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It has been shown that using at least two authors may reduce the possibility that relevant reports will be discarded Edwards et al , Waffenschmidt et al , Gartlehner et al although other case reports have suggested single screening approaches may be adequate Doust et al , Shemilt et al Opportunities for screening efficiencies seem likely to become available through promising developments in single human screening in combination with machine learning approaches O’Mara-Eves et al Experts in a particular area frequently have pre-formed opinions that can bias their assessment of both the relevance and validity of articles Cooper and Ribble , Oxman and Guyatt Thus, while it is important that at least one author is knowledgeable in the area under review, it may be an advantage to have a second author who is not a content expert.
Disagreements about whether a study should be included can generally be resolved by discussion. Often the cause of disagreement is a simple oversight on the part of one of the review authors. When the disagreement is due to a difference in interpretation, this may require arbitration by another person.
Occasionally, it will not be possible to resolve disagreements about whether to include a study without additional information. In these cases, authors may choose to categorize the study in their review as one that is awaiting assessment until the additional information is obtained from the study authors. A single failed eligibility criterion is sufficient for a study to be excluded from a review.
The eligibility criteria order may be different in different reviews and they do not always need to be the same. For most reviews it will be worthwhile to pilot test the eligibility criteria on a sample of reports say six to eight articles, including ones that are thought to be definitely eligible, definitely not eligible and doubtful.
The pilot test can be used to refine and clarify the eligibility criteria, train the people who will be applying them and ensure that the criteria can be applied consistently by more than one person. During the selection process it is crucial to keep track of the number of references and subsequently the number of studies so that a flow diagram can be constructed. The decision and reasons for exclusion can be tracked using reference management software, a simple document or spreadsheet, or using specialist systematic review software see Section 4.
Broad categorizations are sufficient for records classed as potentially eligible during an initial screen. At least one explicit reason for their exclusion must be documented. Lists of included and excluded studies must be based on studies rather than records. This covers all studies that may, on the surface, appear to meet the eligibility criteria but which, on further inspection, do not. It also covers those that do not meet all of the criteria but are well known and likely to be thought relevant by some readers.
By listing such studies as excluded and giving the primary reason for exclusion, the review authors can show that consideration has been given to these studies. The list of excluded studies should be as brief as possible. It should not list all of the reports that were identified by an extensive search.
In particular, it should not list studies that are obviously not randomized if the review includes only randomized trials. An extensive search for eligible studies in a systematic review can often identify thousands of records that need to be manually screened. Selecting studies from within these records can be a particularly time-consuming, laborious and logistically challenging aspect of conducting a systematic review.
Software to support the selection process, along with other stages of a systematic review, including text mining tools, can be identified using the Systematic Review Toolbox. The SR Toolbox is a community driven, web-based catalogue of tools that provide support for systematic reviews Marshall and Brereton Managing the selection process can be challenging, particularly in a large-scale systematic review that involves multiple reviewers.
Basic productivity tools can help such as word processors, spreadsheets, and reference management software , and several purpose-built systems that support multiple concurrent users are also available that offer support for the study selection process.
Software for managing the selection process can be identified using the Systematic Review Toolbox mentioned above. Compatibility with other software tools used in the review process such as RevMan may be a consideration when selecting a tool to support study selection. Should specialist software not be available, Bramer and colleagues have developed a method for using the widely available software EndNote X7 for managing the screening process Bramer et al Research into automating the study selection process through machine learning and text mining has received considerable attention over recent years, resulting in the development of various tools and techniques for reviewers to consider.
The use of automated tools has the potential to reduce the workload involved with selecting studies significantly Thomas et al Cochrane has also implemented a screening workflow called Screen4Me.
Cochrane author teams conducting intervention reviews that incorporate RCTs can access this workflow via the Cochrane Register of Studies. To date January , Screen4Me has been used in over 50 Cochrane intervention reviews.
Workload reduction in terms of screening burden varies depending on the prevalence of RCTs in the domain area and the sensitivity of the searches conducted. In addition to learning from large datasets such as those generated by Cochrane Crowd, it is also possible for machine learning models to learn how to apply eligibility criteria for individual reviews.
It is difficult for authors to determine in advance when it is safe to stop screening and allow some records to be eliminated automatically without manual assessment. Recent work has suggested that this barrier is not insurmountable, and that it is possible to estimate how many relevant records remain to be found based on the sample already screened Sneyd and Stevenson , Callaghan and Muller-Hansen , Li and Kanoulas The automatic elimination of records using this approach has not been recommended for use in Cochrane Reviews at the time of writing.
This active learning process can still be useful, however, since by prioritizing records for screening in order of relevance, it enables authors to identify the studies that are most likely to be included much earlier in the screening process than would otherwise be possible. Finally, tools are available that use natural language processing to highlight sentences and key phrases automatically e. PICO elements, trial characteristics, details of randomization to support the reviewer whilst screening Tsafnat et al Many of the sources listed in this chapter and the accompanying online Technical Supplement have been brought to our attention by a variety of people over the years and we should like to acknowledge this.
Evidence Based Library and Information Practice ; 14 : Agency for Healthcare Research and Quality. Methods guide for effectiveness and comparative effectiveness reviews: AHRQ publication no.
Annotated bibliography of published studies addressing searching for unpublished studies and obtaining access to unpublished data. Arber M, Wood H. Search strategy development [webpage]. Reporting standards for literature searches and report inclusion criteria: making research syntheses more transparent and easy to replicate. Research Synthesis Methods ; 6 : Alimentary Pharmacology and Therapeutics ; 26 : ; author reply Impact of searching clinical trial registries in systematic reviews of pharmaceutical treatments: methodological systematic review and reanalysis of meta-analyses.
