What are the best practices? (Has Best Practice)
From The Embassy of Good Science
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In a 2007 study, Einarsdóttir collected data in several ways:
'''''Group and individual interviews combined with observation'''''
Interviews were primarily used, which together with observations are the most common method used in research with children. They can be group or individual. The emphasis here is on talking to the child, that is providing an opportunity to be heard. Group interviews involve mostly preschool children who are used to being together in groups, and through interacting with other children they learn and form their attitudes towards the environment.
'''''Using props'''''
Some researchers suggest the use of props such as toys, paper and crayons, clay, or sand. Children’s drawings can also provide insight into the view and experience of young children. The advantage is providing non-verbal expression, and children are active and creative as they draw. The disadvantages are the possible imitation of other children's drawings or simply the child does not like to draw. Many authors recommend the use of photographs taken by children as a method of data collection. Photographing combined with touring increases the power of children because data collection is directly in their hands. Photography gives children the opportunity to express their views in different ways, inviting them to combine visual and verbal language. In addition, in the above-mentioned study, disposable cameras were given to the children. They were told that they could take photos of what they want and what they consider important in kindergarten, and after developing the photos, the teachers sat down with the children individually and talked to them about what was in the photos and why they were taken.
'''''Modified surveys'''''
Surveys are not a common method for research with children primarily because of their age. However, there is the possibility of constructing a questionnaire in the form of a child-friendly game. This may include paper forms of different colors that contain questions that the children in the game answer. This allows data to be collected during everyday children’s activities rather than in a fictional context.
Throughout history, multiple violations of ethical principles in human research have occurred. The most widely known are perhaps the inhumane experiments conducted by the Nazis and Japanese during the WW2. In the aftermath of the WW2, the Nuremberg Code was published to provide basic guidelines in human research. To further improve the ethics of human research, the World Medical Association developed the Declaration of Helsinki in 1964. While providing some guidance, instances of unethical research persisted. In the United States, a large study was conducted to assess the impact of syphilis, and hundreds of participants were barred from seeking treatment in what was known as the Tuskegee experiment. Following the public outcry, the Belmont report was published in 1978. These documents set important standards in human research and provide the foundations of medical ethics. Some of the important points are respect for the person, personal autonomy (and informed consent), justice, and beneficence. Nowadays, different countries have national laws, informed by the aforementioned international guidance, regarding clinical research and oversight by research ethics committees.
'''Related guidelines'''
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*[https://history.nih.gov/research/downloads/nuremberg.pdf Nuremberg code]
*[https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ Declaration of Helsinki]
*[https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html Belmont report]
'''Related cases'''
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*[https://www.cdc.gov/tuskegee/timeline.htm Tuskegee syphilis experiment]
*[https://encyclopedia.ushmm.org/content/en/article/nazi-medical-experiments Nazi human experiments] +
Since World War II, a lot has been said about human experimentation, and vulnerable groups in particular. Many different reports and guidelines have been developed and should be consulted when thinking about involving vulnerable and non-competent individuals. Start with the Declaration of Helsinki and don’t forget to check the appropriate regulations of your own country and institution. +
Each institution should have its official, long and shortened affiliations for the institution in general, as well as its departments in specific.
Every author should list affiliations for all institutions they're connected to, regardless of which institution funds the research. +
Practice guidelines are diverse and vary according to the scientific field. Rather than rules, professional bodies provide guidelines or recommendations and most guidelines leave some room for interpretation.
