Once your title is registered, the first part of the review process is to write a protocol. The protocol includes two important components: planning the eligibility criteria for the review (that is, which studies will be included and excluded), and planning out the methods we plan to use throughout the review process. The protocols for Cochrane reviews are published in The Cochrane Library before we proceed with the review.
So why do we write and publish a protocol in advance of the review?
Systematic reviews are a retrospective piece of research – the results of the studies we include in the review are in theory already available when we start to plan. As we make our decisions about the review methods – the focus of our question, the eligibility criteria for reviews, the outcomes we plan to report – it’s important that we’re not making decisions based on the known results of existing studies. It’s important that we don’t introduce bias to the review process, and risk presenting an inaccurate or biased picture of the evidence. So, one of the ways we try to address this is to plan and document our methods for the review in advance, before we’ve looked at the included studies, and to make them publicly available, published in The Cochrane Library, so that others can see what we’re planning to do and hold us accountable if we make changes along the way that might have been influenced inappropriately. This increases the transparency of the methods we’re using, and as an added benefit, Cochrane protocols are peer reviewed at this stage, so that authors receive feedback on their planned methods at an early stage, when it’s easy to implement changes, rather than waiting until the whole review is complete. Other benefits include reducing duplication – others can see the details of reviews in progress, and won’t start working on a similar review topic. As authors, the protocol has the very practical benefit of helping you plan out the tasks and resources required for the review process – it makes sure you’ve really though through the protocol in detail, and can anticipate any difficulties in advance.
So what does a Cochrane protocol look like?
Cochrane protocols have a standard format, helping readers find what they’re looking for quickly. In The Cochrane Library, the standard structure is displayed on the left hand side of the screen, helping readers navigate. ASK: Has anyone read a protocol in The Cochrane Library? The best way to find out what a protocol should look like is to find some recently published protocols from your Review Group in The Cochrane Library, and get to know them.
The standard format is also designed to help authors with the review. This is a screen shot from RevMan, the software used to write Cochrane reviews. You can see here the structure clearly outlined for authors to work through. The sections relevant to protocols are highlighted in blue, while those not needed until writing a full review are in grey. All you need to do is work through and write the text required under each heading, like you would in a Word Processor. You can see that the sections are mostly the same as you would write for any research paper, starting with some basic in information about the Protocol like the author details, then a Background, and moving through to a Methods section. There are also some details such as acknowledgments, contributions of the authors, and declarations of possible conflicts of interest. When you’re finished, the protocol file will form the basis of your review - you will in effect have written your review up to the end of the Methods Section. Each section has some subheadings – some are mandatory, and some you will be able to switch on and off, and it is possible to add your own subheadings if you choose. Let’s have a look at each section in more detail.
Authors must meet these minimum criteria, and declare that they have made a substantial contribution to the review. The specific contributions of each author are recorded in the ‘Contribution of authors’ section of the protocol (and the final published review). Others who have contributed to the review, but who don’t meet the criteria for authors, should be noted in the Acknowledgements section. Authors are usually individuals, but if you have a research group you’d like to list as an author, you can do that. The authors should be listed in order of their contribution – so the first author is the one who contributed the most to the review, and the last author contributed the least. The authors’ institutional affiliations will be published in the protocol, so make sure these details are correct. These details are stored by your Review Group in our central database, Archie – if the details are not correct, contact youre Review Group to have them updated in the database.
As well as listing all the authors, you will be asked to nominate a Contact Person. This is the person who will take chief responsibility for communicating with the Review Group and organising the review team throughout the process. This person is usually an author, but does not have to be. Once the protocol is complete, the contact person’s details will be published with the protocol, becoming the contact author for any feedback on the protocol. An added benefit of taking on this role is that when the complete review is published, the contact person will receive a complimentary personal subcription to The Cochrane Library.
Now we come to the text of the protocol. Throughout the protocol, it’s important that you write in accessible language – remember that your audience may not be experts in this field, they may not be health professionals or researchers at all, so try to avoid using technical jargon. A protocol is always written in the future tense, e.g. “we will do this...”, and use the active voice, e.g. “we will search” not “the literature will be searched”. A crucial resource for your review is the Cochrane Style Guide. This guide is designed to make it easy to write and copy edit your review in line with our house style. We strongly recommend that you consult the Style Guide – it has helpful advice on terminology and spelling, references, formatting, etc. If you submit your draft and it’s not consistent with the Sryle Guide, the CRG may simply send it back to you until it has been corrected.
