Department of Social Medicine of School of Public Health and Department of Pharmacy of the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Department of Clinical Pharmacy, Zhejiang University School of Medicine First Affiliated Hospital, Hangzhou, China.
BMJ Open. 2023 Oct 28;13(10):e072960. doi: 10.1136/bmjopen-2023-072960.
The increase in the number of patients with uncontrolled type 2 diabetes mellitus (T2DM) is in need of effective management interventions. However, research to date has been limited to the evaluation of the outcomes of community pharmacists alone. Therefore, the aim of the study protocol is to compare the effects of clinical pharmacist-led intervention strategies for the management of T2DM in the outpatient settings.
The study will collect and analyse data applying standard Cochrane methodological procedures. A search for eligible studies and ongoing trials will be conducted using PubMed, Embase, Medline (via Ovid), EBSCO (via Ovid), Lippincott Williams & Wilkins (LWW) Journals (via Ovid), ProQuest Health and Medical Complete, and ClinicalTrials.gov (clinicaltrials.gov) from database inception to December 2023. Clinical and health outcomes will be measured using both glycaemic control related indicators (eg, glycated haemoglobin, fasting blood glucose, postprandial glucose) and general indicators (eg, adherence, disease management and health-related quality of life). The meta-analysis will conduct pairwise meta-analysis using random effects models and network meta-analysis (NMA) employing the Bayesian hierarchical model. The visualisation and statistical analysis will be carried out using RevMan, R Studio and ADDIS. Additionally, we will evaluate the certainty of the evidence by using Grading of Recommendations Assessment, Development and Evaluation system.
There will be no primary data collection from NMA participants, and there is no requirement for formal ethical review. Our aim is to present the results of this NMA in a peer-reviewed scientific journal, at conferences, and in the mainstream media.
CRD42022355368.
患有 2 型糖尿病(T2DM)且血糖控制不佳的患者人数不断增加,因此需要有效的管理干预措施。然而,迄今为止的研究仅限于评估社区药剂师的干预效果。因此,本研究方案旨在比较临床药师主导的 T2DM 管理干预策略在门诊环境中的效果。
本研究将采用标准的 Cochrane 方法学程序收集和分析数据。将通过 PubMed、Embase、Medline(通过 Ovid)、EBSCO(通过 Ovid)、Lippincott Williams & Wilkins(LWW)期刊(通过 Ovid)、ProQuest Health and Medical Complete 和 ClinicalTrials.gov(clinicaltrials.gov)从数据库建立到 2023 年 12 月进行合格研究和正在进行的试验检索。将使用血糖控制相关指标(如糖化血红蛋白、空腹血糖、餐后血糖)和一般指标(如依从性、疾病管理和健康相关生活质量)来衡量临床和健康结果。Meta 分析将使用随机效应模型进行两两 Meta 分析,并使用贝叶斯层次模型进行网络 Meta 分析(NMA)。可视化和统计分析将使用 RevMan、R Studio 和 ADDIS 进行。此外,我们将使用推荐评估、制定和评估系统(Grading of Recommendations Assessment, Development and Evaluation system)来评估证据的确定性。
NMA 参与者不会进行原始数据收集,也不需要进行正式的伦理审查。我们的目标是在同行评议的科学期刊、会议和主流媒体上呈现这项 NMA 的结果。
PROSPERO 注册号:CRD42022355368。