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Free Download Mac version. Free Download Product key. 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.
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.
Version 2: November. Should unpublished data be included in meta-analyses? Current convictions and controversies. JAMA ; : Defining the process to literature searching in systematic reviews: a literature review of guidance and supporting studies.
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
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Available from www. Cochrane Reviews take a systematic and comprehensive approach to identifying studies that meet the eligibility criteria for the review. This chapter outlines some general issues in searching for studies; describes the main sources of potential studies; and discusses how to plan the search process, design and carry out search strategies, manage references found during the search process, correctly document the search process and select studies from the search results.
This chapter aims to provide review authors with background information on all aspects of searching for studies so that they can better understand the search process.
This chapter focuses on searching for randomized trials. Many of the search principles discussed, however, will also apply to other study designs. Considerations for searching for non-randomized studies are discussed in Chapter 24 see also Chapter 19 when these are specifically for adverse effects. Other discussion of searching for specific types of evidence appears in chapters dedicated to these types of evidence, such as Chapter 17 on intervention complexity, Chapter 20 on economic evidence and Chapter 21 on qualitative evidence.
An online Technical Supplement to this chapter provides more detail on searching methods. There is increasing evidence of the involvement of information specialists in systematic reviews Spencer and Eldredge and evidence to support the improvement in the quality of various aspects of the search process Rethlefsen et al , Meert et al , Metzendorf , Aamodt et al Cochrane Review authors should, therefore, contact their Cochrane Information Specialist at the earliest stage to find out what advice and support is available to them.
Authors conducting their own searches should seek advice from their Cochrane Information Specialist not only on which sources to search, but also with respect to the exact strategies to be run see Section 4. Cochrane Information Specialists are responsible for providing assistance to authors with searching for studies for inclusion in their reviews, and for keeping up to date with Cochrane methodological developments in information retrieval Cochrane Information Specialist Support Team a.
Most CRGs offer support to authors in study identification from the early planning stage to the final write-up of the review, and the support available may include some or all of the following:. Systematic reviews require a thorough, objective and reproducible search of a range of sources to identify as many eligible studies as possible within resource limits. This is a major factor distinguishing systematic reviews from traditional narrative reviews, which helps to minimize bias and achieve more reliable estimates of effects and uncertainties.
Searching beyond MEDLINE is important not only for ensuring that as many relevant studies as possible are identified, but also to minimize selection bias for those that are found. Relying exclusively on a MEDLINE search may retrieve a set of reports unrepresentative of all reports that would have been identified through a wider or more extensive search of several sources.
Time and budget restraints require the review team to balance the thoroughness of the search with efficiency in the use of time and funds. The best way of achieving this balance is to be aware of, and try to minimize, the biases such as publication bias and language bias that can result from restricting searches in different ways see Chapter 8 and Chapter 13 for further guidance on assessing these biases.
Unlike for tasks such as study selection or data extraction, it is not considered necessary or even desirable for two people to conduct independent searches in parallel.
Systematic reviews have studies as the primary units of interest and analysis. A single study may have more than one report about it or record for it , and each of these reports or other records may contribute useful information for the review see Section 4. For most of the sources listed in Section 4.
There is, however, an increasing number of study-based sources, which link multiple records of the same study together, such as the Cochrane Register of Studies and the Specialized Registers of a number of CRGs see online Technical Supplement , and some other trials registers and regulatory and industry sources.
Processes and software to select and group publications by study are discussed in Section 4. All review authors and others involved in Cochrane should adhere to copyright legislation and the terms of database licensing agreements. With respect to searching for studies, this refers in particular to adhering to the terms and conditions of use when searching databases and other sources and downloading records, as well as adhering to copyright legislation when obtaining copies of publications.
The search for studies in a Cochrane Review should be as extensive as possible in order to reduce the risk of reporting bias and to identify as much relevant evidence as possible see MECIR Box 4. Database selection should be guided by the review topic Suarez-Almazor et al , Stevinson and Lawlor , Lorenzetti et al When topics are specialized, cross-disciplinary, or involve emerging technologies Rice et al , additional databases may need to be identified and searched Wallace et al , Stevinson and Lawlor , Frandsen et al a.
Plan in advance the methods to be used for identifying studies. Design searches to 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.
