Procedural Sedation and Analgesia in an Australian Emergency Department: Results of the First 3 Months of a Procedural Sedation Registry

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

Good summary of procedures and medications used for PSA.

Busy hospital ED with 75,000/year.

18,750 ED presentations over 3 months.

Total of 80 PSAs over three months.

80/18,750 =0.00042 = 0.042%

Main limitations as authors report are: retrospective study, ambiguous documentation, limited ability to get a representative sample, small sample number of 80 PSAs.

Hard to determine safety of PSAs with such a small number (80) of cases.

It would be better to have at least a year’s sample.

If the ED does 80 per 3 months, this would be 320 over 12 months (1 year).

Questions:

Why was 14 years used as a cutoff point?

What were the 6 post anesthesia complications?

What is meant by the term “team leader’s specialty” in Table 3?

Overall good descriptive study, but major limitation is the small number obtained over a short time (3 months).

My major suggestion is the get more data over a 1 year period and then resubmit.

 

Author Response

Comment	Response
Good summary of procedures and medications used for PSA.	Thankyou
18,750 ED presentations over 3 months. Total of 80 PSAs over three months. 80/18,750 =0.00042 = 0.042%	Not uncommon in Australia unfortunately but agree that it does, for the first time, provide a snapshot of how often procedural sedations are performed
Main limitations as authors report are: retrospective study, ambiguous documentation, limited ability to get a representative sample, small sample number of 80 PSAs.	Thankyou for acknowledging that we have noted this. And we have provided the entirety of this manuscript as a ‘short report’ rather than an ‘original article’.
Hard to determine safety of PSAs with such a small number (80) of cases.	Agree – we have made this comment in the discussion and conclusion: Line 252: “A larger patient cohort is required to determine if our ED aligns with these benchmarks. Based on the frequency of PSAs over this 3-month period, it would require 3 years to reach 1000 cases to determine this.”
It would be better to have at least a year’s sample. If the ED does 80 per 3 months, this would be 320 over 12 months (1 year).	We agree, which is why we made this a short report. We intend to do a much longer study as this progresses. Part of the reason for this early publication was to ensure feasibility of the process.
Why was 14 years used as a cutoff point?	As per line 108 “Pediatric patients are defined as less than 14 years of age in line with local definitions.”
What were the 6 post anesthesia complications?	As per table 2 and line 179 “Six complications were recorded with 4 (10%) related to desaturation, 2 (6%) related to hemodynamic instability and none related to airway compromise or severe events. No complications were recorded for the pediatric cohort.“
What is meant by the term “team leader’s specialty” in Table 3?	We have added a definition in line 65 “Team leaders are often delegated to co-ordinate all aspects of a PSA and are commonly ED specialists although for more complex scenarios may involve other critical care specialists taking on this role in the ED.”
Overall good descriptive study, but major limitation is the small number obtained over a short time (3 months). My major suggestion is the get more data over a 1 year period and then resubmit.	As mentioned above, we agree that a longer study would be useful for a full research article. As this is a short report, our aim was to report a brief period to show the prevelance of PSA in an ED compared to all presentations (which has not been previously reported from our understanding) as well ensure feasibility of the process.

Author Response File: Author Response.docx

Reviewer 2 Report

Comments and Suggestions for Authors

In their manuscript, the authors have described the practice of procedural sedation and analgesia (PSA) performed over a 3-month period in an emergency department in an Australian institution. This information could be of potential clinical value; however, the way the data have been analyzed and presented in the manuscript could be improved.

 

In its current form, readers may be puzzled on why numbers different to 80 (which is the total number of patients that received PSA; line 193 and Table 1) are provided throughout the results section for the studied parameters. The information contained under 3.6 Documentation (lines 186-193) should be moved towards the beginning of the results section; I suggest doing this just after Table 1. This would allow readers to understand since the beginning the variability of the data collected in the PSA forms. Also, consider modifying Table 3 so that documented values, instead of non-documented values, are provided. This should align with the rest of the values described in the results section and, ultimately, improve flow of information.

 

In the Data Analysis section, it should be specified that frequencies and their percentages were calculated (line 129). This is relevant due to the variability in data collected in the PSA forms. Consider reporting percentages at up of tenths of a fraction (e.g., 7.8%).

 

Table 2 summarizes the core of the study; however, it needs to be amended. For completeness, please include totals in Table 2 for each variable and age group (e.g., “21” for Team Leader Specialty, < 14 years and “27” for Team Leader Specialty, 14 years and above). Also, for clarity, consider treating the information about Specialist and Register from Table 2 as a subcategory of Team Leader Specialty for which total should be provided too. This could probably be done by inserting a dotted line or an empty row. A total of 6 for Complications in Table 1 is inconsistent with the way that all other totals in the table were treated; please amend this. Totals should be provided for each of the variables under Complications. Please check all reported percentage values as some are incorrect. For instance, under total for Desaturation there is 4 (10) for Yes and 52 (90) for No when it should read 4 (7) and 52 (93). The increase of 3 points for a 7% value represents a difference of almost +43%.

