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How to put to use The Appendix G Checklist 2010 Form ?

hello and welcome to this webinar on the.concert statement jointly organized by.the equator network Amparo my name is.Shana curtly and I'm the research.information specialist at the equator.network thank you all very much for.attending the webinar today it is.wonderful to see that so many people who.have joined us today is webinar is the.second in a series of webinars on good.reporting of health research studies.organized by the equator network and the.Pan American Health Organization under.their agreement of collaboration to help.improve health research reporting in the.Americas through the use of reporting.guidelines that promote greater accuracy.and transparency the equator network is.an international initiative seeking to.improve the reliability and value of.medical research literature by promoting.transparent and accurate reporting of.research studies the Equator website.provides access to lots of resources.relevant to research reporting and the.online library currently contains over.200 guidelines covering a wide range of.study types and clinical areas we are.very grateful for all the help that we.have received in organizing the webinar.today in particular we would like to.thank Powell who are providing us with.free access to the Blackboard.Collaborate tool and with training and.technical support we also wish to thank.Cochrane Canada for training support and.for sharing their instructional.materials with us.it is with great pleasure that I can now.introduce Professor Doug Altman Doug is.director of the Center for statistics.and medicine in Oxford and dissolves a.senior statistics editor at the BMG & Co.editor-in-chief of trials he is actively.involved in leading the development of.guidelines for reporting research.including concert Straub and Prisma and.in 2006 he funded the equator network so.Doug I will now hand over to you for.your presentation thank you very much ok.thank you very much.I hope people can hear me good morning.or good afternoon depending where you.are um so as you know I'm going to talk.to you about the consul's statement.which is a reporting guideline guidance.for randomized trials so I'm going to.start with a quotation from an editorial.in the Journal of National Cancer.Institute a couple of years ago results.from randomized controlled trials can.have an immediate impact on patient care.accurate and complete reporting is.essential to determine whether trial.designed conduct and analyses are.scientifically creditable and in some.sense that summarizes where we are with.reporting it's terribly important for.consumers of research reports to be able.to understand exactly what was done and.Consort is a leading resource to help.that happen so if we consider research.articles and what therefore I believe.that a scientific manuscript as present.as a journal article should present.sufficient data so that the reader can.fully evaluate the information in that.article and reach their own conclusions.about the results to assess the study's.reliability and its relevance to them.so readers have to have a clear.understanding exactly what was done and.that's true whether there are clinicians.other researchers systematic reviewers.policymakers or or anyone else the goal.here I think quite clearly should be.transparency but also the article should.not mislead it should I believe have.enough information provided to allow.somebody else in principle to replicate.that study I think that's a good working.definition of what we mean by.transparency and lastly the results.should be presented in a way that allows.them to be included in future systematic.reviews and meta-analyses and I'll come.back to those points in due course there.is.sadly the considerable amount of.evidence that many published articles.don't adhere to those principles and.omit vital information there are in fact.hundreds of reviews of that type and.they show that very often we cannot tell.exactly how a piece of research was done.and although I'm going to focus today of.course on randomised trials these.problems have been seen across the.medical research literature they aren't.specific to randomised trials they're.not specific to studies of medicines and.they aren't specific to commercial.research so moving on here's another.quotation which I which I rather I think.some things are rather well whatever the.outcome of a study it is really hard for.the average reader to interpret and.verify the reliability of a poorly.reported RCT randomized trial in turn.this problem could result in changes in.clinical practice that are based on.false evidence and that may harm.patients so we aren't just talking about.fussy methodologists like myself we're.talking about important information that.could actually have an impact on the.my patients are treated and their.long-term prognosis so what should be.included included in a report well in.terms of the methods I believe that we.should expect that all essential aspects.of how the study was done should be.reported the many years ago the.International Committee of medical.journal editors produced the sentence.which relates to statistics it says.describe statistical methods with enough.detail to enable a knowledgeable reader.with access to the original data to.verify the reported results