Nursing Roles in the Quality of Information in Informed Consent Forms of a Spanish County Hospital

Round 1

Reviewer 1 Report

Nursing Reports

November 10^th, 2023

Title: Nursing role in the quality of information in informed consent forms

General comments:

Thank you for the opportunity to review this timely article on an important topic for Nursing and Research, once Nursing professionals should be actively involved with of information in informed consent form and their improvement to facilitate patient  decision making is crucial. In fact, the nursing professional has an important role to play in the informed consent process, since he carries out his healthcare work in direct and continuous contact with the  patient and his family, and is one of those responsible for ensuring that patients are adequately informed about the procedures they are going to undergo. 

The authors have reported a cross-sectional study aimed to analyze the readability and formal quality of the informed consent forms for non-surgical procedures at the "Vega Lorenzo Guirao" Hospital (Cieza, Spain) in March 2023.

I have some comments/concerns regarding some aspects on the method section, suggestions in order to strengthen the potential contribution of this topic in any revision the author(s) might undertake. 

Firstly, the study design needs to be better described.

Well, either the study is descriptive observational (when no hypothesis is tested) or it is a cross-sectional analytical observational study (which seems to be the case here, since in addition to descriptive statistical analyses, hypothesis tests are presented to verify possible associations between variables).

In this sense, I recommend replacing it with: “A observational cross-sectional study was conducted....”

The inclusion and exclusion criteria for this research need to be better reported, it is necessary to follow and check the STROIBE guideline to adequately report a cross-sectional study.

Regarding the INFLESZ Scale, the authors need to provide more details, for example: is this a validated scale? What are the psychometric properties presented by the scale?

Statistical analysis needs to be better written for the specific objectives of this research instead of reporting in a single table with several tests, without explaining them. For example, Spearman's correlation coefficient was used to check whether there is a relationship with the INFLESZ readability score and formal quality score... The way in which the tests were used is not clear and it sounds somewhat confusing to present them all in a table called inferential statistics...

What criteria were used to decide between one statistical test and another?

Minor editing of English language required

Author Response

Dear reviewer.

Thank you very much for your recommendations and suggestions. They have guided us to improve the quality of the manuscript and we have tried to follow them with the utmost rigor.

Comments and Suggestions for Authors

Firstly, the study design needs to be better described. Well, either the study is descriptive observational (when no hypothesis is tested) or it is a cross-sectional analytical observational study (which seems to be the case here, since in addition to descriptive statistical analyses, hypothesis tests are presented to verify possible associations between variables). In this sense, I recommend replacing it with: “A observational cross-sectional study was conducted....”

Thanks for your recommendation. We have proceeded to modify it (line 111).

The inclusion and exclusion criteria for this research need to be better reported, it is necessary to follow and check the STROBE guideline to adequately report a cross-sectional study.

Thanks for your comment. We have proceeded to better specify these criteria by including the following paragraph: "This study analyzed informed consents from those disciplines that usually performed their interventional procedures outside the surgical area" (lines 114-115).

Regarding the INFLESZ Scale, the authors need to provide more details, for example: is this a validated scale? What are the psychometric properties presented by the scale? 

Thanks for your comment. We have proceeded to include more details regarding the INFLESZ scale by adding the following paragraphs: “This scale is specific to the reading habits of the Spanish population and has been validated to analyze the readability of Spanish healthcare texts” (lines 119-121). “This scale establishes as normal the readability score obtained by adult publications in newsstands because their reading is accessible to the average Spanish citizen" (lines 127-128).

Statistical analysis needs to be better written for the specific objectives of this research instead of reporting in a single table with several tests, without explaining them. For example, Spearman's correlation coefficient was used to check whether there is a relationship with the INFLESZ readability score and formal quality score... The way in which the tests were used is not clear and it sounds somewhat confusing to present them all in a table called inferential statistics... What criteria were used to decide between one statistical test and another? 

Thanks for your comments. We have added the following paragraph: "Analysis of variance (ANOVA) was used to analyze the association between type of specialty (nominal qualitative polytomous variable) and INFLESZ readability score (continuous quantitative variable). The chi-square test was used to analyze the association between type of specialty and formal quality criteria (polytomous nominal qualitative variable). The Kruskal-Wallis test was used to analyze the association between type of specialty and formal quality score (ordinal quantitative variable). Spearman's correlation coefficient was used to determine whether there is a relationship between INFLESZ readability score and formal quality score." (lines 205-213).

Author Response File: Author Response.pdf

Reviewer 2 Report

Informed consent is one of the main topic not only in nursing but especially in legal medicine. 

