연구질문의 설정Defining a review question
코크란 체계적 문헌고찰의 과정        Steps of a Cochrane systematic review1.    연구 질문 설정2.    선정 기준 계획3.     연구 방법 계획4.    연구자료 ( 원자료 )...
개요                  Outline• 잘 정의된 연구 질문의 중요성• 연구 질문의 구성 요소• 연구계획서 (protocol) 에 포함되어야 할 내용        See Chapter 5 of the Han...
연구 질문 설정           Defining your question• 문헌고찰의 필수적인 첫 단계• 연구 방법 상 여러 요소들의 설정에 중요한 역할을  함.  • 선정 기준  • 연구자료 검색 전략  • 자료 추...
연구주제와 범위 설정       Planning your topic and scope• 연구주제의 중요도와 연관성을 고려하여 연구질문을 설  정할 것 • 보건의료에 미치는 영향력 고려 – 인구집단 및 개별 환자 • 해당...
연구 질문의 범위 설정           A broad or narrow question?       협소한 질문                광범위한 질문       • 작성이 쉬워짐             • 포괄적임 ...
개요               Outline• 잘 정의된 연구 질문의 중요성• 연구 질문의 구성 요소• 연구 계획서 (protocol) 에 포함되어야 할 내용                         cochrane ...
연구 질문의 구성 요소         Components of a question• 아래 요소를 상세히 설명할 것• 연구자가 문헌고찰을 통해 탐색하고자 하는 변수를  고려할 것    P   population ( 연구 ...
선정 기준          Eligibility criteria• 문헌고찰에 포함시킬 연구자료의 결정 기준• 아래 항목을 기반으로 기준 설정 : • PICO 요소 전체 혹은 일부    및 • 선정 가능한 연구자료의 디자...
연구 대상 집단              Population• 연구 대상 집단을 명확히 정의할 것• 두 가지 고려 요소 • 건강 상태 및 질환   • 진단이 어떻게 , 누구에 의해 내려졌는가 ? • 연구 대상 및 연구가 ...
동질성 및 특정 인구집단       Equity and special populations• 성별 , 연령 , 인종 , 지역적 / 경제적 상태 , 교육 정  도등왜 이러한 요소들을 고려해야 하는가 ?• 유병률 , 질병의...
치료 / 중재법                Intervention• 최대한 상세히 서술할 것 •   치료 / 중재법의 효과를 발현시키는 활성 구성 요소 •   용량 , 강도 •   수행 방법 / 투여 경로 •   수행 ...
지역 및 맥락               Location and context• 치료 / 중재법은 특정 환경에서는 효과적일 수 있지  만 , 다른 환경에서는 그렇지 않을 수 있음 •   적용 가능성 및 접근성 •   의료...
대조군             Comparison• 문헌고찰의 목적에 기반할 것 • 치료 / 중재법과 마찬가지로 , 대조 치료 / 중재법의 구   성요소를 최대한 자세히 정의할 것 • ‘ 무처치 대조군’ 일 경우 , 그 ...
결과 평가 변수               Outcomes• 선정 기준에서 필수 항목은 아님• 유의미한 결과 평가 항목 설정 • 일반 사용자 ( 환자 ), 의료진 및 보건의료 전문가 , 정책결정자   등을 위함 • 이상반...
결과 평가 변수의 우선순위 설정          Prioritising outcomes• 일차 평가 변수 ( 최대 3 개 )• 이차 평가 변수 • 일차 평가 변수 외의 주요 평가 변수 • 기타 평가 변수 ( 예 ; 대리...
특수한 평가 변수 유형               Special outcome types• 관련 자료 및 도움말 제공 웹사이트 •   Cochrane Adverse Effects Methods Group •   Cochr...
연구자료의 디자인               Study designs• 연구질문의 해결에 가장 적합한 연구 디자인 선택• 대부분의 코크란 문헌고찰에 포함된 디자인 : • 무작위 대조군 연구 (randomised contr...
비 - 무작위 대조 연구              Non-randomised studies• 해당 CRG 의 동의가 있어야 함• 명확한 이유가 있어야 함  • RCT 의 수행이 부적합하거나 비현실적인 분야    ( 예 ,...
연구 제목 설정               Turning a question into a title• 코크란 문헌고찰은 표준화된 제목 형식을 사용함 .• ‘ 질환 / 주제’ 에 대한 ‘ 치료 / 중재’ • 급성 기관지염에...
