Charlotte Beaudart 22

23 Translation Gree h Czec Lithuan Spanish k Already Available in ch Fren German 16 languages ian ian n a Rom rian a g n Hu (UK) Dutch Polish English Italian Swedish Thai Portuguese (European) Arabic (KSA) Malaysian (Malay) Philippian Russian Hindi Croatian In process of translation in 18 other languages Quality of Life in Sarcopenia Charlotte Beaudart 23 Farsi Ukrainian Portuguese (Brazil) Serbian Slovenian Turkish Vietnamese Japanese Indonesian Bulgarian Chinese Lettonian Marathi

24 About SarQoL v Website SarQoL : Quality of Life in Sarcopenia Charlotte Beaudart 24

25 About SarQoL v Smartphone application Quality of Life in Sarcopenia Charlotte Beaudart 25

26 About SarQoL C. Beaudart, E. Biver, JY Reginster, R. Rizzoli, Y. Rolland, I. Bautmans, J. Petermans, S. Gillain,, F. Buckinx, J. Van Beveren, JM. Jacquemain, P. Italiano, N. Dardenne, O. Bruyère. Development of a self-administrated quality of life questionnaire for sarcopenia in elderly 65 years and older: the SarQoL. Age Ageing Oct 3. pii: afv133. [Epub ahead of print] C. Beaudart, JY Reginster, R. Rizzoli, Y. Rolland, I. Bautmans, E. Biver, J. Petermans, S. Gillain, N. Dardenne, O. Bruyère. Validation of SarQoL, a specific health-related quality of life questionnaire for sarcopenia. Journal of cachexia, Sarcopenia and Muscle. J Cachexia Sarcopenia Muscle Oct 22. doi: /jcsm [Epub ahead of print] C. Beaudart, M. Edwards, C. Moss, J-Y. Reginster, R. Moon, C. Parsons, C. Demoulin, R. Rizzoli, E. Biver, E. Dennison, O. Bruyère, C. Cooper. English translation and validation of the SarQoL, a 26 Quality for of Life in Sarcopenia Charlotte Beaudart quality of life questionnaire specific sarcopenia. Age

27 About SarQoL Next projects: - Responsiveness to change - Observational studies - - SarcoPhAge study (Liège); - OFELY Study in Lyon - Geneva Retirees Cohort (GERICO) study in Geneva - EPIDOS study in Toulouse Interventional study : SARCARE Geneva - Short-Form - Utility score : quality adjusted life-years Quality of Life in Sarcopenia Charlotte Beaudart 27

28 Thank you C. Beaudart Department of Public Health, Epidemiology and Health Economics, University of Liège, Belgium 28