PDF(Pubmed)
Abstract：
UNASSIGNED: Our goal was to review current peer-reviewed articles in which the BDI (Beck Depression Inventory), PHQ-9 (Patient Health Questionnaire), or QIDS-SR16 (16-Item Quick Inventory of Depressive Symptomatology) was used as the primary or secondary outcome measure and to evaluate the quality of PRO (Patient-Reported Outcome) reporting in RCTs (Randomized Controlled Trials) according to the 2013 PRO-specific CONSORT (Consolidated Standards of Reporting Trials) extension.
UNASSIGNED: We systematically searched in electronic databases. A study would be included if it included patients diagnosed with major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM) or International Classification of Diseases, version 10 (ICD-10) as participants, was a randomized controlled trial, included the BDI, PHQ-9, or QIDS-SR16 as the primary or secondary outcome measure, published between 1990 and 2013, and was in English. Two of the authors evaluated the quality of PRO reporting according to the 2013 CONSORT-PRO. Logistic regression were used to evaluate the association between reporting completeness and trial characteristics.
UNASSIGNED: A total of 116 studies were included. These studies were conducted in 25 countries. Sample sizes ranged from 12 to 750. The CONSORT-PRO was not cited in any one of the included studies. Among the 116 studies, 2 (1.72%) studies introduced the rationale for PRO assessment, 60 (51.72%) studies explicitly stated statistical approaches for dealing with missing data, 87 (75.00%) studies reported PRO outcome data at baseline and at subsequent time points. The mean score of reporting completeness was 66.24%. Significantly higher reporting completeness was found for RCTs published after 2013 (OR, 95%CI: 3.81, 1.32-10.99). Studies with a higher sample size were more completely reported than studies with a lower sample size (OR, 95%CI: 1.01, 1.00-1.02).
UNASSIGNED: The CONSORT-PRO guidance was rarely cited. The quality of PRO reporting in depression studies requires improvement. This result may be meaningful for the promotion of PRO reporting in RCTs.
UNASSIGNED: We systematically searched in electronic databases. A study would be included if it included patients diagnosed with major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM) or International Classification of Diseases, version 10 (ICD-10) as participants, was a randomized controlled trial, included the BDI, PHQ-9, or QIDS-SR16 as the primary or secondary outcome measure, published between 1990 and 2013, and was in English. Two of the authors evaluated the quality of PRO reporting according to the 2013 CONSORT-PRO. Logistic regression were used to evaluate the association between reporting completeness and trial characteristics.
UNASSIGNED: A total of 116 studies were included. These studies were conducted in 25 countries. Sample sizes ranged from 12 to 750. The CONSORT-PRO was not cited in any one of the included studies. Among the 116 studies, 2 (1.72%) studies introduced the rationale for PRO assessment, 60 (51.72%) studies explicitly stated statistical approaches for dealing with missing data, 87 (75.00%) studies reported PRO outcome data at baseline and at subsequent time points. The mean score of reporting completeness was 66.24%. Significantly higher reporting completeness was found for RCTs published after 2013 (OR, 95%CI: 3.81, 1.32-10.99). Studies with a higher sample size were more completely reported than studies with a lower sample size (OR, 95%CI: 1.01, 1.00-1.02).
UNASSIGNED: The CONSORT-PRO guidance was rarely cited. The quality of PRO reporting in depression studies requires improvement. This result may be meaningful for the promotion of PRO reporting in RCTs.
摘要：
■我们的目标是回顾当前同行评审的文章，其中BDI(贝克抑郁量表)，PHQ-9（患者健康问卷），或QIDS-SR16(16项抑郁症状快速量表)被用作主要或次要结局指标,并根据2013年PRO-specificCONSORT(报告试验合并标准)扩展,评估RCT(随机对照试验)中PRO(患者报告结局)报告的质量.
■我们在电子数据库中进行了系统搜索。如果根据《精神障碍诊断和统计手册》（DSM）或《国际疾病分类》的标准，将被诊断患有重度抑郁症的患者纳入研究，第10版(ICD-10)作为参与者，是一项随机对照试验，包括BDI,PHQ-9或QIDS-SR16作为主要或次要结果指标，1990年至2013年出版，英文。两位作者根据2013年CONSORT-PRO评估了PRO报告的质量。使用Logistic回归评估报告完整性与试验特征之间的关联。
■共纳入116项研究。这些研究在25个国家进行。样本量范围从12到750。纳入的任何一项研究均未引用CONSORT-PRO。在116项研究中，2项(1.72%)研究介绍了PRO评估的基本原理，60项(51.72%)研究明确指出了处理缺失数据的统计方法，87（75.00%）研究报告了基线和随后时间点的PRO结果数据。报告完整性的平均得分为66.24%。2013年以后发布的RCT的报告完整性显著提高(或，95CI：3.81，1.32-10.99）。样本量较高的研究比样本量较低的研究报告得更完整(OR，95CI：1.01，1.00-1.02）。
■CONSORT-PRO指南很少被引用。抑郁症研究中PRO报告的质量需要改进。这一结果可能对RCT中PRO报告的推广有意义。
■我们在电子数据库中进行了系统搜索。如果根据《精神障碍诊断和统计手册》（DSM）或《国际疾病分类》的标准，将被诊断患有重度抑郁症的患者纳入研究，第10版(ICD-10)作为参与者，是一项随机对照试验，包括BDI,PHQ-9或QIDS-SR16作为主要或次要结果指标，1990年至2013年出版，英文。两位作者根据2013年CONSORT-PRO评估了PRO报告的质量。使用Logistic回归评估报告完整性与试验特征之间的关联。
■共纳入116项研究。这些研究在25个国家进行。样本量范围从12到750。纳入的任何一项研究均未引用CONSORT-PRO。在116项研究中，2项(1.72%)研究介绍了PRO评估的基本原理，60项(51.72%)研究明确指出了处理缺失数据的统计方法，87（75.00%）研究报告了基线和随后时间点的PRO结果数据。报告完整性的平均得分为66.24%。2013年以后发布的RCT的报告完整性显著提高(或，95CI：3.81，1.32-10.99）。样本量较高的研究比样本量较低的研究报告得更完整(OR，95CI：1.01，1.00-1.02）。
■CONSORT-PRO指南很少被引用。抑郁症研究中PRO报告的质量需要改进。这一结果可能对RCT中PRO报告的推广有意义。
