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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-2018-024290 on 26 September 2019. 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 25, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-024290 on 26 September 2019. Downloaded from Somatic Symptom Scale-China (SSS-Ch) study: protocol for measurement and severity evaluation of a self-report version of a somatic symptom questionnaire in a general hospital in China ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2018-024290 Article Type: Protocol Date Submitted by the Author: 28-May-2018 Complete List of Authors: Su, Xuan; Renji Hospital, School of Medicine, Shanghai Jiaotong University, Department of Cardiology Zhang, Weituo; Clinical Research Center, School of Medicine, Shanghai Jiaotong University Gao, Chuang; Clinical Research Center, School of Medicine, Shanghai Jiaotong University Mao, Jialiang; Renji Hospital, School of Medicine, Shanghai Jiaotong University, Department of Cardiology Jiang, Meng; Renji Hospital, School of Medicine, Shanghai Jiaotong University, Department of Cardiology Pu, Jun; Renji Hospital, School of Medicine, Shanghai Jiaotong University Somatic Symptom Scale-China, somatic symptom disorder, mental http://bmjopen.bmj.com/ Keywords: disorders management on September 25, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-024290 on 26 September 2019. Downloaded from 1 2 3 Somatic Symptom Scale-China (SSS-Ch) study: protocol for measurement 4 5 6 and severity evaluation of a self-report version of a somatic symptom 7 8 questionnaire in a general hospital in China 9 10 Xuan Sua1, MD, Weituo Zhanga2, PhD, Chuang Gao, MPH2, Jialiang Mao*1, MD, PhD, Meng 11 12 *1 *1 13 Jiang , MD, PhD, Jun Pu , MD, PhD 14 1 15 Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiaotong 16 For peer review only 17 University, Shanghai, China 200127; 18 19 2 Clinical Research Center, School of Medicine, Shanghai Jiaotong University, Shanghai, 20 21 China 200025 22 23 24 25 a 26 Cofirst author: Xuan Su and Weituo Zhang contribute equally to the paper. 27 28 * Name and address for cocorrespondence: Meng Jiang, MD, Ph.D., FSCMR; Jialiang Mao, 29 30 MD, Ph.D.; and Jun Pu, MD, Ph.D., FACC. Department of Cardiology, Renji Hospital, 31 32 School of Medicine, Shanghai Jiaotong University, Shanghai, China; 160 Pujian Road, 33 http://bmjopen.bmj.com/ 34 Shanghai, China, 200127. Tel: 0862168383447, Fax: 0862168383447; Email: 35 36 [email protected]; [email protected] and [email protected] . 37 38 39 40 Word count: 3498 41 on September 25, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 1 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 21 BMJ Open: first published as 10.1136/bmjopen-2018-024290 on 26 September 2019. Downloaded from 1 2 3 ABSTACT 4 5 Aim The current self-reporting questionnaires neither sufficiently consider accompanying 6 7 8 anxiety and depression nor are validated for monitoring the treatment efficacy of the patients 9 10 with somatic symptom disorder (SSD). The Somatic Symptom Scale-China (SSS-Ch) 11 12 questionnaire was developed due to the urgent clinical demand in general hospitals. We 13 14 attempt to determine if this self-administered SSS-Ch could serve as a timely and practical 15 16 instrument to detectFor SSD andpeer to assess thereview severity of this disorder. only 17 18 19 Methods/Design A prospective diagnostic study conducted at 3 centres. Patients without 20 21 organic disease but presenting with physical discomfort will be recruited and undertake the 22 23 SSS-Ch, the Patient Health Questionnaire-15 (PHQ-15), the Patient Health Questionnaire-9 24 25 (PHQ-9) and the Generalized Anxiety Disorder Scale-7 (GAD-7) checklists. An independent 26 27 diagnosis will be made by a primary care physician using the fifth edition of the Diagnostic 28 29 30 and Statistical Manual of Mental Disorders (DSM-5) criterion standards. Patient with SSD 31 32 will be selectively prescribed according to the severity category assessed by physician, 33 http://bmjopen.bmj.com/ 34 selective serotonin reuptake inhibitors or serotonin–norepinephrine reuptake inhibitors. Two, 35 36 6, and 10week follow-ups will be scheduled for repeating the questionnaires in patient with 37 38 SSD. The primary outcomes will be diagnosis and severity assessment accuracy of SSD. 39 40 Secondary outcomes will be whether the SSS-Ch is effective in monitoring treatment efficacy 41 on September 25, 2021 by guest. Protected copyright. 42 43 of SSD in primary care patients, whether the current cut-off value needs to be optimized, and 44 45 how often somatic disorder is accompanied by anxiety or depression. 46 47 Ethics and dissemination Ethical approval was provided by the Renji Hospital Human 48 49 Research Ethics Committee, approval number 2015016. The findings of this study will be 50 51 52 disseminated via peer-reviewed journals and presented at international conferences. 53 54 55 56 57 58 59 2 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-024290 on 26 September 2019. Downloaded from 1 2 3 Strengths and limitations of this study 4 5 1. A strength of this study is that solid validation is achieved. The SSS-Ch is designed to be 6 7 8 double verified by both the DSM-5 and treatment efficacy. 9 10 2. It is suitable for Chinese national conditions. 11 12 13 3. 50% of the items in the SSS-Ch are designed for depression or anxiety since it is stated in 14 15 the DSM-5 that SSD can be accompanied by depression or anxiety. 16 For peer review only 17 4. The current SSS-Ch study is further modified based on the DSM-5 and, for the first time, is 18 19 20 applied for evaluating its clinical utility. 21 22 5. A potential limitation of this study is that our current study only represents the efficacy of 23 24 SSS-Ch utility in patients without organic diseases, and the study was designed as a midterm 25 26 investigation with four measurement points, so missing data are to be considered. 27 28 29 Keywords 30 31 32 Somatic Symptom Scale-China; somatic symptom disorder; mental disorders management. 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 on September 25, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 3 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 21 BMJ Open: first published as 10.1136/bmjopen-2018-024290 on 26 September 2019. Downloaded from 1 2 3 INTRODUCTION 4 5 One of the most common medical conditions seen in general hospitals is somatic symptom 6 7 1 2 8 disorder (SSD) . SSD refers to symptoms reported by patients that often difficult to explain 9 3 10 after adequate evaluation , and even when significant medical disease is present, the patients’ 11 2 12 symptoms may nonetheless be unrelated to their disease . Cardiac neurosis, irritable bowel 13 14 syndrome, fibromyalgia, and chronic fatigue syndrome are related terms to describe these 15 16 “functional diseases”For in variouspeer clinical review departments, while only “SSD” is the term used in the 17 18 field of psychiatry and psychology (ICD-10, DSM-5)2 4. The disorder has an estimated 19 20 2 21 current prevalence in the general population of 1% to 19% and in general medical practice of 22 5-7 23 16% to 30% . Up to 7080% of patients choose to visit a general hospital instead of a 24 2 25 psychiatric clinic . The recognition rate is unsatisfactory due to the diagnostic complexity; 26 27 therefore, patients would sustain somatic symptoms without appropriate treatment due to the 28 29 lack of awareness or effective screening instruments for SSD. Patients with somatization had 30 31 approximately twice the outpatient and inpatient medical care utilization and twice the annual 32 33 http://bmjopen.bmj.com/ 34 medical care costs as nonsomatizing patients. An estimated $256 billion in annual medical 35 1 36 care cost is attributable to the incremental effects of somatization alone . Whereas depression 37 38 and anxiety disorders are widely researched, SSD has been far less studied. Follow-up or 39 40 treatment studies of this kind are even scarcer.
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