PONE-D-21-40129Provider Reported Challenges with Completing Death Certificates: A Focus Group Study Demonstrating Potential Sources of ErrorPLOS ONE

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PLOS ONE

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Reviewers' comments:

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Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Partly

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: N/A

Reviewer #3: Yes

Reviewer #4: N/A

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3. Have the authors made all data underlying the findings in their manuscript fully available?

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Dear, this is an important topic. However I have some comments:

- the background section reveals interesting papers. However the WHO has published important documents on this issue and I think it is important toe read them and see what can be worthwhile (1979 en 2020°. As I was told WHO has an e-learning on this topic. Please control it and give comments on what it can do on the education topic

- line 71: 4 groups is a low figure and 2 tot 5 participants is also a low figure. comment on that in the discussion section

- method: check for the Coreq criteria for the publication of Q research.

- line 99 it is predominantly in-patient 9 versus 5 it is almost the double. Please mention this as a weak point

- there are important papers explaining, like for cancer, that dementia is a problem: dying with or dying caused by dementia. Can you discuss that in the discussion section

- Line 141 are data available on the effectiveness of the electronic certification other than what you already mentioned?

- I was wandering that nothing came out of the results as to the problem of death certification in case of a doctor on duty, who does not know the patient and has only an (incomplete) medical file. Can you discuss this issue, because in other studies it is a problem.

- line 164-170 if doctors have different views on the importance of death certificates, it has an impact on the motivation to do some training and effort to do i properly. What is you idea about it?

- discussion section: I think a table with all the possible errors is useful

- line 273-275: is doing more autopsies a way to have better death certificates? In my clinical situation autopsies hardly are done (except in cases of criminality.

- As to spending of public funding, the epidemiology derived form death certificates, is enourmously important. It is cleat that cardiovascular and cancer deaths are far overestimated. Can you discuss the consequences of all this? What is the effect on the value of some so called evidence based figures and guidelines?

We did a research, not yet published where 92 physicians filled death certificates of 5 case vignettes: I put the results from the abstract:

91 participants filled in a death certificate for 5 cases. 90% stated the correct nature of death. The chain of death causes was correct in 30% of cases, partially correct in 45% of cases and false in 25% of cases.

Reviewer #2: This is a very sound research article. You present a concise but thorough methodology, specifically one that includes exceptional analyses of the issue at hand. Particularly your discussion of the infrastructural challenges and the issues surrounding patients with cancer was refreshing and much needed in the discipline. The Background at the beginning of the paper is somewhat brief but what’s lacking in the Background section, I think you make up for in the Discussion section. You do an excellent job at laying out the importance of your findings, strengths, weaknesses, applicable recommendations, and ideas for future exploration in the Discussion.

In lines 285 – 287 you mention “Feedback is particularly important during public 286 health crises such as the opioid epidemic and Covid-19 pandemic to ensure that deaths are 287 certified using consistent methods…” I think it might be worth adding a few sentences to this statement. No need to add in a new section of the Discussion, as we don’t want to distract from the purpose of your paper. However, as these two occurrences are highly vulnerable to the cause death determining/certification process, it may be worth adding a few sentences discussing this issue further or adding in some recent citations on the issue. Overall, this was a very solid and impactful contribution. Thank you.

Reviewer #3: Summary of the research

Cause of death certification is a timely and important topic to study. I congratulate the authors for choosing this all-important topic.

This study has been conducted to characterize the experiences of the certifiers in completing the cause of death section of death certificates. Four focus group discussions were conducted over a period of three months until the thematic saturation was reached. Three challenges leading to misclassification of causes of deaths in death certificates have been identified during the study.

The rationale for the study is clear and valid. The researchers have used a technically sound protocol and a feasible methodology to achieve the study's aims effectively.

However, I do have the following concerns about their findings and conclusions.

The international standard death certificate format that WHO recommends is also the form used in the USA. This form has two parts, namely part 1 and part 2. Part 1 has four lines for reporting conditions leading to death in a logical sequence. Part 2 is for reporting other significant conditions that may have contributed to the death. The column to the right is for reporting the approximate time interval between the onset of each of these conditions in the certificate and death.