BMJ ; : j Bennett DA, Jull A. FDA: untapped source of unpublished trials. Lancet ; : A cross-sectional audit showed that most Cochrane intervention reviews searched trial registers. Journal of Clinical Epidemiology ; : Bero L. Searching for unpublished trials using trials registers and trials web sites and obtaining unpublished trial data and corresponding trial protocols from regulatory agencies.
Booth A. How much searching is enough? Comprehensive versus optimal retrieval for technology assessments. Searching for qualitative research for inclusion in systematic reviews: a structured methodological review. Systematic Reviews ; 5 : The “realist search”: A systematic scoping review of current practice and reporting. Research Synthesis Methods ; 11 : Bramer WM. Variation in number of hits for complex searches in Google Scholar.
Journal of the Medical Library Association ; : Reviewing retrieved references for inclusion in systematic reviews using EndNote. Challenges in systematic reviews: synthesis of topics related to the delivery, organization, and financing of health care. Annals of Internal Medicine ; : Briscoe S. A review of the reporting of web searching to identify studies for Cochrane systematic reviews. Research Synthesis Methods ; 9 : Identifying additional studies for a systematic review of retention strategies in randomised controlled trials: making contact with trials units and trial methodologists.
Systematic Reviews ; 6 : Statistical stopping criteria for automated screening in systematic reviews. Systematic Reviews ; 9 : Callaway J. Journal of Health Information and Libraries Australasia ; 2 : Center for Drug Evaluation and Research. Auto Injector. Centre for Reviews and Dissemination. Systematic Reviews: CRD’s guidance for undertaking reviews in health care.
York: University of York; Chan AW. Out of sight but not out of mind: how to search for unpublished clinical trial evidence. BMJ ; : d Discontinuation and non-publication of surgical randomised controlled trials: observational study.
BMJ ; : g The role of modelling in prioritising and planning clinical trials. Health technology assessment Winchester, England ; 7 : iii, Chow TK. Electronic search strategies should be repeatable. European Journal of Pain ; 19 : Cochrane Information Specialist Support Team. Section 1: Role of a Cochrane Information Specialist. Section 6: Author support.
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Revisiting the need for a literature search narrative: A brief methodological note. Research Synthesis Methods b; 9 : Evaluating the effectiveness, efficiency, cost and value of contacting study authors in a systematic review: a case study and worked example.
A technical review of three clinical trials register resources indicates where improvements to the search interfaces are needed. Research Synthesis Methods a; 12 : What you see depends on where you sit: The effect of geographical location on web-searching for systematic reviews: A case study.
Research Synthesis Methods b; 12 : Cooper H, Ribble RG. Influences on the outcome of literature searches for integrative research reviews. Science Communication ; 10 : Craven J, Levay P. Recording database searches for systematic reviews – What is the value of adding a narrative to peer-review checklists? A case study of NICE interventional procedures guidance.
Evidence Based Library and Information Practice ; 6 : Chapter 7: Searching for studies. What time-lag for a retraction search on PubMed? BMC Research Notes ; 7 : Information science.
Going, going, gone: lost Internet references. Science ; : Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ ; : f Identifying studies for systematic reviews of diagnostic tests was difficult due to the poor sensitivity and precision of methodologic filters and the lack of information in the abstract.
Journal of Clinical Epidemiology ; 58 : Publication bias in clinical research. Identification of randomized controlled trials in systematic reviews: accuracy and reliability of screening records. Statistics in Medicine ; 21 : Language bias in randomised controlled trials published in English and German. Egger M, Smith GD. Bias in location and selection of studies. BMJ ; : How important are comprehensive literature searches and the assessment of trial quality in systematic reviews?
Empirical study. Health Technology Assessment ; 7 : How do authors of systematic reviews deal with research malpractice and misconduct in original studies? A cross-sectional analysis of systematic reviews and survey of their authors. BMJ Open ; 6 : e Embase Classic Fact Sheet; Embase in Fact Sheet; Embase content coverage; Process of information retrieval for systematic reviews and health technology assessments on clinical effectiveness.
European Food Safety Authority. Application of systematic review methodology to food and feed safety assessments to support decision making. EFSA Journal ; 8 : Eysenbach G, Trudel M. Going, going, still there: using the WebCite service to permanently archive cited web pages. Journal of Medical Internet Research ; 7 : e A capture-recapture analysis demonstrated that randomized controlled trials evaluating the impact of diagnostic tests on patient outcomes are rare.
Journal of Clinical Epidemiology ; 65 : Identification of problems in search strategies in Cochrane Reviews. Searching for qualitative health research required several databases and alternative search strategies: a study of coverage in bibliographic databases. Journal of Clinical Epidemiology a; : PubMed coverage varied across specialties and over time: a large-scale study of included studies in Cochrane reviews.
Journal of Clinical Epidemiology b; : The evolving role of preprints in the dissemination of COVID research and their impact on the science communication landscape. PLoS Biology ; 19 : e Cochrane Rapid Reviews Methods Group offers evidence-informed guidance to conduct rapid reviews.
Single-reviewer abstract screening missed 13 percent of relevant studies: a crowd-based, randomized controlled trial. Characteristics of academic publications, preprints, and registered clinical trials on the COVID pandemic. PLoS One ; 15 : e Searching ClinicalTrials. A digital media strategy to obtain unpublished data for a systematic review yields a very high author response rate.
Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study. Greenhalgh T, Peacock R. Effectiveness and efficiency of search methods in systematic reviews of complex evidence: audit of primary sources. The role of Google Scholar in evidence reviews and its applicability to grey literature searching.
PLoS One ; 10 : e Value and usability of unpublished data sources for systematic reviews and network meta-analyses. Evidence-based Medicine ; 21 : Using data sources beyond PubMed has a modest impact on the results of systematic reviews of therapeutic interventions. Journal of Clinical Epidemiology ; 68 : The contribution of databases to the results of systematic reviews: a cross-sectional study. Grey literature in systematic reviews: a cross-sectional study of the contribution of non-English reports, unpublished studies and dissertations to the results of meta-analyses in child-relevant reviews.
Retrospective and prospective identification of unpublished controlled trials: lessons from a survey of obstetricians and pediatricians. Pediatrics ; 84 : Hinde S, Spackman E. Bidirectional citation searching to completion: an exploration of literature searching methods.
Pharmacoeconomics ; 33 : Horton R. Medical editors trial amnesty. Evaluation of PICO as a knowledge representation for clinical questions. Failure of investigational drugs in late-stage clinical development and publication of trial results.
Should systematic reviewers search for randomized, controlled trials published as letters? Institute for Quality and Efficiency in Health Care. Cologne; Institute of Medicine. Finding what works in health care: Standards for systematic reviews. Irvin E, Hayden J. Developing and testing an optimal search strategy for identifying studies of prognosis [Poster] 14th Cochrane Colloquium, Dublin, Ireland; October Challenges of identifying unpublished data from clinical trials: getting the best out of clinical trials registers and other novel sources.
Research Synthesis Methods When to include clinical study reports and regulatory documents in systematic reviews. Review of Cochrane reviews on acupuncture: how Chinese resources contribute to Cochrane reviews.
Journal of Alternative and Complementary Medicine ; 19 : Direction and impact of language bias in meta-analyses of controlled trials: empirical study. International Journal of Epidemiology ; 31 : The capture-mark-recapture technique can be used as a stopping rule when searching in systematic reviews.
Journal of Clinical Epidemiology ; 62 : Systematic examination of preprint platforms for use in the medical and biomedical sciences setting. BMJ Open ; 10 : e Trial registry searches for randomized controlled trials of new drugs required registry-specific adaptation to achieve adequate sensitivity.
Journal of Clinical Epidemiology ; 94 : Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports.
BMJ ; : h How health technology assessment agencies address the issue of unpublished data. Ten years after the International Committee of Medical Journal Editors’ clinical trial registration initiative, one quarter of phase 3 pediatric epilepsy clinical trials still remain unpublished: a cross sectional analysis.
PLoS One ; 11 : e Capture-mark-recapture as a tool for estimating the number of articles available for systematic reviews in critical care medicine. Journal of Critical Care ; 28 : Layton D. A critical review of search strategies used in recent systematic reviews published in selected prosthodontic and implant-related journals: Are systematic reviews actually systematic? International Journal of Prosthodontics ; 30 : Publication of clinical trials supporting successful new drug applications: a literature analysis.
PLoS Medicine ; 5 : e Emerging Themes in Epidemiology ; 5 : Methodological developments in searching for studies for systematic reviews: past, present and future? Systematic Reviews ; 2 : Lefebvre C, Duffy S. Peer review of searches for studies for health technology assessments, systematic reviews, and other evidence syntheses. Li D, Kanoulas E. Cultures of evidence across policy sectors: systematic review of qualitative evidence.
European Journal of Public Health ; 24 : How useful are unpublished data from the Food and Drug Administration in meta-analysis? Journal of Clinical Epidemiology ; 56 : Manheimer E, Anderson D. Survey of public information about ongoing clinical trials funded by industry: evaluation of completeness and accessibility. Marshall C, Brereton P. Systematic review toolbox: a catalogue of tools to support systematic reviews. Machine learning for identifying randomized controlled trials: an evaluation and practitioner’s guide.
A study of the value of requesting information from drug manufacturers for systematic reviews; 9 years of experience from the drug effectiveness review project. Systematic Reviews ; 7 : Journal of Clinical Epidemiology b; 75 : Impact of librarians on reporting of the literature searching component of pediatric systematic reviews. Metzendorf M-I. Why medical information specialists should routinely form part of teams producing high quality systematic reviews — a Cochrane perspective.
Frandsen et al. Contacting of authors modified crucial outcomes of systematic reviews but was poorly reported, not systematic, and produced conflicting results. The inclusion of reports of randomised trials published in languages other than English in systematic reviews.
The effect of English-language restriction on systematic review-based meta-analyses: a systematic review of empirical studies. Reporting quality of search methods in systematic reviews of HIV behavioral interventions — : are the searches clearly explained, systematic and reproducible?
Research Synthesis Methods ; 5 : National Institute for Health and Care Excellence. Chapter 5: Identifying the evidence: literature searching and evidence submission. Developing NICE guidelines: the manual. London: Process and methods [PMG20]; Niederstadt C, Droste S. Reporting and presenting information retrieval processes: the need for optimizing common practice in health technology assessment. An evaluation of Cochrane Crowd found that crowdsourcing produced accurate results in identifying randomized trials.
