系统评价计划书撰写-侯

系统评价计划书撰写
系统评价的步骤和方法
（1）确立题目
（2）制定系统评价计划书-protocol （3）检索文献
（4）选择文献
（5）评价文献质量
（6）资料提取
（7）数据分析和结果描述
（8）解释系统评价的结果
（9）系统评价的改进与更新
数据分析（Meta分析的过程）（1）数据的类型及效应量的表达
（2）数据的汇总
（3）异质性检验
（4）合并效应量
（5）合并效应量的检验
（6）Meta-分析常见的偏倚和漏斗图分析（7）敏感性分析
概述01Cochrane系统评价计划书撰写内容与流程02计划书撰写注意事项
03目录CONTENTS
a.制定系统评价操作指南，避免迷失方向
b.公开发表，接受各方评议，避免重复研究
c.使偏倚最小化1
①Cochrane 系统评价特点
系统、全面、清晰
确保制作过程偏倚最小化
②Cochrane 系统评价制作流程
✓ 确定题目与注册
✓ 撰写计划书
✓ 制作系统评价
✓ 更新系统评价
2一、概述
撰写系统评价计划书的重要性Cochrane 系统评价
二、Cochrane系统评价计划书撰写内容与流程
A Cochrane系统评价计划书内容
B计划书撰写与发表流程
C计划书改变需注意事项
I.Cochrane系统评价计划书内容•计划书主要内容包括：背景、目的和方法
•方法学部分是重点，主要内容：
研究纳入与排除标准
研究检索策略制定
数据收集和分析的方法
（研究选择、纳入研究偏倚风险评估、数据提取与汇总分析）
⏹系统评价计划书与全文在内容上的比较：
✓前者没有结果、讨论、结论等
✓前者必须发表在全文之前
✓方法学描述：前者使用将来时态，后者使用过去时态
Ⅱ.计划书撰写与发表流程
用一句话表明进行系统评价制
作的主要目的，明确关注干预
措施对某种疾病或健康问题的
具体治疗效果目的
根据研究目的，明确相关的检索来源名称、时间和文献语种，制定完善的检索策略。

制定检索策略与查找文献计划书完成后，应交送相应评价小组审阅，对研究目的、方法提出修改意见和建议
评审和修改计划书提出立案依据，描述研
究问题的重要性及不确
定性、干预措施可能有
效的作用机制背景①研究对象的类型②研究的干预措施和对照措施③研究结局指标
④研究设计方案确定纳入排除研究标准 1.选择和纳入临床研究2.评估纳入研究的偏倚风险3.提取数据。

数据收集与分析发表计划书
评审合格的系统评价计划书将发表在Cochrane图书馆上
背景
•包括：基本概念的介绍、流行病学特点、相关危险因素、当前诊疗手段现状和存在的问题、系统评价制作的必要性和合理性等 研究情况描述
干预措施描述
干预措施可能有效地作用方式和机制
研究问题的不确定性和制作系统评价的必要性
目的
•用一句话表明进行系统评价制作的主要目的，明确关注干预措施对某疾病或健康问题的具体治疗效果
确定纳入排除标准
•研究设计类型（D）
根据研究目的，选择能回答说关注问题的研究设计类型，优选当前方法学质量较高的类型•研究对象类型（P）
使用明确的标准来界定疾病或所关注状况，疾病或健康问题的种类或亚型
•干预措施与对照措施（I, C）
具体说明所关注的干预措施以及作为对照的处理措施
还应考虑到干预措施的变化在多大程度上对研究对象和关注的结局指标产生不同的影响•结局指标（O）
✓确立结局指标
PICO原则
✓确立结局指标测量方式
✓确立结局测量的时间
制定检索策略和寻找文献
•根据系统评价研究目的，明确研究相关的检索来源名称、检索时间（检索起止日期）和文献语种
Cochrane图书馆试验注册库、相关专业数据库、MEDLINE、EMBASE、试验在研数据库
•同时，尽可能补充检索其他专业相关的资源
包括人工检索灰色文献、查找相关研究参考文献清单或与研究作者进行联系
•在计划书中应注明是否进行人工检索
•制定完善的检索策略
PICO原则、关键词或主题词，检索提问式
数据收集和分析
选择与纳入临床研究
评估纳入研究的偏倚风险 提取数据
治疗效果的测量
分析单位
缺失数据处理 评估异质性 评估报告偏倚 数据合成
亚组分析
敏感性分析
评审和修改计划书
•计划书完成后，应送交相应评价小组审阅，通过逻辑组内外的方法学和同行专家评审，对研究目的、方法提出修改意见和建议•评审→修改→再评审，符合发表要求为止
发表计划书
•经评审合格的系统评价计划书将发表在Cochrane图书馆上，进一步广泛征求意见，确保系统评价实施方案的完善可靠
Ⅲ.计划书改变需注意事项
•实际操作中，计划书可能未包含系统评价可能遇到的各种情况
如：计划书中的选择标准可能并不适用于研究筛查，或计划书中未能估计到能够收集的数据需要再分析的等
此时，与其完成一个没有任何意义和无帮助的系统评价，还不如对计划书内容进行修改
注意：此时对计划书的改变，应有别于改变原先打算纳入和排除研究的情形 通常情况下，作者能做的，而且应该做的，就是按照计划书事先设定的方法进行操作
如果确实需要对计划书进行某些改变，必须在全文与计划书的区别处报告所有改变的细节
应注意，无论改变何种规则，都有可能会影响系统评价的结果，此点非常重要。

三、计划书撰写注意事项与相关资源•完成系统评价过程中常见的问题与困难：
✓选题不清楚
✓计划书撰写意义不清楚
✓方法学欠缺
✓信息资源不够
✓语言交流困难
✓时间和经费不足
✓......