The importance of IC and the nursing role are interesting arguments, but I think that the authors have to enrich the discussion and the introduction by talking about IC and its medicolegal aspects and also about some particular conditions. 

To help the author to enrich the paper, I suggest the following articles:

Informed Consent: Legal Obligation or Cornerstone of the Care Relationship?

Pallocci, M., Treglia, M., Passalacqua, P., ...Quintavalle, G., Marsella, L.T. International Journal of Environmental Research and Public Health, 2023, 20(3), 2118  

Il consenso informato e i farmaci off-label durante l'emergenza covid-19

LAW n.219/17: Reflecting on shared care plan

Law proposal provisions on the post-mortem body donation and the use of bodies for the purposes of study, scientific research and training: Comment and analysis of the bill and the historical-juridical-ethical aspects of cadaveric dissection and practice of the donation of a corpse for scientific and medical training purposes

Author Response

 Dear reviewer.

Thank you very much for your recommendations and suggestions. They have guided us to improve the quality of the manuscript and we have tried to follow them with the utmost rigor.

Thanks for your suggestions. We have incorporated the main ideas of the indicated articles into our manuscript and have included them in the references so that readers can delve deeper into the subject of this research.

We have added the following paragraphs:

• "The patient must be able to decide based on the technical and scientific information provided by the health professional [3]" (lines 38-39).

• “The lack of information or the difficulty in understanding it means that the informed consent form ceases to be an effective tool and becomes a mere bureaucratic formality aimed at avoiding any legal liability [15]. Although it is not always possible to achieve these objectives, especially in patients with serious pathologies in whom treatments without sufficient scientific evidence are used as a last resort [16]” (lines 60-64).

Author Response File: Author Response.pdf

Reviewer 3 Report

The article can be a contribution to the literature. However, some modifications, explanations, and corrections need to be introduced:

1. Line 2: The article's title should be more specific (improved) because the results obtained by the authors pertain to a single county hospital in Spain. The current title may mislead readers. In other words, from a methodological standpoint, the article's title is broader than its content.

2. Lines 33-35: It can be added that ethical and legal regulations also aim to make decision-making transparent and fair.

3. Line 46: It seems that there is more literature on this topic. Additional literature can be included at this point.

4. Lines 106-107 and 193: Why do the authors choose this particular measurement scale? This should be clarified more explicitly. Are other scales less efficient, worse, less precise, etc?

5. Line 143: The word "inform ed" should be corrected.

6. Limitations should be clearly separated from the Discussion. In other words, an additional section titled 'Limitations' should be introduced in the article. This section should encompass the content found in lines 288-301.

7. Weakness of the study: The research is limited to a single county hospital in Spain and only involves 37 informed consent forms (lines 142-143). It is difficult to consider them as representative. The authors are aware of these limitations (line 288). Nonetheless, I believe that the authors' assertion that their research can be generalized to all of Spain (line 292) seems very risky and even unscientific. Mere speculation is not yet a justification. The opinion expressed by the authors should be modified or removed.

Author Response

Dear reviewer.

Thank you very much for your recommendations and suggestions. They have guided us to improve the quality of the manuscript and we have tried to follow them with the utmost rigor.

Comments and Suggestions for Authors 

Line 2: The article's title should be more specific (improved) because the results obtained by the authors pertain to a single county hospital in Spain. The current title may mislead readers. In other words, from a methodological standpoint, the article's title is broader than its content. 

Thanks for your comment. We have modified the title.

Lines 33-35: It can be added that ethical and legal regulations also aim to make decision-making transparent and fair. 

Thanks for your comment. We have included the following paragraph: “Ethical and legal regulations also aim to make decision making transparent and fair “(lines 37-38).

Line 46: It seems that there is more literature on this topic. Additional literature can be included at this point.

Thanks for your suggestion. We have proceeded to add references 7, 8 and 9 so that the reader can go deeper into this aspect of the research.

Lines 106-107 and 193: Why do the authors choose this particular measurement scale? This should be clarified more explicitly. Are other scales less efficient, worse, less precise, etc.?

Thanks for your comment. We have proceeded to include more details regarding the INFLESZ scale by adding the following paragraphs: “This scale is specific to the reading habits of the Spanish population and has been validated to analyze the readability of Spanish healthcare texts” (lines 119-121). “This scale establishes as normal the readability score obtained by adult publications in newsstands because their reading is accessible to the average Spanish citizen" (lines 127-128).

Line 143: The word "inform ed" should be corrected.

Thanks for your comment. We have corrected the error (line 160).

