Validation of an Arabic Version of the ORWELL97 Questionnaire in Adults with Obesity

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Validation of an Arabic Version of the ORWELL97 Questionnaire in Adults with Obesity Leila Itani 1, Simona Calugi 2, Dima Kriedieh 1, Germine El Kassas

1 Validation of an Arabic Version of the ORWELL97 Questionnaire in Adults with Obesity Leila Itani 1, Simona Calugi 2, Dima Kriedieh 1, Germine El Kassas 1, Dana El Masri 1, Hana Tannir 1, Riccardo Della Grave 2, Aya Harfoush 1, and Marwan El Ghoch 1,2* 1 Beirut Arab University 2 Villa Garda Hospital /Italy

Naweed AlZaman and Asem Ali. Obesity and diabetes mellitus in the Arab World.

2 Arab countries Males Obesity Affects of 1-55% the population in 2010 and is on the rise Females Associated with several comorbidities and functional disabilities Naweed AlZaman and Asem Ali. Obesity and diabetes mellitus in the Arab World. Journal of Taibah University Medical Sciences. Volume 11, Issue 4, August 2016, Pages

7 Obesity related diseases are on the rise in Arab countries The Lancet , DOI: ( /S (13) )

8 Obesity related comorbidities Functional disability

9 Obesity, functional mobility and QoL Body functions and structures Postural control Impact on bones and joints Neurocognitive function Pain forward anterior posterior instability/ affecting steps/falls knee osteoarthritis (OA)/BMD Visuospatial ability/ executive functioning(planning)/visual memory knee pain/ back pain Personal factors Activities and tasks: functional mobility gender age habits race Walking speed Psychologic function Stability Participation in life situations lifestyles education and profession Environmental factors Physical Social Political

10 Obesity, functional mobility and QoL M. Forhan, S.V. Gill. Obesity, functional mobility and quality of life. Best 130 Practice & Research Clinical Endocrinology & Metabolism 27 (2013)

Quality of life Health related Quality of life Is a multidimensional concept of well being encompassing physical and occupational function psychological state social interaction somatic sensation

11 Quality of life Health related Quality of life Is a multidimensional concept of well being encompassing physical and occupational function psychological state social interaction somatic sensation overall life satisfaction perceptions of health status Health-related quality of life is the value assigned to duration of life as modified by the impairments, functional states, perceptions, and social opportunities that are influenced by disease, injury, treatment, or policy. Reflects how the individual s well being may be affected overtime by a disease, disability or disorder. Schipper H, Clinch, JJ, Olweny CLM (1996) Quality of life studies: definitions and conceptual issues, In Spilker B (ed) Quality of Life and Pharmacoeconomics in Clinical Trials. Lippincott-Raven Publishers:Philadelphia. PP Garrat,A;Scmidt,L.;Mackintish,A.;Fitzpatrick, R. Quality of life measurement:bibliographic study of patient assessed outome measure. BMJ2002, 324,1417.

12 Definition of health related QoL WHO 1946 Constitution A state of complete physical, mental, and social wellbeing and not merely the absence of disease or infirmity Evaluation of outcomes in medical care Clinical indicators Clinically significant change Patient reported outcome information reported by the patient that is not filtered by an observer or clinician Health related Qol Monika Bullinger, PhD; Julia Quitmann, PhD, DipPsych. Quality of life as patient-reported outcomes: principles of assessment. Dialogues Clin Neurosci. 2014;16:

13 Obesity Obesity treatment and weight loss 1. Reduced physical health 2. Impaired neurocognitive function 3. Stigmatization and discrimination leading to impaired mental well being 4. Psychosocial health 1. Negative association between weight loss and impaired QoL Impaired quality of life Improved quality of life Clinically significant impairment Clinically significant improvement A TOOL IS NEEDED

14 Measures of HRQoL Generic measures Short Form-36 (SF-36) Sickness Impact Profile (SIP) Quality of Well-being Scale (QWB) European Quality of Life Survey (EQ- 5D) Health Utilities Index (HUI). EuroQol- 5 Dimension (EQ-5D) HRQOL 14 WHOQOL Disease Specific measures Obesity Arthritis Diabetes Asthma Pulmonary disease cancer epilepsy HIV