Searches should be motivated directly by the eligibility criteria for the review, and it is important that all types of eligible studies are considered when planning the search. If searches are restricted by publication status or by language of publication, there is a possibility of publication bias, or language bias whereby the language of publication is selected in a way that depends on the findings of the study , or both.
Removing language restrictions in English language databases is not a good substitute for searching non-English language journals and databases. Searches for studies should be as extensive as possible in order to reduce the risk of publication bias and to identify as much relevant evidence as possible.
Expertise may be required to avoid unnecessary duplication of effort. These databases are described in more detail in Sections 4.
A key advantage of such databases is that they can be searched electronically both for words in the title or abstract and by using the standardized indexing terms, or controlled vocabulary, assigned to each record see Section 4. They may be available through national provisions, site-wide licences at institutions such as universities or hospitals, through professional organizations as part of their membership packages or free-of-charge on the internet. Some international initiatives provide free or low-cost online access to databases and full-text journals over the internet.
Electronic Information for Libraries EIFL is a similar initiative based on library consortia to support affordable licensing of journals and other sources in more than 50 low-income and transition countries in central, eastern and south-east Europe, the former Soviet Union, Africa, the Middle East and South-east Asia.
The online Technical Supplement provides more detailed information about how to search these sources and other databases. The accompanying Appendix provides a list of general healthcare databases by region and healthcare databases by subject area. Further evidence-based information about sources to search can be found on the SuRe Info portal , which is updated twice per year.
MEDLINE as of January contains approximately 30 million references to journal articles in biomedicine and health from onwards. When searching MEDLINE via service providers or interfaces other than Ovid or PubMed, we recommend verification of the exact coverage of the database in relation to PubMed, where no explicit information on this is readily available.
Embase as of January contains over 35 million records from onwards, including records from more than currently published journals from approximately countries Elsevier Further details on the implications of this for searching are available in the online Technical Supplement. Embase Classic provides access to almost two million records digitized from the Excerpta Medica print journals the original print indexes from which Embase was created from to Elsevier Embase now also includes pre-print articles from multiple sources Elsevier Embase is only available by subscription, either directly via Elsevier as Embase.
Note that Embase is searched regularly by Cochrane for reports of trials. The actual degree of reference overlap between MEDLINE and Embase varies widely according to the topic, but studies comparing searches of the two databases have generally concluded that a comprehensive search requires that both databases be searched Lefebvre et al , Bramer et al see MECIR Box 4.
Conversely, two studies examined different samples of Cochrane Reviews and identified the databases from which the included studies of these reviews originated Halladay et al , Hartling et al Both studies, one across all healthcare areas Halladay et al and the other on child health Hartling et al , report a minimal extent to which the inclusion of studies not indexed in PubMed altered the meta-analyses.
PubMed coverage across systematic review topics has been further evaluated in a recent study based on a comprehensive sample of Cochrane Reviews. Hence, the current recommendation of searching multiple databases needs to be evaluated further, so as to confirm under which circumstances comprehensive searches of multiple databases are warranted.
CENTRAL, however, also includes citations to reports of randomized trials that are not indexed in MEDLINE, Embase or other bibliographic databases; citations published in many languages; and citations that are available only in conference proceedings or other sources that are difficult to access.
It also includes records from trials registers and trials results registers beyond ClinicalTrials. These additional records are, for the most part, identified by Cochrane Information Specialists, many of whom conduct comprehensive searches to populate CRG Specialized Registers, collecting records of trials eligible for Cochrane Reviews in their field.
In these cases, the search will be more precise, but an equivalent number of included studies will be identified with lower numbers of records to screen. Many review authors have full access free-of-charge at the point-of-use through national provisions and other similar arrangements, or as part of a paid subscription to the Cochrane Library. Many countries and regions produce bibliographic databases that focus on the literature produced in those regions and which often include journals and other literature not indexed elsewhere.
It is highly desirable that searches be conducted of appropriate national, regional and subject specific bibliographic databases see MECIR Box 4. Further details are provided in the online Technical Supplement.
Citation indexes are bibliographic databases that record instances where a particular reference is cited, in addition to the standard bibliographic content. Citation indexes can be used to identify studies that are similar to a study report of interest, as it is probable that other reports citing or cited by a study will contain similar or related content.
