Equal detection rate of cervical heterotopic gastric mucosa in standard white light, high definition and narrow band imaging endoscopy.

BACKGROUND AND AIM: The prevalence of cervical heterotopic gastric mucosa (HGM) of the proximal oesophagus differs widely between studies, perhaps due to examination conditions during endoscopy. In this study we aimed to determine whether narrow band imaging (NBI) or high definition (HD) imaging improves detection of HGM. Possible factors of influence for HGM detection, in particular setting (position, timing, in-/out-patient), examination time and sedation parameters, were analysed. METHODS: Retrospective analysis of 641 consecutive patients who underwent an oesophagogastroduodenoscopy (EGD) by the same, substantially experienced endoscopist between June 2011 and August 2013. The type of endoscope was randomly assigned to patients. RESULTS: A total of 85 patients showed HGM with an overall prevalence of 13.3 %. The detection rate in the HD-NBI group was 18/127 (14.2 %) and in the HD white light (HDWL) group, 15/104 (14.4 %, p = 0.957). The detection rate between standard definition white light (SDWL) endoscopy (52/410, 12.7 %) and HD endoscopy did not differ significantly (33/231, 14.3 %, p = 0.566). Setting, sedation dosage and examination times were equally distributed between study groups. The indication of dysphagia (11.8 % vs. 2.4 % with p = 0.000, respectively) and dyspepsia (19.1 % vs. 10.8 %, p = 0.047, respectively) occurred significantly more often in HGM patients than in the control group. There was no difference in the detection rate depending on HGM size. CONCLUSIONS: The prevalence of HGM in the upper EGD is high and does not differ significantly between the study groups of SDWL, HDWL and HD-NBI under equivalent conditions.

Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial.

BACKGROUND: Diabetes self-management is a mainstay of diabetes care, but the implementation of self-management regimens into daily life is complex and often results in discouragement and distress. Modern approaches such as smartphone-based self-management applications are therefore needed to support people with diabetes. Since reimbursability would increase the availability of such digital applications to people with diabetes, we designed a study that meets all scientific and methodological requirements set by the German Digital Healthcare Act to allow reimbursement for a specific application (mySugr PRO). Here, we report the protocol of this study that aims at evaluating the efficacy of the digital self-management application with regard to patient-reported outcomes and medical benefits. METHODS/DESIGN: This multicenter, open-label, randomized, parallel-group, controlled trial will evaluate the health care effects and medical benefits of mySugr PRO. A total of 466 people with diabetes will be randomly allocated (2:1 randomization) to the interventional group (n = 311) that will use the digital self-management application during the 12-week study period or the control group (n = 155; no usage of the application). Baseline and follow-up examinations will assess diabetes distress as the primary endpoint as well as empowerment, HbA1c, blood glucose data, self-management, general well-being, and treatment satisfaction as secondary endpoints. Statistical analyses will use an intention-to-treat procedure (using multiple imputation for missing values) as well as a per-protocol approach for sensitivity analysis. DISCUSSION: To the best of our knowledge, this study will be one of the largest diabetes-specific evaluations of a digital health application supporting people with diabetes in their diabetes self-management that follow the requirements of the German Digital Healthcare Act. TRIAL REGISTRATION: German Clinical Trial Register DRKS00022923 . Registered on 22 October 2020.