===='''Medicine'''====
The best-known authorship guideline comes from the International Committee of Medical Journal Editors. The ICMJE recommends that an author should meet all four of the following criteria: '"`UNIQ--ref-0000016F-QINU`"'‘‘Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work,’’'"`UNIQ--ref-00000170-QINU`"'’’Drafting the work or revising it critically for important intellectual content,’’ '"`UNIQ--ref-00000171-QINU`"' ‘‘Final approval of the version to be published,’’ and '"`UNIQ--ref-00000172-QINU`"'‘‘Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved’’. The committee further designates that in addition to excluding a scholar who has not met all four criteria, any scholar who meets all four should be included as an author. Following the authorship criteria, the ICMJE expressly describes contributions that should be included as an acknowledgment, and not authorship (i.e., funding, supervision, writing assistance, technical or language editing, proofreading). '"`UNIQ--ref-00000173-QINU`"'
===='''Science'''====
The Council of Science Editors describes authors as “individuals identified by the research group to have made substantial contributions to the reported work and agree to be accountable for these contributions. In addition to being accountable for the parts of the work he or she has done, an author should be able to identify which of their co-authors are responsible for specific other parts of the work. In addition, an author should have confidence in the integrity of the contributions of their co-authors. All authors should review and approve the final manuscript.”'"`UNIQ--ref-00000174-QINU`"'
===='''Chemistry, Physics, and Mathematics'''====
Guidelines in the physical and mathematical sciences offer somewhat less precise definitions, such as this from the American Physical Society: “Authorship should be limited to those who have made a significant contribution to the concept, design, execution or interpretation of the research study. All those who have made significant contributions should be offered the opportunity to be listed as authors. Other individuals who have contributed to the study should be acknowledged, but not identified as authors.”'"`UNIQ--ref-00000175-QINU`"'
===='''Sociology'''====
The American Sociological Association includes the following in its Code of Ethics: “(a) Sociologists take responsibility and credit, including authorship credit, only for work they have actually performed or to which they have contributed. (b) Sociologists ensure that principal authorship and other publication credits are based on the relative scientific or professional contributions of the individuals involved, regardless of their status. In claiming or determining the ordering of authorship, sociologists seek to reflect accurately the contributions of main participants in the research and writing process. (c) A student is usually listed as principal author on any multiple-authored publication that substantially derives from the student’s dissertation or thesis.” '"`UNIQ--ref-00000176-QINU`"'
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There are numerous cases of violation of publication ethics with regards to authors’ rights. For instance, when journals publish articles without the authors’ consent. One of the representative examples is an article on the quality of therapeutic trials in perinatal medicine, written by Dr Jon Tyson and his colleagues and published in the Journal of Pediatrics in 1983.'"`UNIQ--ref-000000E3-QINU`"' Six months after that, the paper was published in full in the journal of Obstetrics and Gynecology without the authors’ consent only to be described “as a poor study” in a hostile accompanying editorial.'"`UNIQ--ref-000000E4-QINU`"''"`UNIQ--ref-000000E5-QINU`"'
Another case regards dispute between the authors. An article was submitted to a journal by corresponding author (CA), at the time a PhD student, and published online. Later, co-author A (head of the research group) informed the publisher that the paper was submitted to a journal by CA during her absence (maternity leave) and that she as well as other 7 co-authors were not informed about the publication. Additionally, she requested the retraction of the article. She also mentioned that she had recently submitted an updated version of the same paper to another journal and that all authors, including CA, had agreed to the publication. When journal contacted CA, he stated that he had asked co-author A for permission to submit the article but that the had not received an answer for one year.'"`UNIQ--ref-000000E6-QINU`"' The CA replied that he had signed contract at the research institution where co-author A worked and where the research had been conducted. He agreed to retract the article. One of the co-authors also contacted the publisher asserting that CA had published the paper without his approval and he also suggested retraction of the paper. '"`UNIQ--ref-000000E7-QINU`"'In the end, the authors submitted an updated version of the same paper to another journal.'"`UNIQ--ref-000000E8-QINU`"'
