Abstract：
OBJECTIVE: There is a need to consolidate reporting guidance for nutrition randomised controlled trial (RCT) protocols. The reporting completeness in nutrition RCT protocols and study characteristics associated with adherence to SPIRIT and TIDieR reporting guidelines are unknown. We, therefore, assessed reporting completeness and its potential predictors in a random sample of published nutrition and diet-related RCT protocols.
METHODS: We conducted a meta-research study of 200 nutrition and diet-related RCT protocols published in 2019 and 2021 (aiming to consider periods before and after the start of the COVID pandemic). Data extraction included bibliometric information, general study characteristics, compliance with 122 questions corresponding to items and subitems in the SPIRIT and TIDieR checklists combined, and mention to these reporting guidelines in the publications. We calculated the proportion of protocols reporting each item and the frequency of items reported for each protocol. We investigated associations between selected publication aspects and reporting completeness using linear regression analysis.
RESULTS: The majority of protocols included adults and elderly as their study population (n = 73; 36.5%), supplementation as intervention (n = 96; 48.0%), placebo as comparator (n = 89; 44.5%), and evaluated clinical status as the outcome (n = 80; 40.0%). Most protocols described a parallel RCT (n = 188; 94.0%) with a superiority framework (n = 141; 70.5%). Overall reporting completeness was 52.0% (SD = 10.8%). Adherence to SPIRIT items ranged from 0% (n = 0) (data collection methods) to 98.5% (n = 197) (eligibility criteria). Adherence to TIDieR items ranged from 5.5% (n = 11) (materials used in the intervention) to 98.5% (n = 197) (description of the intervention). The multivariable regression analysis suggests that a higher number of authors [β = 0.53 (95%CI: 0.28-0.78)], most recent published protocols [β = 3.19 (95%CI: 0.24-6.14)], request of reporting guideline checklist during the submission process by the journal [β = 6.50 (95%CI: 2.56-10.43)] and mention of SPIRIT by the authors [β = 5.15 (95%CI: 2.44-7.86)] are related to higher reporting completeness scores.
CONCLUSIONS: Reporting completeness in a random sample of 200 diet or nutrition-related RCT protocols was low. Number of authors, year of publication, self-reported adherence to SPIRIT, and journals\' endorsement of reporting guidelines seem to be positively associated with reporting completeness in nutrition and diet-related RCT protocols.
METHODS: We conducted a meta-research study of 200 nutrition and diet-related RCT protocols published in 2019 and 2021 (aiming to consider periods before and after the start of the COVID pandemic). Data extraction included bibliometric information, general study characteristics, compliance with 122 questions corresponding to items and subitems in the SPIRIT and TIDieR checklists combined, and mention to these reporting guidelines in the publications. We calculated the proportion of protocols reporting each item and the frequency of items reported for each protocol. We investigated associations between selected publication aspects and reporting completeness using linear regression analysis.
RESULTS: The majority of protocols included adults and elderly as their study population (n = 73; 36.5%), supplementation as intervention (n = 96; 48.0%), placebo as comparator (n = 89; 44.5%), and evaluated clinical status as the outcome (n = 80; 40.0%). Most protocols described a parallel RCT (n = 188; 94.0%) with a superiority framework (n = 141; 70.5%). Overall reporting completeness was 52.0% (SD = 10.8%). Adherence to SPIRIT items ranged from 0% (n = 0) (data collection methods) to 98.5% (n = 197) (eligibility criteria). Adherence to TIDieR items ranged from 5.5% (n = 11) (materials used in the intervention) to 98.5% (n = 197) (description of the intervention). The multivariable regression analysis suggests that a higher number of authors [β = 0.53 (95%CI: 0.28-0.78)], most recent published protocols [β = 3.19 (95%CI: 0.24-6.14)], request of reporting guideline checklist during the submission process by the journal [β = 6.50 (95%CI: 2.56-10.43)] and mention of SPIRIT by the authors [β = 5.15 (95%CI: 2.44-7.86)] are related to higher reporting completeness scores.