개요              Outline• 잘 정의된 연구 질문의 중요성• 연구 질문의 구성 요소• 연구 계획서 (protocol) 에 포함되어야 할 내용                        cochrane tr...
연구 계획서에 포함되어야 할 내용        What to include in your protocol• 배경 (Background)  • 해당 질환 / 상태 및 치료 / 중재에 대한 구체적 기술• 연구방법 (Meth...
cochrane training
cochrane training
cochrane training
cochrane training
핵심 전달 사항          Take home message• 연구 시작 전 , 문헌고찰이 포괄할 내용 및 범위 scope  를숙고할 것 ( 예 ; PICO 모델을 이용할 것 )• 그 과정을 통해 얻은 정보를 , 명...
References•   O’Connor D, Green S, Higgins JPT (editors). Chapter 5: Defining the review    question and developing criter...
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Defining a review question - Korean

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Before you begin work on your review, it is important to have a clear and detailed idea of the question you plan to answer with your review. This presentation gives guidance on defining your review question, including the eligibility criteria and other factors you may wish to consider.

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  • Defining your review question is the first step in starting your Cochrane systematic review. You begin this process at the title registration stage, but there’s often more work to be done in really thinking through your question in detail.
  • A well-defined review question is essential to your review. It’s important that you’re clear about what your review will cover, as the question will define many of the subsequent steps of the review: it will determine your eligibility criteria – that is, which studies are included in the review, and which are excluded it will determine how you go about your search strategy, and what kinds of studies you find. If you’re not clear enough about your question at this stage, you may miss papers that are really of interest to you, or find lots of paper that’s not what you wanted. your question will also determine your analysis of the results of the studies – which outcomes do you want to measure, are there specific issues you want to explore, what information do you need to find in the included studies? It’s worth spending time to think this through in some detail at the beginning of the process. Not only can it help you plan your work, but a clear idea of the scope of your review will help you avoid bias later on. By laying down your parameters objectively in advance, you can reduce the risk of making decisions or changing your mind later, on the fly, in a way that might be influenced by the results of particular studies. Your question will be discussed and agreed with your CRG at the title registration stage. It’s not impossible to make changes to the scope of your review later on, but make sure you speak to your CRG if you plan to do so.
  • Take some time to think about the importance of your question: who is it relevant to? Does it address an important burden of disease? What is the possible impact of your intervention on that burden? Try to select a question of real importance to consumers and care providers. It’s also important to select a question that addresses the real choices faced in decision-making. What are the intervention options available? What are the outcomes that influence those choices? Cochrane reviews should always consider an international perspective. The burden of specific diseases may vary greatly in different countries or different populations. The intervention options available and the way health systems operate may also be different, as well as the outcomes of importance. Cochrane reviews may be used by people anywhere the world, in contexts very different from yours, so it’s important not to make assumptions when planning or interpreting the results of your review.
  • Consider whether you wish to answer a narrow question, e.g. looking at one specific intervention in a specific patient group, or a broader question, e.g. looking at all interventions to address a particular health condition, or something more complex like health system or community interventions. A well-focussed systematic review question will be broad enough to answer a useful question, allowing for some of the variations that will always be observed in a field, but not so broad that it doesn’t make sense to consider all those studies together in one review. Narrower reviews are easier to write and easier to read, but you may need to have multiple reviews to answer all the questions relating to a condition or type of intervention. Broad reviews are more comprehensive, but they can be complex, more difficult for authors to write, and can miss some of the detail possible in a narrower review. In some cases what’s most appropriate can change over time. There was once a Cochrane review, ‘Interventions for shoulder pain’, that looked at all possible interventions – steroid injections, physiotherapy, exercise, pain killers. Over time, however, as more and more studies were published, it became unmanageable, and has now been split into a set of reviews looking at one specific intervention. One way that the Cochrane Collaboration manages sets of narrow reviews is to publish Overviews of Reviews – these are brief papers that summarise the findings of multiple related reviews. More information about these Overviews is available in Chapter 22 of the Handbook, if you’re interested in reading more. There’s no right or wrong answer to this - it depends on what you’re interested in. Your Review Group may have a preference based on their experience and how your review fits with other similar reviews already published.
