2.研究对象

2.研究对象

这一部分需要对研究对象(Sample,Participants,Subjects)进行描述,包括:样本来源或研究对象招募场所、样本量、抽样方法、纳入和排除标准。有些期刊明确要求说明样本量计算方法,所以在研究设计阶段,就要对此方面进行仔细考量。

如示例2-38所示,该研究介绍了样本来源以及样本量计算方法。如示例2-39所示,该研究介绍了样本量及研究对象的招募方法和场所。

示例2-38 样本来源及样本量计算

Sample and procedure

The study took place within a large care organization in the Netherlands,counting 17 nursing homes,with about 2000 employees.Taking into account a 25%loss to follow-up,a power analysis indicated that 86 participants divided over two groups were needed to have 80%power for detecting a smallsized effect.

示例2-39 样本量、招募场所和方法

Participants

We aimed to recruit 404 participants and achieved a final sample size of 410(205 in each arm).Participants were recruited from the community through multiple channels;for example,the study web-link was sent to contact lists of people who had previously expressed an interest in taking part in sleep research and advertised on websites and social media platforms.

多数情况下,需要对纳入标准和排除标准进行详细描述,以便供其他研究人员参考。有时候,针对某个纳入或排除标准,需要说明设置此标准的原因或相应的支撑文献(例如,某疾病诊断标准)。如示例2-40所示,研究给出了具体的纳入和排除标准,同时给出了相应的引文进行支持。(https://www.daowen.com)

示例2-40 纳入和排除标准(含引文支撑疾病诊断)

Inclusion criteria were(1)aged 25 years and older,(2)meet DSM-5 criteria for insomnia disorder according to the Sleep Condition Indicator[21],(3)report difficulties with concentration or memory[22],(4)have reliable Internet access,(5)read and understand English,and(6)currently reside in the United Kingdom.Exclusion criteria were(1)screen positive for or report a diagnosis of additional sleep disorder[23],(2)report a diagnosis of mild cognitive impairment,dementia.

另外,对于二次分析,可以通过引用既往发表过的论文,而不再赘述。但是,需要对所提供的信息量进行权衡。一方面,本论文没有必要对既往介绍过的内容逐字逐句进行描述,这反而会增加论文与既往文献的重复率(一旦你的论文发表出来,它就不再属于你而属于出版商);另一方面,论文所提供的内容不可过于简短。对于审稿人来说,论文要为他们提供足够的信息,以便其对论文进行审阅,这一点对于审稿人来说尤其重要。虽然他们可以通过查询你所引用的原始文献获取更加详细的信息,但是很少有审稿人愿意花费更多的时间获取此文献。此种情况下,可以采取以下撰写策略:Detailed inclusion and exclusion criteria have been described in a previous report.In brief...(大致介绍一下纳入和排除标准,而无须给出选择某纳入或排除标准的原因)。如示例2-41和示例2-42所示,该论文通过引用既往发表过的文献,介绍了研究对象。

示例2-41 研究对象举例1

Participants

All participants were members of the prospective occupational cohort study,Whitehall Ⅱ[13]and the Whitehall II Imaging Sub-Study[14].

示例2-42 研究对象举例2

The DPP

The DPP was a multicenter randomized control trial with a median follow-up of 3.2 years among individuals at high risk for diabetes.Inclusion and exclusion criteria were published previously(14).