Cochrane Centralised Search Service showed high sensitivity identifying randomized controlled trials: A retrospective analysis. Excluding non-English publications from evidence-syntheses did not change conclusions: a meta-epidemiological study.
Using text mining for study identification in systematic reviews: a systematic review of current approaches. Systematic Reviews ; 4 : 5. Erratum in: Systematic Reviews ; Changes in evidence for studies assessing interventions for COVID reported in preprints: meta-research study. BMC Medicine ; 18 : The science of reviewing research. Annals of the New York Academy of Sciences ; : ; discussion Tools for assessing risk of reporting biases in studies and syntheses of studies: a systematic review.
BMJ Open ; 8 : e BMJ a; : n PRISMA explanation and elaboration: updated guidance and exemplars for reporting systematic reviews. BMJ b; : n Clinical trial registries: more international, converging efforts are needed.
Trials ; 18 : Petticrew M, Roberts H. Oxford UK : Blackwell; Language of publication restrictions in systematic reviews gave different results depending on whether the intervention was conventional or complementary.
Pieper D, Puljak L. Language restrictions in systematic reviews should not be imposed in the search strategy but in the eligibility criteria if necessary.
Journal of Alternative and Complementary Medicine ; 11 : Methods for documenting systematic review searches: a discussion of common issues. Relevo R, Paynter R. Peer Review of Search Strategies. Librarian co-authors correlated with higher quality reported search strategies in general internal medicine systematic reviews.
Systematic Reviews ; 10 : An e-mail survey identified unpublished studies for systematic reviews. Journal of Clinical Epidemiology ; 59 : A review of meta-analyses. Journal of Psychosomatic Research ; 87 : The well-built clinical question: a key to evidence-based decisions. Poor reporting of search strategy and conflict of interest in over narrative and systematic reviews of two biologic agents in arthritis: a systematic review.
Royle P, Milne R. Literature searching for randomized controlled trials used in Cochrane reviews: rapid versus exhaustive searches. Royle P, Waugh N. Should systematic reviews include searches for published errata? Errors in search strategies used in systematic reviews and their effects on information retrieval. Should meta-analysts search Embase in addition to Medline?
An alternative to the hand searching gold standard: Validating methodological search filters using relative recall. Sampson M, McGowan J. Errors in search strategies were identified by type and frequency. No consensus exists on search reporting methods for systematic reviews. Journal of Clinical Epidemiology ; 61 : Research Synthesis Methods ; 2 : Journal of Clinical Epidemiology ; 78 : Authors report lack of time as main reason for unpublished research presented at biomedical conferences: a systematic review.
Searching for unpublished data for Cochrane reviews: cross sectional study. Pinpointing needles in giant haystacks: use of text mining to reduce impractical screening workload in extremely large scoping reviews. Use of cost-effectiveness analysis to compare the efficiency of study identification methods in systematic reviews.
Sneyd A, Stevenson M. Roles for librarians in systematic reviews: a scoping review. Use of the capture-recapture technique to evaluate the completeness of systematic literature searches.
Peer review of literature search strategies: does it make a difference? Spry C, Mierzwinski-Urban M. The impact of the peer review of literature search strategies in support of rapid review reports.
Stevinson C, Lawlor DA. Searching multiple databases for systematic reviews: added value or diminishing returns? Complementary Therapies in Medicine ; 12 : Controlled Clinical Trials ; 21 : Living systematic reviews: 2. Combining human and machine effort. Journal of Clinical Epidemiology ; 91 : Machine learning reduced workload with minimal risk of missing studies: development and evaluation of a randomized controlled trial classifier for Cochrane Reviews.
Impact of covert duplicate publication on meta-analysis: a case study. Systematic review automation technologies. Systematic Reviews ; 3 : US National Library of Medicine. PubMed Overview no date. Viergever RF, Li K.
Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from to BMJ Open ; 5 : e Different patterns of duplicate publication: an analysis of articles used in systematic reviews. Single screening versus conventional double screening for study selection in systematic reviews: a methodological systematic review.
Dividend from other potential sources of randomised controlled trials. Unpublished research from a medical specialty meeting: why investigators fail to publish.
Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications. Witkowski MA, Aldhouse N. Transparency and reproducibility of supplementary search methods in NICE single technology appraisal manufacturer submissions.
Value in Health ; 18 : A Woods D, Trewheellar K. Medline and Embase complement each other in literature searches. Wright K, McDaid C. Reporting of article retractions in bibliographic databases and online journals. Journal of the Medical Library Association ; 99 : Systematic reviews and meta-analyses of traditional Chinese medicine must search Chinese databases to reduce language bias.
Evidence-Based Complementary and Alternative Medicine ; : Analysis of the reporting of search strategies in Cochrane systematic reviews. Journal of the Medical Library Association ; 97 : Young T, Hopewell S.
Methods for obtaining unpublished data. Ziel J. BMC Palliative Care ; 17 : For permission to re-use material from the Handbook either academic or commercial , please see here for full details. Top menu Contact Cochrane. Studies not reports of studies are included in Cochrane Reviews but identifying reports of studies is currently the most convenient approach to identifying the majority of studies and obtaining information about them and their results.
Trials registers should be searched for all Cochrane Reviews and other sources such as regulatory agencies and clinical study reports CSRs are increasingly important for identifying study results. Searches should aim for high sensitivity, which may result in relatively low precision. Search strategies should avoid using too many different search concepts but a wide variety of search terms should be combined with OR within each included concept.
