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在快速发展技术的卫生技术评估中,会议摘要和报告与全文文章的比较。

Comparison of conference abstracts and presentations with full-text articles in the health technology assessments of rapidly evolving technologies.

作者信息

Dundar Y, Dodd S, Dickson R, Walley T, Haycox A, Williamson P R

机构信息

Liverpool Reviews and Implementation Group, University of Liverpool, UK.

出版信息

Health Technol Assess. 2006 Feb;10(5):iii-iv, ix-145. doi: 10.3310/hta10050.

Abstract

OBJECTIVES

To assess the extent of use of data from conference abstracts and presentations in health technology assessments (HTAs) provided as part of the National Institute for Health and Clinical Excellence (NICE) appraisal process. Also to assess the methodological quality of trials from conference abstracts and presentations, the consistency of reporting major outcomes between these sources and subsequent full-length publications, the effect of inclusion or exclusion of data from these sources on the meta-analysis pooled effect estimates, and the timeliness of availability of data from these sources and full articles in relation to the development of technology assessment reviews (TARs).

DATA SOURCES

A survey of seven TAR groups. An audit of published TARs: included all NICE TARs published between January 2000 and October 2004. Case studies of selected TARs.

REVIEW METHODS

Analyses of the results of the survey and audit were presented as a descriptive summary and in a tabular format. Sensitivity analyses were carried out to compare the effect of inclusion of data from abstracts and presentations on the meta-analysis pooled effect estimates by including data from both abstracts/presentations and full papers, and data from only full publications, included in the original TAR. These analyses were then compared with meta-analysis of data from trials that have subsequently been published in full.

RESULTS

All seven TAR groups completed and returned the survey. Five out of seven groups reported a general policy that included searching for and including studies available as conference abstracts/presentations. Five groups responded that if they included data from these sources they would carry out methodological quality assessment of studies from these sources using the same assessment tools as for full publications, and manage the data from these sources in the same way as fully published reports. All groups reported that if relevant outcome data were reported in both an abstract/presentation and a full publication, they would only consider the data in the full publication. Conversely, if data were only available in conference abstract/presentation, all but two groups reported that they would extract and use the data from the abstract/presentation. In total, 63 HTA reports for NICE were identified. In 20 of 63 TARs (32%) explicit statements were made with regards to inclusion and assessment of data from abstracts/presentations. Thirty-eight (60%) identified at least one randomised controlled trial (RCT) available as a conference abstract or presentation. Of these, 26 (68%) included trials available as abstracts/presentations. About 80% (20/26) of the 26 TARs that included RCTs in abstract/presentation form carried out an assessment of the methodological quality of such trials. In 16 TARs full reports of these trials were used for quality assessment where both abstracts/presentations and subsequent full publications were available. Twenty-three of 63 TARs (37%) carried out a quantitative analysis of results. Of these, ten (43%) included trials that were available as abstracts/presentations in the review; however, only 60% (6/10) of these included data from abstracts/presentations in the data analysis of results. Thirteen TARs evaluated rapidly evolving technologies and only three of these identified and included trial data from conference abstracts/presentations and carried out a quantitative analysis where abstract/presentation data were used. These three TARs were used as case studies. In all three case studies the overall quality of reporting in abstracts/presentations was generally poor. In all case studies abstracts and presentations failed to describe the method of randomisation or allocation concealment. Overall, there was no mention of blinding in 66% (25/38) of the abstracts and in 26% (7/27) of the presentations included in case studies, and one presentation (4%) explicitly stated use of intention-to-treat analysis. Results from one case study demonstrated discrepancies in data made available in abstracts or online conference presentations. Not only were discrepancies evident between these sources, but also comparison of conference abstracts/presentations with subsequently published full-length articles demonstrates data discrepancies in reporting of results. Sensitivity analyses based on one case study indicated a change in significance of effect in two outcome measures when only full papers published to date were included.

CONCLUSIONS

There are variations in policy and practice across TAR groups regarding searching for and inclusion of studies available as conference abstracts/presentations. There is also variation in the level of detail reported in TARs regarding the use of abstracts/presentations. Therefore, TAR teams should be encouraged to state explicitly their search strategies for identifying conference abstracts and presentations, their methods for assessing these for inclusion, and where appropriate how the data were used and their effect on the results. Comprehensive searching for trials available as conference abstracts/presentations is time consuming and may be of questionable value. However, there may be a case for searching for and including abstract/presentation data if, for example, other sources of data are limited. If conference abstracts/presentations are to be included, the TAR teams need to allocate additional time for searching and managing data from these sources. Incomplete reporting in conference abstracts and presentations limits the ability of reviewers to assess confidently the methodological quality of trials. Where conference abstracts and presentations are considered for inclusion in the review, the TAR teams should increase their efforts to obtain further study details by contacting trialists. Where abstract/presentation data are included, reviewers should discuss the effect of including data from these sources. Any data discrepancies identified across sources in TARs should be highlighted and their impact discussed in the review. In addition, there is a need to carry out, for example, a sensitivity analysis with and without abstract/presentation data in the analysis. There is a need for research into the development of search strategies specific to identification of studies available as conference abstracts and presentations in TARs. Such strategies may include guidance with regard to identification of relevant electronic databases and appropriate conference sites relevant to certain clinical areas. As there are limited case studies included in this report, analyses should be repeated as more TARs accrue, or include the work of other international HTA groups.