  • You will need to define each aspect of your question very clearly. ASK: Who has seen this PICO format before? It can be used to design a study, or a literature search, and it’s also useful for thinking through the question for your systematic review. You will need to think about each of these components and define in detail: who are you interested in studying in your review? What is the intervention or group of interventions you want to test? What will the interventions be compared to? What outcomes will tell you which intervention is the most effective? Think about what you’re interested in, and what you’re not interested in. Within each component, it’s also important to think about the variations that you would like to explore further, such as different populations for whom the intervention might work differently, or variations on the way the intervention can be applied.
  • When you have clearly defined your question, and identified in detail the components you would like to investigate, you can then define the eligibility criteria for your review. Eligibility criteria are the essential components, the boundaries, that determine whether a study is included and discussed in the review, or whether it is excluded. Remember that the eligibility criteria for a review may be different from the ideal criteria you might set if you were designing a primary study yourself. For example, you may wish to look specifically at the impact on people with a certain stage of disease, or you might have a preferred model for implementing a complex intervention. However, the body of studies you find in the literature might show considerable variation from your ideal model, or might incorporate a mixture of participants with different stages of disease. If these studies are included in your eligibility criteria, you can explore the effect of these differences within the review. If you rule them out, they will be excluded altogether. It’s important to articulate each component carefully, so that when you come to making decisions about including studies in the review, you are doing so as objectively as possible. Having clear criteria to refer to will help you avoid ad hoc decisions that may introduce bias. We’ll go through each of these components in more detail.
  • First: the population (sometimes also called the participants, or people). What are the most important characteristics that describe the people you are interested in? The level of precision you need will depend on the topic of your review, but should always be detailed enough to identify which studies you wish to exclude from the review. For example, if you are interested in a specific population with defined diagnostic criteria, e.g. a particular stage of breast cancer, or a particular genetic marker, you will need to describe the criteria in some detail. Keep in mind that your ideal diagnostic criteria may not be universally used, or even available, and older studies may not have access to the newest available tests. Alternatively, if you are looking at a broader group of people with a health condition, e.g. any stage of breast cancer, or even a healthy population with no health condition, less detail will be needed. Whatever limits you place around the group of people should have a clear rationale: if you are limiting to a specific stage of disease, or to a specific age group, is this because you expect this group to react differently to an intervention than other people? Remember: once you have defined your eligibility criteria, you can also identify other differences of interest that you would like to explore in the review.
  • Cochrane reviews seek to be relevant internationally and across contexts, and it’s important to consider your question in relation to all the different types of people who may be affected. Prevalence and progress – e.g. antibiotics for sore throat – may not be useful in high-income settings, where impact of the disease is not great. In some low-income countries there is a greater likelihood of progression to rheumatic fever, with very serious consequences, such that you might come to a different conclusion about the importance of intervention. Different effects or safety – e.g. some interventions may work differently in different cultural settings (e.g. communication and education interventions), or there may be biological differences in the way interventions work among different ethnic groups, in women compared to men, or in children compared to adults. Different outcomes of importance – e.g. for interventions in children, developmental milestones or attendance at school may be important outcomes that don’t apply to adults. You may need to measure outcomes differently in some populations, e.g. measuring pain in newborn babies. The cost of an intervention may be very important for people without health insurance, or for policy makers planning implementation in resource-poor settings. The duration of treatment required may be important for participants in rural settings who travel long distances to access treatment. Although these may not form part of your eligibility criteria, they will assist you in considering other aspects of your question as you plan your review.
  • Next, you will need to describe the intervention in enough detail to distinguish your intervention of interest from those interventions that fall outside the scope of the review. So, if your review is looking at a very specific topic, such as a specific dose of a specific drug, you can be very narrow in your definition. If you are looking at a more general topic, such as a class of drugs, or a more complex, multi-component intervention, you can be less detailed in your criteria, allowing for expected variations in the literature. However, you must be able to clearly identify the core or common factors that determine whether each study, each variation, falls within the review, or is so different that it should be excluded – whether this is a minimum clinically effective dose or duration of drug treatment, or essential components of a complex intervention. Based on the objective of your question, think carefully about the advantages and disadvantages of including studies that test your intervention in combination with other interventions. If you are interested in the direct effects, say, of phsyiotherapy for shoulder pain, then a study that looks at physiotherapy in conjunction with painkillers will not answer that question, because the effects of physiotherapy are confounded with those of painkillers . Alternatively, you might be interested in the effects of multi-component interventions, in which case a study of physiotherapy plus painkillers might be appropriate. It is particularly important to be as clear and informative as you can when describing complex interventions, such as multi-component clinical interventions like rehabilitation programs, educational or behavioural interventions, community-based interventions, etc. These are often poorly described in the literature, which makes it difficult to make decisions about inclusion, and difficult for users of the review to implement the intervention if it is found to be effective.