here again.you see the idea of replication they.don't however make similar statements.about other aspects of studies which I.think they should so we should really.also expect that the intervention should.be described with enough detail to.enable somebody else to apply them the.outcome measures should be described in.adequate detail as well and so on when.it comes to the results we should expect.a journal article to present all the.main fighting findings in a useful and.usable way and that those findings would.correspond to what was in the protocol a.pre-specified plan of how the study was.going to be conducted our focus here on.methods and results of course there are.other elements in in a journal article.which I'll refer to in due course so.what is poor reporting poor reporting or.perhaps more accurately bad reporting is.when well there are several types there.is the non publication of a complete.study obviously this is something that.doesn't reach publication so it isn't.part of today's consideration what I'm.focusing on mainly today is when in a.published article key information is.missing it is incomplete or it's in.ambiguous and as I said that relates to.methods and to findings it also extends.to misleading interpretation where.the results are presented maybe and then.interpreted with with inappropriate.emphasis on on perhaps on minor findings.rather than the main result and that can.be extended to the idea of selective.reporting where authors only present.parts of the methods or those findings.which they find most conducive to their.preconceptions and those obviously are.not good practices and lastly on this.slide we know that very often what's in.a journal article doesn't actually agree.with what was in the trial protocol but.there's no mention in the article of.that difference nor why such a.difference took place and that's.something when it's discovered which is.of real concern why is this study being.reported in a different way as I said.there is considerable evidence of poor.reporting I've seen many hundreds of.published reviews that published.published reviews have published reports.of randomized control trials they go.across the whole spectrum of Medicine.they're not in any particular specialty.they show that a high proportion of.published articles simply do not contain.the key information about the methods.and results that we would expect as a.reader we cannot tell exactly how the.trial was done nor can we be sure.exactly what was found and that's.unacceptable so here's my first example.this is based on two reviews of the.literature of randomized trial reports.published first in 2000 in the left-hand.column and secondly in 2006 exactly the.same information was sought and the.percentages shown are the percentage of.reports in these samples of five or six.hundred each that did report whether.what the primary outcome was that there.was a sample size calculation two.aspects of randomization the method of.random sequence.generation and of allocation concealment.and lastly whether the trial is blinded.or not not um whether this isn't this is.whether it was or wasn't blinded not so.those percentages in the last row are.simply whether it was made clear to the.reader whether or not blinding was.implemented not what proportion were.blinded so those dice entities show two.things they show firstly that there has.been a clear improvement between 2000.and 2006 and we would hope in in the.subsequent six or seven years we've seen.more improvement but they also show that.nearly all the voters and percentages.remain very low even after the.improvement most of them are well below.50% and that's obviously of great.concern to take a second example this is.a review of 262 reports of trials in.oncology journals Dharan colleagues.looked to see how well the actual.interventions were reported they.produced a list of ten elements which.they believed were essential beginning.with simple stuff like the drug name but.also the dose root regimen and so on and.only one out of nine eleven percent of.these articles gave all the essential.details which would be needed to repeat.those therapies and the quote at the.bottom from their article makes that.point clear that randomised trials were.published in major oncology journals do.not consistently report essential.therapeutics details necessary for.translation of the trial findings to.clinical practice again clearly that's.not acceptable and another example this.is a review of 49 trials of.antiretroviral therapy of patients with.Jovie only 16 just about a third of the.trials reported all adverse events the.other two-thirds reported any summer.press events sometimes they reported the.most frequent adverse events sometimes.only those which was statistically.significant and sometimes they simply.reported quote selected adverse events.without any information about which.other adverse events they might have.recorded and these authors said that.these facts II's figures here as I've.just shown you obstruct our ability to.choose hearts as in psycho treatment.based on currently published data again.this is really not acceptable and last.in this sequence of examples is is some.evidence about selective reporting this.paper by dreimann colleagues was a.review of studies which themselves had.compared protocols with subsequent.publications.it found that some of these studies.which