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This document provides guidance on how to implement the Cochrane Policy for Managing = Potentially Problematic Studies which details what Cochrane Review= authors and Editors should do when serious concerns are raised about the t= rustworthiness of an included study or a study that may be eligible for inc= lusion in a Cochrane Review. This includes:
Such issues in included studies may arise due to scientific misconduct, = however untrustworthy study data does not necessarily occur as a result of = misconduct and may be the result of poor research practices or honest error= .
Cochrane Review Groups (CRGs) must ensure that the search strategy for a= Cochrane Review captures any post-publication amendments published on incl= uded or eligible studies. Post-publication amendments include expressions o= f concern, errata, corrigenda and retractions.
Further guidance on how to include post-publication amendments in search= strategies is available in:
Although it is not within Cochrane=E2=80=99s remit to conduct a formal i= nvestigation or arrive at a formal conclusion regarding the misconduct of a= n individual (or group of individuals), or about whether a published articl= e should be retracted, Cochrane has a responsibility not to include studies= on which there are serious concerns about the trustworthiness of the data.= CRGs are expected to take steps to minimise the risk of including problema= tic studies in Cochrane Reviews, such as checking for post-publication amen= dments and acting on any concerns raised by review authors, peer reviewers,= Editors, or readers about included studies.
This section details what should be done where there are concerns about = the trustworthiness of the data in a study that is included, or is eligible= for inclusion, in a Cochrane Review. These actions will differ depending o= n whether the potentially problematic study has a post publication amendmen= t and whether the Cochrane Review is unpublished or published.
Retracted studies should not be included in a Cochrane Review. See secti= on 1 Searching for post-publicatio= n amendments for links to resources on how to avoid inclusion of retrac= ted studies (see MECIR C48).
The retracted study should be listed in the =E2=80=9Cexcluded studies=E2= =80=9D section, with the reason noted, and including a citation to the publ= ished retraction notice. This reason must be noted using neutral language a= nd should not accuse authors of scientific misconduct. If there is any doub= t about the phrasing of such a note, the CRG must contact the named Associa= te Editor (who will refer on to the Research Integrity Team) before publica= tion of the Review.
If an included study is retracted after the Cochrane Review has been pub= lished, the study data must be removed from all analyses and the extent of = changes required in response to the retraction should be determined. While = this takes place, an Editorial Note should be added to the Cochrane Review = to clearly alert the reader that an included study has been retracted. The = wording of the Editorial Note should be agreed with the EMD before publicat= ion and should cite the retraction notice. The CRG should contact the named= Associate Editor (who will refer on to the Research Integrity Team as need= ed). See section 7.4 Template text for Edito= rial Note on a Cochrane Review for template text.
Depending on the extent of changes required in response to the retractio= n(s), it might be appropriate to withdraw (retract) the Cochrane Review. Th= e withdrawn notice should include a complete listing of the studies retract= ed, including citation to the retracted studies, and an indication of wheth= er the intention is to update and republish the Cochrane Review or not. See= Cochrane=E2=80=99s withdrawal pol= icy for further information on what to include in withdrawn notices.
If the Cochrane Review is determined not to require withdrawal, a citati= on to the published retraction notice (of the included study) should be add= ed to the text of the Cochrane Review as one of the references under the st= udy ID, resulting in the publication of a new citation version of the revie= w (using the =E2=80=9CWhat=E2=80=99s new=E2=80=9D events =E2=80=9CAmended= =E2=80=9D AND EITHER =E2=80=9CNew citation: conclusions not changed=E2=80= =9D OR =E2=80=9CNew citation: conclusions changed=E2=80=9D, as appropriate)= . See the What=E2=80=99s new publishing event= s policy for further information.
In cases where a journal is aware of concerns regarding a published arti= cle, an Expression of Concern may be published to alert readers to these co= ncerns while an investigation takes place to determine whether the findings= of the study can be relied upon or whether further action is needed, such = as retraction or correction.
Where there is an Expression of Concern published on an included study, = or a study that is eligible for inclusion in a Cochrane Review, the results= of that study should be treated with a high degree of caution. The CRG Edi= tor may wish to consider contacting the journal editor for additional infor= mation, however journals are often unable to give further information that = is stated in an Expression of Concern while an investigation is ongoing. If= further information is sought from a journal, all correspondence m= ust be kept neutral and should follow the provided template provid= ed in section 7.1.1 Asking a Journal Editor for further information about a= n Expression of Concern. All communication and information disclosed by= journal editors must be treated confidentially by Cochrane authors and CRG= Editors.