  • Again, it’s important to consider your intervention and how it might be applied internationally, and in a variety of contexts. Interventions may work differently in some contexts, or need to be applied differently. Factors you may wish to consider can include: whether the intervention is available in every context, or does it depends on specialised equipment itself that may not be available, where that’s an expensive scanning machine or something simple like running water? are there specific skills or training that the staff implementing the intervention will need? Will different staff be implementing the intervention in different settings? is the intervention acceptable in all cultural contexts, and will it work the same way? is the intervention affordable to people with different incomes, or under different insurance systems?
  • The comparisons you’re testing against your intervention of interest should be clearly based on the objective of your review question. If you review is comparing the intervention against a specific active alternative (or more than one), e.g. one drug versus another, or health professional versus peer-led interventions for mental illness, the comparisons should be described in as much detail as the intervention. You may be interested in the effects of caffeine compared to any alternative intervention, or no intervention at all. In which case, you don’t need to specify a specific comparison for your eligibility criteria. Even if your objective is to test your intervention against no intervention, remember that may be important differences between inactive comparisons – such as truly doing nothing, or using a placebo, or leaving in place whatever ‘usual care’ is for this population. Remember, too, that ‘usual care’ may vary a lot from study to study, so plan to examine these differences carefully if this applies to your review. Again, remember to consider the real choices available to people making decisions in this area – what are the options currently available in different contexts? Have some intervention options become obsolete (remembering that interventions that are obsolete in high-income countries and large urban hospitals may still be in use in other places)? If your review is broad, you can choose to include studies comparing your intervention to any possible comparison – if that’s the case, make sure you state this clearly.
  • Plan to report outcomes of importance to people making decisions, starting with those people who are affected by the condition, and those who are making decisions about care. It’s important that you plan in advance which outcomes you will report, to minimise bias in the selection of outcomes when you come to complete the review. Some fields have articulated key outcomes, such as the work done by OMERACT for rheumatology studies – if so, take advantage of these standards. If not, you may wish to look at other reviews in similar areas to see the outcomes they report. Don’t forget to always include possible adverse effects. You might consider how outcomes might be measured – for example, are there published, validated measurement instruments for your outcomes? Consider the variety of ways in which an outcome may be measured and reported in the studies you find, and only be restrictive if you have a good rationale – for example, the latest validated test might be the best, but if it was only released last year, or has not been widely adopted internationally, it may exclude the majority of studies. You may also specify important time points for the measurement of outcomes. Is there a minimum period of time before you could expect the intervention to have an effect? e.g. interventions to improve bone density will take longer than a few weeks. Note that it is not always expected that outcomes will form part of the eligibility criteria for a review. Commonly, studies that do not measure your outcomes of interest are still included and noted in the review, although they cannot contribute to your analysis of those outcomes. It is important to include these studies so that you are presenting a complete picture of the literature. In some cases it is appropriate to include the outcomes in your eligibility criteria – for example, if you are interested in prevention, then your included studies must measure prevention, and not only treatment outcomes. For interventions with many applications, you may wish to define your review to cover one particular field – the Cochrane Library currently has separate reviews looking at hormone replacement therapy for menopausal symptoms, for cardiovascular outcomes, and cognitive outcomes. Select your outcomes based on the information you think is important, not based on what you think you will find in the literature. For example, if you’re interested in mortality, include that as an outcome, even if it’s a long-term outcome that few studies will measure. Short-term surrogate outcomes, such as improvement in the regularity of heartbeat, may be easier to measure, but don’t always correspond to longer-term outcomes in the way you expect. You will be expected to report on all your planned outcomes in the final review, even if you don’t find any studies that measure some outcomes – picking and choosing outcomes based on those with good available data can introduce bias, and reporting that outcomes of importance have not been adequately measured is a useful finding.
