Writing essentials and common issues in randomized controlled trials on nursing

doi:10.3761/j.issn.0254-1769.2024.03.003

Abstract

Abstract:

Randomized controlled trial（RCT） is the most rigorous scientific method of evaluating interventions and validating new techniques in nursing. Scientific research papers are not only the carrier of scientific knowledge dissemination，but also an important way of academic thoughts exchange. However，the quality of published randomized controlled studies in nursing research is uneven，and the paper writing are not standard. Based on existing literature review，CONSORT statements，and experience in writing and reviewing papers，the authors expound on the overall structure of RCTs and the essentials of each section，and summarize the common issues，to provide references for researchers to standardize the writing of RCTs in nursing.

Key words: Randomized Controlled, Writing, Standardization, Nursing Care

摘要：

随机对照研究是评估护理干预技术最严谨的科学方法和手段。科研论文不仅是科学知识的传播载体，也是学术思想交流的重要途径。目前公开发表的中、英文护理类随机对照研究论文质量参差不齐，论文撰写的规范性欠佳。该文结合既往文献总结、报告规范及论文撰写和审稿经验，阐述随机对照研究论文的整体架构及各部分内容的撰写要点，总结论文撰写中的常见问题，以期为护理研究人员规范撰写随机对照研究论文提供参考。

关键词: 随机对照, 论文撰写, 规范性, 护理

HU Rong, WANG Chunfeng. Writing essentials and common issues in randomized controlled trials on nursing[J]. Chinese Journal of Nursing, 2024, 59(3): 271-275.

胡荣, 王春凤. 随机对照研究护理论文的撰写要点及常见问题分析[J]. 中华护理杂志, 2024, 59(3): 271-275.

References 14

[1]	胡雁, 王志稳. 护理研究[M]. 6版. 北京: 人民卫生出版社, 2022.
	Hu Y, Wang ZW. Nursing research[M]. 6th ed. Beijing: People’s Medical Publishing House, 2022.
[2]	Adams YJ, Kamp K, Liu CC, et al. Revisiting the quality of reporting randomized controlled trials in nursing literature[J]. J Nurs Scholarsh, 2018, 50(2):200-209. DOI URL
[3]	Wang DG, Wang L, Tong X, et al. Spin in the abstracts of randomized controlled trials of nurse-led care:a cross-sectional study[J]. Int J Nurs Stud, 2023, 145:104543. DOI URL
[4]	李锐臻, 韩世范, 程金莲, 等. 国内护理学领域高影响因子期刊中临床RCT文献的质量评价[J]. 循证护理, 2015, 1(3):101-105.
	Li RZ, Han SF, Cheng JL, et al. Quality evaluation on clinical RCT literatures in journals with high impact factors in domestic nursing field[J]. Chin Evid Nurs, 2015, 1(3):101-105.
[5]	Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement:updated guidelines for reporting parallel group randomized trials[J]. Open Med, 2010, 4(1):e60-e68.
[6]	Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration:updated guidelines for reporting parallel group randomised trials[J]. J Clin Epidemiol, 2010, 63(8):e1-e37.
[7]	Wang CF, Chen JY, Wang Y, et al. Effects of family participatory dignity therapy on the psychological well-being and family function of patients with haematologic malignancies and their family caregivers:a randomised controlled trial[J]. Int J Nurs Stud, 2021, 118:103922. DOI URL
[8]	夏艳玲, 潘文彦, 赵洋洋, 等. 虚拟现实技术在ICU患者早期活动中的应用研究[J]. 中华护理杂志, 2023, 58(9):1050-1055. DOI
	Xia YL, Pan WY, Zhao YY, et al. Application of virtual reality technology in early activities of ICU patients[J]. Chin J Nurs, 2023, 58(9):1050-1055. DOI
[9]	Liao YC, Hsu LF, Hsieh LY, et al. Effectiveness of green tea mouthwash for improving oral health status in oral cancer patients:a single-blind randomized controlled trial[J]. Int J Nurs Stud, 2021, 121:103985. DOI URL
[10]	王丽, 吕天婵, 李丽玲, 等. 阶段性经口喂养促进方案在胎龄小于32周早产儿中的应用研究[J]. 中华护理杂志, 2023, 58(6):701-706. DOI
	Wang L, Lü TC, Li LL, et al. Study on the application of a phased oral feeding promotion program in preterm infants with gestational age less than 32 weeks[J]. Chin J Nurs, 2023, 58(6):701-706. DOI
[11]	徐昱璐, 顾莺, 朱孟欣, 等. 俯卧位通气在先天性心脏病术后急性肺损伤患儿中的应用效果[J]. 中华护理杂志, 2023, 58(3):311-317. DOI
	Xu YL, Gu Y, Zhu MX, et al. Effect of prone ventilation in children with acute lung injury after congenital heart disease surgery[J]. Chin J Nurs, 2023, 58(3):311-317. DOI
[12]	李丽玲, 王丽, 于玲, 等. 非营养性乳房吸吮对极低出生体重早产儿经口喂养能力的影响[J]. 中华护理杂志, 2023, 58(12):1422-1427. DOI
	Li LL, Wang L, Yu L, et al. Effects of non-nutritive breast sucking on the oral feeding ability of very low birth weight preterm infants[J]. Chin J Nurs, 2023, 58(12):1422-1427. DOI
[13]	吴艳妮, 李柴秀. 我国护理科技期刊稿约中临床试验注册规范的调查研究[J]. 科技传播, 2021(11):18-21.
	Wu YN, Li CX. Investigation and study on the registration norms of clinical trials in the manuscripts of nursing sci-tech journals in China[J]. China Ind Econ, 2021(11):18-21.
[14]	General Assembly of the World Medical Association. World Medical Association Declaration of Helsinki:ethical principles for medical research involving human subjects[J]. J Am Coll Dent, 2014, 81(3):14-18.

