tag:blogger.com,1999:blog-8346061623186564263.comments2023-06-28T06:36:02.110-04:00Thoughts on Medical InformaticsArmando Oliva, M.D.http://www.blogger.com/profile/02189597761383088518noreply@blogger.comBlogger51125tag:blogger.com,1999:blog-8346061623186564263.post-36268137923874855052019-04-01T04:27:03.280-04:002019-04-01T04:27:03.280-04:00The coastline example is of course an extreme one,...The coastline example is of course an extreme one, as a coastline essetially is a fractal (see e.g. https://en.wikipedia.org/wiki/Coastline_paradox). Fortunately (?), not everything in life is a fractal, so we mostly take it for granted and do not think further about it that every measurement requires a disturbance of the system (I am also thinking about Schrödinger's cat). We can learn so much from other systems such as OpenEHR archetypes, where each "observations" also has a "protocol", stating the circumstances and procedures under which the "observation" was done. <br />Major problem however is that FDA reviewers are still only thinking in terms of tables, with little room for relations between observations and interventions. These are implicit in SDTM, unfortunately not explicit.XML4Pharmahttps://www.blogger.com/profile/05523910878300565120noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-41675272060078716622018-09-17T19:42:06.261-04:002018-09-17T19:42:06.261-04:00Thank you for your thoughtful comments, with which...Thank you for your thoughtful comments, with which I agree. It's a reality that for the foreseeable future we will need a validation report; but let's call it that and not something else. The entire issue of study data validation is ripe for a separate, more meaningful discussion. That topic is on my "to do list" for a future post. Thanks again. Armando Oliva, M.D.https://www.blogger.com/profile/02189597761383088518noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-46461245552545861752018-09-15T01:33:00.993-04:002018-09-15T01:33:00.993-04:00Dear Armando,
I mostly agree. Unfortunately, the S...Dear Armando,<br />I mostly agree. Unfortunately, the SDRG is some kind of "garbage can" for "everything that went wrong". A lot (and more and more) can already be provided in the define.xml, but the latter e.g. still lacks the possibility of text formatting (could be done using XHTML). More serious is that one of the main uses of the SDRG is to report and explain false positive errors of the validation software used by FDA and the sponsor. Isn't that the world upside down? Wouldn't it be better that the software is corrected regularly? This isn't done at all: the latest version is already 2 years old, very buggy, and there is no sign at all that a new, better version will become available. If we would not have these false positives, we would have another good argument to not need an SDRG.XML4Pharmahttps://www.blogger.com/profile/05523910878300565120noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-29611673055151261892017-05-18T16:28:17.892-04:002017-05-18T16:28:17.892-04:00.
Thanks for your comments, xxx. You add an import....<br />Thanks for your comments, xxx. You add an important twist to the issue...why would a subject recruited for a trial not grant informed consent when formally asked to grant it. Very good question. Assuming they are formally counseled and asked to grant informed consent but they don't, do we want them categorized as Screened and failed screening (reason: Informed Consent not granted) or do we say Not screened (Informed Consent not granted so screening never started). I will look around various ICH sources. If you find anything, please let me know. Cheers!Armando Oliva, M.D.https://www.blogger.com/profile/02189597761383088518noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-79817673130478701042017-05-18T16:27:31.316-04:002017-05-18T16:27:31.316-04:00A colleague posted this on LinkedIn: "Very th...A colleague posted this on LinkedIn: "Very thought provoking. For your existential question, I wonder if there is any industry (ICH perhaps) or regulatory guidance around ObtainingInformedConsent when it is not obtained? Do you know of any? It seems on the surface that investigators would only approach potential study subjects they feel would qualify for the study, and would have at least a reasonable likelihood of passing screening. Nobody likes to waste time. So with that assumption in-mind, it seems reasonable that regulators may want to consider (at least know) if there are any common themes why potential study subjects might be saying no. Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-87932052275296943462017-03-14T15:19:02.978-04:002017-03-14T15:19:02.978-04:00This was recommended reading for ODM v2 discussion...This was recommended reading for ODM v2 discussion. Consider project DataSphere. A sponsor de-identified patient level data and is making them available to other researchers.Vojtech Huserhttps://www.blogger.com/profile/17180875686156096790noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-2453071822891917522017-03-08T03:50:30.915-05:002017-03-08T03:50:30.915-05:00Your blog has given me that thing which I never ex...Your blog has given me that thing which I never expect to get from all over the websites. Nice post guys!<br /><br />Melbourne Mobile Developerhttp://www.papdan.com/iphone-and-mobile-development.phpnoreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-1264693647861018792017-02-17T15:51:17.995-05:002017-02-17T15:51:17.995-05:00Great Stuff! I have taught a lot of the rules you ...Great Stuff! I have taught a lot of the rules you mentioned.Allan Deweshttps://www.blogger.com/profile/05103525074693242935noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-82109262848242004932017-01-31T07:30:43.515-05:002017-01-31T07:30:43.515-05:00I totally got what you had to say in your post. I&...I totally got what you had to say in your post. I'm going to give you a thumbs up for excellent work. This would be the right weblog for everyone who is wishes to be made aware of this topic. You recognize a great deal of its almost tough to argue along (not too I really would want.) Anyhow thanks for sharing this great article with us.<br /><br />Best <b><a href="https://optimized360.com/pediatric-websites/" rel="nofollow">Kids Website Design</a></b> Trend 2017.Anonymoushttps://www.blogger.com/profile/06177293653805525761noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-64320159147948821462016-11-07T18:53:49.053-05:002016-11-07T18:53:49.053-05:00Another excellent post, Armando. I think moving a...Another excellent post, Armando. I think moving away from so many separate domains toward a condition makes sense. I believe that these conditions, assessments and observations should be defined consistent with the way they are represented in healthcare, to minimize transformations. There's also an implication of a hierarchical structure of observations by disorder, when in reality a given observation may relate to many different disorders (and clinical objectives. I think an RDF representation of the many complex relationships together with this observation based structure would be an interesting approach for a next generations standard.Wayne Kubickhttps://www.blogger.com/profile/01922125025118463662noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-2599153443948281902016-11-05T13:34:34.828-04:002016-11-05T13:34:34.828-04:00Just wanted to follow up: See a recent publication...Just wanted to follow up: See a recent publication by two of the authors from the foundational paper from 2009: Diagnosis, misdiagnosis, lucky guess, hearsay, and more: an ontological analysis https://jbiomedsem.biomedcentral.com/articles/10.1186/s13326-016-0098-5. Werner has a massive collection of material, check out his Lectures from 2016 http://www.referent-tracking.com/RTU/?page=ceusters_vita#teachingAnonymoushttps://www.blogger.com/profile/14441161082622324677noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-79812302393578618102016-11-05T12:23:37.177-04:002016-11-05T12:23:37.177-04:00Yet another interesting post Armando. Excellent to...Yet another interesting post Armando. Excellent to see you reference to one of my favorite papers: "Toward an Ontological Treatment of Disease and Diagnosis". Have you been in contact with Richard Scheuermann or Barry Smith? Anonymoushttps://www.blogger.com/profile/14441161082622324677noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-3242446906982141052016-10-21T08:07:16.871-04:002016-10-21T08:07:16.871-04:00Thank you, Wayne. I agree with your comments, part...Thank you, Wayne. I agree with your comments, particularly around terminologies and existing FHIR resources. Armando Oliva, M.D.https://www.blogger.com/profile/02189597761383088518noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-76745785787174097702016-10-19T15:59:47.081-04:002016-10-19T15:59:47.081-04:00Great blog as usual! Great blog as usual! Miami psychiatristshttp://www.topfloridapsychiatrists.comnoreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-51693618727479809762016-10-07T04:35:10.744-04:002016-10-07T04:35:10.744-04:00Hey,
Thanks for sharing such an amazing and in...Hey,<br /> Thanks for sharing such an amazing and informative post. Really enjoyed reading it. :) <br /><br /><br />Apu<br /><a href="https://payerfusion.com/our-services/medical-case-management/" rel="nofollow">Medical Case Management</a>Apu Mridhahttps://www.blogger.com/profile/07191485323772995004noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-26957622441434682552016-09-30T12:59:01.866-04:002016-09-30T12:59:01.866-04:00Hi,
