Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf and Schön Clinic Hamburg Eilbek, Hamburg, Germany.
General Practice/Primary Care, Center for Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
BMJ Open. 2017 Aug 11;7(8):e014157. doi: 10.1136/bmjopen-2016-014157.
Somatoform or somatic symptom disorders ((S)SD) are common and have a negative impact on the patients' health-related quality of life, healthcare use and costs. In primary care, which is central to the management of (S)SD, diagnosis and treatment tend to be delayed. There is a significant lack of evidence regarding the barriers in the diagnostic process of (S)SD in primary care and how interventions should be tailored to address them. The aim of this study is to analyse the diagnostic process in primary care that results in the diagnosis or non-diagnosis of a (S)SD.
This mixed methods study will investigate the topic with qualitative methods, subsequently proceeding to a quantitative phase where the initial results will be validated and/or generalised. First, focus groups will explore meanings and patterns, inconsistencies and conflicts in general practitioners' (GPs) thoughts and behaviours when diagnosing (S)SD. Second, the results of these focus groups will be used to develop interview guidelines for subsequent face-to-face interviews. Patients and their treating GPs will be interviewed separately on how they experience the history of illness, the diagnostic process and treatment. Third, based on the results of the first two study parts, a questionnaire will be derived and a nationwide survey among German GPs will be conducted, quantifying the barriers and difficulties identified before.
Ethics approval was obtained from the Ethics Committee of the Hamburg Medical Association, Germany (approval number PV4763). The results of this study will be disseminated through conference presentation and publications in peer-reviewed journals.
The study is registered in the German Clinical Trial Register (DRKS), DRKS-ID DRKS00009736.
躯体形式或躯体症状障碍（(S)SD）较为常见，对患者的健康相关生活质量、医疗保健的使用和费用有负面影响。在以（S）SD 管理为中心的初级保健中，诊断和治疗往往会被延迟。在初级保健中，（S）SD 的诊断过程中存在哪些障碍，以及应该如何针对这些障碍进行干预，这方面的证据严重不足。本研究旨在分析导致（S）SD 诊断或不诊断的初级保健诊断过程。
这项混合方法研究将使用定性方法来研究该主题，随后进入定量阶段，在该阶段将验证和/或推广初始结果。首先，焦点小组将探讨全科医生（GP）在诊断（S）SD 时的思维和行为中的意义和模式、不一致和冲突。其次，这些焦点小组的结果将用于为随后的面对面访谈制定访谈指南。将分别对患者及其治疗医生进行访谈，了解他们对疾病史、诊断过程和治疗的体验。第三，基于前两部分研究的结果，将衍生出一份问卷，并对德国全科医生进行全国性调查，量化之前确定的障碍和困难。
该研究已获得德国汉堡医师协会伦理委员会的批准（批准号 PV4763）。本研究的结果将通过会议演讲和同行评议期刊发表进行传播。
该研究在德国临床试验注册处（DRKS）注册，DRKS-ID DRKS00009736。
