Essuman Vera Adobea, Tagoe Naa Naamuah, Akpalu Josephine, Essuman Akye, Sackey Adziri H, Hayfron-Benjamin C F, Asare George, Abaidoo Benjamin, Amoah Agb, Ndanu Thomas, Ofori-Adjei Idb, Barnes N A, Appiah-Thompson B L, Amoaku Winfried M
Ophthalmology Unit, Department of Surgery, University of Ghana Medical School, Accra, Ghana.
Eye Department, Korle Bu Teaching Hospital, Accra, Ghana.
JMIR Res Protoc. 2021 Jan 6;10(1):e21440. doi: 10.2196/21440.
Diabetes is associated with premature morbidity and mortality from its many complications. There are limited data on the chronic complications of diabetes in children and adolescents in sub-Saharan Africa.
The study aims to determine the (1) burden and related factors of chronic systemic complications of diabetes, including diabetic and nondiabetic ocular conditions in children and adolescents, and (2) quality of life (QoL) of participants compared to healthy controls. This manuscript describes the study methodology.
Demographic information, medical history, anthropometric measurements, and laboratory characteristics were collected, and the participants were screened for microvascular and macrovascular complications as well as nondiabetic ocular disease. QoL questionnaires were administered to participants, their caregivers, and controls. Participants were followed up annually up to 3 years to determine the natural history of and trends in these conditions. SPSS Version 25.0 will be used for data analysis. Continuous and categorical data will be presented as mean (SD) and as percentages (%), respectively. t tests and analysis of variance will be used to compare means, and chi-square tests will be used to compare categorical data. Correlation, regression, and logistic regression analyses will be employed to establish linear associations and causal associations as appropriate. Relative risk and odds ratios will be used to estimate risk. QoL outcomes in Ghanaian children and adolescents with diabetes mellitus compared with caregivers and healthy controls will be assessed using the Pediatric Quality of Life inventory. Significance will be set at α=.05.
Institutional approval from the Ethical and Protocol Review Committee of the University of Ghana Medical School was received on August 22, 2014 (Protocol Identification Number: MS-Et/M.12-P4.5/2013-2014). Funding for the project was received from the University of Ghana Research Fund (#UGRF/9/LMG-013/2015-2016) in March 2016. Patient recruitment, clinical examination, and data collection commenced in August 2016 and was completed in September 2019. A total of 58 children and adolescents with diabetes mellitus have been recruited. Blood samples were stored at -80 °C for analysis, which was completed at the end of July 2020. Data analysis is ongoing and will be completed by the end of December 2020. Investigators plan to submit the results for publication by the end of February 2021.
The prevalence, natural history, trends in diabetic complications and nondiabetic ocular disease, and QoL will be provided. Our data may inform policies and interventions to improve care given to children and adolescents with diabetes.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21440.
糖尿病与其诸多并发症导致的过早发病和死亡相关。关于撒哈拉以南非洲儿童和青少年糖尿病慢性并发症的数据有限。
本研究旨在确定（1）糖尿病慢性全身性并发症的负担及相关因素，包括儿童和青少年的糖尿病性和非糖尿病性眼部疾病，以及（2）与健康对照相比参与者的生活质量（QoL）。本文描述了研究方法。
收集人口统计学信息、病史、人体测量数据和实验室特征，并对参与者进行微血管和大血管并发症以及非糖尿病性眼病的筛查。向参与者、其照顾者和对照发放生活质量问卷。对参与者进行长达3年的年度随访，以确定这些情况的自然史和趋势。将使用SPSS 25.0版进行数据分析。连续数据和分类数据将分别以均值（标准差）和百分比（%）表示。t检验和方差分析将用于比较均值，卡方检验将用于比较分类数据。将采用相关分析、回归分析和逻辑回归分析来酌情建立线性关联和因果关联。相对风险和比值比将用于估计风险。将使用儿童生活质量量表评估加纳糖尿病儿童和青少年与照顾者及健康对照相比的生活质量结果。显著性水平设定为α = 0.05。
2014年8月22日获得了加纳大学医学院伦理与方案审查委员会的机构批准（方案识别号：MS-Et/M.12-P4.5/2013 - 2014）。2016年3月从加纳大学研究基金（#UGRF/9/LMG-013/2015 - 2016）获得了该项目的资金。患者招募、临床检查和数据收集于2016年8月开始，并于2019年9月完成。共招募了58名糖尿病儿童和青少年。血样保存在 -80°C用于分析，分析于2020年7月底完成。数据分析正在进行，将于2020年12月底完成。研究人员计划在2021年2月底前提交结果以供发表。
将提供糖尿病并发症和非糖尿病性眼病的患病率、自然史、趋势以及生活质量。我们的数据可为改善糖尿病儿童和青少年护理的政策和干预措施提供参考。
国际注册报告识别码（IRRID）：DERR1-10.2196/21440。