Limitations should be clearly separated from the Discussion. In other words, an additional section titled 'Limitations' should be introduced in the article. This section should encompass the content found in lines 288-301.

Thanks for your comment. We have included this section (lines 328-345).

Weakness of the study: The research is limited to a single county hospital in Spain and only involves 37 informed consent forms (lines 142-143). It is difficult to consider them as representative. The authors are aware of these limitations (line288). Nonetheless, I believe that the authors' assertion that their research can be generalized to all of Spain (line 292) seems very risky and even unscientific. Mere speculation is not yet a justification. The opinion expressed by the authors should be modified or removed.

Thanks for your comment. We have replaced it with the following paragraph:” Therefore, further studies are needed to determine whether these results can be generalized to the rest of Spanish hospitals” (lines 331-332).

Author Response File: Author Response.pdf

Reviewer 4 Report

Interesting study. Appreciate your approach to evaluating informed consent readability and nursing role in this process. One important thing that would improve your manuscript would be to address sentences that are longer than 2-3 lines - similar to your evaluation of consent forms. I always recommend that we use plural they rather than a gender specific pronouns. This addresses important gender equality issues in only using he or she in writing.

There are a few word suggestions: Page 2 line 91: use of term allowing is confusing - suggest facilitating instead. and later , ans specifically (the development and review of the informed consent form... Content presented interesting and important for nurses to know.

I will address other issues by listing page/line number and suggestions for improvement.

Page 3 lines 104-105 the terms that you used to identify the medical specialties were not familiar to me, recommend using more common terms such as pulmonology, allergy and immunology, gastroenterology. The last sentence is too long and difficult to understand. I recommend: A readability score equal to or higher than 55 indicates a greater probability of being comprehended by patients. Please left justify your table columns to make it easier to read. Last sentence on this page: We used the STROBE guidelines to ensure adequate reporting of our findings. Table 3: I would only report means, with so few forms from different departments the standard deviation will be skewed. Bottom of page 6: please place item number in parenthesis after description of the issue being addressed, i.e. verification of delivery of a copy to the patient (item 19) in 100% of the forms. If you do not have adequate pages for these descriptions, you could refer the reader to the item number in Table 2.

Page 7 in the paragraph describing your statistical analysis (lines 174-181). Hard to read paragraph only one sentence! Perhaps simply state Table 5. summarizes the frequencies of non-compliant quality criteria. The highest frequencies were contraindications and alternatives to the procedure, and verification of the patient having received a copy of their consent form. 

Page 7 please explain why you used multiple statistical procedures. 

In discussion: Please re-word second sentence of first paragraph. It does not make sense to me such that I can't suggest alternative wording. 

Line 195 need to cite the other studies to which you are referring. 

I'm not sure of the point you are making for first full paragraph starting on line 217. Recommend deleting. I'm not sure if consent qualities could be a discipline specific professional attribute rather than a professional who writes better than others? Also relates to discussion point on page 9 lines 259-265.

Lines 247-252 - really interesting point and deserves its own paragraph!

And finally I would consider a box that includes what you glean as your most important take-aways for the reader regarding how to improve informed consent writing. 

I would recommend that you also go back through your paper and critically examine how much content is needed to make your important points. I wish you the best in continuing the development of this important work. 

As described above. English quality acceptable but too wordy. And increase use of active voice to ensure short, crisp sentences to engage your readers. 

Author Response

 Dear reviewer.

Thank you very much for your recommendations and suggestions. They have guided us to improve the quality of the manuscript and we have tried to follow them with the utmost rigor.

Comments and Suggestions for Authors 

Interesting study. Appreciate your approach to evaluating informed consent readability and nursing role in this process. One important thing that would improve your manuscript would be to address sentences that are longer than 2-3 lines - similar to your evaluation of consent forms. I always recommend that we use plural they rather than a gender specific pronouns. This addresses important gender equality issues in only using he or she in writing. 

Thank you for your suggestion. We have taken it into account for the whole study.

There are a few word suggestions: Page 2 line 91: use of term allowing is confusing - suggest facilitating instead. and later, ans specifically (the development and review of the informed consent form... Content presented interesting and important for nurses to know.

Thanks for your suggestion. We have modified it (lines 100-101).