⏹解决方法：
•如果有一定的专业背景积累和语言交流基础，可向专业小组注册，优点在于：
①获得专业小组指导，免费使用相关资源
②系统评价题目一旦注册，专业小组团队会主动帮助其作者按时完成，确保发表
质量
③如有需要，专业小组还会提供以下帮助：协助制订检索策略、查寻原始资料、
翻译非英文语种文献和资料分析
④与同行建立国际合作联系，提高自身系统评价研究水平和知名度
⑤及时跟踪本领域最新研究进展前沿，保持学术研究创新性
示例
Effects of aerobic exercise on pain and disability in patients with non-specific chronic low back pain（非特异性慢性腰痛）: a systematic review protocol
Introduction-重要性
•Low back pain is one of the most prevalent and disabling musculoskeletal conditions in the adult population and is considered a major public health problem world wide.
•Aerobic exercise is defined as a form of exercise with relatively low intensity, with a duration ranging between 15 and 60 continuous minutes, and intensity of 60 to 90% of the maximum heart rate.
•Aerobic exercise programs have shown physiological, psychological, and articular benefits in patients with chronic diseases (e.g., arthritis, osteoarthritis, and fibromyalgia)
•Aerobic exercise stimulates the release of endorphins that relieve pain by inhibiting the pain pathways.
•It also makes the patient more active, reducing the fear of moving (kinesiophobia) and increasing self-confidence. •Lastly, these exercises increase muscle blood flow and may reduce the stiffness commonly observed in patients with low back pain.
•To date, only two systematic reviews have been published on the effectiveness of aerobic exercise in patients with low back pain.
• The first systematic review (These factors limit an in-depth evaluation of the effects of aerobic exercise on the treatment of patients with chronic low back pain)
•The second systematic review also has some methodological limitations.
•In summary, neither reviews evaluated the isolated effect of aerobic exercise, adequately measured by randomized controlled trials.
Introduction-目的
•Thus, the objective of this systematic review will be to investigate the isolated effectiveness of aerobic exercise in patients with chronic non-specific low back pain measured in randomized controlled trials on pain and disability outcomes.
Methods
• this systematic review protocol was registered on the Prospective International Register of Systematic Reviews (PROSPERO) number CRD42017071945.
•PROSPERO注册平台,International prospective register of systematic reviews
•由英国国家健康研究所属下的评价和传播中心于2011年2
月正式启动，为非Cochrane系统评价提供了一种注册途径，涉及领域为健康和社会关怀、公共卫生、教育、司法犯罪
和国际发展等方面
Methods
•This systematic review will be conducted following the guidelines of the Cochrane Handbook of Systematic Reviews. We followed the Preferred Reporting Items for Systematic review and Meta-Analyses Protocols (PRISMA-P) (see Additional file 1) guidelines and the checklist available (see Additional file1).
Methods •1. Inclusion criteria of studies
•2. Study search and selection process •3. Data extraction
•4. Assessment of risk of bias
•5. Measures of treatment effect •6. Heterogeneity analysis
•7. Synthesis of data
•1.1 Types of studies
•1.2 P articipants
•1.3 Types of i ntervention and c omparisons •1.4 Assessed o utcomes
•1.1 Types of studies
•1.2 Participants
•1.3 Types of intervention and comparisons •1.4 Assessed outcomes
1.1 Types of studies
•This review will only include randomized controlled trials comparing the use of isolated aerobic exercise to any comparison group in patients with chronic non-specific low back pain.
•Non-randomized controlled trials will be excluded.