were reviewed found that the.outcomes the patient outcomes that was.statistically significant were more.likely to be fully reported in journal.articles than outcomes that were not.significant and further between 40 and.60 percent of publications had at least.one primary outcome that was changed.newly introduced or omitted compared to.the protocol about half in other words.about half the time what's published.does not correspond to the protocol for.the primary outcome and this is.extremely worrying the consequences of.bad reporting are that assessing the.reliability of published articles is.seriously impeded clinicians reading.this cannot judge whether to use the.treatment even if the trial shows that.it's beneficial and data often cannot be.included in the systematic review.therefore as was suggested in my early.quotes there are serious consequences.for clinical practice for research for.policymaking and of course ultimately.for patients and the quote from The.Lancet nearly 10 years ago now saying.the idea of a drugs use being based on.the selective reporting of favorable.research should be unimaginable changes.are required every level of the global.healthcare infrastructure so that.comment based more on selective.reporting than just bad reporting in.terms of methods and so on but all of.these pieces of information point in the.same direction but research is simply.not being reported adequately enough and.picking up the theme of systematic.reviews I won't read every bit here but.this is important as I said at the top.here randomised trials have a second.life where their results can be.incorporated into the future systematic.review and and contribute to much.stronger evidence to underpin clinical.practice here are four quotes from four.systematic reviews all complaining about.the poor reporting in the primary papers.they were looking at the first one for.reporting of trial methods the second.poor reporting the interventions the.third one complaining that they couldn't.use the data the way that the data had.been presented in most of the trials and.the last one.poor reporting of duration of follow-up.so this isn't just a few examples.there's persistent and widespread.evidence that reporting of randomised.trials is inadequate very often and this.is a huge concern bearing in mind that.randomised trials are amongst the most.important evidence that underpins the.choice of clinical treatments and for.patients so all of this leads to the.idea that maybe if there were guidelines.for reporting research exporters might.do a better job.based on the idea that perhaps they.don't really know how to present the.results in the best way.so reporting guideline does a minimum.set of items required for a clear and.transparent account of what was done and.what was found in a research study and.this corresponds obviously to the.methods in the results section what was.done in the methods box found then.results and the guidelines reflect in.particular those issues that might.introduce bias into the research things.that you really want to know about how.the study was done where possible these.guidelines are evidence-based and also.they reflect a consensus opinion not.just one or two people's views but based.on quite a thorough review of the.literature and large numbers of.participants to help come up with with.their hope sort of consensus view on.what's the most important information to.be reported the benefits of using.reporting guidelines and of course today.I'm talking only about randomised trials.but the principles apply to all research.that there will be improved accuracy.transparency and indeed completeness of.journal articles of publications that.would make it much easier to appraise.those reports for research quality and.for their relevance it would make it.easier as I said also to include the.data and systematic review and it would.improve people's ability to search the.literature to find relevant studies so.what I show here is that the early.history of you life of reporting.guidelines for randomized control trials.before the 1990s there were very few.reporting guidelines although there had.been sporadic suggestions that such.guidelines would be useful then in 1994.two groups simultaneously published.reporting recommendations um.these were the sort group and the.Asilomar group and without going to.detail about those names there what.happened was that clearly the idea was a.good one.and two groups who had no overlap of.membership met roughly at the same time.and came to similar but somewhat.different recommendations there was then.an editorial in JAMA written by Drummond.Reni the deputy editor who argued that.really there was no room for two.competing guidelines and that what would.be desirable was for those groups to get.together and come to a unified set of.recommendations and that's what happened.in 1995 there was a meeting in Chicago.the name Consort was created it stands.for consolidated standards of reporting.trials and following that meeting in.1995 the first consul statement was.published in JAMA in 1996 and this is.the title and the authorship of that.paper as I say published in 1996 it.included the checklist which I show here.and you can see on the left covers the.title abstract introduction but mainly.the methods and results of a little bit.at the end about the discussion and on.the right a whole