This case was discussed at the COPE Forum. The Forum suggested for future notice that when a journal receives a manuscript, it must send an acknowledgement to all of the authors, not just the corresponding author.'"`UNIQ--ref-000000E9-QINU`"' Most Forum members agreed that there was no ground for retraction of the article, because there was no issue concerning the scientific content of the article. However, since the editor did not have authors’ consent for publication, some members of the Forum concluded that the authors did have some ground for retraction.'"`UNIQ--ref-000000EA-QINU`"'
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There is no single uniform consent form for all journals, only general principles and guidance provided by committees for publication ethics. The British Medical Journal (BMJ) Ethics Committee, for example, offers recommendations on how to obtain the participant’s consent. The consent is necessary even if identifying details are removed. Participant’s personal information will not be published if he or she refuses to give consent, with the exception of high importance to public health.'"`UNIQ--ref-000002F4-QINU`"' Some recommendations to publish research findings without participant’s consent include these conditions:
-the participant cannot be found in order to give his consent or it is impossible or unreasonable to expect to gain consent from the patient or his next-of-kin
-the article contains data which importance for public health overrides the importance of participant’s consent
-it is expected that a participant would not object to the publication of the case. This requires an assessment of the intrusiveness of the disclosure and potential embarrassment or distress
-the case is anonymized so that the participant’s identity will not be revealed.'"`UNIQ--ref-000002F5-QINU`"'
The committee has also stated that giving absolute priority to confidentiality would hold back medical research and education, so there must be a balance between confidentiality and the need for data sharing.'"`UNIQ--ref-000002F6-QINU`"'
Committee on Publication Ethics (COPE) has released a [https://publicationethics.org/files/u7140/Discussion_document_on_Best_Practice_for_Consent_for_Publishing_Medical_Case_Reports.pdf Discussion document on Best Practice for Consent for Publishing Medical Case Reports]. The document stated that authors are obliged to collect the signed consent forms, not journals, and that forms should be used for cases where an individual or a group of individuals could be identified.'"`UNIQ--ref-000002F7-QINU`"' It concluded that no single form would be adequate for all journals, so it presented some specific points that a consent form should include:
-a place for the name of the patient and the name of the individual signing the form
-a place for the name of the person who has explained the form to the patient or family member
-indication that the patient has seen the case report and pictures regarding it and that they agree to it
-information that the journal cannot guarantee confidentiality after publishing the case report
-information under what license the report is published
-information that form does not remove the patient’s rights to privacy
-information that the patient has been informed of his right to revoke consent at any time before publication
-information that patients cannot expect any financial benefit from the publication of the case.
The document also provided links to examples of cases report forms and relevant guidance.'"`UNIQ--ref-000002F8-QINU`"' Example of participant’s consent for publication in a PLos One journal can be found [https://journals.plos.org/plosone/s/file?id=8ce6/plos-consent-form-english.pdf here].
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HIRMEOS integrates five publishing platforms:
-[https://books.openedition.org/ OpenEdition Books], the OpenEdition platform dedicated to open access books. It is run by the Center for Open Electronic Publishing (Cléo) in France. The platform disseminates more than 2700 open access books from 51 publishers from the SSH fields.
-[https://www.oapen.org/ OAPEN Library], a service run by OAPEN Foundation in Netherlands. It contains 2600 freely accessible academic books, mostly in the SSH disciplines. The platform collaborates with 120 publishers and provides services for publishers, libraries and research funders for deposit, quality assurance, dissemination as well as digital preservation.
-[https://epublishing.ekt.gr/ ΕΚΤ ePublishing], the ePublishing platform of the National Documentation Centre in Greece. It offers advanced e-infrastructures and related services to institutional publishers in Greece such as universities, research centers, scholarly societies and memory institutions, with aim of publishing peer-reviewed journals, proceedings and monographs in the SSH disciplines.
-[https://www.sub.uni-goettingen.de/en/publishing-open-access/goettingen-university-press/ Göttingen University Press], the publishing house of Göttingen University in Germany which has published scholarly texts by researchers affiliated with the university since 2003. It supports the principles of open access, meaning it provides online content for users free of costs and limitations. All digital publications of Göttingen University Press are available for the public use permanently.
