Appendix A — 報告ガイドライン

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A.1 キーワード

論文を書く際には、一般的なガイドラインやジャーナルごとのガイドラインがありました。

臨床研究では、これらに加えて、研究デザインごとのガイドラインが策定されています。

研究デザイン	ガイドライン
システマティックレビューメタアナリシス	PRISMA
ランダム化比較試験	CONSORT
非ランダム化比較試験	TREND
分析疫学的研究	STROBE

A.2 Summary

Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study’s generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September, 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed explanation and elaboration document is published separately and is freely available on the websites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE statement will contribute to improving the quality of reporting of observational studies.

A.3 Introduction

Many questions in medical research are investigated in observational studies.\(^1\) Much of the research into the cause of diseases relies on cohort, case-control, or cross-sectional studies. Observational studies also have a role in research into the benefits and harms of medical interventions.\(^2\) Randomised trials cannot answer all important questions about a given intervention. For example, observational studies are more suitable to detect rare or late adverse effects of treatments, and are more likely to provide an indication of what is achieved in daily medical practice.\(^3\)

観察研究: 治療のまれな副作用や遅発性の副作用を検出するのにより適している

コホート研究 cohort studies
症例対照研究 case-control studies
横断研究 cross-sectional studies

Research should be reported transparently so that readers can follow what was planned, what was done, what was found, and what conclusions were drawn. The credibility of research depends on a critical assessment by others of the strengths and weaknesses in study design, conduct, and analysis. Transparent reporting is also needed to judge whether and how results can be included in systematic reviews.\(^{4,5}\) However, in published observational research important information is often missing or unclear. An analysis of epidemiological studies published in general medical and specialist journals found that the rationale behind the choice of potential confounding variables was often not reported.\(^6\) Only a few reports of case-control studies in psychiatry explained the methods used to identify cases and controls.\(^7\) In a survey of longitudinal studies in stroke research, 17 of 49 articles (35%) did not specify the eligibility criteria.\(^8\) Others have argued that without sufficient clarity of reporting, the benefits of research might be achieved more slowly,9 and that there is a need for guidance in reporting observational studies.\(^{10,11}\)

透明性のある報告が必要

だが、実際は

潜在的な交絡変数の選択の背後にある理論的根拠が報告されていない
症例と対照を特定するために使用される方法が説明されていない
適格基準が指定されていない

Recommendations on the reporting of research can improve reporting quality. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed in 1996 and revised 5 years later.\(^{12}\) Many medical journals supported this initiative,\(^{13}\) which has helped to improve the quality of reports of randomised trials.\(^{14,15}\) Similar initiatives have followed for other research areas—eg, for the reporting of meta-analyses of randomised trials\(^{16}\) or diagnostic studies.\(^{17}\) We established a network of methodologists, researchers, and journal editors to develop recommendations for the reporting of observational research: the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement.

RCT のガイドラインは成功している
メタ分析などほかの分野でもある
本ドキュメントは、疫学における観察研究の報告の強化 (STROBE) ステートメント

A.4 Aims and use of the STROBE statement

The STROBE statement is a checklist of items that should be addressed in articles reporting on the three main study designs of analytical epidemiology: cohort, case-control, and cross-sectional studies. The intention is solely to provide guidance on how to report observational research well: these recommendations are not prescriptions for designing or conducting studies. Also, while clarity of reporting is a prerequisite to evaluation, the checklist is not an instrument to evaluate the quality of observational research.

主要な研究デザインについて報告する記事で取り上げるべき項目のチェックリスト

Here we present the STROBE statement and explain how it was developed. In a detailed companion paper, the explanation and elaboration article,\(^{18,19,20}\) we justify the inclusion of the different checklist items and give methodological background and published examples of what we consider transparent reporting. We strongly recommend using the STROBE checklist in conjunction with the explanatory article, which is available freely on the websites of PLoS Medicine (www.plosmedicine.org), Annals of Internal Medicine (www.annals.org), and Epidemiology (www.epidem.com).

