“针刺临床试验干预措施报告标准”(Standards,for Reporting Interventions in Clinical Trials of Acupuncture,STRICTA)于2001年和2002年在5种期刊上发表。该指南以对照试验检查清单及解释的形式供作者和期刊编辑使用,旨在提高针刺临床试验报告的质量,尤其是对其中干预措施的报告,因而有助于对这些试验的解释和重复。随后对STRICTA的应用及影响的述评都强调了STRICTA的价值,也提出了改进和修订的建议。 为使修订过程顺利进地,STRICTA工作组、CONSORT工作组和中国Cochrane中心于2008年开始合作,召集成立的包含47名成员的专家小组对清单的修改稿提出了电子版反馈意见。在后来于弗莱堡(Freiburg)召开的见面会上,由21名专家组成的工作组进一步修订了STRICTA对照检查清单,并计划如何对其进行发布。 新的STRICTA对照检查清单作为CONSORT的正式扩展版,包含6项条目及17条二级条目。这些条目为报告针刺治疗的合理性、针刺的细节、治疗方案、其他干预措施、治疗师的背景以及对照或对照干预提供了指南。而且,作为修订工作的一部分,对每一条目作了详尽解释,并针对每一条目给出了良好报告的实例。此外,STRICTA中的“对照”(controlled)一词被替换成了“临床”(clinical),以示STRICTA适用于更广泛的各类临床评价设计,包括非对照结局研究和病例报道。修订的STRICTA对照检查清单有望与CONSORT声明及其非药物治疗扩展版一起共同提高针刺临床试验的报告质量。
Objective To preliminarily assess the ameliorative effect of Mom’s Good Mood (MGM) on the prevalence of antenatal depression based on a pilot study, and to provide evidence for a scale-up study. Methods This study was conducted in Ma’anshan Maternal and Child Health Center as a pilot study of an implementation study conducted in China called the Perinatal Depression Screening and Management (PDSM) program. In 2019, 1 189 participants (gestational week ≤14+6 weeks) were included in the implementation group. Females were recruited in the first trimester and followed up in the second and third trimesters. At each time point, the participants’ depression status was screened by the Edinburgh postpartum depression scale (EPDS), and those who were screened as having depression were provided the MGM intervention. In 2020, 1 708 participants who underwent screening with the EPDS in either the first, second or third trimester at Ma’anshan Maternal and Child Health Center were included in the control group. Mann‒Whitney U test, Chi-square, and multivariate logistic regression analysis were used to compare the EPDS scores and depression prevalence between the control and implementation groups to assess the ameliorative effect of MGM (screening and intervention) on antenatal depression. Results In the first trimester, there were no statistically significant differences in EPDS scores or depression prevalence between the two groups (P>0.05). In the second and third trimesters, both the EPDS scores and depression prevalence of the implementation group were lower than those of the control group (P<0.05). After adjusting for confounders, logistic regression analysis showed that the risks of depression in the implementation group in both the second and third trimesters were lower than those in the control group (ORsecond trimester=0.55, 95%CI 0.37 to 0.81, P=0.003; ORthird trimester=0.51, 95%CI 0.35 to 0.74, P<0.001). Conclusion Implementation of the MGM based on the primary care system can effectively reduce the prevalence of antenatal depression, providing evidence for further scale up.