The design of the death certificate form itself is prescriptive for the correct reporting of causes of deaths in a logical sequence. The provider’s perception of the restrictive nature of the form is due to their ignorance of the international standard death certificate format and the best practice death certification standards required to select the proper underlying cause of death.

Electronic certification can improve certification quality by avoiding common death certification errors such as illegibility, use of non-standard abbreviations, etc. However, an electronic death certificate can also be restrictive to the providers due to suggestive texts, drop-down cause lists, and other functionalities included in the format.

Therefore the solution suggested by the providers may be due to their misunderstanding of the benefits of using electronic formats. In other words, the electronic form will never reduce the misclassification of causes of deaths caused by other certification errors such as reporting ill-defined underlying causes, incorrect sequencing of causes in part 1, reporting competing causes, etc.

The appointment and providing access to death coordinators within hospitals suggested by the providers could be a meaningful solution to improve the certification practices of doctors.

Lack of training and lack of real-time feedback are important challenges for the certifying physicians, and they have been described in the published literature as well. Clinical uncertainty and certifying deaths due to cancer are already known sources of certification errors, and in this study, those issues have been reiterated from a certifier's perspective.

I also have the following concerns regarding their methodology;

1.The research question is relevant to the present context, and the rationale given in the introduction is satisfactory. However, a clear justification should be given for selecting FGD as the method of investigation.

2.Recruitment, sampling, and approach: The authors used a single case study and advocated the FGD at a single academic institution in rural New England. This selection can cause issues on the representativeness of the information obtained during FGD, therefore the generalizability of findings.

3.Strategic group bias is a recognized issue arising during organizing the FGD. The authors should explain the measures taken to minimize this bias.

4.The authors should elaborate in the methods section on the experience and the role of facilitators specifically related to the FGD.

5.The authors should explain why they use the constant comparison method as the method of thematic analysis (https://files.eric.ed.gov/fulltext/EJ1004995.pdf).

6.The authors have not discussed the limitations of the study in the discussion section.

Reviewer #4: Undoubtedly the public health significance of death reports is important and unrealized by many trainees. As such the premise for this manuscript is relevant and of significance. I liked their focus groups and interventions and breaking it down to three challenges. They focused on unwitnessed deaths and cancer patients -- it would be nice for some estimates of the proportion of this. I wish they discussed the Electronic Death Certification better, more than just real-time feedback. Is this something in pipeline for all states - what are the roadblocks?

Accuracy vs Specificity was another great question, but it didn't provide an answer which is more important or how to balance them in uncertain and cancer cases.

Finally, the autopsy requirement was an interesting area. Outside scope of paper but would love to hear reasons behind this change - cost, resources, invasiveness. Is the accuracy of death certificates worth changing this policy for?

Overall, very interesting topic with great provider identification and focus groups. I think the most useful intervention is improved education in preparing death documents with systems for real-time feedback (either on phone or electronic.) The largest interventions are a leap and would need more nuanced discussion, outside scope of this article.

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: Yes: DR. U S H Gamage

Reviewer #4: Yes: Adith Sekaran, MD

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Provider Reported Challenges with Completing Death Certificates: A Focus Group Study Demonstrating Potential Sources of Error

PONE-D-21-40129R1

Dear Dr. Morgan,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Kind regards,

Benjamin P. Geisler, M.D., M.P.H., F.A.C.P., M.R.C.P. (London), F.H.M.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

Reviewer #3: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: N/A

Reviewer #3: Yes

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4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: You answered succesfully to my remarks and I hope that this paper will have an interesting impact. About line 69 dying with or dying caused by it was not my goal to comment on dementia (it was just an example of my own research). It is important to make the difference between the two concepts.

Reviewer #2: Thank you for your revisions. Your additions add nicely to the quality of your study and help to position your findings in contemporary contexts.

Reviewer #3: You have addressed all my previous comments adequately. Thanks for choosing such an interesting topic for your study.

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Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: De Lepeleire Jan

Reviewer #2: No

Reviewer #3: No