The Background should be like the Background for any other research paper: it should put this study in the context of what we already know, and the questions we want to answer. The Background should include: a description of condition: biology, diagnosis, prognosis, prevalence or incidence, impact on affected people or communities a description of intervention: in the context of standard or alternative interventions for drugs – pharmacology, dosage, metabolism, selective effects, half-life, duration, interactions with other drugs for complex interventions – description of components how intervention might work: theoretical reasoning, empirical evidence to support reasoning why it’s important to do the review: brief statement of the rationale – e.g. to bring together evidence settle uncertainty.
Once you have prepared the background, you will have a good idea about the important questions that need to be answered by this. The objectives really are the questions you want to have answered. Generally this is framed as a single sentence, derived from your question as stated in your review title. If you have key additional outcomes, for example to explore effects in specific participant groups or compare specific alternative interventions, you may state them here, but you should not try to outline all your planned analyses and explorations here – there will be plenty of space to do that in the Methods section.
The Methods section is where we set out in detail our plans for the review. As we mentioned, this is designed to minimise bias in our decision-making later on, once we have the results of the included studies. It’s also a very valuable way to plan out your tasks, and you can begin to allocate work within your team, and get a good idea of how long each part of the process will take. Make sure you describe your planned methods in enough detail so that someone else could follow the steps and replicate them if they wanted to. After all, you will need to follow these steps yourself when you begin working on the complete review. At every stage, we want to make sure we’re selecting the best possible methods to give us reliable answers for decision-making. That’s why we consult the Cochrane Handbook, and it’s guidance based on the latest methodological research. You should also consult your Review Group – they may have guidance on preferred methods, and they may even have a template for the text of your protocol for you to follow. If not, look at some other examples of recently published protocols from your Review Group. One final note: always write your protocol as if you will find enough studies to give you all the information you need to conduct all the measurements and analyses you’d like. Even if you suspect there are not many published studies in your field, don’t censor your protocol by assuming you won’t find any. You might find more studies than you think, but even if you don’t, future updates might find more studies, and the methods outlined in your protocol should be a useful plan of action in that case.
The Methods are broken down into a number of sections: the eligibility criteria, where you will define which studies will be included and excluded from the review. the outcomes you plan to report on how you will conduct your literature search to identify included studies how you will collect data from your included studies how you will critically appraise your included studies for possible biases how you will conducted your analysis of the results how you will summarise and report the findings of your results, including standard Cochrane formats such as ‘Summary of Findings’ tables. Each of these sections will be covered in detail in separate sessions in this workshop.
When you have finished writing the methods, there are a few minor details to be completed before your protocol is ready for submission. You will need to make sure that your references are completed. RevMan will keep a list of all your references, and allow you to link to them in the text of the protocol. RevMan keeps two kinds of references: references to studies – these are the references to the included and excluded studies in your review. At the protocol you won’t have any of these, and these sections will be empty. other references – this is where all the references for your protocol should be listed, e.g. those used in the Background or Methods section.
There is an acknowledgements section for you to recognise additional contributors to the protocol. The contributions of authors section should include a specific description of how each author has contributed to the protocol – again, this is to ensure transparency, and demonstrate that all the named authors have contributed, and that all the contributors have been named. The declarations of interest section allows you to declare any present or past involvement with any organisation or activity that could constitute an actual or perceived conflict of interest. If there are no known conflicts of interest, state “None known”. In addition, a complete list of all your sources of support should also be provided for each author in the review, whether or not they constitute a conflict, including specific funding for the project, support in the form of salary, and any in-kind support. Sources of support are divided into “internal” (from the institution(s) at which the review was produced), and external (provided by other organisations). Most authors should at least list the source of their salary (unless they are explicitly working on the review in their own time, outside the scope of their paid job). Finally, you can add any additional tables or appendices, if you have any at the protocol stage. For example, if your review is on herbal medicines, you may wish to include a table to describe the different names and components of the herbs you plan to investigate in the review, if these are too complex to describe completely in the Background.