Both free-text and subject headings e. C19 : Planning the search Mandatory Plan in advance the methods to be used for identifying studies. C25 : Searching specialist bibliographic databases Highly desirable Search appropriate national, regional and subject-specific bibliographic databases. C31 : Searching by contacting relevant individuals and organizations Highly desirable Contact relevant individuals and organizations for information about unpublished or ongoing studies.
C27 : Searching trials registers Mandatory Search trials registers and repositories of results, where relevant to the topic, through ClinicalTrials. C28 : Searching for grey literature Highly desirable Search relevant grey literature sources such as reports, dissertations, theses and conference abstracts. C29 : Searching within other reviews Highly desirable Search within previous reviews on the same topic.
C30 : Searching reference lists Mandatory Check reference lists in included studies and any relevant systematic reviews identified. C26 : Searching for different types of evidence Mandatory If the review has specific eligibility criteria around study design to address adverse effects, economic issues or qualitative research questions, undertake searches to address them.
C32 : Structuring search strategies for bibliographic databases Mandatory Inform the structure of search strategies in bibliographic databases around the main concepts of the review, using appropriate elements from PICO and study design. C33 : Developing search strategies for bibliographic databases Mandatory Identify appropriate controlled vocabulary e. C35 : Restricting database searches Mandatory Justify the use of any restrictions in the search strategy on publication date and publication format.
C48 : Examining errata Mandatory Examine any relevant retraction statements and errata for information. C37 : Rerunning searches Mandatory Rerun or update searches for all relevant sources within 12 months before publication of the review or review update, and screen the results for potentially eligible studies.
C38 : Incorporating findings from rerun searches Highly desirable Fully incorporate any studies identified in the rerun or update of the search within 12 months before publication of the review or review update.
C36 : Documenting the search process Mandatory Document the search process in enough detail to ensure that it can be reported correctly in the review. C42 : Collating multiple reports Mandatory Collate multiple reports of the same study, so that each study, rather than each report, is the unit of interest in the review.
C39 : Making inclusion decisions Mandatory Use at least two people working independently to determine whether each study meets the eligibility criteria, and define in advance the process for resolving disagreements. C19 : Planning the search Mandatory. C25 : Searching specialist bibliographic databases Highly desirable. The cookie is used to store information of how visitors use a website and helps in creating an analytics report of how the website is doing.
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A recent audit by Cochrane investigators showed that the majority of Cochrane Reviews do comply with this standard Berber et al Although there are many other trials registers, ClinicalTrials.
Research has shown that even though ClinicalTrials. The extent to which this might still be the case with the new ICTRP interface released in its final version in June see online Technical Supplement remains to be ascertained. Therefore, the current guidance that it is not sufficient to search the ICTRP alone still stands, pending further research. Guidance for searching these and other trials registers is provided in the online Technical Supplement. In addition to Cochrane, other organizations also advocate searching trials registers.
There has been an increasing acceptance by investigators of the importance of registering trials at inception and providing access to their trials results. Despite perceptions and even assertions to the contrary, however, there is no global, universal legal requirement to register clinical trials at inception or at any other stage in the process, although some countries are beginning to introduce such legislation Viergever and Li Efforts have been made by a number of organizations, including organizations representing the pharmaceutical industry and individual pharmaceutical companies, to begin to provide central access to ongoing trials and in some cases trial results on completion, either on a national or international basis.
Increasingly, as already noted, trials registers such as ClinicalTrials. Search trials registers and repositories of results, where relevant to the topic, through ClinicalTrials. Although ClinicalTrials. A number of organizations, including Cochrane, recommend searching regulatory agency sources and clinical study reports. Details of these are provided in the online Technical Supplement. Clinical study reports CSRs are the reports of clinical trials providing detailed information on the methods and results of clinical trials submitted in support of marketing authorization applications.
The policy applies only to documents received since 1 January The terms of use for access are based on the purposes to which the clinical data will be put. Further details of this and other resources are available in the online Technical Supplement. A recent study by Jefferson and colleagues Jefferson et al that looked at use of regulatory documents in Cochrane Reviews, found that understanding within the Cochrane community was limited and guidance and support would be required if review authors were to engage with regulatory documents as a source of evidence.
Specifically, guidance on how to use data from regulatory sources is needed. The online Technical Supplement describes several other important sources of reports of studies.
Review authors may also consider searching the internet, handsearching journals and searching full texts of journals electronically where available see online Technical Supplement for details.
They should examine previous reviews on the same topic and check reference lists of included studies and relevant systematic reviews see MECIR Box 4. Search relevant grey literature sources such as reports, dissertations, theses and conference abstracts. Check reference lists in included studies and any relevant systematic reviews identified. This section highlights some of the issues to consider when designing search strategies. Designing search strategies can be complex and the section does not fully address the many complexities in this area.
Many of the issues highlighted relate to both the subject aspects of the search e. For a search to be robust, both aspects require attention to be sure that relevant records are not missed. Further evidence-based information about designing search strategies can be found on the SuRe Info portal , which is updated twice per year. If the review has specific eligibility criteria around study design to address adverse effects, economic issues or qualitative research questions, undertake searches to address them.
Sometimes a review will address questions about adverse effects, economic issues or qualitative research using a different set of eligibility criteria from the main effectiveness component. In such situations, the searches for evidence must be suitable to identify relevant study designs for these questions. Different searches may need to be conducted for different types of evidence.