Depending on the reason for the published Expression of Concern, it may = be appropriate to exclude the study or its data from the Cochrane Review (e= .g. if the Expression of Concern is for serious concerns about the validity= of the data). Note that Expressions of Concern may be published for reason= s that do not affect the validity of the data (e.g. authorship disputes), i= n which case it may be considered appropriate to include the study in the C= ochrane Review. If uncertain, contact the named Associate Editor (who will = refer on to the Research Integrity Team as needed).
Based on the reason for the Expression of Concern, a decision may be mad= e to include or exclude data from that study until such time that either th= e study or the Expression of Concern itself is retracted, or further eviden= ce comes to light.
Depending on which decision is made, the following actions should be tak= en:
Following investigation by the Journal or study author=E2=80=99s institu= tion, the study may subsequently be retracted, or the Expression of Concern= itself retracted. If this happens after the Cochrane Review has been publi= shed, the authors of the Review should follow the actions in section 2.2.3 W= hat to do if the study or Expression of Concern is subsequently retracted= a>.
If the Expression of Concern relates to the validity of the data in the = included study, an Editorial Note should be added to the Cochrane Review to= acknowledge that concerns have been raised about one or more studies and/o= r study data included in the Cochrane Review. This should remain in place u= ntil either the Expression of Concern on the included study or the included= study itself is retracted. The text of the Editorial Note on the review sh= ould be agreed with the named Associate Editor, who will refer to the Resea= rch Integrity Team, and should cite the Expression of Concern that is publi= shed on the included study. See section 7.4 Template text for Editorial Note on a Cochrane Review= a> for template text.
A citation to the Expression of Concern published by the journal on the = included study must be added to the text of the Cochrane Review as one of t= he references under the study ID, and a note must be added to the Cochrane = Review to reference the Expression of Concern (e.g. in the description of s= tudies, results, discussion and abstract). Note that this will require a&nb= sp; =E2=80=9CWhat=E2=80=99s new=E2=80=9D event =E2=80=9CAmended=E2=80=9D bu= t does not require a new citation version of the review to be published =E2= =80=93 see the What=E2=80=99s new publishing = events policy for further information.
It may then be appropriate to analyse the effect of removal of the study= /studies from the Cochrane Review. Depending on the outcome of this analysi= s, the following steps should be taken:
Following investigation by the Journal or study author=E2=80=99s institu= tion, the included article with the Expression of Concern may be retracted,= or the Expression of Concern itself may be retracted (indicating that the = concerns about the study have been dismissed). In such a situation, the Coc= hrane Review authors should re-assess the potential inclusion of the study = in the Cochrane Review and the following actions should be taken:
In some cases, Cochrane Review authors or CRG Editors may have serious c= oncerns about an included study (see section 7.3 Examples of serious concerns about the t= rustworthiness of a study), or a study that is eligible for inclusion i= n a Cochrane Review, but there is no formal post-publication amendment publ= ished for that study.
At present there is no standard definition of, nor validated method to i= dentify, a problematic study. As such evidence becomes available and consen= sus emerges in this area, this guidance will be updated. Until such a time,= the following steps should be taken:
If, after attempting to draft a letter to the Journal Editor as describe= d in section 7.2= Methods for determining whether you have concerns about a study, you d= ecide that you do not have sufficient concerns about the study to contact t= he Journal Editor, the study can be included in the Cochrane Review. No fur= ther action is needed.
If concerns remain and you contact the Journal Editor to request an inve= stigation and/or clarification of whether the data can be included in a Coc= hrane Review (which can take a considerable time where a Journal and potent= ially also an institution is involved) the publication of a new or updated = Cochrane Review should not usually be delayed. If you have sufficient conce= rns about an included study to warrant contacting the Journal Editor, the s= tudy of concern should be categorized as =E2=80=9CAwaiting Classification= =E2=80=9D, with a note added to explain why. The language of the note must = be kept neutral, for example =E2=80=9CThe data could not be verified=E2=80= =9D. If any other note of explanation is required, you must contact the nam= ed Associate Editor, who will refer to the Research Integrity Team.
There is no time limit on how long studies can remain in the =E2=80=9CAw= aiting Classification=E2=80=9D category. It may be appropriate during protr= acted investigations to prompt the Journal Editor, as appropriate, for upda= tes.
See section 2.3.3 What to do when= a journal investigates for steps to take once an investigation is comp= leted.