-[https://www.ubiquitypress.com/ Ubiquity Press], an open access publisher of peer-reviewed academic journals, books and data affordable for everyone. This publisher collaborates with RUA - an open source application developed by Ubiquity Press and designed to assist with the stages of the publishing monographs process: optional proposal, submission, internal review, peer review, copy editing, production and publication.'"`UNIQ--ref-000000B6-QINU`"'
One of the HIRMEOS objectives is to enrich these five digital publishing infrastructures with more functionalities and features to facilitate their further integration into the European Science Open Cloud.'"`UNIQ--ref-000000B7-QINU`"'
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Around 13 000 scholarly publishers, those with both open access and subscription requirement, have already been submitting their bibliographic metadata and references to Crossref.'"`UNIQ--ref-0000017E-QINU`"' At the launch of I4OA in September 2020, 8.3% of journal articles with a Crossref DOI had their abstracts available in the repository.'"`UNIQ--ref-0000017F-QINU`"' Publishers such as [https://www.bmj.com/ BMJ], [https://www.thebritishacademy.ac.uk/ The British Academy], [https://www.life-science-alliance.org/ Life Science Alliance], [https://academic.oup.com/journals/pages/open-abstracts-i4oa Oxford University Press], [https://us.sagepub.com/en-us/nam/home SAGE], [https://f1000research.com/ F1000], [https://www.mdpi.com/ MDPI], and many others have already joined I40A or have accepted to join. Longer list of these publishers is available [https://i4oa.org/#:~:text=Publishers%20supporting%20I4OA here]. +
The Initiative has asked scholarly publishers, who were already depositing the reference lists of their publications at Crossref, to make them open and available to everyone. Before this Initiative, only 1% of all references deposited at Crossref were open. As of August 2021, the percentage of publications with open references has grown from 1% to 88% out of 56.1 million articles with references submitted to Crossref.'"`UNIQ--ref-00000237-QINU`"'
Among significant publishers there are [https://www.crossref.org/members/prep/239 BMJ], [https://www.crossref.org/members/prep/56 Cambridge University Press], [https://www.crossref.org/members/prep/281 MIT Press], [https://www.crossref.org/members/prep/286 Oxford University Press], [https://www.crossref.org/members/prep/292 The Royal Society of Chemistry], [https://www.crossref.org/members/prep/179 SAGE Publications], and [https://www.crossref.org/members/prep/311 Wiley].'"`UNIQ--ref-00000238-QINU`"' You can see the full list [https://i4oc.org/#:~:text=Participating%20publishers here].
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There are different ways to make research open access. The two main routes that authors can take towards publishing open access are self-archiving, the so-called green route, and open access publishing, the gold route. '"`UNIQ--ref-0000000F-QINU`"' When taking the green route, the article is published behind a paywall, but a free copy is published in an online repository. In the gold route, articles are published immediately in open access mode.
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COPE has guidelines on many different topics, for different target stakeholders, including those for [https://publicationethics.org/resources/code-conduc editors] and [https://publicationethics.org/system/files/Code_of_conduct_for_publishers_Mar11.pdf publishers]. In addition, there are ten core practices formulated by cope, ranging from allegations of misconduct to ethical oversight to data and reproducibility. For all ten practices and explanations, see the [https://publicationethics.org/core-practices COPE core practices]. +
For example, the U.S. National Library of Medicine, which produces PubMed, the largest bibliographical database in health research, describes different types of procedures for amendments to the [http://wayback.archive-it.org/org-350/20180312141525/https://www.nlm.nih.gov/pubs/factsheets/errata.html published scientific record]. Retraction of an article involves publishing a retraction notice that explains the reasons for retraction and who is making the retraction. This notice links to the retracted article, which is clearly marked in the indexing database.
The current list of all retractions in PubMed, regardless of the cause (error or misconduct) is available [https://www.ncbi.nlm.nih.gov/pubmed?term=retracted+publication+%5Bpt%5D here].
Some journals want to differentiate between retractions due to misconduct and those that are due to an error that makes a research conclusion wrong, but can be corrected. Such corrections have been termed “retraction with republication” or “retraction with replacement” by the International Committee of Medical Journal Editors (ICMJE). This type of retraction is used when a serious error makes published results unreliable, but it was judged that the error was not intentional and the corrections are possible. Such retraction and replacement should be accompanied by full explanation, including a clear presentation of the extent of changes that were made.