 

In each one of the different statements that include frequencies in the results and discussion, it would be relevant to mention the total number of patients analyzed for the variable. For instance, in lines 260-262, “93% of cases” corresponds to 67 out of a total of 72, and “1 (2%)” corresponds 1 out of a total of 60. Similarly, the statement in lines 180-182 is difficult to follow and should be rephrased; the same happens again in line 245.

 

It is mentioned that under 1 PSDA per day was performed at the emergency department (e.g., lines 19, 199, and 313). Because the distribution of PSAs over the 3-month period is not presented in the manuscript, it is impossible to determine whether this statement is accurate or not.  Consider including a figure with the distribution of PSAs, maybe by day or week, to have a better understanding of this issue and amend the statement in question if needed.

 

One major limitation that is not discussed, and should be included, is the limited timeframe of the study. Why records for 3 consecutive months only were included? A longer study period would have provided more robust data from which more relevant inferences could have been made. This is somehow recognized (lines 253-254) but not properly addressed as a limitation of the study.

 

A copy of the PSA form should be included in the manuscript as an Annex. This would complement the Materials and Methods.

 

Specific comments

Line 106. Please provide the full name and location of the emergency department.

Line 131. There were no statistical analyses performed; please amend this sentence.

Line 140. Please rephrase this sentence as patients, but not PSAs, are male or female.

Line 167-168. Please rephrase this sentence. Figure 1 shows cumulative data for the studied 3 months and therefore demonstrates no “daily peak”. Also, provide number of patients and frequencies (%) for the mentioned timeframes.

Figure 1. In the legend, please include the total number of PSAs depicted in the graph.

Line 175. Consider including propofol alone (12, 24%) as this would provide the bulk of the analyzed PDAs (i.e., ~93%).

Line 207. Change “rates” for “rate”.

Line 223. Reference 19 may not be appropriate to support this statement; amend if needed.

Lines 233-235. This statement is speculative. Can you confirm, from the records of the 18 patients that received propofol alone, that this really happened?

Line 249. Reference 20 and 24 may not be appropriate to support this statement; amend if needed.

Line 207. Replace “is” for “are”.

Line 374. Provide full journal title instead of its abbreviated form.

Line 421. Reference 34. Should read: Australian Institute of Health and Welfare. Injuries in children and adolescents 2021–22. Available online://www.aihw.gov.au/reports/injury/injuries-in-children-and-adolescents-2021-22. (accessed on 20/04/2024)

Line 436. The author in reference 40 should read “Australian Institute of Health and Welfare”. Also, the link seems not to work.

 

Comments on the Quality of English Language

Just a few minor typos that need to be corrected.

Author Response

Please see the attachment

Author Response File: Author Response.docx

Reviewer 3 Report

Comments and Suggestions for Authors

The manuscript is a well-written study on ‘Procedural Sedation and Analgesia in an Australian Emergency Department: Results of the first 3 months of a procedural sedation registry’. This issue merits research in both public health perspective and in clinical terms, namely, diagnosis and management. It is a retrospective study of the initial 3 months of a PSA registry as part of the Tasmanian Emergency Care Outcomes Registry involving children. The work is of considerable importance for both the patients and caregivers. However, there are areas for improvement.

 

There is an issue of inclusion of the sample into the study. The authors cited that ‘The mean age for pediatric patients was 6.9 years (SD 4.3 IQR 3.0-10.0) and for 142 adults was 48.8 years (SD 23.4, IQR 26.5-70.5). The oldest patient was 89 years old.’ Although this appears to represent the richness of the sample, it addresses a challenge to draw firm conclusions from a homogeneous population sharing similar characteristics. Doses and selection principles of the medications, airway maneuvers and other interventions have little in common among all ages. Geriatric patients and small children are treated in the same PSA research. Both the retrospective nature of the study and broad variation in the patient characteristics are major limitations of the study. Also, standardization of the expertise of the intervening physicians is impossible in this retrospective study. 