1. Inclusion criteria of studies •1.1 Types of studies
•1.2 Participants
•1.3 Types of intervention and comparisons •1.4 Assessed outcomes
1.2 Participants-纳入标准
•We will include studies that evaluated patients over 18 years of age and with chronic non-specific low back pain defined as pain or discomfort lasting more than 12 weeks in the region below the last costal margins and above the lower gluteal folds, with or without symptoms in the lower limbs.
•If a study presents a mixed sample of patients with low back pain of different durations,we will request the separate data from the authors.
1.2 Participants-排除标准
•Studies will be excluded if they evaluated patients with nerve root compromise, metabolic or serious spinal pathologies (e.g., fractures, tumors, inflammatory, and infectious diseases), previous spinal surgery, postpartum low back pain or pelvic pain due to pregnancy, and pain unrelated to the lower back.
•In case separate data cannot be acquired, we will only include the articles with mixed population regarding duration and type of low back pain as long as most of the patients have chronic non-specific low back pain (> 75%).
1. Inclusion criteria of studies •1.1 Types of studies
•1.2 Participants
•1.3 Types of intervention and comparisons •1.4 Assessed outcomes
1.3 Types of intervention and comparisons •The experimental intervention investigated in this systematic review will be aerobic exercise with a duration of 15 to 60 continuous minutes and intensity of 60 to 90% of the maximum heart rate.
•We will include studies with aerobic exercise prescribed by any health professional.
•In addition, the main comparisons will be aerobic exercise versus placebo, aerobic exercise versus control without any intervention (e.g., waiting list), and aerobic exercise versus other interventions.
1. Inclusion criteria of studies •1.1 Types of studies
•1.2 Participants
•1.3 Types of intervention and comparisons •1.4 Assessed outcomes
1.4 Assessed outcomes
•The primary outcome assessed in this review will be pain intensity. The secondary outcomes will be disability, quality of life, return to work, and kinesiophobia（运动恐惧症）measured by any validated instrument.
2. Study search and selection process •Searches will be conducted in the following databases: PubMed, EMBASE, CINAHL, PEDro, Lilacs, and Cochrane Central Register of Controlled Trials (CENTRAL).
•Manual searches will also be carried out through the reference list of previous systematic reviews on the topic and of the clinical trials included in this review.
•We will also search for ongoing or unpublished studies by searching on the International Clinical Trial Registry Search Platform.
•Searches will not be restricted by language or date of publication.•The search strategy was constructed by three main groups of terms related to (1) type of study, (2) chronic non-specific low back pain, and (3) aerobic exercise (Additional file 2).
•We will use all the existing synonyms for each search term (see Additional file1). These terms are the same as those used by the Cochrane Back and Neck Review Group.
•The studies will be assessed according to the eligibility criteria and the selection will be divided into two phases.•The screening of titles, abstracts, and full texts will be screened by two independent reviewers. Any disagreement will be resolved by a third reviewer.
•If uncertainties persist as to the eligibility of an article, the authors may be contacted for clarification.
3. Data extraction
• A data extraction form will be used to extract data from each study. •Data will be extracted on the size and characteristics of the sample (i.e., age, gender, duration of symptoms), characteristics of the interventions (number of sessions, duration of each session of treatment, intensity of training), instruments used to evaluate the outcomes, and results of the included studies.
•Two independent reviewers will perform the data extraction, and the disagreements will be resolved by a third reviewer.
•When data are not available in the manuscripts or in case of uncertainty, the authors may be contacted for clarification.
4. Assessment of risk of bias •Risk of bias will be assessed with the PEDro (Physiotherapy Evidence Database) scale, which has good levels of validity and reliability and is strongly correlated with the Cochrane risk of bias tool.
•The PEDro scale evaluates the risk of bias and the statistical reporting of randomized controlled trials.
•This scale has 11 items: eight items (items 2–9) related to risk of bias (random allocation, concealed allocation, baseline comparability, blinded subjects, blinded therapists, blinded assessors, adequate follow-up, and intention-to-treat analysis) and two items (10 and 11) related to statistical reporting (between-group comparisons and point estimates and variability) .
•The first item (eligibility criteria) is not considered in the total score because it is related to external validity.
•the scale will be applied by two independent reviewers and a third reviewer will mediate any disagreement.•Because blinding of therapists and patients in exercise trials are impossible, we will consider trials with a PEDro score of 8 as low risk of bias.
•Our primary analysis will include only trials with low risk of bias (i.e., 8/10).
•We will then conduct secondary analysis regardless the risk of bias.
5. Measures of treatment effect
•The treatment effects for continuous data will be reported as mean difference with 95% confidence intervals.
•If the outcomes are evaluated by different scales, we will calculate standardized mean differences and 95% confidence intervals.
•The treatment effects of categorical outcomes will be calculated using the risk ratio (RR) with 95% confidence intervals.。