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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.
The search strategies should not be re-typed, because this can introduce errors. The same process is also good practice for searches of trials registers and other sources, where the interface used, such as introductory or advanced, should also be specified. Creating a report of the search process can be accomplished through methodical documentation of the steps taken by the searcher. This need not be onerous if suitable record keeping is performed during the process of the search, but it can be nearly impossible to recreate post hoc.
Many database interfaces have facilities for search strategies to be saved online or to be emailed; an offline copy in text format should also be saved. For some databases, taking and saving a screenshot of the search may be the most practical approach Rader et al Documenting the searching of sources other than databases, including the search terms used, is also required if searches are to be reproducible Atkinson et al , Chow , Witkowski and Aldhouse Details about contacting experts or manufacturers, searching reference lists, scanning websites, and decisions about search iterations can be produced as an appendix in the final document and used for future updates.
The purpose of search documentation is transparency, internal assessment, and reference for any future update. It is important to plan how to record searching of sources other than databases since some activities contacting experts, reference list searching, and forward citation searching will occur later on in the review process after the database results have been screened Rader et al The searcher should record any correspondence on key decisions and report a summary of this correspondence alongside the search strategy in a search narrative.
The narrative describes the major decisions that shaped the strategy and can give a peer reviewer an insight into the rationale for the search approach Craven and Levay A worked example of a search narrative is available Cooper et al b.
Local copies should be stored in a structured way to allow retrieval when needed. There are also web-based tools which archive webpage content for future reference, such as WebCite Eysenbach and Trudel The results of web searches will not be reproducible to the same extent as bibliographic database searches because web content and search engine algorithms frequently change, and search results can differ between users due to a general move towards localization and personalization Cooper et al b.
It is still important, however, to document the search process to ensure that the methods used can be transparently reported Briscoe In cases where a search engine retrieves more results than it is practical to screen in full it is rarely practical to search thousands of web results, as the precision of web searches is likely to be relatively low , the number of results that are documented and reported should be the number that were screened rather than the total number Dellavalle et al , Bramer Decisions should be documented for all records identified by the search.
Numbers of records are sufficient for exclusions based on initial screening of titles and abstracts. Broad categorizations are sufficient for records classed as potentially eligible during an initial screen of the full text. Authors will need to decide for each review when to map records to studies if multiple records refer to one study.
The flow diagram records initially the total number of records retrieved from various sources, then the total number of studies to which these records relate. Review authors need to match the various records to the various studies in order to complete the flow diagram correctly. Lists of included and excluded studies must be based on studies rather than records see also Section 4. A Cochrane Review is a review of studies that meet pre-specified eligibility criteria.
Since each study may have been reported in several articles, abstracts or other reports, an extensive search for studies for the review may identify many reports for each potentially relevant study. Two distinct processes are therefore required to determine which studies can be included in the review. One is to link together multiple reports of the same study; and the other is to use the information available in the various reports to determine which studies are eligible for inclusion.
Although sometimes there is a single report for each study, it should never be assumed that this is the case. As well as the studies that inform the systematic review, other studies will also be identified and these should be recorded or tagged as they are encountered, so that they can be listed in the relevant tables in the review:. Duplicate publication can take various forms, ranging from identical manuscripts to reports describing different outcomes of the study or results at different time points von Elm et al The number of participants may differ in the different publications.
Where uncertainties remain after considering these and other factors, it may be necessary to correspond with the authors of the reports. Multiple reports of the same study should be collated, so that each study, rather than each report, is the unit of interest in the review see MECIR Box 4. Review authors will need to choose and justify which report the primary report to use as a source for study results, particularly if two reports include conflicting results. They should not discard other secondary reports, since they may contain additional outcome measures and valuable information about the design and conduct of the study.
Collate multiple reports of the same study, so that each study, rather than each report, is the unit of interest in the review. It is wrong to consider multiple reports of the same study as if they are multiple studies.
Secondary reports of a study should not be discarded, however, since they may contain valuable information about the design and conduct. Review authors must choose and justify which report to use as a source for study results. A typical process for selecting studies for inclusion in a review is as follows the process should be detailed in the protocol for the review :. Note that studies should not be omitted from a review solely on the basis of measured outcome data not being reported see MECIR Box 4.
Systematic reviews typically should seek to include all relevant participants who have been included in eligible study designs of the relevant interventions and had the outcomes of interest measured.
Reviews must not exclude studies solely on the basis of reporting of the outcome data, since this may introduce bias due to selective outcome reporting and risk undermining the systematic review process. While such studies cannot be included in meta-analyses, the implications of their omission should be considered.
Note that studies may legitimately be excluded because outcomes were not measured. Furthermore, issues may be different for adverse effects outcomes, since the pool of studies may be much larger and it can be difficult to assess whether such outcomes were measured. Decisions about which studies to include in a review are among the most influential decisions that are made in the review process and they involve judgement.
Use at least two people working independently to determine whether each study meets the eligibility criteria. Ideally, screening of titles and abstracts to remove irrelevant reports should also be done in duplicate by two people working independently although it is acceptable that this initial screening of titles and abstracts is undertaken by only one person. 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.
The inclusion decisions should be based on the full texts of potentially eligible studies when possible, usually after an initial screen of titles and abstracts. It is desirable, but not mandatory, that two people undertake this initial screening, working independently. 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.
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