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BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available BMJ Open: first published as 10.1136/bmjopen-2017-016745 on 1 September 2017. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay- per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 26, 2021 by guest. Protected copyright. BMJ Open: first published as 10.1136/bmjopen-2017-016745 on 1 September 2017. Downloaded from BMJ Open Psychological distress and quality of life: Rationale and protocol of a prospective cohort study in a rural district in Bangladesh For peer review only Journal: BMJ Open Manuscript ID bmjopen-2017-016745 Article Type: Protocol Date Submitted by the Author: 16-Mar-2017 Complete List of Authors: Uddin, Mohammed ; Swinburne University of Technology, Department of Statistics, Data Science and Epidemiology Bhar, Sunil ; Swinburne University of Technology, Department of Psychological Sciences Al-Mahmud , Abdullah ; Swinburne University of Technology, School of Design; Faculty of Health, Arts and Design Islam, Fakir; Swinburne University of Technology, Deapartment of Statistics, Data Science and Epidemiology <b>Primary Subject Public health Heading</b>: http://bmjopen.bmj.com/ Secondary Subject Heading: Mental health Psychological distress, Quality of Life, Validation, K1O, WHOQOL-BREF, Keywords: Rasch Analysis on September 26, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2017-016745 on 1 September 2017. Downloaded from Page 1 of 21 BMJ Open Page 1 of 17 1 2 3 4 Psychological distress and quality of life: Rationale and 5 6 7 protocol of a prospective cohort study in a rural district in 8 9 10 Bangladesh 11 12 13 14 15 M Nazim UddinFor1, Sunil Bharpeer2, Abduallh reviewAl-Mahmud3, Fakir Monly Amirul Islam1,4* 16 17 18 1. Department of Statistics, Data Science and Epidemiology; Faculty of Health, Arts and 19 20 Design; Swinburne University of Technology, Hawthorn VIC 3122, Australia 21 22 23 2. Department of Psychological Sciences; Faculty of Health, Arts and Design; Swinburne 24 25 University of Technology, Hawthorn VIC 3122, Australia 26 27 3. School of Design; Faculty of Health, Arts and Design; Swinburne University of 28 29 Technology, Hawthorn VIC 3122, Australia 30 31 32 4. Organisation for Rural Community Development (ORCD), Dariapur, Narail, Bangladesh http://bmjopen.bmj.com/ 33 34 35 36 37 Email: M Nazim Uddin – [email protected]; Sunil Bhar - [email protected]; 38 39 Abdullah Al-Mahmud – [email protected]; Fakir M Amirul Islam* - 40 on September 26, 2021 by guest. Protected copyright. 41 [email protected] 42 43 44 Corresponding author: 45 46 47 Email: [email protected] 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2017-016745 on 1 September 2017. Downloaded from BMJ Open Page 2 of 21 Page 2 of 17 1 2 3 ABSTRACT 4 Introduction: A significant proportion of the global burden of disease has been attributed to 5 mental and behavioural disorders. People with mental health disorders (MHD) have lower 6 levels of health-related quality of life than those without MHD. Several studies have shown 7 that in low-resource countries, a range of social determinants including poor health literacy 8 9 are critical in the epidemiologic transition of disease outcome. There is a lack of evidence of 10 mental health literacy, the prevalence and risk factors of common mental health problems, or 11 any validated instruments to measure psychological distress, or to evaluate the quality of life 12 in rural areas of Bangladesh. 13 14 Methods and Analysis: Using an appropriate statistical power and sample size calculation, a 15 sample of 1500For adults agedpeer 18-59 years review and 1200 older adults only aged 60 to 90 years will be 16 interviewed from a multi-level cluster random sample. Each participant will go through a 17 face-to-face interview, consisting of a semi structured questionnaire that will assess 18 participant awareness and knowledge of MHD, as well as their current mental health status 19 and how they managed such disorders. Along with the K10 and WHOQOL-BREF 20 questionnaire, information about the participant’s demographic and socio-economic status 21 22 will be collected. Internal consistency, validity, reliability, and item discrimination of K10 23 and WHOQOL-BREF instruments will be determined by item response theory. Awareness 24 and KAP of MHD will be assessed using Rasch analysis, and regression techniques. 