There are some final checks you should do before submitting your protocol. First, make sure you’ve run a spell check. Next to the spell check button in RevMan is another button called a Validity check – that will make sure you’ve filled in all the details you need to, and let you know of anything you need to fix. Your CRG may also have provided you with a checklist to complete before submission – if so, make sure you do so, to make sure your protocol is in good shape and ready for editorial review. Then, you can go ahead and submit your draft. Although each Review Group may have slightly different editorial processes, it’s likely that the first step will be internal review by one or more of the Review Group’s editors, and you may get comments back at this stage that you will be expected to address. When the Review Group is happy, the draft will go out for external peer review, and your draft may also be seen by a consumer referee, a statistical editor and others at this stage. Although the Review Group will work to make sure this process goes smoothly, it can take some time. You will need to be patient, and respond as quickly as you can when asked to address comments from the editors and referees. It’s worth being patient at this point – you don’t want to rush ahead and start working on the review. If your methods had to change in response to editorial feedback, you would need to go back and start over again. As soon as they can, the Review Group will let you know that the protocol has been approved for publication, and at that point you can go ahead and begin work. Once the draft has been approved, it will be published in The Cochrane Library within 2 months.
Writing a protocol - Korean
연구계획서 작성Writing a protocol
코크란 체계적 문헌고찰의 과정Steps of a Cochrane systematic review1. 연구질문 설정 연구주제 등2. 선정기준 작성 록3. 연구방법 계획 연구계획서 출4. 연구자료 ( 원자료 ) 검색 판5. 선정 기준 적용6. 자료 추출7. 분석 대상 연구들의 비뚤림 위험 평가8. 결과 분석 및 제시9. 분석 결과 해석 및 결론 도출10. 문헌고찰 개선 및 주기적 갱신 cochrane training
개요 Outline• 연구계획서 작성의 논리적 근거• 코크란 체계적 문헌고찰 연구계획서의 구조 See Chapter 2 of the Handbook cochrane training
연구계획서 작성의 논리적 근거 Rationale for protocols• 체계적 문헌고찰 시 , 판단이 개입됨 • 예 ) 연구질문 정의 , 선정기준 및 평가도구 결정 등 • 문헌고찰은 후향적 연구임 – 기존 연구결과에 의해 판 단이 좌우되어서는 안 됨 .• 연구방법을 미리 결정하고 문서화함 • 비뚤림의 영향을 줄임 • 동료 평가 를 가능하게 함 • 동일 / 유사한 문헌고찰의 중복 수행을 방지함 • 업무분담 계획을 수립하고 자원을 알맞게 배분함 • The Cochrane Library 에 출판 cochrane training
개요 Outline• 연구계획서 작성의 논리적 근거• 코크란 체계적 문헌고찰 연구계획서의 구조 See Chapter 4 of the Handbook cochrane training
저자 Authors• 다음의 업무에 충분한 공헌도가 있어야 함 • 문헌고찰 착안 및 설계 , 혹은 자료의 분석 및 해석 • 리뷰 초안 작성 및 학술적 내용에 대한 중요한 자문 제 공 • 연구계획서 및 문헌고찰 출판본의 최종 검토 및 승인• ‘ 저자 공헌도’ ‘ Contribution of authors’ 항목에 세부 참여 내 용을 기재함• 개인 , 단체 명의 사용 또는 둘 다 가능• 공헌도에 따라 저자 순서 결정• 저자의 소속기관 역시 출판내용에 포함됨 cochrane training
교신 담당자 Contact person• 주로 아래 책임이 있음 • 리뷰 연구진 구성 • CRG 와 연락 담당 • 협의한 일정대로 연구가 진행되는지 점검 • 완성된 연구계획서 (protocol) 및 문헌고찰의 투고 • 공저자들에게 및 CRG 의 기타 연락사항 전달 • 문헌고찰 갱신을 위한 준비사항 총괄 ( 문헌고찰 갱신 을 위한 공저자 확보 및 업무분담 , 갱신 일정 관리 등 )• 반드시 저자 중 한 명일 필요는 없음• 모든 연락처 정보가 출판될 것임 cochrane training