摘要

目的

评估在作为英国国家卫生与临床优化研究所(NICE)评估流程一部分的卫生技术评估(HTA)中,会议摘要和报告中的数据使用程度。同时评估来自会议摘要和报告的试验的方法学质量、这些来源与后续全文出版物之间主要结果报告的一致性、纳入或排除这些来源的数据对荟萃分析合并效应估计值的影响,以及这些来源的数据和全文文章在技术评估综述(TAR)制定方面的可得及时性。

数据来源

对七个TAR小组进行的一项调查。已发表TAR的审核:包括2000年1月至2004年10月期间发表的所有NICE TAR。选定TAR的案例研究。

综述方法

以描述性总结和表格形式呈现调查和审核结果的分析。进行敏感性分析,通过纳入摘要/报告和全文的数据,以及仅纳入原始TAR中全文出版物的数据,比较纳入摘要和报告数据对荟萃分析合并效应估计值的影响。然后将这些分析与随后全文发表的试验数据的荟萃分析进行比较。

结果

所有七个TAR小组都完成并返回了调查。七个小组中有五个报告了一项总体政策,其中包括搜索并纳入以会议摘要/报告形式提供的研究。五个小组回应称,如果他们纳入这些来源的数据,他们将使用与全文出版物相同的评估工具对这些来源的研究进行方法学质量评估,并以与全文发表报告相同的方式管理这些来源的数据。所有小组都报告称,如果相关结果数据在摘要/报告和全文出版物中都有报告,他们只会考虑全文出版物中的数据。相反,如果数据仅在会议摘要/报告中可用,除两个小组外,所有小组都报告称他们将从摘要/报告中提取并使用这些数据。总共识别出63份NICE的HTA报告。在63份TAR中的20份(32%)中,就纳入和评估摘要/报告中的数据做出了明确说明。38份(60%)识别出至少一项可作为会议摘要或报告的随机对照试验(RCT)。其中,26份(68%)纳入了可作为摘要/报告的试验。在以摘要/报告形式纳入RCT的26份TAR中,约80%(20/26)对这类试验的方法学质量进行了评估。在16份TAR中,当摘要/报告和随后的全文出版物都可用时,使用这些试验报告的全文进行质量评估。63份TAR中的23份(37%)对结果进行了定量分析。其中,十份(43%)在综述中纳入了可作为摘要/报告的试验;然而,在这些试验中,只有60%(6/10)在结果数据分析中纳入了摘要/报告中的数据。13份TAR评估了快速发展的技术,其中只有三份识别并纳入了会议摘要/报告中的试验数据,并在使用摘要/报告数据时进行了定量分析。这三份TAR用作案例研究。在所有三个案例研究中,摘要/报告中的总体报告质量普遍较差。在所有案例研究中,摘要和报告均未描述随机化或分配隐藏方法。总体而言,在案例研究纳入的摘要中,66%(25/38)未提及盲法,在纳入的报告中,26%(7/27)未提及盲法,且有一份报告(4%)明确声明使用意向性分析。一个案例研究的结果表明,摘要或在线会议报告中提供的数据存在差异。这些来源之间不仅存在明显差异,而且会议摘要/报告与随后发表的全文文章在结果报告方面也存在数据差异。基于一个案例研究的敏感性分析表明,当仅纳入迄今为止发表的全文时,两个结果测量指标的效应显著性发生了变化。

结论

在搜索和纳入以会议摘要/报告形式提供的研究方面,各TAR小组的政策和实践存在差异。TAR在使用摘要/报告方面报告的详细程度也存在差异。因此,应鼓励TAR团队明确说明其识别会议摘要和报告的搜索策略及其纳入评估的方法,以及在适当情况下数据的使用方式及其对结果的影响。全面搜索以会议摘要/报告形式提供的试验耗时且价值可能存疑。然而,如果例如其他数据来源有限,则可能有理由搜索并纳入摘要/报告数据。如果要纳入会议摘要/报告,TAR团队需要分配额外时间来搜索和管理这些来源的数据。会议摘要和报告中的报告不完整,限制了评审人员自信评估试验方法学质量的能力。在考虑将会议摘要和报告纳入综述时,TAR团队应加大力度通过联系试验者获取进一步的研究细节。在纳入摘要/报告数据时,评审人员应讨论纳入这些来源数据的影响。在TAR中发现的不同来源之间的任何数据差异都应突出显示,并在综述中讨论其影响。此外例如在分析中需要进行有或没有摘要/报告数据的敏感性分析。有必要开展研究,制定专门用于识别TAR中以会议摘要和报告形式提供的研究的搜索策略。此类策略可能包括关于识别相关电子数据库和与某些临床领域相关的适当会议网站的指南。由于本报告纳入的案例研究有限,应随着更多TAR的积累重复进行分析,或纳入其他国际HTA小组的工作。

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