If after your own assessment (which may include following the steps desc=
ribed in section 7.2 Methods for determining whether you have concerns about a study
If concerns remain and you contact the Journal Editor to request an inve= stigation and/or clarification to determine whether the data can be include= d in a Cochrane Review (which can take a considerable time where a Journal = and potentially also an institution is involved), an Editorial Note should = be added to the Cochrane Review to state that the journal editor has been c= ontacted with concerns about the included study. The statement should remai= n as neutral as possible and include links to any published articles that m= ight provide additional information (e.g. Letter to the Editor, etc.) and p= ropose a timeline for any update (if known). The text of any Editorial Note= must be agreed with the Research Integrity Team before publication. You sh= ould contact the named Associate Editor who will refer to the Research Inte= grity Team.
After contacting the Journal Editor, the steps described in section 2.3.3 What to do when a journal inv= estigates should be followed once the journal agrees to investigate the= concern.
If the Journal Editor does not respond when concerns are raised, and no = response is received on following up with the Journal Editor, consider cont= acting the Journal Publisher. If no response is received from the Journal P= ublisher, contact the named Associate Editor who will refer to the Research= Integrity Editor for advice.
Once you have contacted a Journal Editor, they should follow CO= PE guidelines to investigate the concerns raised to them. If concerns r= elate to trustworthiness of the data in a study, the Journal Editor may con= tact the author=E2=80=99s institution to ask them to conduct a formal inves= tigation into the study data. This may take some time and the Journal may d= ecide to publish an Expression of Concern to alert readers to the concerns = while an investigation is underway. If this occurs, the Editorial Note on t= he Cochrane Review should be updated to cite the Expression of Concern on t= he article and the steps described in section 2.2.2 Resolution for a pu= blished Cochrane Review (published Expression of Concern) should be fol= lowed.
If the Journal Editor confirms that an investigation will take some time= , it may be appropriate to analyse the effect of removal of the study/studi= es from the Cochrane Review. Depending on the outcome of this analysis, the= following steps should be taken:
Following completion of a journal and/or institutional investigation, th= e concerns may be upheld or dismissed, and the journal may take one the fol= lowing actions:
If the Journal/Institutional Investigation deems that the study is trust= worthy and decides to take no action, the study should be included in the C= ochrane Review. In the case of a published Cochrane Review where the study = was moved to =E2=80=9CAwaiting Classification=E2=80=9D, a =E2=80=98What=E2= =80=99s New event=E2=80=99 must be added to indicate the change (i.e. the f= ull inclusion of a study previously awaiting classification). See =E2=80=98= Assigning What=E2=80=99s New events to Cochr= ane Reviews=E2=80=99 for details on actions that need to be taken when = a study is added to a Cochrane Review. If an Editorial Note was added to th= e Cochrane Review, this should be revised to state that the Expression of C= oncern on the included study has now been removed. The Editorial Note can b= e removed from the Cochrane Review at the next update.
If the article is retracted, the steps detailed in Section 2.1 What to d= o when a study is retracted should be followed.
If a Correction article is published on the included study, the effect o= f this on the Cochrane Review should be determined and the Review updated i= f the correction affects the outcome of the review. If an Editorial Note wa= s added to the Cochrane Review, this will need to be updated as appropriate= . The named Associate Editor, who will refer on to the Research Integrity T= eam, should be contacted to agree the wording.
This section is relevant to Cochrane Information Specialists (CISs) and = others who have a responsibility for searching bibliographic databases, imp= orting records into the Cochrane Register of Studies (CRS), and adding elig= ible studies to the Cochrane Central Register of Controlled Trials (CENTRAL= ).
When a retraction notice relevant to a study that is already included in= the CRS (or that will be imported into the CRS) is identified, it should b= e imported into the relevant CRS segment. Please refer to the Ha= rmoniSR Guidance for formatting core (or mandatory) fields in refe= rence and study records in the CRS.
CISs should link imported retraction notices to the CRS records for the = retracted studies. For further guidance on how to do this, please refer to = the Informational Specialists Portal on the Cochrane Community = site and the Quick Reference Guide: How to deal with retractions in CRS.
Retracted studies that are eligible for CENTRAL (e.g. randomized and qua= si-randomized controlled trials) should be added to CENTRAL via CRS. Retrac= tion notices for CENTRAL study records should also be added to CENTRAL. Lin= king the retraction notice to the article being retracted using the CRS (se= e 3.2) will ensure that both the retraction notice and the article being re= tracted are visibly linked together in CENTRAL.
Sample CENTRAL records showing how retractions should appear in Cochrane= Library:
Support and advice are available to CRGs from the EMD on managing cases = where there are concerns about the trustworthiness of an included study, or= a study that is eligible for inclusion in a Cochrane Review. You can acces= s this support by contacting the named Associate Editor who will refer to t= he Research Integrity Team as needed. They will advise on the wording of co= mmunications to authors, journal editors, institutions and also text within= a Cochrane Review (for example, explaining why data from a study were excl= uded from the analyses, or why a study is =E2=80=9Cawaiting classification= =E2=80=9D) to mitigate the risk of defamation/libel. If further legal advic= e or support is required, it can be arranged by the EMD.