PLoS Medicine、Annals of Internal Medicine、Epidemiology に説明記事がある

A.5 Development of the STROBE statement

We established the STROBE initiative in 2004, obtained funding for a workshop, and set up a website (www.strobe-statement.org). We searched textbooks, bibliographic databases, reference lists, and personal files for relevant material, including previous recommendations, empirical studies of reporting, and articles describing relevant methodological research. Because observational research makes use of many different study designs, we felt that the scope of STROBE had to be clearly defined early on. We decided to focus on the three study designs that are used most widely in analytical observational research: cohort, case-control, and cross-sectional studies.

2004年に立ち上げられた

We organised a 2-day workshop in Bristol, UK, in September, 2004. 23 individuals attended this meeting, including editorial staff from Annals of Internal Medicine, BMJ, Bulletin of the World Health Organization, International Journal of Epidemiology, JAMA, Preventive Medicine, and The Lancet, as well as epidemiologists, methodologists, statisticians, and practitioners from Europe and North America. Written contributions were sought from ten other individuals who declared an interest in contributing to STROBE, but could not attend. Three working groups identified items deemed to be important to include in checklists for each type of study. A provisional list of items prepared in advance (available from our website) was used to facilitate discussions. The three draft checklists were then discussed by all participants and, where possible, items were revised to make them applicable to all three study designs. In a final plenary session, the group decided on the strategy for finalising and disseminating the STROBE statement.

英国 Bristole で２日間のワークショップ
３つの研究デザインごとに項目を作成

After the workshop we drafted a combined checklist including all three designs and made it available on our website. We invited participants and additional scientists and editors to comment on this draft checklist. We subsequently published three revisions on the website, and two summaries of comments received and changes made. During this process the coordinating group (ie, the authors of the present paper) met on eight occasions for 1 or 2 days and held several telephone conferences to revise the checklist and to prepare the present paper and the explanation and elaboration paper.\(^{18,19,20}\) The coordinating group invited three additional co-authors with methodological and editorial expertise to help write the explanation and elaboration paper, and sought feedback from more than 30 people, who are listed at the end of this paper. We allowed several weeks for comments on subsequent drafts of the paper and reminded collaborators about deadlines by e-mail.

８回の会議と数回の電話会議で改定
30 人以上からフィードバック

A.6 STROBE components

The STROBE statement is a checklist of 22 items that we consider essential for good reporting of observational studies (table). These items relate to the article’s title and abstract (item 1), the introduction (items 2 and 3), methods (items 4–12), results (items 13–17), and discussion sections (items 18–21), and other information (item 22 on funding). 18 items are common to all three designs, while four (items 6, 12, 14, and 15) are design-specific, with different versions for all or part of the item. For some items (indicated by asterisks), information should be given separately for cases and controls in case-control studies, or exposed and unexposed groups in cohort and cross-sectional studies. Although presented here as a single checklist, separate checklists are available for each of the three study designs on the STROBE website.

項目数は 22

記事のタイトルと要約 (項目 1)
Introduction (項目 2 と 3)
Methods (項目 4 ～ 12)
Results (項目 13 ～ 17)
Discussion (項目 18 ～ 21)
その他の情報（資金調達に関する項目 22）

表

A.7 Implications and limitations

The STROBE statement was developed to assist authors when writing up analytical observational studies, to support editors and reviewers when considering such articles for publication, and to help readers when critically appraising published articles. We developed the checklist through an open process, taking into account the experience gained with previous initiatives, in particular CONSORT. We reviewed the relevant empirical evidence as well as methodological work, and subjected consecutive drafts to an extensive iterative process of consultation. The checklist presented here is thus based on input from a large number of individuals with diverse backgrounds and perspectives. The comprehensive explanatory article,\(^{18,19,20}\) which is intended for use alongside the checklist, also benefited greatly from this consultation process.