CONCLUSIONS: Reporting completeness in a random sample of 200 diet or nutrition-related RCT protocols was low. Number of authors, year of publication, self-reported adherence to SPIRIT, and journals\' endorsement of reporting guidelines seem to be positively associated with reporting completeness in nutrition and diet-related RCT protocols.
摘要：
目的：有必要巩固营养随机对照试验（RCT）方案的报告指南。营养RCT方案的报告完整性和与遵守SPIRIT和TIDieR报告指南相关的研究特征未知。我们,因此,在已发表的营养和饮食相关RCT方案的随机样本中评估报告的完整性及其潜在预测因素。
方法：我们对2019年和2021年发布的200项与营养和饮食相关的RCT方案进行了荟萃研究（旨在考虑COVID大流行开始之前和之后的时期）。数据提取包括文献计量信息，一般研究特征，符合与SPIRIT和TIDieR清单中的项目和子项目相对应的122个问题，并在出版物中提及这些报告准则。我们计算了报告每个项目的协议的比例以及每个协议报告的项目的频率。我们使用线性回归分析研究了选定的出版方面与报告完整性之间的关联。
结果：大多数方案包括成年人和老年人作为他们的研究人群（n=73;36.5％），补充作为干预措施（n=96；48.0％），安慰剂作为比较物（n=89；44.5%），并评估临床状态作为结果（n=80；40.0％）。大多数方案描述了具有优势框架(n=141;70.5%)的平行RCT(n=188;94.0%)。总体报告完整性为52.0%(SD=10.8%)。对SPIRIT项目的依从性范围从0%(n=0)(数据收集方法)到98.5%(n=197)(合格标准)。对TIDieR项目的依从性范围从5.5％（n=11）（干预中使用的材料）到98.5％（n=197）（干预描述）。多元回归分析表明，作者数量较多[β=0.53(95CI：0.28-0.78)]，最新发布的协议[β=3.19（95CI：0.24-6.14）]，期刊[β=6.50(95CI:2.56-10.43)]在提交过程中要求报告指南清单和作者提到SPIRIT[β=5.15(95CI:2.44-7.86)]与较高的报告完整性评分相关.
结论：在200份饮食或营养相关RCT方案的随机样本中报告的完整性较低。作者数量,出版年份,自我报告对精神的坚持，和期刊对报告指南的认可似乎与营养和饮食相关RCT方案的报告完整性呈正相关。
方法：我们对2019年和2021年发布的200项与营养和饮食相关的RCT方案进行了荟萃研究（旨在考虑COVID大流行开始之前和之后的时期）。数据提取包括文献计量信息，一般研究特征，符合与SPIRIT和TIDieR清单中的项目和子项目相对应的122个问题，并在出版物中提及这些报告准则。我们计算了报告每个项目的协议的比例以及每个协议报告的项目的频率。我们使用线性回归分析研究了选定的出版方面与报告完整性之间的关联。
结果：大多数方案包括成年人和老年人作为他们的研究人群（n=73;36.5％），补充作为干预措施（n=96；48.0％），安慰剂作为比较物（n=89；44.5%），并评估临床状态作为结果（n=80；40.0％）。大多数方案描述了具有优势框架(n=141;70.5%)的平行RCT(n=188;94.0%)。总体报告完整性为52.0%(SD=10.8%)。对SPIRIT项目的依从性范围从0%(n=0)(数据收集方法)到98.5%(n=197)(合格标准)。对TIDieR项目的依从性范围从5.5％（n=11）（干预中使用的材料）到98.5％（n=197）（干预描述）。多元回归分析表明，作者数量较多[β=0.53(95CI：0.28-0.78)]，最新发布的协议[β=3.19（95CI：0.24-6.14）]，期刊[β=6.50(95CI:2.56-10.43)]在提交过程中要求报告指南清单和作者提到SPIRIT[β=5.15(95CI:2.44-7.86)]与较高的报告完整性评分相关.
结论：在200份饮食或营养相关RCT方案的随机样本中报告的完整性较低。作者数量,出版年份,自我报告对精神的坚持，和期刊对报告指南的认可似乎与营养和饮食相关RCT方案的报告完整性呈正相关。
