Standardized study performance, quality assurance, and quality control in a cluster-randomized trial: the Pneumococcal Vaccine Schedules trial.

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Trials Pub Date : 2024-12-18 DOI:10.1186/s13063-024-08677-7
Isaac Osei, Benjamin Young, Golam Sarwar, Yekini A Olatunji, Ilias Hossain, Babila G Lobga, Baleng M Wutor, Williams Adefila, Emmanuel Mendy, Banjo Adeshola, Yasir Shitu Isa, Yusuf A Olawale, Keita M Lamin, Ebrimah Nyimanta, Bubacarr Baldeh, Abdoullah Nyassi, Momodou M Drammeh, Barjo Ousman, Minteh Molfa, Rasheed Salaudeen, Grant A Mackenzie
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引用次数: 0

Abstract

Randomized controlled trials are considered the "gold standard" for evaluating the effectiveness of an intervention. However, large-scale, cluster-randomized trials are complex and costly to implement. The generation of accurate, reliable, and high-quality data is essential to ensure the validity and generalizability of findings. Robust quality assurance and quality control procedures are important to optimize and validate the quality, accuracy, and reliability of trial data. To date, few studies have reported on study procedures to assess and optimize data integrity during the implementation of large cluster-randomized trials. The dearth of literature on these methods of trial implementation may contribute to questions about the quality of data collected in clinical trials. Trial protocols should consider the inclusion of quality assurance indicators and targets for implementation. Publishing quality assurance and control measures implemented in clinical trials should increase public trust in the findings from such studies. In this manuscript, we describe the development and implementation of internal and external quality assurance and control procedures and metrics in the Pneumococcal Vaccine Schedules trial currently ongoing in rural Gambia. This manuscript focuses on procedures and metrics to optimize trial implementation and validate clinical, laboratory, and field data. We used a mixture of procedure repetition, supervisory visits, checklists, data cleaning and verification methods and used the metrics to drive process improvement in all domains.

群随机试验中的标准化研究表现、质量保证和质量控制:肺炎球菌疫苗计划试验。
随机对照试验被认为是评估干预措施有效性的“黄金标准”。然而,大规模的集群随机试验是复杂和昂贵的实施。生成准确、可靠和高质量的数据对于确保研究结果的有效性和普遍性至关重要。健全的质量保证和质量控制程序对于优化和验证试验数据的质量、准确性和可靠性非常重要。迄今为止,很少有研究报道在实施大型集群随机试验期间评估和优化数据完整性的研究程序。关于这些试验实施方法的文献的缺乏可能会导致有关临床试验中收集的数据质量的问题。试验方案应考虑纳入质量保证指标和实施目标。发表临床试验中实施的质量保证和控制措施应增加公众对这类研究结果的信任。在本文中,我们描述了目前正在冈比亚农村进行的肺炎球菌疫苗计划试验中内部和外部质量保证和控制程序和指标的发展和实施。这份手稿的重点是程序和指标,以优化试验实施和验证临床,实验室和现场数据。我们混合使用程序重复、监督访问、检查表、数据清理和验证方法,并使用度量来推动所有领域的过程改进。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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