Formal Quality and Compliance of Informed Consent Forms in Critical Care and Surgical Areas in Spain: An Observational Study

Round 1

Reviewer 1 Report

This is an appropriately-summarized report of a study conducted in one hospital in Cieza, Spain to assess the compliance in meeting criteria associated with completing informed consent forms prior to patients’ undergoing surgery. The Abstract and the Keywords need a little adjustment, as noted below. The type of information provided by the authors and the tables constructed are generally clear and well-thought out, although there are some formatting issues for the tables. There are problems with English word choices throughout the paper, but these are easily corrected. A deficiency of this report is the outdated references that were used to support the authors’ claims. Almost all the references will need to be redone to ensure they are ones published within the last five years.

 

Line by line suggested edits

27 Change “showed” to “were shown”.

29-30 There needs to be another sentence included here to indicate why nursing professionals would be well-considered to take the lead in obtaining informed consent. Otherwise, this final sentence appears entirely unrelated to the rest of the abstract. The bridging phrase that could be used in one found in the body of the paper in lines 69-70: “As nurses have a responsibility to ensure that patients are adequately informed about both nursing interventions and care, as well as the surgical treatments they receive, consideration should be given to the possibility of nursing professionals taking the lead in obtaining informed consent.”

31-32 Each of the Keywords should be found in the Abstract. If they are not, either the Abstract should be changed to include them or they should not be Keywords. Furthermore, the Keywords should appear in the order they do in the Abstract. As such, these should be the Keywords and they should be listed as follows: informed consent; patient’s freedom to choose; compliance; critical care; surgical areas; consent forms; nursing professionals (this should be added as a Keyword once a sentence is also added to indicate why nursing professionals are appropriate for taking the lead in obtaining informed consent—as mentioned above in relation to lines 29-30).

35 Change “The unstoppable technological” to “Continuing technological”.

37-38 In line 36 the authors say that there is “a bridge”. Here, the authors say “one of the bridges”. Change “One of the bridges” to “One part of the bridge”.

41 Given the new social attention to non-binary individuals, change “his or her” to “the patient’s”.

43 Change “that is specific” to “that is: specific”.

45 Change “, developed” to “, and developed”.

63 Change “conformity” to “consent”.

74 An additional remark needs to be provided for why it is not a good thing for the patient to be left to read the information alone.

74-75 Change “himself and, depending on what he understands” to “alone and, depending on what the patient understands”.

83 Change “by all” to “of all”.

85 Change “which include” to “which included”.

87 Change “In first” to “In the first”.

Table 1

Please extend the width of this table to be the entire width of the printable page. As well, create two separate columns—a column for numbering the criteria, and a separate column for the criteria. Head the first column with ”#” and the second column with “Criteria”. 

 Change “having all the doubts” to “having all doubts”.

Change “the consent can be revoked” to “consent can be revoked”.

99 Change “with for” to “for”.

Table 2

Please extend the width of this table to be the entire width of the printable page.

Change “with the name, last names, and registration” to “with the physician’s name, last names, and registration”.

Change “with the name, last names, identification” to “with the patient’s name, last names, identification”.

Table 3

Please reformat the column heads to be two lines instead of three and place “Discipline” on the top line of the two.

122 Change “he or she will be subjected to” to “to which the patient will be subjected ”.

Table 4 

Change “1,3” to “1.3”.

Table 5

As the title of this table is “Percentage of compliance of the surgical consent forms from the hospital” the type of information listed can’t be headed by “Yes” or “No”. The heading must be “Percentage”. As such, there is no need for the “No” column. All that is necessary to know is what is under the “Yes” column, which will now be renamed “Percentage”.

129 Change “On the contrary” to “Instead”.

135 Change “On the contrary” to “In contrast”.

Table 6

Please change all of the commas to decimal points to correspond with the other tables.

Please reorder the disciplines to correspond to the ordering of the disciplines in Table 3 and Table 4.