  • You should specify a small number of primary outcomes, that will form the basis of the conclusions of your review, including at least one potential harm. The rest of your outcomes will be considered secondary outcomes, but keep in mind that the total number of outcomes to be addressed should be kept as small as is reasonable for your question, and focus on those outcomes that are important for decision-making. It’s important to prioritise your outcomes to help you in reporting the results of your review, particularly when it comes to summarising your results. Cochrane reviews have a range of short formats to summarise results, such as the abstract, plain language summary, or Summary of Findings table of your review. You may not be able to report against all your primary and secondary outcomes in each summary, so we recommend that you identify a group of outcomes – including your primary outcomes and perhaps a small number of your secondary outcomes – that can be designated as your main outcomes, and prioritised in any summary of your results. These should be the outcomes that are most important for decision-making, whether or not you expect to find enough data in the literature. Also, try not to duplicate within your main outcomes – avoid including multiple variations on the same outcome (e.g. weight, BMI), or measures of the same outcome at multiple time points, without a clear rationale. Additional variations and time points can be included among your other secondary outcomes.
  • At these early stages, it’s appropriate to consider whether the important outcomes for your review incorporate some of these outcome types. Cochrane reviews allow for more in-depth consideration of outcome types that are commonly encountered, such as adverse effects and issues of equity. Alternatively, you may wish to incorporate specialised outcome types such as economic or qualitative evidence. Consideration of these topics may require additional systematic literature searching, and more advanced analysis methods. These topics will not be covered in depth in this course, but further information is available in the Handbook, and on the websites of the Methods Groups who contribute to the Cochrane Collaboration in these areas – website details are available on the cochrane.org website.
  • ASK: who was under the impression that Cochrane reviews only include randomised trials? In fact, Cochrane reviews mostly include RCTs, but in some cases we do include other study designs. We always aim to include the most appropriate study designs to answer the review question. For straightforward questions about the effects of interventions, that will usually be RCTs. Methodological research tells us that RCTs are the best way to avoid bias introduced by systematic differences between the groups in a study. Usually that’s all you need to specify for your eligibility criteria. In some cases you might want to be specific about an aspect of study design for example if you wish to specifically exclude crossover trials from your review , or in some cases we also include quasi-randomised trials (those trials with methods of allocation that are almost random but not quite, such as alternating allocation).
  • Some Cochrane reviews will look at non-randomised studies. You must have a clear rationale for doing this – that is, why would RCTs not be able to provide this evidence? It is not enough to say that you don’t believe there are any RCTs measuring this outcome. If an RCT is the most appropriate way to measure an effect, and there are none, then Cochrane reviews can conclude that there is no appropriate evidence, and that new studies should be conducted. Unlike a guideline or a local policy, we are not obliged to provide a recommendation if we don’t believe the evidence is sufficient. However, in some cases other study designs are appropriate to answer questions. For example, in some cases RCTs may not be appropriate, e.g. where they might be unethical, or seriously impractical, such as in the case of large-scale changes to health system structures, or public health interventions across whole communities or even countries. There are also some outcomes that RCTs are not able to measure well. RCTs are not always good at measuring adverse effects, particularly rare or long-term effects. In those cases, you might need to look for cohort or case-control studies, perhaps government monitoring data, etc. If you’re incorporating economics or qualitative data in your reviews, these have their own study designs that you may wish to consider. These kinds of studies aren’t usually incorporated in your primary analysis of the effectiveness of the intervention, but can be used to inform and interpret the results. ASK: Is anyone planning to include non-randomised studies in their review? Whenever you plan to include non-randomised studies, you must have the agreement of your CRG – not all CRGs will be happy for you to do this. You should also specify which non-randomised designs you will include. Further advice on this is available from your CRG, including recommended minimum design criteria for non-randomised studies. Whenever you’re including non-randomised studies, you must be aware of the increased risk of bias in the results. Make sure you are familiar with the risks, how to assess them, and how best to analyse the results of these studies.
  • The titles of Cochrane reviews are usually based on the standard format: ‘intervention’ for ‘population’. In some cases there are variations, for example if you wish to include a specific comparison, a specific population, or if yours is a review of a prevention rather than treatment intervention. This will be agreed with your CRG at the title registration stage.