25 Psychometric properties of WHOQOL-BREF in four domains will be assessed using 26 confirmatory factor analysis. Psychological distress severity will be defined from combined 27 K10 score and factors associated with it’s prevalence will be assessed. 28 29 Ethics and Dissemination: Human Ethics Approval was received from the Swinburne 30 University of Technology Human Ethics Committee (SHR Project 2015/065). Results of the 31 main trial will be submitted for publication in peer-reviewed journals. 32 http://bmjopen.bmj.com/ 33 34 Strengths and limitations of this study 35 36 • This study will be conducted in a large and representative sample from a typical rural 37 district to report the awareness, knowledge, attitudes and practice about mental health 38 disorders. Therefore, the study will provide a unique opportunity to assess the gaps in 39 public awareness of mental health disorders in rural Bangladesh. 40 • Data will be collected through a face-to-face interview process which will eliminate on September 26, 2021 by guest. Protected copyright. 41 the possible response bias given the literacy level is different in males and females 42 43 and in different age groups. 44 • The study will be able to estimate the prevalence of and factors associated with 45 psychological distress to conduct appropriate intervention programs. 46 • The study will use a sophisticated Rasch analysis technique to validate the 47 psychometric properties of the WHOQOL-BREF and Kessler 10 items (K10) 48 questionnaire to use in Bangladesh. The study will provide the first validated tools to 49 measure psychological distress and quality life in rural Bangladesh, which can be 50 used in other developing countries with the similar socio-economic condition. 51 • The limitation of the study include, we are attempting to conduct in one area of rural 52 53 Bangladesh. The study would need to be repeated in a random sample of other remote 54 areas in order for the results to be truly representative of the national level. 55 56 Keywords: Psychological distress, quality of life, validation, Rasch analysis, WHOQOL- 57 BREF, K10, Rural Bangladesh 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2017-016745 on 1 September 2017. Downloaded from Page 3 of 21 BMJ Open Page 3 of 17 1 2 3 Background 4 Mental Health Disorders: 5 Mental health disorders (MHD) are one of the leading contributors to the global burden of 6 disease in both high and low income countries, accounting for 13% of disease measured as 7 1 8 disability adjusted life years . Common types of MHD include conditions such as major 9 depressive disorders, bipolar disorders, anxiety disorders, psychotic disorders, and substance 2 10 use disorders . Of these, major depressive and anxiety disorders contribute to approximately 11 50% of the international disease burden 3. Such conditions are frequently comorbid with other 12 health and psychosocial problems and are among the most serious causes of morbidity 4-6. 13 Despite the adverse impacts of such mental health conditions, they receive little attention in 14 most low and middle-income countries, and hence, treatment of such conditions are not 15 considered nationalFor health peer priorities 7 8. Mentalreview health complaints only create a major public health 16 4 9 10 17 concern in Bangladesh, especially in rural areas . The prevalence of mental health disorders in such areas varies between 6.5% and 31% possibly due to the use of different 18 11 19 protocol and definitions of MHD . 20 21 Factors associated with mental health disorders: 22 23 A number of factors have been identified as increasing risk for MHD. These factors include a 24 lack of access to, and utilisation of, mental health services, stigma about mental health 25 treatment, and poor physical health 12. MHD are present to a greater extent amongst low 26 socioeconomic status (SES) groups 13, and research shows that financially poor countries 27 14-18 28 with poor health literacy are critical in the epidemiologic transition of disease outcome . 29 A lot of evidence supported that knowledge, attitude and practice (KAP) studies are needed 30 for greater awareness of prevention, diagnosis, risk factor control, and disease management 31 of psychological distress 14-21.
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