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I’m working part-time on a research grant and I want to publish some of the work I’ve done on this grant. The title of the paper tentatively is “Validating elastic net generated electronic health record breast cancer phenotypes against hospital tumor registries: a case control study.” My co-authors are Dan Connolly and Russ Waitman. I want to summarize the history of the effort so far and why I am considering the BMC Medical Informatics and Decision Making as the next place to submit the article.
I started this work back in February 2016, and was only able to work on this part-time. I got some results that looked publishable by September 2016. Based on the recommendation of my Russ Waitman, I submitted this for the AMIA 2017 Joint Summit on Translational Research. AMIA stands for the American Medical Informatics Association. I was all for this. I’d get to see what others were doing in the work of Informatics, get some feedback about my work, and best of all get to say hello to all the sea lions at Pier 39 in San Francisco. You had to submit pretty much a complete research paper for consideration.
This paper didn’t make the cut, but I got some nice feedback. Some of the feedback won’t make sense unless you have the paper in front of you, but i wanted to include it here anyway.
1: This paper develops a predictive regression model to determine if a patient has breast cancer based on structured data in the electronic health record. Training and test sets are membership in the breast cancer registry.
The paper is a promising approach to selecting patients with a disease with high confidence. However, the argument that this approach can be used for clinical trial recruiting is rather weak. Most clinical trials include many complex criteria, many of which are not included at all in structured data. For the paper to discuss clinical trial recruitment, this complexity would need to be dealt with. Furthermore, a real trial from ClinicalTrials.gov would be essential as a use case. This reviewer suggests focusing the paper only on disease determination, which is still an important topic.
The format of this paper is incorrect, no abstract is included, and references are lacking.
Additional comments -
* The details of building the consensus model (i.e. run the regression on control and test sets and then remove the indicators from the control sets) should be included in the methods instead of the discussion.
* Please include more technical details in addition to the statistical models (e.g., details of the data model and platform used).
* Table 1 – this table seems unnecessary. There are only two exclusions and the paper only discusses the breast cancer cohort. Also, “belong to second group” is never defined.
* Table 2 – some examples of the metadata are helpful, but table 3 covers this well. This table also seems unnecessary. It is interesting that note titles are included in this table as example -were these included as input to the regression model?
Table 3 – The contents of this table is good but the formatting could use some work to highlight that these are elements in an ascending tree hierarchy. Also, the font should be smaller.
* Why does “malignant neoplasm of upper outer quadrant of female breast” have an odds ratio of only 1.06? P
* Please include a figure with ROC curves. Including all of the consensus models including the final one would be very helpful. Also, a comparison with the hand constructed model would be very helpful to motivate the informatics work in this paper. E.g., what is gained from using a regression model on all data in the warehouse verses only (for example) “malignant neoplasm of breast”.
* “HER”-> EHR
* Erroneous “I” at end
2: The research describes an approach to matching patients to clinical trials using EHR data. Clinical trial recruitment is an important problem, especially as eligibility criteria become more specific. The authors describe an approach that creates a model using elastic net regression to predict which patients are likely to be enrolled in a clinical trial.
The methods section describes how models were built to predict which patients would be in a breast cancer tumor registry. The authors are using the registry as a proxy for which patients should be enrolled in the trial. But this seems like a poor indicator of who is eligible. The authors need to do a better job of defending the use of the registry. Why wouldn’t you just us a rules-based approach that compared the EHR data to the eligibility criteria for the clinical trial? Are the patients in the tumor registry only participating in one clinical trial? Maybe you could show that elastic net models are easier to build and just as predictive of a rules based model to justify your approach.
The description of how each of the consensus models was built was detailed, but you need to include some description of how all the models eventually come together to predict likelihood of inclusion in a trial. The last paragraph of the methods section should be part of the discussion section.
In the discussion section, you state “The size and complexity of the EHR, however, makes it difficult for human review”. But it is easy for a computer to do the matching, so, again, this is where you need to justify why a rules based approach to matching patients to clinical trials won’t work.
You also state that “A physician who has to rely on memory to identify patients is likely to identify patients who are “memorable.”” This is not supported in your methods or results section. I think you just want to discuss how an algorithmic approach is potentially unbiased.
The paragraph that starts “There are two important extensions of this work.” describes exactly the approach that I believe your research should really take. At the very least, you have to do a better job of showing how your elastic net model approach is a step in that direction.
I think this research is very timely and useful and I would encourage you to address these issues to improve this paper.
3: The authors discuss an analysis that utilizes ICD9/ICD10 from their clinical data warehouse to predict whether a patient would eventually be diagnosed with breast cancer (and reported in the SEER registry). Codes were categorized into different events (e.g., diagnosis, medication, etc), and the presence/absence of a code was used to train a elastic regression model. While the authors provide an organized, systematic presentation of how their model was developed, the overall premise for the model, and the model performance are not clearly described. At the outset, the authors frame the problem of recruiting patients to clinical trials. However, the link between the question being answered by the model (predicting patients who would have breast cancer) and clinical trial recruitment is not explicit and could be made clearer. The authors also do not cite the large body of work in this area. In the evaluation, the authors should consider performing a cross validation study. Additional metrics about the model performance (e.g., true positive rate/false positive rate for each predicted class) would be helpful when interpreting the AUC value (e.g., does a class imbalance in the data exist?). Please also note for future reference that the AMIA template should be used for the submission and that the submission is missing an abstract.
4: This is an interesting paper. Authors might also want to address insufficient granularity of EMR diagnoses for oncology trials, as well as inherent “dirtiness” of EMR diagnostic data compared with cancer registry data.
5: As noted by reviewers, the goal and methods of the paper need to be more clearly aligned.
That feedback arrived quickly (December 2016) and we decided to shoot for a journal publication. The length of the article was brief enough that we could submit it as a brief communication to the Journal of the American Medical Informatics Association. This is the same group that sponsored the San Francisco conference. The paper was sent out August 2017.
A month later, I got a rejection letter with this very terse comment:
While it is important to gain new insights into inconsistency and incompleteness of information in the EHR, this paper examines a single condition (breast cancer) using data from a single EHR (Univ of Kansas). It is therefore limited in the extent to which we can draw generalizable conclusions about the quality of EHR data.
We decided to resubmit, and there was no point making major revisions, because we didn’t get any helpful feedback. Because of a hiccup in funding, I lost several months at this point.
But now I’m back on task. I got several good suggestions, and decided to try for a journal published by Biomed Central. My original plan was to send it to BMC Bioinformatics, and formatted everything to their specifications. But I got cold feet because most of the articles in BMC Bioinformatics were targeted towards genetics. Thankfully, there is another journal, BMC Medical Informatics and Decision Making, that had at least two very recent articles dealing with the Electronic Health Record.
Here’s what they say about themselves on their website:
BMC Medical Informatics and Decision Making is an open access journal publishing original peer-reviewed research articles in relation to the design, development, implementation, use, and evaluation of health information technologies and decision-making within the healthcare setting.
This journal, like all BMC Journals, is open source. I am a big proponent of open source publication, and while I have been forced at times to publish in journals that are trapped behind pay walls, I don’t like it.
The other interesting thing about BMC Medical Informatics and Decision Making is that they have an open peer review process. That means that the original manuscript and the peer review comments appear on the website in addition to the final manuscript (assuming it gets published, of course).
There are some minor reformatting issues, but it should not take too long to get those changes ready and get the article shipped off.
Wish me luck!