The problem may occur when the retracted and replaced articles keep the same pagination and bibliographic identifiers (such as DOI – digital object identifier). Some bibliographical databases may not recognize this as a proper correction of literature. Databases usually require that the original and corrected/replaced publication are kept as separated publication items, with added notice that links them. Different understanding of how a retracted publication can be replaced with a corrected publication has caused differences in indexing of such publications in bibliographical databases, creating confusion for the users of published research articles.
A relevant tool to detect retracted papers and keep up to date on retraction scandals is Retraction Watch. Retraction watch is both a blog and a database of an estimated 17,000 retracted papers. The blog regularly updates on papers and authors that are retracted/about to be retracted. The database, found [http://retractiondatabase.org/ here], is a tool to find out whether a paper has been retracted. Journals, authors and reasons for retractions are given in the search results.
===Difficulties===
Common practises on standards of authorship vary between scientific disciplines, and between countries, making standardizing difficult. They also change over time. As the Swiss Academies of Arts and Sciences note:
''“Customs have changed over the past few decades; for example, the practice of granting “honorary” authorship to an eminent researcher – formerly not unusual – is no longer considered acceptable.”'''"`UNIQ--ref-00000140-QINU`"'
==='''European Code of Conduct '''===
''The European Code of Conduct for Research Integrity (2017)'' states the following:'"`UNIQ--ref-00000141-QINU`"'
*All authors are fully responsible for the content of a publication, unless otherwise specified
*All authors agree on the sequence of authorship, acknowledging that authorship itself is based on a significant contribution to the design of the research, relevant data collection, or the analysis or interpretation of the results
*Authors acknowledge important work and intellectual contributions of others, including collaborators, assistants, and funders, who have influenced the reported research in appropriate form, and cite related work correctly
*All authors disclose any conflicts of interest and financial or other types of support for the research or for the publication of its results
==='''COPE'''===
*Guideline: [https://publicationethics.org/files/2003pdf12_0.pdf How to handle authorship disputes: a guide for new researchers]
*Guideline: [https://publicationethics.org/files/International%20standard_editors_for%20website_11_Nov_2011.pdf Responsible research publication: international standards for editors]
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Although it is evident that non-peer-reviewed information has its pros and cons, it is not evident what the obligations of researchers are with regard to the dissemination of their research. The European Code of Conduct in Research Integrity, for instance, states that authors should be “…. honest in their communication to the general public and in traditional and social media.” <sup>13</sup> Thus, it does not explicitly forbid the pre-publication dissemination of results. In a public health emergency such as the ongoing pandemic, the situation is even more complex. The WHO Working Group on Ethics and COVID-19 states that “researchers generating information that has the potential to aid response efforts have an ethical obligation to share that information as soon as it is quality-controlled for release (e.g., peer-reviewed),” and that they should “…share this information without waiting for publication in scientific journals.” <sup>14</sup> These statements seem confusing, as it is unclear whether authors should wait until the manuscript is peer reviewed (which could be a long period) or circumvent this step. Here, the benefits of timely communication should be balanced against the potential risk of spreading inaccurate information, which can have lasting consequences.
When unreviewed information is communicated, however, it should be clearly labelled as such. In line with the principles of honesty, accuracy and transparency recommended by the ECCRI, neither the findings nor the relevance of the research should be exaggerated or misrepresented. +
The most prominent examples in practice are diagnostic studies and hypothesis generating studies. When developing new diagnostic models authors tend to combine multiple prognostic factors and then test such models using the ROC analysis on whole sample without validating the model on a separate sample. However, sometimes the need for validation of model is not disclosed in discussion section. Hypothesis generating studies are usually done on “big data” from databases such as The Cancer Genome Atlas. The primary goal of such studies is to build models based on large data sets and “get the feeling for the data”, or in more technical language to do exploratory data analysis, sometimes such studies do not disclose need for model validation (i.e. confirmatory data analysis). Sometimes after ANOVA, correction for multiple comparison testing also known as post hoc testing is done, these post hoc tests have more stringent statistical significance criteria with the purpose of somewhat replacing model validation. However, replacing model validation with more stringent statistical significance criteria is highly debated topics in a world of statistics.
