GENERAL ORTHOPAEDICS
Randomised controlled trials in plastic surgery: a systematic review of reporting quality
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(9):11 Eur J Plast Surg. 2014;37:55-62. Epub 2013 Oct 30.57 randomized controlled trials (RCTs) pertaining to plastic surgery research (from 28 journals) were included in this systematic review. The purpose of this study was to determine the overall reporting quality among these RCTs. Results indicated that the median CONSORT score was low (11.5/23), however there is a general trend of improvement over time. There was no correlation between CONSORT score and either the number of authors (Spearman rho=0.12), the journal's impact factor (Spearman rho=0.26) or the geographical origin of the RCT.
Were the search methods used to find evidence (original research) on the primary question or questions stated?
Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?
Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?
Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?
Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?
How would you rate the scientific quality of this evidence?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
3/4
Introduction
4/4
Accessing Data
3/4
Analysing Data
2/4
Results
3/4
Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
In 2008, The Consolidated Standards of Reporting Trials (CONSORT) guidelines for non-pharmacological interventions were released to improve and standardize reporting among randomized controlled trials in the literature. It has previously been found that, among randomized controlled trials in the field of plastic surgery, there is room for improvement in regards to methodological quality. However, to date, reporting quality among plastic surgery research papers has not yet been systematically reviewed, emphasizing the need for this study.
主な研究課題は何ですか？
What is the overall reporting quality among randomized controlled trials in plastic surgery research?
重要な知見は？
- 57 randomized controlled trials from 28 journals were included in this review. Among these RCTs, 7 were multi-centre studies.
- The median CONSORT score was 11.5/23 (range: 4.5-21.0), with a Kappa score of 0.80.
- Median consort scores were 9.9 in 2009, 11.5 in 2010 and 12.9 in 2011, displaying a trend towards improvement in overall reporting quality over time.
- Compliance for the standard CONSORT criteria were lowest for intervention/comparison details (7%), randomization (11%) and blinding (26%).
- In regards to additional CONSORT criteria, 61% of studies stated potential conflict of interest, 75% reported details regarding ethical approval, 47% reported sources of funding, and 16% identified a trial registry number.
- There was no correlation between CONSORT score and either the number of authors (Spearman rho=0.12), the journal's impact factor (Spearman rho=0.26) or the geographical origin of the RCT.
最も覚えておくべきことは？
In general, reporting quality was poor (11.5/23) among randomized controlled trials pertaining to plastic surgery, however there is a general trend of improvement over time. There was no correlation between CONSORT score and either the number of authors (Spearman rho=0.12), the journal's impact factor (Spearman rho=0.26) or the geographical origin of the RCT.
それが私の患者ケアにどのように影響するか？
The results from this study suggest that, although there are improvements as time goes on, researchers in the field of plastic surgery should focus on improving the reporting quality of their future studies according to the CONSORT guidelines. As this systematic review only included publications written in English and only up to 2011, additional systematic reviews are needed to monitor any improvement in reporting quality (or lack thereof).
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