15 Properties of QoL Measures Content Validity. Content validity is the extent to which the items are sensible and reflect the intended domain of interest. Are the items included relevant to the domain of interest? Do the items cover the full range relevant to that domain? Are the items comprehensible to respondents Internal consistency is the extent to which items intended to assess health or functional status in a particular domain are correlated with each other and not correlated with items intended to measure other domains (Cronbach's alpha. Scores > 0.70) Test-Retest Reliability. Test-retest reliability examines the agreement among scores in stable persons at two points in time. The interval between testing is generally one to two weeks long enough that the person is unlikely to recall their previous response and short enough that it is unlikely the condition of the person has changed. (ICCs > 0.70 or t-test, P<0.05) Construct Validity. Construct validity is a measure's ability to perform as expected. Assessed by CFA or know groups comparison ( measures of goodness of fit)

.) Generic questionnaires on HRQoL SF-36,

Quality of Life Questionnaire (AQLQ), ETC

16 Studies on HRQoL IN Wide spectrum of diseases (CVD, DM, liver, neurological etc..) Generic questionnaires on HRQoL SF-36, EQ-5D, HRQOL 14, WHOQOL, WHOQOL-HIV, Asthma Quality of Life Questionnaire (AQLQ), ETC Evaluation and Increased effect of treatment OF DISEASES Translated and validated in different languages including Arabic OBESITY OB TREATMENT OB-QoL

Measures of OB-QoL in Arabic language OBESITY Several Obesity specific measures of HRQoL in obesity were developed and translated and validated in different languages Translated

17 Measures of OB-QoL in Arabic language OBESITY Several Obesity specific measures of HRQoL in obesity were developed and translated and validated in different languages Translated and validated in different languages Arabic OB-QoL Questionnaire Mannucci et al 1999 Obesity related well being questionnaire ORWELL 97 Translated and validated in different languages

Physical Symptoms 5 items intended to measure obesity-related somatic symptoms and physical functioning.

Discomfort 7 items Psychosocial Impact 6 items O: Do you suffer from excessive sweating?

(0, not at all; 1, just a little; 2, not so much; 3, much) 4 point likert scale O: Do you feel uneasy in showing your body?

19 Physical Symptoms 5 items intended to measure obesity-related somatic symptoms and physical functioning. The items of this subscale evaluate the symptoms and impairments of physical functioning that are most common in obese patients without concurring physical illnesses ORWELL item Emotional Discomfort 7 items Psychosocial Impact 6 items O: Do you suffer from excessive sweating? (0, not at all; 1, just a little; 2, not so much; 3, much) R: Does sweating interfere with your daily activities? (0, not at all; 1, just a little; 2, not so much; 3, much) 4 point likert scale O: Do you feel uneasy in showing your body? (0, not at all; 1, just a litte; 2, not so much; 3, much) R: Does this uneasiness interfere with your leisure activities? (0, not at all; 1, just a little; 2, not so much; 3, much) ORWELL-97 score R: Is it important for you to live in a serene family environment? (0, not at all; 1, just a little; 2, not so much; 3, much) O: Does being overweight prompt discussions in your family? (0, not at all; 1, just a little; 2, not so much; 3, much) Clinically significant impairment of QoL aimed at the evaluation of the impact of obesity on patients emotional status and obesity-related worries. This scale is not a general psychopathology index, and therefore it is not designed to detect symptoms related to anxiety, mood, and eating disorders, which are frequently found in obese patients designed to measure the effects of obesity on familial relationship, role functioning, and social network. (O )Occurrence For each item subject will score n=18 n=1 O R = ORWELL97 score ORWELL97 score > 75 pctl (R )Relevance Mannucci et al, Quality of life and overweight: The obesity related well-being (Orwell 97) Questionnaire Addictive Behaviors 24(3):

21 Objectives Arabic version of the ORWELL 97 Validity Reliability

Inclusion criteria: 1. Ability to follow instruction to fill questionnaire 2. Cases: BMI 30 Kg/m 2 ; controls 18.5 BMI<25 Kg/m 2 3.

Did not lose 10% in the last 6 months BAU /IRB approval Written consent BMI Cross sectional study (January- August 2017) 1-β=80%, α=5%, Difference =10

participants Community sample n=212 18.5 BMI<29.