series of pieces of.information which the group believed was.essential to be reported in in a report.for a randomized trial I won't go into.the detail of that because it's been.superseded as I'll describe also these.authors at that time recommended a flow.diagram to show how participants went.from the start where they were.registered or determined the eligibility.through randomization treatment.follow-up and completion of the trial.and data analysis.and the idea was that each trial report.should include the flow diagram like.this indicating not just the numbers.going right through but why people drop.down to different steps where and why so.as I say that was published in 1996 the.rationale for the items on that.checklist was the rationale I've been.describing to you it was necessary to.have this information for the reader to.evaluate the study the items as I also.suggested were evidence based wherever.possible that means that there was.evidence that the information being.sought was necessary to assess.reliability or that there is evidence.that these things were not being.reported well and the view was that this.isn't a complete set but a minimum set.of essential items and of course there.will be other things that are important.and that will vary from trial to trial.after a few years in a rapidly moving.field it became clear that this guidance.needed to be updated and following.another meeting in 2001 a major revision.was published the checklist was revised.quite considerably and a few minor.changes were made to the flow diagram.and there were two publications a short.paper which is called the consult.statement was published perhaps uniquely.at that time in 3 leading journals.simultaneously in addition a very long.Spanish three penny per eye was.published in the annals of internal.medicine at the same time I think 32.journal pages explaining all the.background and giving examples of good.reporting so this is we may not be able.to read that but this is the consult.checklist in 2001 there are now 22.numbered items.and again though you can see that the.bulk of the information requested.relates to the methods and the results.sections and the right-hand column is.intended to allow authors to indicate.where they've addressed these points in.their manuscript the flow diagram has.tied it up is slightly different but is.essentially based on the earlier one but.now it's explicit that there are four.stages here at the top enrollment then.allocation follow-up and analysis but.the principle is the same to document.the flow the participants from the very.start through to the analysis at the end.so I mentioned the explanation paper we.call it the explained explanation and.elaboration manuscript or E&D paper and.this is produced to help users of.console understand why these things were.important and what the rationale was for.asking for these elements to be reported.so this paper gave examples of good.reporting for each of the 22 items it.gave a detailed explanation and further.it summarized the relevant empirical.evidence about the way in which that was.currently being reported well that was.in 2001 at that time I think the the.goals were made rather more clear than.perhaps previously so the main objective.of console is to facilitate critical.appraisal and interpretation of RCTs by.providing guidance to authors about how.to improve the reporting of their trials.but a secondary objective was mentioned.and which was to encourage and provide.incentives for researchers to conduct.high-quality unbiased randomised trials.as sort of more diffuse but wide-ranging.secondary objective.but CLE the primary objective is to.improve reporting in 2007 there was a.meeting at about revising it again and.that led to the 2010 revision of consort.you'll see it took three years it's a.lot of work this revision again led to.revised checklist there was a short.paper this time published in 9/1 but.from the BMJ 25 items now in the console.checklist by 2010 but this is the.current version doesn't look I don't.think there's anything on that list that.looks particularly unusual but it's.having it all laid out in a logical way.that is meant to help people think how.to structure their reporting how to make.sure they include all the important.pieces of information and point out that.there are three separate elements to.randomization which of course is the.most important part of a trial it's the.element that makes a randomized trial so.much stronger method logically than.other research designs so it is.critically important that authors do.tell us in some detail how they went.about doing the randomizing here's a.list of major changes after one previous.revision it's interesting how much more.was was able to be changed in 2010 so.firstly three completely new items were.added reflecting current concerns are.one about trial registration asking for.details of where the trials registered.information also about where the.protocol could be obtained and about the.fundings of the trial so these are if.you like non scientific issues but.increasingly seen as very important.parts of information about the total.trial.we added a new item to clarify the trial.design we added several sub items one of.which is quoted here any changes to the.trial outcomes after the trial commenced.with reasons and this links to the.evidence I showed you earlier about.frequent