  • There are several places in your protocol where the details of your question are explained. In the Background, you can give your detailed descriptions of the condition of interest, including the burden of disease, the population, and how the condition affects people. In the Methods section, your eligibility criteria are listed in the section called ‘Criteria for considering studies for this review’. Your list of outcomes to be reported is also included here, even if they are not part of your eligibility criteria. Finally, those additional factors and variations that you want to explore within your review can be planned as subgroup analyses in the section called ‘Data collection and analysis’. We’ll be talking in more detail about analysis methods in separate sessions.
  • Defining a review question - Korean

    1. 1. 연구질문의 설정Defining a review question
    2. 2. 코크란 체계적 문헌고찰의 과정 Steps of a Cochrane systematic review1. 연구 질문 설정2. 선정 기준 계획3. 연구 방법 계획4. 연구자료 ( 원자료 ) 검색5. 선정 기준 적용6. 자료 추출7. 비뚤림 위험 평가8. 결과 분석 및 제시9. 분석결과 해석 및 결론 도출10. 문헌고찰 개선 및 주기적 갱신 cochrane training
    3. 3. 개요 Outline• 잘 정의된 연구 질문의 중요성• 연구 질문의 구성 요소• 연구계획서 (protocol) 에 포함되어야 할 내용 See Chapter 5 of the Handbook cochrane training
    4. 4. 연구 질문 설정 Defining your question• 문헌고찰의 필수적인 첫 단계• 연구 방법 상 여러 요소들의 설정에 중요한 역할을 함. • 선정 기준 • 연구자료 검색 전략 • 자료 추출 및 분석• 문헌고찰 시작 전 숙고가 필요함 • 문헌고찰을 위한 업무 계획에 도움이 됨 • 비뚤림 방지에 도움이 됨• 제안한 연구 주제를 변경 시 , CRG (Cochrane Review Group) 과 상의할 것 cochrane training
    5. 5. 연구주제와 범위 설정 Planning your topic and scope• 연구주제의 중요도와 연관성을 고려하여 연구질문을 설 정할 것 • 보건의료에 미치는 영향력 고려 – 인구집단 및 개별 환자 • 해당 치료 / 중재법의 잠재적 영향력 고려• 의사 - 결정 시 실제로 선택에 직면하게 되는 요소들을 다루어야 함• 국내외 보건의료 환경을 모두 고려한 관점을 유지할 것 cochrane training
    6. 6. 연구 질문의 범위 설정 A broad or narrow question? 협소한 질문 광범위한 질문 • 작성이 쉬워짐 • 포괄적임 장점 • 읽기 쉬워짐 • 외적 타당도 증가 • 복잡해짐 • 여러 개의 세부적 • 세부집단 (subgroup) 별 효과차 review 가 필요함 이를 간과하고 지나칠 수 있음 단점 • 저자가 원하는 결과를 • 문헌고찰에 대한 종설 얻기 위한 목적으로 질 문이 설정될 수 있음 Overview of reviews 이 더 적절 할 수 있음See Chapter 22 of the Handbook cochrane training
    7. 7. 개요 Outline• 잘 정의된 연구 질문의 중요성• 연구 질문의 구성 요소• 연구 계획서 (protocol) 에 포함되어야 할 내용 cochrane training
    8. 8. 연구 질문의 구성 요소 Components of a question• 아래 요소를 상세히 설명할 것• 연구자가 문헌고찰을 통해 탐색하고자 하는 변수를 고려할 것 P population ( 연구 대상 집단 ) I intervention ( 치료 / 중재법 ) C comparison ( 대조군 ) O outcomes ( 결과 평가 변수 ) cochrane training
    9. 9. 선정 기준 Eligibility criteria• 문헌고찰에 포함시킬 연구자료의 결정 기준• 아래 항목을 기반으로 기준 설정 : • PICO 요소 전체 혹은 일부 및 • 선정 가능한 연구자료의 디자인 정의 cochrane training
