Chew Boon-How
Family Medicine, Universiti Putra Malaysia, Serdang, MYS.
Cureus. 2019 Feb 20;11(2):e4112. doi: 10.7759/cureus.4112.
The goal of this review was to present the essential steps in the entire process of clinical research. Research should begin with an educated idea arising from a clinical practice issue. A research topic rooted in a clinical problem provides the motivation for the completion of the research and relevancy for affecting medical practice changes and improvements. The research idea is further informed through a systematic literature review, clarified into a conceptual framework, and defined into an answerable research question. Engagement with clinical experts, experienced researchers, relevant stakeholders of the research topic, and even patients can enhance the research question's relevance, feasibility, and efficiency. Clinical research can be completed in two major steps: study designing and study reporting. Three study designs should be planned in sequence and iterated until properly refined: theoretical design, data collection design, and statistical analysis design. The design of data collection could be further categorized into three facets: experimental or non-experimental, sampling or census, and time features of the variables to be studied. The ultimate aims of research reporting are to present findings succinctly and timely. Concise, explicit, and complete reporting are the guiding principles in clinical studies reporting.
本综述的目的是介绍临床研究全过程的基本步骤。研究应始于源于临床实践问题的一个有根据的想法。一个植根于临床问题的研究主题为完成研究提供了动力，并与影响医学实践的变化和改进具有相关性。通过系统的文献综述进一步完善研究想法，将其提炼成一个概念框架，并界定为一个可回答的研究问题。与临床专家、经验丰富的研究人员、研究主题的相关利益攸关方甚至患者进行交流，可提高研究问题的相关性、可行性和效率。临床研究可分两个主要步骤完成：研究设计和研究报告。应依次规划并反复进行三种研究设计，直至完善：理论设计、数据收集设计和统计分析设计。数据收集设计可进一步细分为三个方面：实验性或非实验性、抽样或普查以及待研究变量的时间特征。研究报告的最终目的是简洁、及时地呈现研究结果。简洁、明确和完整的报告是临床研究报告的指导原则。