The first version of this policy a= nd guidance was drafted following discussions with members of the members o= f the Cochrane scientific misconduct policy advisory group (Andrew Moore, I= an Roberts, Emma Sydenham, Alison Avenell, Gerben ter Riet, Fergus MacBeth,= Angela Webster, Brian Stafford, John Carlisle, Mbah Patrick Okwen, Anne-Ma= rie Stephani, Joshua Cheyne, Gerry Stansby). The version has been revised f= ollowing wider consultation with the Cochrane Community. The final policy s= tatement and implementation guidance do not necessarily reflect the views o= f all participants of the advisory group.
Carlisle, J. B., Dexter, F., Pandit, J. J., Shafer, S. L. and Yentis, S.= M: Calculating the probability of random sampling for continuous variables= in submitted or published randomised controlled trials. Anaesthesia 2015 70(7): 848=E2=80=93858
International standards for clinical trial registries =E2=80=93 2nd edit= ion. Geneva: World Health Organization; 2018. Licence: CC BY-NC-SA 3.0 IGO.=
The appendix contains the following sections:
All correspondence must be kept neutral and the followi= ng templates should be followed. If a template is deemed inappropriate for = a particular situation or the CRG would like to deviate from the template, = the named Associate Editor must be contacted, and will refer to the Researc= h Integrity Team, before contacting the study author(s) or Journal Editor. = Correspondence must never accuse individuals of misconduct or fraud= .
If an Expression of concern has been published on an included study, or = study that is eligible for inclusion in a Cochrane Review and the CRG edito= r decides to ask the Journal Editor for further information, the following = template should be followed. For further information, see section 2.2 What to do when there is = a published Expression of Concern.
Dear <Journal Editor>,
My name is <name> and I am <role> at <CRG group name>.=
I am writing to you about the following article published in the <jou= rnal>: <citation, including DOI> which has an Expression of Concer= n Published.
[For an unpublished Cochrane Review= :]
<We have identified the above article as eligible for inclusion in a = Cochrane Review. In order to determine whether this study is appropriate fo= r inclusion in our review, we would be grateful if you were able to provide= any further information about the concerns relating to this study that led= to the publication of the Expression of Concern.>
[OR for a published Cochrane Review= :]
<The article has been included in a published Cochrane Review <ins= ert citation/link to published Cochrane Review>. In order to determine t= he effect this Expression of Concern has on the review, and whether we need= to take any action, we would be grateful if you were able to provide any f= urther information about the concerns relating to this study that led to th= e publication of the Expression of Concern.>
In addition, I would be grateful if you could answer the following quest= ions: [insert any specific questions f= or the editor, for example:]
<Do the concerns raised relate to the = validity or reliability of the data reported in the article?>
<Is the study subject to an ongoing in= stitutional investigation? If so, do you have an estimate for when this wil= l be completed?>
<Is this article currently under asses= sment for potential retraction from the journal?>
I thank you for your time and look forward to hearing back from you.
Best wishes,
<name and affiliation>
If you have concerns about the trustworthiness of an included study, the= following template should be used when contacting the Journal Editor for f= urther information. For further information, see section 2.3 What to do if you have concerns ab= out an included study.
Dear <Journal Editor>,
My name is <name> and I am <role> at <CRG group name>.=
I am writing to you about the following article published in the <jou= rnal>: <citation, including DOI>.
[For an unpublished Cochrane Review= :]
<We have identified the above article as eligible for inclusion in a = Cochrane Review. Following our assessment of included studies, we have iden= tified the following concerns with the article:>
[OR for a published Cochrane Review= :]
<The article has been included in a published Cochrane Review <ins= ert citation/link to published Cochrane Review> and we have subsequently= identified the following concerns with this article:>
[Insert factual, detailed descripti= on of your concerns regarding the article, including the exact method the author / review group used to decide there was a potential problem wi= th the study. Example text to be expanded on with specific concerns/method = of identification:]
<The article reports similar data to a= nother published article in <journal name>: <full citation>.>= ;
<The article reports data that seem in= consistent in <section of the paper where the data are inconsistent>.= >
<The article reports a study involving= human subjects but does not include a statement that ethics approval was g= ranted to conduct the study.>
<The article reports a clinical trial = but does not include a Trial Registration Number>
<Concerns about this paper have been r= aised on PubPeer, on <date> at <link>>
As Editor of the Journal publishing this article, please could you inves= tigate these concerns in line with guidelines from the Committee on Publica= tion Ethics (COPE).
