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Investigating the rigour of research findings in experimental studies assessing the effects of breaking up prolonged sitting - extended scoping review.

调查实验研究中研究结果的严谨性,评估打破长时间坐着的影响-扩展范围审查。

  • 影响因子:0
  • DOI:10.1016/j.bjpt.2020.04.007
  • 作者列表:"English C","Weerasekara I","Carlos A","Chastin S","Crowfoot G","Fitzsimons C","Forster A","Holliday E","Janssen H","Mackie P","Mead G","Dunstan D
  • 发表时间:2021-01-01
Abstract

OBJECTIVES:Sedentary behaviour research is a relatively new field, much of which has emerged since the widespread acceptance of clinical trial registration. The aim of this study was to investigate the trial registration and related issues in studies investigating the effect of frequent activity interruptions to prolonged sitting-time. METHODS:Secondary analysis of a scoping review including systematic searches of databases and trial registries. We included experimental studies investigating the effects of frequent activity interruptions to prolonged sitting-time. RESULTS:We identified 32 trials published in 45 papers. Only 16 (50%) trials were registered, with all 16 trials being completed and published. Of the unregistered trials, we identified three (19%) for which similarities in the sample size and participant demographics across papers was suggestive of duplicate publication. Identification of potential duplicate publications was difficult for the remaining 13 (81%). Results from 53 (76%) of the 70 registered outcomes were published, but 11 (69%) registered trials reported results from additional outcomes not prospectively registered. A total of 46 different outcomes (out of 53 reported outcome measures, similar measures were collated) were reported across all trials, 31 (67%) of which were collected in ≤2 trials. CONCLUSIONS:We found direct evidence of trial registration issues in experimental trials of breaking up sitting-time. The lack of prospective registration of all trials, and the large number of outcomes measured per trial are key considerations for future research in this field. These issues are unlikely to be confined to the field of sedentary behaviour research.

摘要

目的: 久坐行为研究是一个相对较新的领域,其中大部分是在广泛接受临床试验注册后出现的。本研究的目的是调查研究频繁活动中断对长时间坐着的影响的试验注册和相关问题。 方法: 对范围审查的二次分析,包括对数据库和试验注册系统的搜索。我们纳入了调查频繁活动中断对久坐时间影响的实验研究。 结果: 我们确定了发表在45篇论文中的32项试验。只有16项 (50%) 试验被注册,所有16项试验都已完成并发表。在未注册的试验中,我们发现了三个 (19%) 在样本量和参与者人口统计学方面的相似性暗示了重复发表。其余13人 (81%) 很难确定潜在的重复出版物。发表了70项注册结局中的53项 (76%) 的结果,但11项 (69%) 注册试验报告了未前瞻性注册的其他结局的结果。在所有试验中,共报告了46项不同的结局 (在53项报告的结局指标中,收集了相似的指标),其中31项 (67%) 在 ≤ 2项试验中收集. 结论: 我们在打破坐位时间的实验试验中发现了试验注册问题的直接证据。缺乏所有试验的前瞻性登记,以及每个试验测量的大量结局是该领域未来研究的关键考虑因素。这些问题不太可能局限于久坐行为研究领域。

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METHODS:BACKGROUND:Cholinergic neurotransmission regulates neuroinflammation in Parkinson disease (PD). RESEARCH DESIGN AND METHODS:The authors conducted a delayed-start study of donepezil for cognitive decline in non-demented PD patients. The study consisted of a 96-week randomized placebo-controlled double-blind phase 1, followed by a 24-week donepezil extension phase 2. The primary outcome measure was a change in the Mini-Mental State Examination (MMSE) at week 120. RESULTS:A total of 98 patients were randomly allocated to the early-start (donepezil-to-donepezil) and delayed-start (placebo-to-donepezil) groups. Mean (SD) of the baseline MMSE was 27.6 (2.0) and 28.0 (2.1), respectively. MMSE change at week 120 was better in the early-start group than in the delayed-start group, but the difference was not significant. The MMSE declined in apolipoprotein ε4 carriers, but not in non-carriers, and the factor interaction (intervention × ε4 genotype) was highly significant (P < 0.001). Analyzed with the interaction, the difference was significant (group difference 1.95 [0.33 to 3.57], P = 0.018). The MMSE decline slope in phase 1 was significantly better in the early-start group than in the delayed-start group (P = 0.048). CONCLUSIONS:Cognitive function deteriorated in ε4 carriers, but not in non-carriers, and early-start donepezil may postpone cognitive decline in the former.

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