연구계획서 작성 Writing your protocol• 평이한 용어를 사용할 것 • 해당 분야의 비전문가도 쉽게 읽고 이해할 수 있도록 작 성• 미래형 시제 , 능동형 구문 사용• Cochrane Style Guide 참조 • www.cochrane.org/training/authors-mes/cochrane-style-guide • 용어 , 통계 , 철자 , 참고문헌 , 형식등 cochrane training
배경 Background• 기존 지식체계의 맥락 내에서 리뷰를 시작할 것 • 리뷰 대상 질환 / 상태 및 그 중요성에 대해 기술함 • 치료 / 중재 기술에 대해 기술함 • 치료 / 중재 기술의 작용원리에 대해 기술함 • 해당 리뷰의 수행이 중요한 이유 cochrane training
목적 Objectives• 일차적 목적을 명확하게 기술할 것• 대체로 한 문장임• 아래에 따라 특정 목적을 부가할 수도 있음 • 상이한 인구집단 • 상이한 치료 / 중재법 비교 • 상이한 평가도구[ 특정 인구집단 , 질환군 혹은 증상 및 환경 ( 필요시 )] 에서 [ 해당 건강 문제 ] 에 대한 [ 치료 / 중재및 대조군 ] 의 효과를 평가하고자 함 .To assess the effects of [intervention or comparison]for [health problem] for/in [types of people, disease or problem andsetting if specified]. cochrane training
연구방법 Methods• 문헌고찰 시작 전 , 예상 업무를 계획함 • 비뚤림 위험을 최소화함 • 저자 간 업무를 분담하고 , 문헌고찰 수행을 위한 예 상 스케줄을 정함 • 연구방법 및 결정 사안에 대해 충분히 자세하게 기술 함으로써 , 재현성을 유지할 것 • 보건의료 의사결정의 주요 기반이 될 최선의 근거를 산출할 수 있는 방법을 선택할 것 • 해당 분야 CRG 와 상의할 것 – 표준 양식 제공 여부• 충분한 수의 연구자료가 검색될 것이라고 가정할 것 • 지금이 아니더라도 , 추후 갱신 작업 시 가능할 수 있 음 cochrane training
연구방법 Methods• 선정 기준 eligibility criteria• 평가 도구 outcomes• 검색 searching• 자료 추출 data collection• 비뚤림 위험 평가 risk of bias assessment• 결과 분석 analysis• ‘ 결과 요약’ 표 ‘ Summary of Findings’ tables 추후 별도로 상세히 다룰 것임 cochrane training
연구자료 및 참고문헌 Studies and references• 연구자료 • 문헌고찰에 선정 / 배제된 연구 • 연구계획서 (protocol) 단계에서는 공란으로 비워둠• 기타 참고문헌 • 연구계획서 내의 모든 참고문헌 예 ) 배경 , 연구방법 등 cochrane training
부가적 정보 Additional information• 사사 ( 謝辭 ) acknowledgements• 저자 공헌도 contributions of authors• 이해 상충 고지 declarations of interest• 지원 출처 sources of support• 기타 추가 표 및 부록 any additional tables or appendices cochrane training
연구계획서 작성을 완료하였을 때 When your protocol is complete• 세부사항을 점검할 것 • 철자 및 오타 , 내부 오류 Validity 점검 (RevMan 이용 ), CRG checklist• 편집국의 승인을 받기 위해 , CRG 에 투고할 것• 내부 심사 및 외부 동료 평가 를 받게 됨 • 편집장 Managing Editor, 편집위원 , 통계부문 편집위원 , 동료 심사자 , 사용자 (consumer) • 기타 저널처럼 , 수 개월이 걸릴 수도 있음• 출판 승인을 얻은 경우 • 출판 허가서 및 이해상충 고지 양식 작성 • 문헌고찰을 시작할 것 • 약 1-2 달 내에 출판됨 cochrane training
핵심 전달 사항 Take home message• 연구계획서 출판은 비뚤림 위험을 최소화하기 위해 코크란 체계적 문헌고찰 시 요구하는 사항임• 독자들이 연구자가 무엇을 하고자 하는지 상세히 알 수 있도록 연구계획서를 작성할 것• RevMan 에서 사용할 수 있는 표준 양식을 준수할 것 cochrane training
References• Green S, Higgins JPT (editors). Chapter 2: Preparing a Cochrane review. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 (updated September 2008). The Cochrane Collaboration, 2008. Available from www.cochrane-handbook.org.• Higgins JPT, Green S (editors). Chapter 4: Guide to the contents of a Cochrane protocol and review. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 (updated September 2008). The Cochrane Collaboration, 2008. Available from www.cochrane-handbook.org. Acknowledgements • 편집 : Miranda Cumpston • 호주 코크란 센터 (Australasian Cochrane Centre) 교육자료를 원자료로 함 • 본 교육자료는 Cochrane Methods Board 가 승인하였음 • Translated by Kun Hyung Kim, Myeong Soo Lee and Byung-Cheul Shin cochrane training