The starting point for developing a search strategy is to consider the main concepts being examined in a review. For a Cochrane Review, the review objective should provide the PICO concepts, and the eligibility criteria for studies to be included will further assist in the selection of appropriate subject headings and text words for the search strategy.
The structure of search strategies in bibliographic databases should be informed by the main concepts of the review see Chapter 3 , using appropriate elements from PICO and study design see MECIR Box 4.
Although a research question may specify particular comparators or outcomes, these concepts may not be well described in the title or abstract of an article and are often not well indexed with controlled vocabulary terms. Therefore, in general databases, such as MEDLINE, a search strategy will typically have three sets of terms: i terms to search for the health condition of interest, i. Typically, a broad set of search terms will be gathered for each concept and combined with the OR Boolean operator to achieve sensitivity within concepts.
The results for each concept are then combined using the AND Boolean operator, to ensure each concept is represented in the final search results. It is important to consider the structure of the search strategy on a question-by-question basis. In some cases it is possible and reasonable to search for the comparator, for example if the comparator is explicitly placebo; in other cases the outcomes may be particularly well defined and consistently reported in abstracts. The advice on whether or not to search for outcomes for adverse effects differs from the advice given above see Chapter Inform the structure of search strategies in bibliographic databases around the main concepts of the review, using appropriate elements from PICO and study design.
In structuring the search, maximize sensitivity whilst striving for reasonable precision. Inappropriate or inadequate search strategies may fail to identify records that are included in bibliographic databases.
The structure of a search strategy should be based on the main concepts being examined in a review. In general databases, such as MEDLINE, a search strategy to identify studies for a Cochrane Review will typically have three sets of terms: i terms to search for the health condition of interest, i. There are exceptions, however. For instance, for reviews of complex interventions, it may be necessary to search only for the population or the intervention.
Some search strategies may not easily divide into the structure suggested, particularly for reviews addressing complex or unknown interventions, or diagnostic tests Huang et al , Irvin and Hayden , Petticrew and Roberts , de Vet et al , Booth or using specific approaches such as realist reviews which may require iterative searches and multiple search strategies Booth et al Cochrane Reviews of public health interventions and of qualitative data may adopt very different search approaches to those described here Lorenc et al , Booth see Chapter 17 on intervention complexity, and Chapter 21 on qualitative evidence.
Some options to explore for such situations include:. Searches for systematic reviews aim to be as extensive as possible in order to ensure that as many of the relevant studies as possible are included in the review.
It is, however, necessary to strike a balance between striving for comprehensiveness and maintaining relevance when developing a search strategy.
Sensitivity is defined as the number of relevant reports identified divided by the total number of relevant reports in the resource. Precision is defined as the number of relevant reports identified divided by the total number of reports identified. Increasing the comprehensiveness or sensitivity of a search will reduce its precision and will usually retrieve more non-relevant reports. Article abstracts identified through a database search can usually be screened very quickly to ascertain potential relevance.
At a conservatively estimated reading rate of one or two abstracts per minute, the results of a database search can be screened at the rate of 60— per hour or approximately — over an 8-hour period , so the high yield and low precision associated with systematic review searching may not be as daunting as it might at first appear in comparison with the total time to be invested in the review. Table 4. This section should be read in conjunction with Section 3. One is based on text words, that is terms occurring in the title, abstract or other relevant fields available in the database.
The other is based on standardized subject terms assigned to the references either by indexers specialists who appraise the articles and describe their topics by assigning terms from a specific thesaurus or controlled vocabulary or automatically using automated indexing approaches.
Searches for Cochrane Reviews should use an appropriate combination of these two approaches, i. Approaches for identifying text words and controlled vocabulary to combine appropriately within a search strategy, including text mining approaches, are presented in the online Technical Supplement.
C33 : Developing search strategies for bibliographic databases Mandatory. Identify appropriate controlled vocabulary e. MeSH, Emtree, including ‘exploded’ terms and free-text terms considering, for example, spelling variants, synonyms, acronyms, truncation and proximity operators. Search strategies need to be customized for each database. The same principle applies to Emtree when searching Embase and also to a number of other databases. In order to be as comprehensive as possible, it is necessary to include a wide range of free-text terms for each of the concepts selected.
This might include the use of truncation and wildcards. Developing a search strategy is an iterative process in which the terms that are used are modified, based on what has already been retrieved. Searches should capture as many studies as possible that meet the eligibility criteria, ensuring that relevant time periods and sources are covered and not restricted by language or publication status see MECIR Box 4.
Review authors should justify the use of any restrictions in the search strategy on publication date and publication format see MECIR Box 4. To reduce the risk of introducing bias, searches should not be restricted by language.
Recommendations for rapid reviews searches to limit publication language to English and add other languages only when justified Garritty et al are supported by evidence that excluding non-English studies does not change the conclusions of most systematic reviews Morrison et al , Jiao et al , Hartling et al , Nussbaumer-Streit et al However, exceptions that non-English studies do influence review findings have been observed for complementary and alternative medicine Moher et al , Pham et al , Wu et al , psychiatry, rheumatology and orthopaedics Egger et al Additionally, when searches are limited to English or to databases containing only English-language articles, there is a risk that eligible studies may be missed from countries where a particular intervention of interest is more common e.
For further discussion of these issues see Chapter Particularly when resources and time are available, the inclusion of non-English studies in systematic reviews is recommended to minimize the risk of language bias Egger et al , Pilkington et al , Morrison et al It has also been argued that, when language restrictions are justified, these should not be imposed by limiting the search but by including language as an eligibility criterion during study selection Pieper and Puljak Further use of a supportive narrative may help explain why a particular date restriction was applied Craven and Levay , Cooper et al b.
