Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.
Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
BMJ Open. 2019 Jul 26;9(7):e029716. doi: 10.1136/bmjopen-2019-029716.
Prospective cohort studies on the association between subclinical thyroid dysfunction and depressive symptoms have yielded conflicting findings, possibly because of differences in age, sex, thyroid-stimulating hormone cut-off levels or degree of baseline depressive symptoms. Analysis of individual participant data (IPD) may help clarify this association.
We will conduct a systematic review and IPD meta-analysis of prospective studies on the association between subclinical thyroid dysfunction and depressive symptoms. We will identify studies through a systematic search of the literature in the Ovid Medline, Ovid Embase, Cochrane Central Register of Controlled Trials (CENTRAL) and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases from inception to April 2019 and from the Thyroid Studies Collaboration. We will ask corresponding authors of studies that meet our inclusion criteria to collaborate by providing IPD. Our primary outcome will be depressive symptoms at the first available individual follow-up, measured on a validated scale. We will convert all the scores to the Beck Depression Inventory scale. For each cohort, we will estimate the mean difference of depressive symptoms between participants with subclinical hypothyroidism or hyperthyroidism and control adjusted for depressive symptoms at baseline. Furthermore, we will adjust our multivariable linear regression analyses for age, sex, education and income. We will pool the effect estimates of all studies in a random-effects meta-analysis. Heterogeneity will be assessed by I. Our secondary outcomes will be depressive symptoms at a specific follow-up time, at the last available individual follow-up and incidence of depression at the first, last and at a specific follow-up time. For the binary outcome of incident depression, we will use a logistic regression model.
Formal ethical approval is not required as primary data will not be collected. Our findings will have considerable implications for patient care. We will seek to publish this systematic review and IPD meta-analysis in a high-impact clinical journal.
CRD42018091627.
前瞻性队列研究表明,亚临床甲状腺功能障碍与抑郁症状之间存在关联,但研究结果存在差异,这可能是由于年龄、性别、促甲状腺激素截断值或基线抑郁症状程度的不同。对个体参与者数据(IPD)的分析可能有助于阐明这种关联。
我们将对亚临床甲状腺功能障碍与抑郁症状之间关联的前瞻性研究进行系统评价和 IPD 荟萃分析。我们将通过系统检索 Ovid Medline、Ovid Embase、Cochrane 对照试验中心注册库(CENTRAL)和 Cumulative Index to Nursing and Allied Health Literature(CINAHL)数据库中的文献,从建库至 2019 年 4 月以及从甲状腺研究合作组织中进行文献检索,以确定研究。我们将要求符合纳入标准的研究的对应作者通过提供 IPD 进行合作。我们的主要结局将是首次个体随访时可获得的抑郁症状,使用经过验证的量表进行测量。我们将把所有的分数转换为贝克抑郁量表的分数。对于每个队列,我们将根据基线时的抑郁症状,估计亚临床甲状腺功能减退或甲状腺功能亢进症患者与对照组之间抑郁症状的平均差异。此外,我们将调整多变量线性回归分析以考虑年龄、性别、教育和收入。我们将在随机效应荟萃分析中汇总所有研究的效应估计值。异质性将通过 I²进行评估。我们的次要结局将是特定随访时间的抑郁症状、最后一次个体随访的抑郁症状以及首次、最后和特定随访时间的抑郁发生率。对于抑郁发生率的二分类结局,我们将使用逻辑回归模型。
由于不会收集原始数据,因此不需要正式的伦理批准。我们的研究结果将对患者护理产生重大影响。我们将寻求在高影响力的临床期刊上发表这项系统评价和 IPD 荟萃分析。
PROSPERO 注册号:CRD42018091627。