discrepancies between protocols.and publications some items were made.more specific for example we added.request for specification of how.blinding was done not just whether it.was done and if relevant a description.of the similarity of the interventions.and the procedures conversely we removed.one sub item about testing and blinding.because we didn't feel there was good.enough evidence that this was a reliable.way to assess whether the trial.genuinely had been blinded on top of.that we simplified and clarified the.wording throughout the checklist so that.of these of the original 22 items only.six were completely unchanged between.2001 and 2010 and an important point.since we are very keen on transparency.is that all the changes which were made.are documented in the paper that we.published in 2010 so exact details of.what has changed and indeed why are.listed just to show you a couple of.examples of the evolution of the wording.as we strive for greater clarity for.patient outcomes.the original 1996 console asked for.primary and secondary outcome measures.by 2001 we realize that might not be.adequate and said clearly defined.primary and secondary outcome measures.but clearly that didn't quite fit the.bill either so the current version.stronger still completely defined.pre-specified primary secondary outcome.measures and we added including how and.when they were assessed recognizing that.knowing what the what was measured is.one thing but knowing how it was done.and when often also extremely important.likewise for interventions rather simple.in 1996 the checklist asked for planned.interventions and the timing by 2001.this had become precise details of the.interventions intended for each group.and how and when they were actually.administered and the idea of replication.is brought in in 2010 the interventions.for each group with sufficient details.to allow replication including how and.when they were actually administered and.you can see here how accumulating.evidence about reporting as it's.practiced in the medical literature.influences the way the consort checklist.evolves over time and just to give you a.single example the from the 2010.explanation and elaboration document.item 17 B says for binary outcomes.presentation both absolute and relative.effect sizes is recommended and there's.a lot of text explaining why it is.recommended but this table from a.published trial is an example of very.simple presentation which shows the.results for each of two groups and a.randomized trial in risk ratio with the.confidence interval and also the risk.difference with the confidence interval.and that information is very helpful if.someone for example wishes to calculate.a number needed to treat but it shows.that you know these we can find examples.of good reporting for all the items on.the console checklist it's quite hard.though to find the Tri report that.reports all or even most of them well.and that's clearly then still a lot of.room for improvement so at the bottom on.this slide is the reference of that.paper the E and E paper there have been.quite a lot of extensions to consort.extensions with guidelines on what.should go in the abstract guidance on.how to report harms in particular as.opposed to intended effects of.treatments a recent extension for.reporting of patient reported outcomes.and there are also extensions to cover.specific trial designs in particular.cluster randomized trials and.non-inferiority and equivalence trials.in addition there have been quite a lot.of what we call implementations of.console which take the console.guidelines and consider how they might.be applied for particular types of.intervention or particular study types.the distinction between expansion and.implementation is perhaps not all that.clear.so implementation articles have.addressed herbal medicines non.pharmacological treatments which is a.very wide area pragmatic trials and very.now much more narrow area of acupuncture.to pick up the non pharmacological.treatments this slide shows that we.actually added some specific items about.the interventions are relevant for non.pharmacological treatments recognizing.that these are often complicated they.may have multiple components and they.might be tailored to individual.participants in 4b questions the issue.of whether interventions have been.standardized and if so how and for C.about adherence with the protocol by the.care providers these trials are much.more complicated than trials of drugs.and that was the rationale for.developing this extension all of the.papers are just referred to can be found.mentioned on the consul website this is.the home page of the concert website and.the web address is at the bottom of this.slide and so as I say everything I've.talked about you can find much more.detail on the website including links to.all the consort publications so here's.the question does all this effort.actually make an impact on the quality.of reporting of trials well let's have a.look at some evidence firstly uptake.consort has very wide support from.journals on our website you can find a.list of over 600 journals which have.supported consort in some way we use the.term endorsed but endorsement is a.fairly loose description of support for.consort the principles of it we've also.had support from major editorial groups.the Council of science editors world.association