For example, a database date restriction of current for a review of nurse-led community training of epinephrine autoinjectors is justified because this is the approval date of the first device Center for Drug Evaluation and Research Conversely, arbitrary date restrictions intended to reduce search yield e.
Caution should be exercised when designing database search strategies with date restrictions. Information specialists should be aware of the various date fields available from database providers e. It may be necessary to search additional sources or datafiles to ensure adequate coverage of the date period of interest for the review. To account for inconsistent publication dates in database records e. As any information about an eligible study may contain valuable details for analysis, document format restrictions should not be applied to systematic review searches.
For example, excluding letters is not recommended because letters may contain important additional information relating to an earlier trial report or new information about a trial not reported elsewhere Iansavichene et al As with comments and letters, preprints versions of scientific articles that precede formal peer review and publication in a journal should also be considered a potentially relevant source of study evidence.
Recent and widespread availability of preprints has resulted from an urgent demand for emerging evidence during the COVID pandemic Gianola et al , Kirkham et al , Callaway , Fraser et al As study data are often reported in multiple publications and may be reported differently in each Oikonomidi et al , efforts to identify all reports for eligible studies, regardless of publication format, are necessary to support subsequent stages of the review process to select, assess and analyse complete study data.
Justify the use of any restrictions in the search strategy on publication date and publication format. Date restrictions in the search should only be used when there are date restrictions in the eligibility criteria for studies. They should be applied only if it is known that relevant studies could only have been reported during a specific time period, for example if the intervention was only available after a certain time point.
Searches for updates to reviews might naturally be restricted by date of entry into the database rather than date of publication to avoid duplication of effort. Publication format restrictions e. When considering the eligibility of studies for inclusion in a Cochrane Review, it is important to be aware that some studies may have been found to contain errors or to be fraudulent or may, for other reasons, have been corrected or retracted since publication.
For review updates, it is important to search MEDLINE and Embase for the latest version of the citations to the records for the previously included studies, in case they have since been corrected or retracted. Errata are published to correct unintended errors accepted as errors by the author s that do not invalidate the conclusions of the article. Including data from studies that are fraudulent or studies that include errors can have an impact on the overall estimates in systematic reviews.
There is an increasing awareness of the importance of not including retracted studies or those with significant errata in systematic reviews and how best to avoid this Royle and Waugh , Wright and McDaid , Decullier et al A recent study, however, showed that even when review authors suspect research misconduct, including data falsification, in the trials that they are considering including in their systematic reviews, they do not always report it Elia et al Details of how to identify fraudulent studies, other retracted publications, errata and comments are described in the online Technical Supplement.
Some studies may have been found to be fraudulent or may have been retracted since publication for other reasons. Errata can reveal important limitations, or even fatal flaws, in included studies. All of these may lead to the potential exclusion of a study from a review or meta-analysis. Care should be taken to ensure that this information is retrieved in all database searches by downloading the appropriate fields, together with the citation data.
Search filters are search strategies that are designed to retrieve specific types of records, such as those of a particular methodological design. When searching for randomized trials in humans, a validated filter should be used to identify studies with the appropriate design see MECIR Box 4. The site includes, amongst others, filters for identifying systematic reviews, randomized and non-randomized studies and qualitative research in a range of databases and across a range of service providers Glanville et al For further discussion around the design and use of search filters, see the online Technical Supplement.
Use specially designed and tested search filters where appropriate including the Cochrane Highly Sensitive Search Strategies for identifying randomized trials in MEDLINE, but do not use filters in pre-filtered databases e.
Search filters should be used with caution. They should be assessed not only for the reliability of their development and reported performance, but also for their current accuracy, relevance and effectiveness given the frequent interface and indexing changes affecting databases.
It is strongly recommended that search strategies should be peer reviewed before the searches are run. Peer review of search strategies is increasingly recognized as a necessary step in designing and executing high-quality search strategies to identify studies for possible inclusion in systematic reviews.
Studies have shown that errors occur in the search strategies underpinning systematic reviews and that search strategies are not always conducted or reported to a high standard Mullins et al , Layton , Salvador-Olivan et al This has also been shown to be the case within some Cochrane Reviews Franco et al Research has shown that peer review using a specially designed checklist can improve the quality of searches both in systematic reviews Relevo and Paynter , Spry et al and in rapid reviews Spry et al , Spry and Mierzwinski-Urban The PRESS checklist covers not only the technical accuracy of the strategy line numbers, spellings, etc.
It is recommended that authors provide information on the search strategy development and peer review processes. For Cochrane Reviews, the names, credentials, and institutions of the peer reviewers of the search strategies should be noted in the review with their permission in the Acknowledgments section. In practice, alerts are based on a previously developed search strategy, which is saved in a personal account on the database platform e.
These saved strategies filter the content as the database is being updated with new information. The account owner is notified usually via email when new publications meeting their specified search parameters are added to the database. In the case of PubMed, the alert can be set up to be delivered weekly or monthly, or in real-time and can comprise email or RSS feeds.
For review authors, alerts are a useful tool to help monitor what is being published in their review topic after the original search has been conducted. Authors should consider setting up alerts so that the review can be as current as possible at the time of publication.
Another way of attempting to stay current with the literature as it emerges is by using alerts based on journal tables of contents TOCs. These usually cannot be specifically tailored to the information needs in the same way as search strategies developed to cover a specific topic.