Page 3 lines 104-105 the terms that you used to identify the medical specialties were not familiar to me, recommend using more common terms such as pulmonology, allergy and immunology, gastroenterology. The last sentence is too long and difficult to understand. I recommend: A readability score equal to or higher than 55 indicates a greater probability of being comprehended by patients. Please left justify your table columns to make it easier to read. Last sentence on this page: We used the STROBE guidelines to ensure adequate reporting of our findings. Table 3: I would only report means, with so few forms from different departments the standard deviation will be skewed. Bottom of page 6: please place item number in parenthesis after description of the issue being addressed, i.e. verification of delivery of a copy to the patient (item 19) in 100% of the forms. If you do not have adequate pages for these descriptions, you could refer the reader to the item number in Table 2.

Thanks for your suggestion. We have proceeded to modify them.

Page 7 in the paragraph describing your statistical analysis (lines174-181). Hard to read paragraph only one sentence! Perhaps simply state Table 5. summarizes the frequencies of non-compliant quality criteria. The highest frequencies were contraindications and alternatives to the procedure, and verification of the patient having received a copy of their consent form.

Thanks for your comment. We have modified the paragraph referring to the results in table 6: “Statistically significant associations were observed between informed consent forms across disciplines with the INFLESZ readability score, compliance with formal quality criteria, and the formal quality score. No statistically significant correlation was observed between the INFLESZ readability score and the formal quality score (Table 6)” (lines 214-217).

Page 7 please explain why you used multiple statistical procedures.

Thanks for your comment. We have added the following paragraph: “Analysis of variance (ANOVA) was used to analyze the association between type of specialty (nominal qualitative polytomous variable) and INFLESZ readability score (continuous quantitative variable). The chi-square test was used to analyze the association between type of specialty and formal quality criteria (polytomous nominal qualitative variable). The Kruskal-Wallis test was used to analyze the association between type of specialty and formal quality score (ordinal quantitative variable). Spearman's correlation coefficient was used to determine whether there is a relationship between INFLESZ readability score and formal quality score” (lines 205-213).

In discussion: Please re-word second sentence of first paragraph. It does not make sense to me such that I can't suggest alternative wording.

Thanks for your suggestion. We have changed it to the following paragraph: “The complexity in the wording of these forms makes it difficult for patients to achieve sufficient understanding to make decisions according to their needs and interests” (lines 224-226).

Line 195 need to cite the other studies to which you are referring.

Thanks for your comment. We have proceeded to add the references (line 232).

I'm not sure of the point you are making for first full paragraph starting on line 217. Recommend deleting. I'm not sure if consent qualities could be a discipline specific professional attribute rather than a professional who writes better than others? Also relates to discussion point on page 9 lines 259-265.

Thanks for your comment. We have modified it: “In this study, statistically significant differences were observed in the INFLESZ readability score of the different informed consent forms for non-surgical procedures analyzed according to discipline. The complexity of the procedures specific to each specialty may make the drafting of these forms difficult and be a possible cause of this result [28-33,36]” (lines 255-256).

Lines 247-252 - really interesting point and deserves its own paragraph!

Thanks for your suggestion. We have modified it.

I would recommend that you also go back through your paper and critically examine how much content is needed to make your important points. I wish you the best in continuing the development of this important work.

Thank you for your suggestion. We have taken it into account.

As described above. English quality acceptable but too wordy. And increase use of active voice to ensure short, crisp sentences to engage your readers.

Thank you for your suggestion. We have taken it into account.

Author Response File: Author Response.pdf

Round 2

Reviewer 1 Report

The authors addressed a good part of my questions satisfactorily.

The article still needs minor revisions;

The paragraph below, found in the results section, actually belongs to the methods section and needs to be moved there (right after the sentence): "To evaluate the associations between the different 146 variables present in this study, ANOVA, Chi- square, Kruskal-Wallis and Spearman tests 147 were used according to the characteristics of each of the variables, using a p value < 0.05 148 to indicate significance

"Analysis of variance (ANOVA) was used to analyze the association between type of specialty 205 (nominal qualitative polytomous variable) and INFLESZ readability score (continuous 206 quantitative variable). specialty and formal quality criteria (polytomous nominal qualitative variable). 208 The Kruskal-Wallis test was used to analyze the association between type of specialty and 209 formal quality score (ordinal quantitative variable). Spearman's correlation coefficient 210 was used to determine whether there is a relationship between INFLESZ readability score 211 and formal quality score.

The text needs revision in English.

Minor editing of English language required

Author Response

Dear reviewer. 

Thank you very much for your recommendations and suggestions. 

We have proceeded to change the indicated paragraph from the results section to the methods section.

We have also proceeded to make a revision of the English.

Kind regards.

Reviewer 2 Report

The article was reviewed, and it can be accepted.

Author Response

Dear reviewer.

Thank you very much for your recommendations and suggestions that have served to improve the quality of the manuscript.

Kind regards.