medical editors and the.International Committee of medical.journal editors and for some peer review.granting agencies such as the Canadian.Institutes of Health Research but the.reality is that reporting guidelines.have had rather limited impact and I'll.show some numbers in a minute and this.is probably because what we're talking.about is passive dissemination based on.publication only we publish the.guideline I hope that people suddenly.read it and do things a lot better and.then general people don't change the.behavior on in such a simple way and.that means that the potential impact of.consort is really not being fully.realized this is part of the list of.journals on the website of the journal.endorses which I just mentioned.so one big impact of consort has been.the flow diagram it's quite fun to go.onto Google 1 and look for images around.consoles and you get a display like this.there are loads and loads hundreds of.these maybe thousands of these console.flow diagrams out there in in journals.and that's great we conducted a review a.couple of years ago of these flow.diagrams to see how common they were.they were and how well reported they.were and we found as I said they were.very common indeed a majority of.articles these days have one but.elements of the flow diagram.especially the bottom part in terms of.numbers of participants included in.analyses we're often not very well.reported so yeah big a big impact in.terms of adoption but the quality of the.flow diagrams remains less than optimal.here's a review summarized briefly a.review of the reporting of adverse.events I mentioned those earlier but.this time in relation to consort noting.that in this field of antiepileptic.drugs reporting of adverse events is.poor and has not improved since the.publication console guidelines on the.reporting of arms as they say these.findings have serious implications as.poor reporting precludes buyers being.detected and hinders adequate risk.benefit analysis so in the reporting of.harms we have this and other studies.showing that there's still a lot of room.for improvement this paper published by.the console group recently is a review.of studies that themselves had looked at.whether reporting had improved since the.publication of the console statement.so comparing either papers published.before with papers published after.consort or comparing papers published in.journals that did or did not endorse.consult referring to endorsement this.quote points out that although the.review suggests that endorsement may.benefit the completeness of reporting.completeness remains suboptimal very.consistent with what we've seen in all.the other studies journals are not.sending a clear message about.endorsement to authors submitting.manuscripts for publication well they're.not that they could so here's from PLoS.Medicine and the guidance they give to.their authors the part in bold authors.of trials must adhere to the consort.reporting guidelines appropriate to.their trial design.please check the consort statement.website for information on the.appropriate guidelines for specific.drought sites and provide a copy of the.trial protocol and the completing.console objectives as supporting files.and they go on to say they will publish.these so this is a very strong statement.but plus medicine is a big journal with.with resources but some small journals.can also behave in a similar way and try.to strengthen the quality of the reports.of trials that they publish so here is.from the journal headache their guidance.and they say it is a mandatory.requirement with the reporting checklist.is submitted we urge you while.completing this form to consider.amending your manuscript to ensure your.article addresses all issues raised by.the reporting checklist where.appropriate and they suggest go on to.suggest that it might greatly improve.the manuscript and potentially enhance.its chances for eventual publication.this passage is not specific.specifically about concern but consort.is very much one of the guidelines which.they are referring to it is made clear.so in conclusion I believe that the.findings of all randomised trials should.be published trial reports should be.complete and transparent and tell the.reader what they need to know we have a.huge amount of evidence that many trials.report many trial reports omit crucial.information which greatly weakens their.clinical value and indeed as we've seen.the usefulness for systematic reviewers.as well.it follows clearly that peer reviewers.and editors are failing to ensure that.that reports of trials are actually.usable by readers and they could do a.lot more adherence to the console.checklist and to the flow diagram would.maximize the value of trial reports for.future for other groups for future.systematic reviews and ultimately for.patients and journals should institute.stronger systems to ensure compliance.with consult and I always tend to end.with this red text good reporting is not.an optional extra it is an essential.component of doing good research so.that's what I wanted to say to you on.this slide you'll find the console.segment web address and also the web.address for the equator network which.will give you links not just a consort.but as shown so to over 200 reporting.guidelines that's it thank you.thank you very much that was really.interesting so we've had quite a bit of.activity