140 Change “comprehensible” to “comprehensive”.

145 Change “setting” to “settings”.

149-150 I am not sure what the authors mean by this sentence. Are the authors saying that the reason for the lack of specific criteria is a result of the particular criteria which the authors chose to study? If this is not what is meant. Please explain. If it is what is meant, change “However, the lack of some of these specific criteria by specialties is determined by the great influence of the guidelines set by the corresponding scientific society” to “That these specialties lack of some of these specific criteria is a result of the particular guidelines chosen for study, i.e., those set by the corresponding scientific society”.

151 Change “coinciding” to “in agreement”.

152 Change “were” to “was” as it refers to the highest number (singular).

184-185 Change “On the contrary” to “In contrast”.

186 Change “forgetfulness” to “forgetfulness regarding the inclusion of all criteria”. Change “the item physician’s” to “the physician’s”.

189 Change “prone to signing” to “inclined to sign”.

194 Change “flawless” to “manageable”.

208 Change “comprehensible” to “comprehensive”.

References

Of the 31 references, only 3 were published within the last five years. Unless a reference is the seminal work in a particular area, all references should be published in 2018 or later. Please update your references to be only articles published within the last five years, that is, unless it is the original article in the area (something which should be pointed out by the authors if this is the case).

Author Response

Dear reviewer, thank you very much for your comments. We have tried to improve this new version of the manuscript, according to your suggestions. Please see the attached rebuttal letter file and the attached manuscript file marked with changes. 

Author Response File: Author Response.docx

Reviewer 2 Report

This is an interesting investigation.

Although it is recognized that the formal deficiencies in informed consent forms in intensive care and surgical areas call into question the autonomy of the patient and the care provided in critical and/or complex situations, the truth is that providing understandable information and guaranteeing consent or cancellation of procedures should be a routine assistance process and not a mere bureaucratic formality. The authors defend this idea and argue, with evidence, their opinion.

In terms of sampling, the study population consisted of all patients who underwent surgical intervention in November 2020, with a non-probabilistic convenience sample being performed, which included all patients from any surgical discipline who had scheduled surgical intervention. In this investigation, a total of 224 documents were analyzed, within the scope of a quantitative, descriptive and cross-sectional study with patients in intensive care and surgical areas undergoing surgical intervention at the Hospital “Vega Lorenzo Guirao” (Cieza, Spain).

It was found that informed consent forms in intensive care and surgical areas were of poor formal quality due to the lack of compliance with important criteria, such as personalized risks, contraindications or providing a copy to the patient.

Given these realities, the authors suggest that protocols should be developed to obtain informed consent, with a clear description of the role of each professional, and state that the patient should be considered as a proactive element in decision-making. Due to the complexity of the continuous information and consent process for interventions and decisions made about the patient, the authors defend the possibility of nursing professionals taking the lead in obtaining informed consent.

The results of this investigation are useful and allow the continuation of lines of investigation that strengthen the argument now defended.

• It would be helpful if some of the works referenced had more recent dates. Even so, in a general appreciation, there is a balance in the alluded works and it is possible to perceive the connection between the literary choices that were made;
• The sample collected is representative and significant according to the circumstances of the study itself. In other words, we can conclude that the investigation is representative of the place where the information was collected, therefore, external validation is limited, but, in any case, the results can be generalized to the whole of Spain, given the similarity of the analyzed documents;

 

• Conducting interviews would be opportune to mitigate clarifications on whether the information provided to patients was adequate and sufficiently understandable for decision-making, but it is also certain that this circumstance opens up new lines of future investigations that could help consolidate the data now worked on, and, above all, increase the expressiveness of the research typology for a wider area.

Author Response

Dear reviewer, thank you very much for your comments. We have tried to improve this new version of the manuscript, according to your suggestions. Please see the attached rebuttal letter file and the attached manuscript file marked with changes. 

Author Response File: Author Response.docx