Thank you for sharing such an amazing and i...Hi,<br /> Thank you for sharing such an amazing and informative post. Really enjoyed reading it. :)<br /><br />Apu<br /><br /><a href="https://goo.gl/rWhWYo" rel="nofollow">Managed Healthcare Solutions</a>Apu Mridhahttps://www.blogger.com/profile/07191485323772995004noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-86342636612618940352016-09-26T16:00:25.467-04:002016-09-26T16:00:25.467-04:00Very insightful post. It is well noted that if cl...Very insightful post. It is well noted that if clinical research wants to effectively reuse health information, it makes sense to align data and terminologies with healthcare rather than living in a separate silo. I also think SOAP and the conceptual model aligns well with HL7 FHIR, notably the resources for Condition, ClinicalImpression, Observation, Medication & Procedures, and even CarePlan. It's time for clinical research to think more like clinicians. Wayne Kubickhttps://www.blogger.com/profile/01922125025118463662noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-77068751858034516772016-09-05T07:29:58.750-04:002016-09-05T07:29:58.750-04:00It's good to see your post for medical his whi...<br />It's good to see your post for medical his which is nice to see here, keep doing well and you have done good work on this post....<a href="http://www.mediartlifesciences.com/transplantation-immunology/" rel="nofollow">Transplantation</a><br />Anonymoushttps://www.blogger.com/profile/00091532063314395279noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-28614785194313726782016-06-27T07:10:46.211-04:002016-06-27T07:10:46.211-04:00wooow! Hello all! I think it's a great article...wooow! Hello all! I think it's a great article! I have a lot to learn from you! Regards!ad agency project management softwarehttp://axadsystem.com/advertising-management-software/featuresnoreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-6261888134465624922016-05-21T13:17:55.816-04:002016-05-21T13:17:55.816-04:00Dear Armando,
You are right: that is not clear fro...Dear Armando,<br />You are right: that is not clear from the IG. If the keys are chosen well, the uniqueness should be at the record level. A better source may be the define.xml 2.0 specification. Good keys are e.g. STUDYID + DOMAIN + USUBJID + CAT + TESTCD + DTC + VISITNUM (but that might be overkill...). However, they seem not to be really used by anyone. The validation tool the FDA is using does not seem to read them from the define.xml at all for validating record uniqueness.XML4Pharmahttps://www.blogger.com/profile/05523910878300565120noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-49852064505431622942016-05-20T08:23:04.680-04:002016-05-20T08:23:04.680-04:00Link to my blog post http://kerfors.blogspot.se/20...Link to my blog post http://kerfors.blogspot.se/2016/05/global-persistent-and-resolvable.htmlAnonymoushttps://www.blogger.com/profile/14441161082622324677noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-46157404238075345812016-05-20T08:22:31.562-04:002016-05-20T08:22:31.562-04:00Armando - your great blog post inspirered me to wr...Armando - your great blog post inspirered me to write one as well builfing on the good duscussion here and on LinkedIn <br />Anonymoushttps://www.blogger.com/profile/14441161082622324677noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-19254912479304742862016-05-20T06:49:53.815-04:002016-05-20T06:49:53.815-04:00Question: Does SDTM support unique identifiers for...Question: Does SDTM support unique identifiers for each record or only at the dataset level? This is not clear in the implementation guide. Armando Oliva, M.D.https://www.blogger.com/profile/02189597761383088518noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-68531449942232989922016-05-20T06:27:07.007-04:002016-05-20T06:27:07.007-04:00Yes, Dave. I agree with you. It's ironic that ...Yes, Dave. I agree with you. It's ironic that your latest post occurred on the same day as mine as there is considerable overlap in thinking. I think my suggestions reinforce your view of splitting the data from the presentation of the data. Armando Oliva, M.D.https://www.blogger.com/profile/02189597761383088518noreply@blogger.comtag:blogger.com,1999:blog-8346061623186564263.post-23568241780141220642016-05-19T03:54:02.835-04:002016-05-19T03:54:02.835-04:00Unique identifiers in SDTM are there: the define.x...Unique identifiers in SDTM are there: the define.xml 2.0 mandates sponsors to provide the primary key (as a combination of variables) for each dataset (KeySequence attributes). However, it looks as these keys are not used, neither by the FDA nor by validation tools (the validation tool the FDA is using even ignores the define.xml). Technically, we can easily provide a better mechanism for referencing using these keys, but there seems no will to do so at this moment nor from the FDA nor from the SDTM team.XML4Pharmahttps://www.blogger.com/profile/05523910878300565120noreply@blogger.com