CONSORT で得られた経験を考慮して、オープンなプロセスを通じてチェックリストを作成
さまざまな背景と視点を持つ多数の個人からインプット

Observational studies serve a wide range of purposes, on a continuum from the discovery of new findings to the confirmation or refutation of previous findings.\(^{18,19,20}\) Some studies are essentially exploratory and raise interesting hypotheses. Others pursue clearly defined hypotheses in available data. In yet another type of studies, the collection of new data is planned carefully on the basis of an existing hypothesis. We believe the present checklist can be useful for all these studies, since the readers always need to know what was planned (and what was not), what was done, what was found, and what the results mean. We acknowledge that STROBE is currently limited to three main observational study designs. We would welcome extensions that adapt the checklist to other designs—eg, case-crossover studies or ecological studies—and also to specific topic areas. Four extensions are now available for the CONSORT statement.\(^{21,22,23,24}\) A first extension to STROBE is underway for gene-disease association studies: the STROBE Extension to Genetic Association studies (STREGA) initiative.\(^{25}\) We ask those who aim to develop extensions of the STROBE statement to contact the coordinating group first to avoid duplication of effort.

観察研究は、

本質的に探索的であり、興味深い仮説を立てていることもある
既存の仮説に基づいて、新しいデータの収集が慎重に計画されることもある

限界

３つの主要な研究デザイン
ケースクロスオーバー研究や生態学的研究には対応していない

The STROBE statement should not be interpreted as an attempt to prescribe the reporting of observational research in a rigid format. The checklist items should be addressed in sufficient detail and with clarity somewhere in an article, but the order and format for presenting information depends on author preferences, journal style, and the traditions of the research field. For instance, we discuss the reporting of results under a number of separate items, while recognising that authors might address several items within a single section of text or in a table. Also, item 22, on the source of funding and the role of funders, could be addressed in an appendix or in the methods section of the article. We do not aim at standardising reporting. Authors of randomised clinical trials were asked by an editor of a specialist medical journal to “CONSORT” their manuscripts on submission.26 We believe that manuscripts should not be “STROBEd”, in the sense of regulating style or terminology. We encourage authors to use narrative elements, including the description of illustrative cases, to complement the essential information about their study, and to make their articles an interesting read.\(^{27}\)

STROBE の形式に厳密に従う必要はない
論文中のどこかに係れていればよい

We emphasise that the STROBE statement was not developed as a tool for assessing the quality of published observational research. Such instruments have been developed by other groups and were the subject of a recent systematic review.28 In the explanation and elaboration paper, we used several examples of good reporting from studies whose results were not confirmed in further research—the important feature was the good reporting, not whether the research was of good quality. However, if STROBE is adopted by authors and journals, issues such as confounding, bias, and generalisability could become more transparent, which might help temper the over-enthusiastic reporting of new findings in the scientific community and popular media,29 and improve the methodology of studies in the long term. Better reporting may also help to have more informed decisions about when new studies are needed, and what they should address.

STROBE は、観察研究の質を評価するためのツールではない (PRISIMA とは異なり)
STROBE を採用すれば、交絡、バイアス、一般化可能性などの問題がより明確になる

We did not undertake a comprehensive systematic review for each of the checklist items and subitems, or do our own research to fill gaps in the evidence base. Further, although no one was excluded from the process, the composition of the group of contributors was influenced by existing networks and was not representative in terms of geography (it was dominated by contributors from Europe and North America) and probably was not representative in terms of research interests and disciplines. We stress that STROBE and other recommendations on the reporting of research should be seen as evolving documents that require continual assessment, refinement, and, if necessary, change. We welcome suggestions for the further dissemination of STROBE—eg, by re-publication of the present article in specialist journals and in journals published in other languages. Groups or individuals who intend to translate the checklist to other languages should consult the coordinating group beforehand. We will revise the checklist in the future, taking into account comments, criticism, new evidence, and experience from its use. We invite readers to submit their comments via the STROBE website.

チェックリスト項目について包括的な体系的なレビューを行っていない
ヨーロッパと北アメリカからの寄稿者が大半