They can, however, be a good way of trying to keep up to date on a more general level by monitoring what is currently being published in journals of interest. Many journals, even those that are available by subscription only, offer TOC alert services free of charge. In addition, a number of publishers and organizations offer TOC services see online Technical Supplement.
Use of TOCs is not proposed as a single alternative to the various other methods of study identification necessary for undertaking systematic reviews, rather as a supplementary method. See also Chapter 22, Section Alerts should also be considered for sources beyond databases and journal TOCs, such as trials register resources and regulatory information.
The published review should be as up to date as possible. Searches for all the relevant databases should be rerun prior to publication, if the initial search date is more than 12 months preferably six months from the intended publication date see MECIR Box 4. This is also good practice for searches of non-database sources. The results should also be screened to identify potentially eligible studies. Ideally, the studies should be incorporated fully in the review.
Rerun or update searches for all relevant sources within 12 months before publication of the review or review update, and screen the results for potentially eligible studies. The search must be rerun close to publication, if the initial search date is more than 12 months preferably six months from the intended publication date, and the results screened for potentially eligible studies.
Fully incorporate any studies identified in the rerun or update of the search within 12 months before publication of the review or review update. After the rerun of the search, the decision whether to incorporate any new studies fully into the review will need to be balanced against the delay in publication. Developing a search is often an iterative and exploratory process.
It involves exploring trade-offs between search terms and assessing their overall impact on the sensitivity and precision of the search. It is often difficult to decide in a scientific or objective way when a search is complete and search strategy development can stop.
The ability to decide when to stop typically develops through experience of developing many strategies. Suggestions for stopping rules have been made around the retrieval of new records, for example to stop if adding in a series of new terms to a database search strategy yields no new relevant records, or if precision falls below a particular cut-off point Chilcott et al Stopping might also be appropriate when the removal of terms or concepts results in missing relevant records.
Another consideration is the amount of evidence that has already accrued: in topics where evidence is scarce, authors might need to be more cautious about deciding when to stop searching.
Although many methods have been described to assist with deciding when to stop developing the search, there has been little formal evaluation of the approaches Booth , Arber and Wood At a basic level, investigation is needed as to whether a strategy is performing adequately.
It is not enough, however, for the strategy to find only those records, otherwise this might be a sign that the strategy is biased towards known studies and other relevant records might be being missed. In addition, citation searches see online Technical Supplement Section 1. If those additional methods are finding documents that the searches have already retrieved, but that the team did not necessarily know about in advance, then this is one sign that the strategy might be performing adequately.
If some of the PRESS dimensions seem to be missing without adequate explanation or arouse concerns, then the search may not yet be complete. Statistical techniques can be used to assess performance, such as capture-recapture Spoor et al , Ferrante di Ruffano et al also known as capture-mark-recapture; Kastner et al , Lane et al , or the relative recall technique Sampson et al , Sampson and McGowan Kastner suggests the capture-mark-recapture technique merits further investigation since it could be used to estimate the number of studies in a literature prospectively and to determine where to stop searches once suitable cut-off levels have been identified.
This would entail potentially an iterative search and selection process. Capture-recapture needs results from at least two searches to estimate the number of missed studies. Further investigation of published prospective techniques seems warranted to learn more about the potential benefits.
Relative recall Sampson et al , Sampson and McGowan requires a range of searches to have been conducted so that the relevant studies have been built up by a set of sensitive searches.
The performance of the individual searches can then be assessed in each individual database by determining how many of the studies that were deemed eligible for the evidence synthesis and were indexed within a database, can be found by the database search used to populate the synthesis.
If a search in a database did not perform well and missed many studies, then that search strategy is likely to have been suboptimal. If the search strategy found most of the studies that were available to be found in the database, then it was likely to have been a sensitive strategy. Assessments of precision could also be made, but these mostly inform future search approaches since they cannot affect the searches and record assessment already undertaken.
Relative recall may be most useful at the end of the search process since it relies on the achievement of several searches to make judgements about the overall performance of strategies.
In evidence synthesis involving qualitative data, searching is often more organic and intertwined with the analysis such that the searching stops when new information ceases to be identified Booth The reasons for stopping need to be documented and it is suggested that explanations or justifications for stopping may centre around saturation Booth Further information on searches for qualitative evidence can be found in Chapter Review authors should document the search process in enough detail to ensure that it can be reported correctly in the review see MECIR Box 4.
The searches of all the databases should be reproducible to the extent that this is possible. By documenting the search process, we refer to internal record-keeping, which is distinct from reporting the search process in the review discussed in online Chapter III. Document the search process in enough detail to ensure that it can be reported correctly in the review. The search process including the sources searched, when, by whom, and using which terms needs to be documented in enough detail throughout the process to ensure that it can be reported correctly in the review, to the extent that all the searches of all the databases are reproducible.
Suboptimal reporting of systematic review search activities and methods has been observed Sampson et al , Roundtree et al , Niederstadt and Droste Research has also shown a lack of compliance with guidance in the Handbook with respect to search strategy description in published Cochrane Reviews Sampson and McGowan , Yoshii et al , Franco et al The lack of consensus regarding optimal reporting has been a challenge with respect to the values of transparency and reproducibility.
These recommendations may influence record keeping practices of searchers. For Cochrane Reviews, the bibliographic database search strategies should be copied and pasted into an appendix exactly as run and in full, together with the search set numbers and the total number of records retrieved by each search strategy.