I thank you for your time and look forward to hearing back from you.
=
&nb=
sp; =
&nb=
sp; =
&nb=
sp;
Best wishes,
<name and affiliation>
There is currently no standard definition of, nor a validated method to = identify, a problematic study that has not otherwise been identified as suc= h through a post-publication amendment. If you have serious concerns about = an included study, you should ask the Journal Editor to investigate (see se= ction 2.3 What to do= if you have concerns about an included study). The following list prov= ides options that others currently use when evaluating a study about which = they have doubts about the trustworthiness. You may wish to consider follow= ing some or all of these steps before contacting the Journal Editor, either= to help you define what your concerns are about the study or to determine = whether you do have concerns about a study where you are unsure. None of th= e actions listed are validated ways for determine whether a study is trustw= orthy, and do not on their own indicate untrustworthiness of a study. You m= ay wish to also look at section 7.3 Examples of serious concerns about the trustworthines= s of a study.
The following cases give anonymised examples based on concerns that have= been raised about studies that are eligible for inclusion in Cochrane Revi= ews.
Example 1
The authors of a review identified that a randomised controlled trial th= at was eligible for inclusion in a Cochrane Review that they were conductin= g contained overlapping text and data with a previously published article b= y different authors. The background, objectives, and conclusions of the art= icles contained identical text, but stated that they took place in differen= t hospitals and between slightly different dates. The number of participant= s per group was identical between the two articles, as was much of the data= reported. This raised concerns about the trustworthiness of the data repor= ted in the second article.
Actions taken: The CRG Editor contacted the Editor of t= he journal that had published the second article raising their concerns and= asking the journal to investigate. The article was placed the article in t= he =E2=80=9CAwaiting Classification=E2=80=9D section of the review.
Example 2
An Editor noticed that the distribution of the data in the control arm o= f a study that was eligible for inclusion in a Cochrane Review did not look= plausible when compared to a more plausible looking distribution in anothe= r article. Further assessment showed that there were exactly equal numbers = in each group, exactly equal mean at baseline between control and intervent= ion, no negative changes, and no odd numbers). Based on this, they had seri= ous concerns that the control arm changes were measured data.
Actions taken: The CRG Editor contacted the Editor of t= he journal that had published the study with a neutrally worded email detai= ling their specific concerns about the data in the control arm, including a= description of the exact method they had used to determine that they had c= oncerns about the data. The study was placed in the =E2=80=9CAwaiting Class= ification=E2=80=9D section of the review.
Example 3
While conducting a Cochrane Review the review authors noticed a study th= at was eligible for inclusion that had a very unlikely distribution of pati= ents between the intervention and control groups. The review authors contac= ted the study authors for further information and they responded that =E2= =80=9CThere was a simple randomization by tossing coin=E2=80=9D. The review= authors still had concerns after this explanation because the chance of th= e distribution of the intervention and control groups occurring was 0.00000= 0000000033%. They therefore contacted the Editor of the journal that had pu= blished the study. The journal investigated and concluded that the article = did not need to be retracted, but that the term =E2=80=9Crandomization=E2= =80=9D should be substituted in the article with "single-centre, prospectiv= e and observational study" as this reflected the methodological approach of= the study. This review authors still had concerns about the study followin= g this and therefore discussed it with the Research Integrity Editors. The = study was excluded from the review as in this case the review included only= RCTs and the reason for not including the study was stated neutrally in th= e review.
Example text is provided below for Editorial Notes to alert readers of a= Cochrane Review to a post publication amendment on an included study. The = text for all Editorial Notes should be agreed with the Research Integrity T= eam and may need to be modified to reflect the exact circumstances. If you = need to add an Editorial Note to a published review, you should contact the= named Associate Editor who will refer to the Research Integrity Team.
Template text for when an included study has been retracted
=E2=80=9CExpression of Concern: Readers are alerted that the included st= udy X et al. 2016 has been retracted [citation for retraction notice]. The = study will be moved to the Excluded Studies table and its impact on the rev= iew findings investigated and acted on accordingly.=E2=80=9D.
Template text for when an included study has an Expression of Co= ncern
=E2=80=9CExpression of Concern: Readers are alerted that an Expression o= f Concern [citation for Expression of Concern, or original article if Expre= ssion of Concern is not citable] has been published on the included study X= et al. 2016. The impact of the study on the review findings will be invest= igated and acted on accordingly.=E2=80=9D