on the chat function and please.do you feel free to submit your.questions through the chat function will.not be able to take any questions and.through audio so if you do want to ask.any questions then please type them into.the to the chat box and then we'll try.to get through those now and so and.we've got quite a few questions here the.first question I have is from Claudia.and she asks is there a special concert.statement for haribol Medicine yes there.is it was published I can't tell you.exactly wearing when Joe or Gagne was.the first author you can certainly find.details of that on either the concert.website or the acquaintance.website the reason for having special.recommendations for interventions like.herbal interventions is that they're not.standard manufactured products and.therefore quite a lot of information is.needed to impart to the reader to.understand exactly what the intervention.was but yes that there is such guidance.okay thank you um I have another.question here from sim and who asks and.was concert published in languages other.than English yes that's another question.which I could have answered in my slides.but I'll answer it now yes I can't give.you the number but I think consort has.been translated into numerous languages.and certainly the checklist has been.translated into very many languages but.I think also the papers have been.published in a Chinese Spanish German I.think and and several other languages.again if you go to the console website.you should find.of translations again with links okay.thinking and I have another question.here from Caesar from Peru and he asks.about the consort methodology and can it.be used for evaluation and for RCT is.applied to complementary and alternative.medicine.okay well that's two questions I think.that the second one is similar to the.question for herbal medicines yeah the.consort is written in a generic way so.it would apply to any randomized trial.of a health care intervention and indeed.by and large to any randomized trial but.obviously there may be specific aspects.of particular interventions that might.need to be thought about which is why.there is a guideline for acupuncture for.example in terms of using console for.appraising reports it is often done the.difficulty is that there is quite an.important distinction between the.quality of reporting of a trial and the.quality of the conduct of that trial and.it's entirely possible that you get very.good reporting and very bad methods it.is not therefore wise to assume that a.well reported trial is an unbiased and.well conducted trial there are other.checklists around for assessing the.methodological quality of trials for.example the Cochrane Collaboration has a.risk of bias assessment tool which is.explicitly designed and its name.indicates and judging the extent to.which the results might have been.influenced by bias through the wireless.study was conducted so I wouldn't.encourage using console in that way.it likewise I think the consort.checklist can be very useful to people.who are designing a new trial but a.better guidance for those people is the.recently published spirit statement.which is a set of guidelines on writing.a clinical trial protocol and I know at.least one person asks a question about.spirit the spirit is quite different.from console it's about the protocol and.concert is about the journal article and.if you compare the checklists you'll see.that there are quite a lot of elements.which are either identical or very.similar indeed and you will be.surprising if that were not the case.okay thinking and I have another.question here from Louie and he's asking.or saying that this sort of it's the.implementation of using the concert.guideline it's a challenge due to during.a word kind and and he wonders how many.words are needed to report following all.the consort items and have you have you.ever managed to calculate them we tried.to calculate in wow that's yeah that's a.fine question I've several things I can.say that firstly if existing reports are.missing key information and they need to.add it then in essence it is bound to.make the paper longer but I and many.others feel that a lot of words often.wasted for example in the results.section by repeating a lot of.information that's already in the tables.and in the discussion section with a.rather extensive speculation about what.what it might all mean and I think there.is saving space saving that could be.achieved in those areas but whereas this.issue of word limits was a real problem.I've certainly 10 years ago.I think it's an on problem now because.really virtually all journals allow Web.appendix electronic only materia.so if there isn't room in the main.article it's entirely reasonable to have.a supplement that's online that gives.full information and indeed I already.mentioned clothes medicine will publish.the whole protocol as a web appendix.other journals will do that as well so.yeah it was a problem it's not really a.problem now okay thank you.and the next question comes from.Christoph and he was wondering can you.speculate the using concert we can or.should reject some RCT results from.meta-analysis because of pure operating.and is that enough justification to do.so this is difficult it links to to what.I'm saying about Cochrane collaborations.risk of bias tool if you don't know for.example if you don't