Another case which is usually confused with HARKing are planned multiple comparisons after ANOVA. In this case the fact that comparisons are planned means that model was built before the experiment and based on it, comparisons are done after gathering data.'"`UNIQ--ref-000002C8-QINU`"'
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This is the definition of duplicate publication by the Committee on Publication Ethics (COPE):
“When a published work (or substantial sections from a published work) is/are published more than once (in the same or another language) without adequate acknowledgment of the source/cross-referencing/justification”.'"`UNIQ--ref-0000019A-QINU`"'
The International Committee of Medical Journal Editors (ICMJE) differentiates between '''duplicate submission''' – when authors submit the same work (possibly in different languages) to two or more journals at the same time; and '''duplicate publication''' – when the same work is already published more than once.
Duplicate publications must be retracted, and duplicate submissions, if discovered by journal editors, are usually rejected. COPE provides guidance on how to handle duplicate publications. Some indexing databases, such as PubMed, automatically tag duplicate publications when they identify them during indexation. '"`UNIQ--ref-0000019B-QINU`"'
Acceptable '''secondary publication''' is publication of the same work but with clear reference to its first publication and is usually intended for a different audience. In addition, authors must have approval from the journal that first published the article. The secondary publication must be a faithful reflection of the original publication and it must clearly reference the primary publication – as a note in the article and in the title of the secondary article.
What is not a duplicate publication? The ICMJE considers that a structured abstract under 500 words and registration of trial results in public trial registries are not redundant publications. This means that publishing a conference abstract is not considered a publication. Presentations at a meeting (poster or a talk) are also not considered to be proper publications, because they are usually not peer reviewed. Increasingly, authors post their work first in a preprint server (online research repositories) and many journals do not consider this to be duplicate publication. Journals expect the authors to inform them about where the work was posted on a preprint server.
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To prevent funding bias, the International Committee of Medical Journal Editors (ICMJE) requires that research articles have Disclosure Form containing:
“-sources of support for the work, including sponsor names along with explanations of the role of those sources if any in study design;
-collecting, analysis, and interpretation of data;
-writing of the report;
-any restrictions regarding submission of the report for publication;
-or a statement declaring that the supporting source had no such involvement or restrictions regarding publication.”'"`UNIQ--ref-0000008E-QINU`"'
In addition to that, editors may request that authors also sign a statement, such as: “I had full access to all of the data in this study and I take complete responsibility for the integrity of the data and the accuracy of the data analysis”.'"`UNIQ--ref-0000008F-QINU`"'
Some investigators have even proposed that academic studies funded by industry should continue only if academic medical centres would be solely responsible for the design, conduct, analysis, and reporting of clinical trials. Others have recommended that conflict-of-interest committees should be created at academic institutions to monitor the finances.'"`UNIQ--ref-00000090-QINU`"'
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On the systemic level, HARKing can be prevented by changing researcher assessment and promoting the preregistration of studies, ideally in a form involving reviewed preregistration with guaranteed publication if the accepted protocol is followed.
Individual researchers should make post hoc hypotheses transparent and thereby avoid deceiving readers to reap the benefits from exploratory studies without misrepresenting them as following a hypothetico-deductive model. +
===Related tools===
By Jensen (2000) '"`UNIQ--ref-000001E9-QINU`"'
*New data and cross-validation
*Sidak, Bonferroni, and other adjustments
*Resampling and randomization techniques
By Glenn & Cormier (2015) '"`UNIQ--ref-000001EA-QINU`"'
*Performing own reviews of the sources of data,
*Checking for retractions and corrections,
*Requiring full disclosure of methods,
*Acquiring original data and reanalyzing it,
*Avoiding secondary sources,
*Avoiding unreplicated studies or studies that are not concordant with related studies, and
*Checking for funding or investigator biases.
===Related cases===
Convenience, dichotomization, stratification, regression to the mean, impact of sample size, competing risks, immortal time and survivor bias, management of missing values . '"`UNIQ--ref-000001EB-QINU`"' '"`UNIQ--ref-000001EC-QINU`"'
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