Readability and Comprehension of Anesthesia Informed Consent Forms in a Spanish County Hospital: An Observational Study

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

Lines 12, 212, and essentially everywhere in the article, revise "four anesthesia informed consent forms" to "our hospital's four anesthesia informed consent forms." Please Repeat multiple times. This is a study of forms from one county hospital.

 

Table 9 line 257, or in the text, include the effect size measures like Spearman correlation coefficient. For the P > 0.05, report the actual P-value because "0.052" is not a reproducible value (i.e., might be different with another set of 357 patients), while P=0.87 will be unlikely significant with repetition.

Author Response

Dear reviewer. 
Please find enclosed a document in response to your comments and suggestions. 
Kind regards.

Author Response File: Author Response.pdf

Reviewer 2 Report

Comments and Suggestions for Authors

Thank you for the opportunity to read review the article entitled “Readability and comprehension of informed consent forms in a county hospital’.

I believe the topic is very interesting and is indeed underexplored in the literature. The issue of informed consent is a priority for healthcare organizations, yet it remains insufficiently examined. It is crucial to continue to find new evidence supporting management decisions within the organizational framework of healthcare services. However, some aspects allow you to dig deeper into the study.

GENERAL ASPECTS

·         For cross-sectional studies, it’s mandatory following the STROBE statement.

·         The questionnaire used in this study is not validated. In this case, the authors must report the essential validation measures and psychometric proprieties.

·         The study seems to be an internal management project and not a research project. The implications for practice and external validity are not well declared and analysed.

TITLE

·         It would be better to indicate the study design in the title.

INTRODUCTION

·         Line 50: It is not necessary to report multiple tools to the reader to assess readability (Fernandez-Huerta Index and Flesh-Kincaid Reading Index), as in the manuscript authors used only one specific tool (INFLESZ scale).

·         Line 65: It is not necessary to cite previous literature describing specific materials and methods, it would be better to analyse and describe the most relevant data present in the scientific panorama.

·         Lines 91-95: although nursing professionals should ensure that the consent form is complete, easy to read by patients, and check that patients have adequately comprehended all the information provided, medical staff should be responsible for these processes, and could influence the comprehension. In some countries, only medical professionals are responsible for the informed consent form. It would be more accurate to introduce a paragraph with the context-specific information.

·         The authors did not specify their prespecified hypotheses (the rationale of the study).

MATERIALS AND METHODS

·         The inclusion and exclusion criteria did not declare in which way the authors decided whether patients can answer the questionnaire. In which wat the cognitive disability has been assessed?

·         It would be more interesting to divide the population study into different age classes, studying the different levels of comprehension related to the same population.

·         Variables and data measurement: it would be more accurate to include potential confounders.

·         The manuscript lacks efforts to address potential sources of bias.

·         Multivariate analyses are missing.

·         The questionnaire used in this study is not validated. The authors declare that the questionnaire was designed by anesthesia service personnel with more than two years of experience. It is not well-defined what kind of experience they had, whether clinical or research.

 

RESULTS

·         Authors should consider the use of a flow diagram to explain numbers and reasons for nonparticipation in the study.

·         Table 1 in the quantitative study should always give the characteristics of the study participants. It should be better to include the missing data for each variable of interest.

·         In the INFLESZ Scale reported (Table 1), please clarify the score range: 40, 55, and 65. What degree the authors considered with regard of these numbers (=they can encompass two different ranges).

·         The manuscript lacks confounder-adjusted estimates and their precision. Confidence intervals are missing.

·         It would be more interesting to perform a linear or logistic regression, to elaborate a provisional model, studying the relationship between readability and variables of interest in the study.

·         Table 9. I’m curious about the reporting of the variables, e.g., ‘age and overall questionnaire score’ instead of means and standard deviation. The same for the categorical ones, e.g., ‘gender’ instead of the frequencies and the percentages.

DISCUSSION

·         Limitations should be deeply analysed, consider also discussing the presence of eventual bias in the manuscript, including a limited period of data collection.

·         The generalisability of the study is limited and not declared in the manuscript.

·         The implications for practice are not well cited and explored.

Author Response

Dear reviewer. 
Please find enclosed a document in response to your comments and suggestions. 
Kind regards.

Author Response File: Author Response.pdf

Reviewer 3 Report

Comments and Suggestions for Authors

Interesting evaluation on an important topic.

The consent form should be on a secondary school level so that patients can understand.  Who chose hte contents of the consent form? Who obtains written consent from the patient? MD anesthesiologist? Nurse? 

Please include an appendix with the consent form in Spanish (and English translation) so that readers can see what information in your consent form you are talking about.

Author Response

Dear reviewer. 
Please find enclosed a document in response to your comments and suggestions. 
Kind regards.

Author Response File: Author Response.pdf

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

I thank the authors for their prompt revision. However, my major concerns regarding their manuscript are not solved. I suggest them taking more time to deeply revise the entire work and to properly address the suggestions given. The authors may consider presenting the results as a quality improvement project rather than a full-fledged research study. Then, the authors should declare the implications to make them more visible to an international audience.

GENERAL ASPECTS:

1.     The authors correctly acknowledge in the manuscript that a validated questionnaire was not used. However, including just a sentence is insufficient to enhance the methodological quality of the study. Using an unvalidated questionnaire weakens the manuscript's quality.

2.     Unfortunately, the conclusions provided are not sufficiently detailed and analyzed. What are the practical and broader implications of this study? How could improving the readability of informed consent forms enhance the relationship with healthcare professionals? The arguments should be thoroughly examined and presented.

INTRODUCTION:

3.     The authors should provide a more comprehensive context description, including references, to clarify and discuss how responsibilities may vary in different settings and contexts. The context’s normative should be cited and presented.

4.     The study's purpose contradicts this argumentation. The authors stated that the study's objective was to analyze the readability and comprehension of anesthesia-informed consent forms in a Spanish county hospital. The pre-specified hypotheses should align with the aim and attempt to address the research questions. If the authors aim to develop a questionnaire to assess and improve the comprehension and adequacy of informed consent, the study should focus on instrument validation.

MATERIALS AND METHODS:

5.     The authors should identify independent variables that could affect readability and comprehension. For example, the type of intervention or anesthesia and reading time could be considered confounders.

6.     The authors have presented the analysis without a clear table to report the results. It is essential to include all findings in a clear and structured manner.

RESULTS:

7.     Typically, the first table in scientific studies describes the demographic characteristics of the sample. Authors used ‘Table 1’ to describe readability levels corresponding to educational levels and types of publications considered easy to understand at each educational level. It would be clearer to follow stylistic conventions and describe the sample in Table 1, and then use another table to detail readability levels.

8.     As mentioned earlier, authors should consider including a table to summarize results for improved readability and comprehension.

9.     It is incorrect to list variables in the result table. Authors should describe them descriptively in the Results section and then present specific results in a separate table, including means and standard deviations.

DISCUSSION:

10.  The suggestion mentioned should be included in the 'discussion' or 'conclusion' section, not elsewhere in the manuscript.

The authors should expand on the implications for practice, reflecting on how a deeper understanding of informed consent could influence the relationship with healthcare professionals.

Author Response

Dear Reviewer.
Please find enclosed a document with the responses to your comments and suggestions.
Kind regards.

Author Response File: Author Response.pdf