know how the trials.randomized or whether it is blinded or.not you have to have some raised.suspicions that the things may not have.been done very well it's of course.entirely possible and there is some.evidence that many trials are done well.but reported badly so to assume that if.it's reported badly and it's unsound.is is not very good idea on the other.hand to assume the opposite that well it.doesn't matter about reporting then.assume it was done well that's not very.wise either and so there's a real.dilemma for for people who is praising.evidence and basically that is really.the whole rationale for console you.shouldn't be in that situation if all.trial reports were adequately reported.as as laid out in console in all.journals then you would be able to.appraise a study far more quickly far.more reliably and.we just need to ensure that peer.reviewers and editors come more on board.and understand why this is so important.but ultimately we need researchers to.buy in to consult and recognize their.responsibilities to the participants and.the trials to the people who funded.those trials to get the maximum value.for the future okay thank you.and the next question comes from hand.and he wonders should spirit 2013.supersede the consort for our cities.guideline well simple answer is no.because as I said it's a guideline for.how to plan a trial how to write a.clinical trial protocol what I would say.though is that if you've written your.protocol the following spirit.it would make adherence to console.easier when you come to write up the.paper because all that material will be.in the protocol and it takes you a long.way if you have a really good protocol.it takes you a long way towards writing.a really good journal article but it's.console that that really is the one to.look at when writing the article okay.thank you and the next question comes.from Steve and he asks do you think.there is value in requiring a manuscript.to be structured content to ensure.compliance with guidelines I really like.that question because I absolutely do.think so I think one of the problems one.of the reasons why a lot of information.is missing is that it's hard to tell.that it's missing because the basic.structure of journal articles is.narrative and not structure so I do.personally favor much more structure.we've seen with the flow diagram but the.people have bought in in a big way to.that very structured way of describing.how participants flow through the trial.from beginning to end we also see in.randomized trial reports Table one is.almost always a structured display of.the baseline characteristics in each.group.I would favor expending these ideas and.having more structure at them a simple.way to do that is to have more headings.subheadings within the methods and.results sections and some journals are.better than others at that but if you.have a section on randomization the.section on blinding and so on it's much.easier to judge whether the information.provided is adequate or not adequate and.certainly you can't miss it out.altogether if you have to have a heading.okay thank you and the next question.comes from Jose and he asks can you.speak about patient reported outcomes.well can I speak about it yes I can we.I'm not going to say a great deal about.if a patient reported outcomes.I do raise certain logical issues which.are different from simpler outcomes one.would certainly for example would like.to have information about the exact.nature of this you know if they're using.a scale to to assess some outcome in one.would like information about the.derivation of that maybe the.repeatability and so forth the consort.extension for patient reported outcomes.was published recently in JAMA Melanie.Calvert is the first author and if.that's your area of interest.I suggest you you consult that article.which goes into these issues quite.thoroughly okay thank you and I think.we've just got time for one last.question and and this is from Louie who.um.asks he's talking about and thank you.for showing you what laws and other.leading journals are doing to implement.our recommendations and yes does equator.or concert offer a standard text similar.to what you should that journals can cut.and paste into their recommendations he.goes on to say sometimes it seems like.those implementing the guidelines get.stuck on things such as this working and.I wonder if a generic phrase would help.yeah our reviews of journals.instructions to authors a few years old.now did show that there was far more.information about process and very.little about content in terms of policy.however yes on the equator networks.website there is a section which is.targeted at journals and you will find.some guidance in there for how journals.can give to word the information for.their authors about you know what they.expect from authors in relation to.reporting guidelines thanks for that.question okay thank you I'm really sorry.we still have quite a lot of questions.in the chat but I'm afraid we are out of.time now and thank you all very much.indeed for participating in the webinar.this afternoon.and we hope that you find it interesting.the PowerPoint presentation and the.recording will both be posted on the.equator website and we'll send our.participants the URLs for that in an.email so thank you very much indeed.

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