Search appropriate national, regional and subject-specific bibliographic databases. Databases relevant to the review topic should be covered e. Initiatives to provide access to ongoing studies and unpublished data constitute a fast-moving field Isojarvi et al It is important to identify ongoing studies, so that when a review is updated these can be assessed for possible inclusion. Awareness of the existence of a possibly relevant ongoing study and its expected completion date might affect not only decisions with respect to when to update a specific review, but also when to aim to complete a review.
Even when studies are completed, some are never published. Finding out about unpublished studies, and including their results in a systematic review when eligible and appropriate Cook et al , is important for minimizing bias. Several studies and other articles addressing issues around identifying unpublished studies have been published Easterbrook et al , Weber et al , Manheimer and Anderson , MacLean et al , Lee et al , Chan , Bero , Schroll et al , Chapman et al , Kreis et al , Scherer et al , Hwang et al , Lampert et al There is no easy and reliable single way to obtain information about studies that have been completed but never published.
There have, however, been several important initiatives resulting in better access to studies and their results from sources other than the main bibliographic databases and journals. These include trials registers and trials results registers see Section 4. A recent study Halfpenny et al assessed the value and usability for systematic reviews and network meta-analyses of data from trials registers, CSRs and regulatory authorities, and concluded that data from these sources have the potential to influence systematic review results.
A Cochrane Methodology Review examined studies assessing methods for obtaining unpublished data and concluded that those carrying out systematic reviews should continue to contact authors for missing data and that email contact was more successful than other methods Young and Hopewell An annotated bibliography of published studies addressing searching for unpublished studies and obtaining access to unpublished data is also available Arber et al One particular study focused on the contribution of unpublished studies, including dissertations, and studies in languages other than English, to the results of meta-analyses in reviews relevant to children Hartling et al They found that, in their sample, unpublished studies and studies in languages other than English rarely had any impact on the results and conclusions of the review.
Correspondence can be an important source of information about unpublished studies. It is highly desirable for authors of Cochrane Reviews of interventions to contact relevant individuals and organizations for information about unpublished or ongoing studies see MECIR Box 4. Letters of request for information can be used to identify completed but unpublished studies. One way of doing this is to send a comprehensive list of relevant articles along with the eligibility criteria for the review to the first author of reports of included studies, asking if they know of any additional studies ongoing or completed; published or unpublished that might be relevant.
This approach may be especially useful in areas where there are few trials or a limited number of active research groups. It may also be desirable to send the same letter to other experts and pharmaceutical companies or others with an interest in the area. Some review teams set up websites for systematic review projects, listing the studies identified to date and inviting submission of information on studies not already listed.
A recent study assessed the value of contacting trial authors and concluded that data supplied by authors modified the outcomes of some systematic reviews, but this was poorly reported in the reviews Meursinge Reynders et al Another case study of a Cochrane Methodology Review reported that making contact with clinical trials units and trial methodologists provided data for six of the 38 RCTs included in the review, which had not been identified through other search methods Brueton et al C31 : Searching by contacting relevant individuals and organizations Highly desirable.
Contact relevant individuals and organizations for information about unpublished or ongoing studies. It is important to identify ongoing studies, so that these can be assessed for possible inclusion when a review is updated. Asking researchers for information about completed but never published studies has not always been found to be fruitful Hetherington et al , Horton though some researchers have reported that this is an important method for retrieving studies for systematic reviews Royle and Milne , Greenhalgh and Peacock , Reveiz et al A recent study reported successful outcomes of a digital media strategy to obtain unpublished data from trial authors Godard-Sebillotte et al A study assessed the value of requesting information from drug manufacturers for systematic reviews and concluded that this helped to reduce reporting and publication bias and helped to fill important gaps, sometimes leading to new or altered conclusions, primarily where no other evidence existed McDonagh et al The RIAT Restoring Invisible and Abandoned Trials initiative Doshi et al aims to address the problems outlined above by offering a methodology that allows others to re-publish mis-reported and to publish unreported trials.
Anyone who can access the trial data and document trial abandonment can use this methodology. The RIAT Support Centre offers free-of-charge support and competitive funding to researchers interested in this approach.
It has also been suggested that legislation such as Freedom of Information Acts in various countries might be used to gain access to information about unpublished trials Bennett and Jull , MacLean et al A recent study suggested that trials registers are an important source for identifying additional randomized trials Baudard et al 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
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