Bhaskarapillai Binukumar, Malo Palash Kumar, Kishore M Thomas, Joseph Anoop, Majhi Gobinda, Jaisoorya T S, Kandavel Thennarasu
Dept. of Biostatistics, National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, Karnataka, India.
Centre for Brain Research, Indian Institute of Science, Bengaluru, Karnataka, India.
Indian J Psychol Med. 2024 Dec 5:02537176241293194. doi: 10.1177/02537176241293194.
Though cluster randomized trials (CRTs) provide robust evidence for intervention by controlling contamination of interventions, there could be some loss of statistical efficiency. The Consolidated Standards of Reporting Trials (CONSORT) recommends reporting intraclass correlation coefficients (ICC) to understand this phenomenon, though not many studies follow this. This meta-analysis explored the compliance of CRTs in major depression for reporting ICC besides deriving the pooled ICC and pooled mean differences of intervention outcomes.
Thirty-four articles on CRTs in major depression were identified from PubMed, Cochrane Library, PsychINFO, and Embase, and relevant data were extracted. Only 20 studies were eligible for meta-analysis of intervention, among which 8 reported ICC. We used DerSimonian and Laird's inverse variance method to calculate the pooled estimates.
Only eight (40%) of the CRTs reported using ICC both for designing the study and examining intervention outcomes. The pooled ICC was 0.07 (95% confidence interval [CI]: 0.05, 0.09) with a low heterogeneity (I = 28%). Among the 20 studies, 65% used different psychosocial methods alone as intervention, with substantial heterogeneity. The pooled standardized mean difference of depression scores (-0.46; 95% CI: -0.79, -0.13) indicated the effectiveness of psychosocial interventions irrespective of combined pharmacotherapy (z = 2.71, value = 0.01). Further, a subgroup analysis of intervention effects revealed that the results were significant only for the CRTs with ICC conformity.
The ICCs can affect the intervention outcomes. Therefore, as indicated by this meta-analysis, CRTs must adhere to the CONSORT guidelines on reporting ICC. Future CRTs on major depression can utilize the pooled ICC estimate from this study, especially for sample size estimations.
尽管整群随机试验（CRTs）通过控制干预措施的污染为干预提供了有力证据，但可能会有一定的统计效率损失。《报告试验的统一标准》（CONSORT）建议报告组内相关系数（ICC）以了解这一现象，不过遵循此建议的研究并不多。本荟萃分析探讨了重度抑郁症整群随机试验在报告ICC方面的依从性，同时得出合并ICC以及干预结果的合并平均差。
从PubMed、Cochrane图书馆、PsychINFO和Embase中识别出34篇关于重度抑郁症整群随机试验的文章，并提取相关数据。仅有20项研究符合干预荟萃分析的条件，其中8项报告了ICC。我们采用DerSimonian和Laird的逆方差法计算合并估计值。
仅有8项（40%）整群随机试验报告在设计研究和检查干预结果时均使用了ICC。合并ICC为0.07（95%置信区间[CI]：0.05，0.09），异质性较低（I² = 28%）。在这20项研究中，65%仅使用不同的心理社会方法作为干预，异质性较大。抑郁评分的合并标准化平均差为-0.46（95%CI：-0.79，-0.13），表明无论是否联合药物治疗，心理社会干预均有效（z = 2.71，P值 = 0.01）。此外，干预效果的亚组分析显示，仅符合ICC标准的整群随机试验结果具有显著性。
ICC会影响干预结果。因此，正如本荟萃分析所示，整群随机试验必须遵循CONSORT关于报告ICC的指南。未来关于重度抑郁症的整群随机试验可以利用本研究的合并ICC估计值，尤其是用于样本量估计。