    10. 10. 연구 대상 집단 Population• 연구 대상 집단을 명확히 정의할 것• 두 가지 고려 요소 • 건강 상태 및 질환 • 진단이 어떻게 , 누구에 의해 내려졌는가 ? • 연구 대상 및 연구가 수행되었던 환경• 연구 대상 집단을 제한할 시 , 명확하고 합리적인 기 준을 제시해야 함 • 혹은 , 연구 대상 집단의 제한 없이 문헌고찰 대상으로 포함시킨 뒤 Subgroup analysis 를 수행하는 방법도 있 음 cochrane training
    11. 11. 동질성 및 특정 인구집단 Equity and special populations• 성별 , 연령 , 인종 , 지역적 / 경제적 상태 , 교육 정 도등왜 이러한 요소들을 고려해야 하는가 ?• 유병률 , 질병의 진행 및 건강에 미치는 영향력 등이 각 집단별로 다를 수 있음 .• 해당 치료 / 중재법의 효과 및 안전성이 각 집단별로 다를 수 있음 .• 중요하게 간주되는 결과 평가 변수가 각 집단별로 다를 수 있음 . cochrane training
    12. 12. 치료 / 중재법 Intervention• 최대한 상세히 서술할 것 • 치료 / 중재법의 효과를 발현시키는 활성 구성 요소 • 용량 , 강도 • 수행 방법 / 투여 경로 • 수행 / 투여 시간 , 빈도 , 기간 • 치료 / 중재 수행에 사용된 의료기구 / 장비 • 치료 / 중재 수행 인원 ( 자격 , 교육 기간 ) • 치료 / 중재가 수행된 지역 및 맥락 • 단독 투여 / 수행 혹은 기타 치료 / 중재법과 병행 여부• 치료 / 중재법 제한 시 명확하고 합리적인 기준을 제시해야 함 • 혹은 , 치료 / 중재법의 제한 없이 문헌고찰 대상으로 포함시킨 뒤 Subgroup analysis 를 수행하는 방법도 있음 cochrane training
    13. 13. 지역 및 맥락 Location and context• 치료 / 중재법은 특정 환경에서는 효과적일 수 있지 만 , 다른 환경에서는 그렇지 않을 수 있음 • 적용 가능성 및 접근성 • 의료기구 및 장비 • 활용가능한 의료진의 경험 및 숙련도 • 지역별로 상이한 우선 해결 필요 과제 • 비용 지불 체계 • 문화적 , 언어적 다양성 • 사회경제적 지위 • 전원 / 도시 환경See Section 12.3.3 of the Handbook cochrane training
    14. 14. 대조군 Comparison• 문헌고찰의 목적에 기반할 것 • 치료 / 중재법과 마찬가지로 , 대조 치료 / 중재법의 구 성요소를 최대한 자세히 정의할 것 • ‘ 무처치 대조군’ 일 경우 , 그 의미를 명확히 할 것 • 예 ) 어떠한 치료도 제공하지 않음 , 플라시보 대조군 , 일상관리군 등 • 확인된 대조군을 모두 포함할 수 있지만 , 그 내용을 명확히 할 것 cochrane training
    15. 15. 결과 평가 변수 Outcomes• 선정 기준에서 필수 항목은 아님• 유의미한 결과 평가 항목 설정 • 일반 사용자 ( 환자 ), 의료진 및 보건의료 전문가 , 정책결정자 등을 위함 • 이상반응을 결과 평가 항목에 포함시킬 것 • 각 인구집단 별로 연관성 있는 항목을 포함시킬 것 • 핵심적인 평가 시점 설정 • 평가 방법 , 평가도구의 타당도 등 고려• 연관된 주제의 기존 문헌고찰에서 사용된 결과 평가 항목을 참조할 수 있음• 중요한 결과 평가 항목이라면 , 자료 검색 가능성 여부와 상관 없이 연구계획서와 문헌고찰에 포함되어야 함 . cochrane training
    16. 16. 결과 평가 변수의 우선순위 설정 Prioritising outcomes• 일차 평가 변수 ( 최대 3 개 )• 이차 평가 변수 • 일차 평가 변수 외의 주요 평가 변수 • 기타 평가 변수 ( 예 ; 대리 평가 변수 , 효과를 설명해 줄 수 있는 임상시험 수행 과정 상의 여러 요소들에 대한 평가 변수 )• 주요 평가 변수 ( 최대 7 개 ) • 의사결정에 필수적임 • 결과분석 및 요약본 작성의 기초가 됨 cochrane training
    17. 17. 특수한 평가 변수 유형 Special outcome types• 관련 자료 및 도움말 제공 웹사이트 • Cochrane Adverse Effects Methods Group • Cochrane Patient Reported Outcomes Methods Group • Campbell and Cochrane Equity Methods Group • Campbell and Cochrane Economics Methods Group • Cochrane Qualitative Research Methods Group • see www.cochrane.org/contact/methods-groupsSee Chapters 14,15,17,20 of the Handbook cochrane training