22 Inclusion criteria: 1. Ability to follow instruction to fill questionnaire 2. Cases: BMI 30 Kg/m 2 ; controls 18.5 BMI<25 Kg/m 2 3. Age 18 years Exclusion criteria: 1. Not undergoing weight loss treatment 2. Did not lose 10% in the last 6 months BAU /IRB approval Written consent BMI Cross sectional study (January- August 2017) 1-β=80%, α=5%, Difference =10 in ORWELL score between cases and controls Quota sampling Clinical sample n=106 BMI 30 Kg/m 2 37 M, 69 F Seeking treatment at BAU/clinic n=318 participants Community sample n= BMI<29.9 Kg/m 2 69 M, 143F General population survey Data collection / BAU Nutritional and weight management clinic Questionnaire mean BMI Sociodemographic characteristics Age, sex, marital status, occupation, income, disease ORWELL items Emotional discomfort Physical symptoms Psychosocial impact t-test Chi squared, t-test Translation Reliability Validity

The validation study Translation and back translation Forward translation Back translation Comparison for equivalence Arabic version of ORWELL 97 Test retest reliability

23 The validation study Translation and back translation Forward translation Back translation Comparison for equivalence Arabic version of ORWELL 97 Test retest reliability Internal consistency Discriminant validity Construct validity Clinical sample n=30 T 0 T days Clinical sample n=106 Clinical sample n=106 Community sample n=212 BMI>30kg/m BMI 29.9kg/m 2 Clinical sample n=106 CFA (AMOS) Mean ORWELL score 0 Mean ORWELL score 1 Mean ORWELL score Mean ORWELL score Mean ORWELL score Model 1 Paired t-test (P<0.05) 0.7<Cronbach s α<0.9 Student t-test Goodness of fit statistics Pearson correlation(p<0.05) CFI 0.90 TLI 0.90 ICC >0.9 Excellent RMSEA < SRMR<0.08

24 Test retest reliability Table 2 Mean scores, Pearson s correlation coefficients and intra-class correlation of the scores given for the Arabic version of ORWELL 97 at T0 and T1 ORWELL 97 scores Mean Scores at T 0 and T 1 (n=30) T 0 T 1 P-value Mean (SD) for Paired T-test Correlation between mean scores at T 0 and T 1 Correlation coefficient Intra-class correlation (ICC) P-value ICC 95% CI P- value ORWELL 97 global score (34.78) (41.42) < <0.001

25 Discriminant validity Mean ORWELL 97 score in cases and controls Cases (N=106) Controls (N=212) T-test P-value ORWELL 97 global score (33.58) (13.71) 9.2 <0.001

26 Construct validity Internal consistency Cronbach s α =0.904 R: How important is it for you to exercise regularly? (0, not at all; 1, just a little; 2, not so much; 3, much) O: Is your weight an obstacle for your physical activity? (0, not at all; 1, just a little; 2, not so much; 3, much) 5.O: 2. R: Do How you suffer important from is excessive it for you sweating? to have regular (0, not sexual at all; activity? 1, just a little; 2, not (0, so not much; at all; 3, 1, much) just a little; 2, not so much; 3, much) R: O: Does Does sweating your weight interfere represent with your a physical daily activities? obstacle for your sexual (0, activity? not at all; 1, just a little; 2, not so much; 3, much) 6. (0, O: Mass not at media all; 1, (TV, just a newspapers, little; 2, not etc.) so much; often 3, report much) that obesity is a major risk for health. Do you pay attention to this subject? (0, not at all; 1, just a little; 2, not so much; 3, much) R: Does this information increase your preoccupation with your health? (0, not at all; 1, just a little; 2, not so much; 3, much) Goodness of fit statistics TLI 0.90 CFI 0.90 RMSEA < SRMR<0.08

27 Conclusion The validation of the Arabic version of ORWELL 97 exhibited favorable results: 1. Excellent internal consistency indicating the items are interrelated 2. Excellent temporal stability demonstrated by test retest reliability, intra class correlation and spearman correlation between ORWELL97 scores obtained between two sittings 7-21 days apart 3. Excellent discriminant validity where there was a significant lower score in the community sample compared to the clinical sample, indicating its ability to distinguish between cases with obesity and normal weight controls 4. The scale is effective in measuring the OB-QoL construct which was demonstrated by CFA

28 CONCLUSION ORWELL97_A Patient reported outcome Evaluate effect of Obesity treatment approaches increased efficacy of treatment Clinically significant change in QOL

29 Thank you Dr. Marwan El Ghoch Mrs. Leila Itani Mrs. Dimas Kreidieh Mrs. Hana Al Tannir Dr. Germine El Kassas Ms. Dana El Masri

Health-related Quality of Life in obesity: The ignored outcome in Arab population Marwan El Ghoch, MD

Health-related Quality of Life in obesity: The ignored outcome in Arab population Marwan El Ghoch, MD NAME: Professor Marwan El Ghoch AFFILIATION: CONFLICT OF INTEREST DISCLOSURE Department of Nutrition