Comments on the Quality of English Language

none

Author Response

Comment	Response
The manuscript is a well-written study on ‘Procedural Sedation and Analgesia in an Australian Emergency Department: Results of the first 3 months of a procedural sedation registry’. This issue merits research in both public health perspective and in clinical terms, namely, diagnosis and management. It is a retrospective study of the initial 3 months of a PSA registry as part of the Tasmanian Emergency Care Outcomes Registry involving children. The work is of considerable importance for both the patients and caregivers. However, there are areas for improvement.	Thankyou for taking the time to review and provide feedback.
There is an issue of inclusion of the sample into the study. The authors cited that ‘The mean age for pediatric patients was 6.9 years (SD 4.3 IQR 3.0-10.0) and for 142 adults was 48.8 years (SD 23.4, IQR 26.5-70.5). The oldest patient was 89 years old.’ Although this appears to represent the richness of the sample, it addresses a challenge to draw firm conclusions from a homogeneous population sharing similar characteristics. Doses and selection principles of the medications, airway maneuvers and other interventions have little in common among all ages.	Thankyou for this feedback. We felt that the current reported research took on a more focused scope such that the overall service delivery aspects were missed. Our aim was to start broad with this short report by quantifying the prevalence of procedural sedations occurring in an ED as this has not been reported to previously.   Throughout the manuscript we also acknowledge that paediatric and adult populations are vastly different and have separated them for the most part. We were also able to compare them to help readers understand specific differences which is useful, especially for those who are less familiar with PSA.
Geriatric patients and small children are treated in the same PSA research.	We disagree when you state that “Geriatric patients and small children are treated in the same PSA research,” although we started with a large cohort of all PSA patients, we did do subgroup analysis throughout the paper, including the statement in the conclusion “The approach to ED PSA is different between pediatric and adult populations and therefore research needs to differentiate both populations.”
Both the retrospective nature of the study and broad variation in the patient characteristics are major limitations of the study.	we agree that a longer study would be useful for a full research article. As this is a short report, our aim was to report a brief period to show the prevelance of PSA in an ED compared to all presentations (which has not been previously reported from our understanding) as well ensure feasibility of the process.
Also, standardization of the expertise of the intervening physicians is impossible in this retrospective study.	Our aim of comparing specialty was moreso to appreciate the collaborative efforts required in the ED for PSA rather than expertise at the procedure. We did find it useful to standardise expertise into medical specialists and training doctors. One example of this was the discussion point “The safety of ED PSA is also determined by the experience of the clinician team leader [2, 13]. Our data shows a lower tolerance for risk reflected by the presence of more senior clinicians for pediatric ED PSA with 15 (75%) team leaders identified as specialist compared with 16 (60%) in the adult cohort.”

Author Response File: Author Response.docx

Round 2

Reviewer 1 Report

Comments and Suggestions for Authors

I disagree with the statement that the authors state that "PSA is commonly performed in our tertiary mixed-ED."

80 out of 75,000 presentations (0.1%) is not common but "rare" in my view.  In my mind, from what you present, you do not commonly do PSAs in your ED. 

And 6 minor complications out of 80 (7.5%) seems a bit high.

I really think that the authors should collect a years data to get a better idea of the true nature of sedation in their ED.

Author Response

Comment	Response
I disagree with the statement that the authors state that "PSA is commonly performed in our tertiary mixed-ED." 80 out of 75,000 presentations (0.1%) is not common but "rare" in my view.  In my mind, from what you present, you do not commonly do PSAs in your ED.	I disagree with the statement that the authors state that "PSA is commonly performed in our tertiary mixed-ED." 80 out of 75,000 presentations (0.1%) is not common but "rare" in my view.  In my mind, from what you present, you do not commonly do PSAs in your ED.	Thank you. We have removed the word common so that the sentence now reads as ‘PSA is commonly performed in our tertiary mixed-ED at just under 1 per day’.
And 6 minor complications out of 80 (7.5%) seems a bit high.	And 6 minor complications out of 80 (7.5%) seems a bit high.	As per lines 247-250 we compared our rate of complications to the literature and found that it was similar.
I really think that the authors should collect a years data to get a better idea of the true nature of sedation in their ED.	I really think that the authors should collect a years data to get a better idea of the true nature of sedation in their ED.	We agree and will be collecting a years worth of data to get a better idea of the true nature of sedation in our ED.   We have written this manuscript as a brief report. As per the MDPI style guide (second edition) 2.1.2 Brief Report, a brief report is described as ‘short, observational studies that report preliminary results or a short complete study or protocol’.  Noting that as per the manuscript, we plan on publishing a more complete data set as an original report, we feel that this meets the definition of a short report and is worthy of publication given the novel approach we have taken to this area as a comparison of the entire ED presentation has not been reported in the literature before.

Reviewer 3 Report

Comments and Suggestions for Authors

Thank you for the responses and revisions. 

Comments on the Quality of English Language

none. 

Author Response

Please see the attachment

Author Response File: Author Response.docx

Round 3

Reviewer 1 Report

Comments and Suggestions for Authors

the statement - "A Brief Report" should be added to the title

Author Response

Please see the attachment

Author Response File: Author Response.docx