    18. 18. 연구자료의 디자인 Study designs• 연구질문의 해결에 가장 적합한 연구 디자인 선택• 대부분의 코크란 문헌고찰에 포함된 디자인 : • 무작위 대조군 연구 (randomised controlled trials) • 각 군간 계통적 이질성의 발생을 방지 • 종종 비무작위 대조군 연구도 포함 ( 유사 - 무작위 대조 연구 ) (quasi-randomised) cochrane training
    19. 19. 비 - 무작위 대조 연구 Non-randomised studies• 해당 CRG 의 동의가 있어야 함• 명확한 이유가 있어야 함 • RCT 의 수행이 부적합하거나 비현실적인 분야 ( 예 , 공공 보건 , 복합적 보건의료 체계를 다루는 연구 등 ) • 특정 결과 평가 변수 측정 시 ( 예 , 이상반응 , 경제성 평가 , 질적 평가 변수 등 ) • 단순히 RCT 가 없다는 이유는 불가• 비무작위 연구의 포함은 특정 연구디자인에만 한정될 수 있음 • 예 ; 전후 대조 연구 (controlled before-and-after), 간여 시계열 분 석 (interrupted time series) • 비무작위 연구 디자인 포함 시 , 연구 디자인에 대한 최소한의 선 정기준을 세울 것• 비뚤림 위험이 증가함을 염두에 둘 것See Chapters 13, 14,15,20, 21 of the Handbook training cochrane
    20. 20. 연구 제목 설정 Turning a question into a title• 코크란 문헌고찰은 표준화된 제목 형식을 사용함 .• ‘ 질환 / 주제’ 에 대한 ‘ 치료 / 중재’ • 급성 기관지염에 대한 항생제 사용 (Antibiotics for acute bronchitis) • 신체활동 증진을 위한 지역사회 중재 (Community-wide Interventions for increasing physical activity)• 기타 세부항목 포함 가능 • 자궁경부상피내종양에 대한 즉시치료 대 지연치료 비교 (Immediate versus delayed treatment for cervical intraepithelial neoplasia) • 미숙아 호흡 부전에 대한 흡입 산화질소 요법 (Inhaled nitric oxide for respiratory failure in preterm infants) • 아동 익사 방지를 위한 수영장 담장 설치 효과 (Pool fencing for preventing drowning in children) cochrane training
    21. 21. 개요 Outline• 잘 정의된 연구 질문의 중요성• 연구 질문의 구성 요소• 연구 계획서 (protocol) 에 포함되어야 할 내용 cochrane training
    22. 22. 연구 계획서에 포함되어야 할 내용 What to include in your protocol• 배경 (Background) • 해당 질환 / 상태 및 치료 / 중재에 대한 구체적 기술• 연구방법 (Methods) • 해당 문헌고찰에 포함될 연구자료의 선정 기준 • 선정 기준의 명확한 기술 • 사전 계획된 평가 변수의 명기 • 자료 수집 및 분석 • 사전 계획된 subgroup analysis 명기 cochrane training
    23. 23. cochrane training
    24. 24. cochrane training
    25. 25. cochrane training
    26. 26. cochrane training
    27. 27. 핵심 전달 사항 Take home message• 연구 시작 전 , 문헌고찰이 포괄할 내용 및 범위 scope 를숙고할 것 ( 예 ; PICO 모델을 이용할 것 )• 그 과정을 통해 얻은 정보를 , 명확하고 구체적인 선 정기준 설정에 활용할 것• 이 정보는 검색 전략 , 자료 수집 및 분석 방법을 결 정할 때에도 역시 도움이 될 것임 . cochrane training
    28. 28. References• O’Connor D, Green S, Higgins JPT (editors). Chapter 5: Defining the review question and developing criteria for including studies. In: Higgins JPT, Green S (editors), Cochrane Handbook of Systematic Reviews of Intervention. 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 Method Board 가 승인하였음• Translated by Kun Hyung Kim, Myeong Soo Lee andcochrane training Byung-Cheul Shin

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