[1]	SHEN Zhijia, CHEN Xinyu, QIAN Zhijie, YIN Limei. Behavioral characteristics of patients with recurrent hypoglycemia in the degeneracy of blood glucose management：a mixed-methods study [J]. Chinese Journal of Nursing, 2024, 59(9): 1043-1050.
[2]	WANG Limei, LI Lu, LI Yuxia, YU Peng, LUO Qian, ZHANG Chongni. The status and influencing factors of kinesiophobia in patients with diabetic peripheral neuropathic pain [J]. Chinese Journal of Nursing, 2024, 59(9): 1051-1056.
[3]	DING Huimin, DAI Limin, CAI Dongqing, YANG Qun. Potential profile analysis and influencing factors of self-management in prediabetic patients [J]. Chinese Journal of Nursing, 2024, 59(9): 1057-1064.
[4]	LIU Haiting, WANG Yongmei, ZHENG Beibei, CAI Lili, YE Linbin, WU Jiayun, NING Li, LI Yimin, CHEN Weixia. Development and reliability and validity test of a Self-Assessment Scale for Medication Literacy in Patients with Coronary Heart Disease Comorbidity Diabetes [J]. Chinese Journal of Nursing, 2024, 59(9): 1065-1071.
[5]	Allergy and Clinical Immunology Committee of Chinese Research Hospital Association, Allergy Care Group, Chinese Society of Allergology, Chinese Medical Association, Allergy Prevention and Control Committee of Chinese Preventive Medicine Association, （Writing Committee：WANG Qing, LIU Jun, ZHI Fan, WAN Wenjin, TIAN Fengying, HUO Xiaopeng, ZHOU Wenhua YANG Yongshi, WANG Tiantian, SUN Jinlü）. Nursing expert consensus on subcutaneous injection for allergen-specific immunotherapy [J]. Chinese Journal of Nursing, 2024, 59(9): 1080-1083.
[6]	LI Qi, SU Qingqing, ZHANG Yaoyao, WANG Tiantian, LÜ Jing, LI Yake, LI Haiyan. A study on the trajectory and influencing factors of joint awareness in patients with total knee arthroplasty [J]. Chinese Journal of Nursing, 2024, 59(9): 1084-1090.
[7]	LIU Ya, LIU Xiaoqing, YANG Xuening, WANG Ping, LIU Xuekui, LUO Dan. Construction and validation of a risk predictive model for the bowel preparation failure in colonoscopy patients [J]. Chinese Journal of Nursing, 2024, 59(9): 1091-1098.
[8]	LI Xuqin, FENG Jiehui, HUANG Fangfang, YU Chao, LIANG Shiyu, WANG Xiao, LI Xufang, ZHU Han. Nursing care of a patient before operation with mechanical circulation-assisted bridging heart transplantation [J]. Chinese Journal of Nursing, 2024, 59(9): 1114-1117.
[9]	JIA Xiaojing, CHEN Yizhu, XU Zhiying, HE Xia, GENG Chao. Nursing care of a patient with acute myocardial infarction after double knee joint replacement due to alkaptonuria [J]. Chinese Journal of Nursing, 2024, 59(9): 1118-1121.
[10]	CUI Yishuang, HE Xifei, WANG Zhaozhao, CHENG Jie, YANG Weimei, LU Lijuan. Shared decision making in acute coronary syndromes：a scoping review [J]. Chinese Journal of Nursing, 2024, 59(9): 1145-1152.
[11]	YU Liangmeng, YU Xiaoling, LI Jiamei, RUAN Xiaofen. Application progress of evidence mapping in nursing field [J]. Chinese Journal of Nursing, 2024, 59(8): 1021-1025.
[12]	GUO Miaomiao, YAN Tingting, XU Dandan, YUAN Ling. Development and application of a whole course management information system for breast cancer [J]. Chinese Journal of Nursing, 2024, 59(8): 901-908.
[13]	QIAO Wenbo, HOU Sijia, ZHU Keping, LI Yaqin, WU Siyuan, QI Ziyi, WANG Wei. Construction and application of a pelvic floor muscle training program for patients with radical prostatectomy [J]. Chinese Journal of Nursing, 2024, 59(8): 909-915.
[14]	LU Ping, WANG Xiaojie, GUO Hailing. Correlation between preoperative frailty and short-term postoperative complications in elderly breast cancer patients [J]. Chinese Journal of Nursing, 2024, 59(8): 916-921.
[15]	YOU Chaoxiang, JIA Mengying, LI Shuang, CHEN Lili, JING Wendan, KOU Hongyan. A study of longitudinal trajectories and predictive factors of symptom clusters in patients with laparoscopic anal preservation surgery for rectal cancer [J]. Chinese Journal of Nursing, 2024, 59(8): 922-929.