Increasing Self-Efficacy for the Management of Patients with Type 2 Diabetes Through an Advanced Practice Education Program for Primary Care Professionals

Round 1

Reviewer 1 Report (Previous Reviewer 3)

Comments and Suggestions for Authors

Congratulations to the authors on the new version of the manuscript. After re-reading the material, I can see that the authors have been attentive to the considerations raised in the first version.

I would point out that this new version clearly consolidates the description of the data analysis and the results. Figure 5 was a timely inclusion in the study, making the differences in comparisons between the intervention group and the control group even clearer. It clarified points about the training that took place during the study. There was also greater use of the discussion of the study.

The study's limitations and conclusions are consistent with the study's format and purpose.

Author Response

We would like to sincerely thank the reviewer for her/his comments. We believe that the improvements have been mainly due to her/his and the other reviewers' recommendations.

Reviewer 2 Report (Previous Reviewer 1)

Comments and Suggestions for Authors

The authors have satisfactorily answered all the comments/questions. There is only a minor suggestion to be consistent with the use of the word "sugar" which was mentioned in the revision, discussion section, lines 522-534. 

Author Response

We would like to sincerely thank the reviewer for her/his comments. We believe that the improvements have been mainly due to her/his and the other reviewers' recommendations. In addition, we have modified the word "sugar" by "glucose". 

Reviewer 3 Report (New Reviewer)

Comments and Suggestions for Authors

Dear Author team. Thank you very much for allowing me to read and provide some feedback to your highly interesting paper. You seem to be the experts in the field of diabetic care in PHC. 

It is a rather complex (but interesting) design you have chosen and that part of your research is well presented. 

The description of your methods and results read well and conclusive. 

The limitation of the chosen methodological approach are elaborated.

I observed some spelling mistakes in the graphs (e.g. figure 4), which need to be systematically checked and fixed. 

Both, the discussion and conclusion chapter however, will significantly benefit from a general shortening of sentences and maybe some re-structuring around the main arguments you want to make. In both chapters, the reader is getting a bit lost in what you want to say exactly. Both chapter should be treated with similar diligence like the method and intro chapter, so they could become stronger. 

A good sentence, which is understandable to a reader is around 20 to max. 30 words long. You instead have sentences of 70 words! 

For e.g line 540-543. The sentence is not only long, but also its difficult to understand the point you want to make.

Another example is the following sentence, line 591-595.

something seems to be missing in the sentence in line 529-530.

Author Response

COMMENTS TO REVIEWER 3.

(The reviewer’s comments are highlighted in bold characters, and the replies are written in italic characters).

Dear Author team. Thank you very much for allowing me to read and provide some feedback to your highly interesting paper. You seem to be the experts in the field of diabetic care in PHC. 

Thank you for your kind words and positive feedback on our work. We truly appreciate your recognition of the interest of our research and expertise in the field—it is both encouraging and motivating.

 It is a rather complex (but interesting) design you have chosen and that part of your research is well presented. The description of your methods and results read well and conclusive. The limitation of the chosen methodological approach are elaborated.

Thank you again for your consideration.

I observed some spelling mistakes in the graphs (e.g. figure 4), which need to be systematically checked and fixed. 

We regret for these mistakes. We have revised the paper for grammatical mistakes. We have made several corrections throughout.

Both, the discussion and conclusion chapter however, will significantly benefit from a general shortening of sentences and maybe some re-structuring around the main arguments you want to make. In both chapters, the reader is getting a bit lost in what you want to say exactly. Both chapter should be treated with similar diligence like the method and intro chapter, so they could become stronger. A good sentence, which is understandable to a reader is around 20 to max. 30 words long. You instead have sentences of 70 words! For e.g line 540-543. The sentence is not only long, but also its difficult to understand the point you want to make. Another example is the following sentence, line 591-595.

We regret the possible confusion made by our redundant style. We have shortened those sentences, as well as all the conclusions, and we believe that in this form, the sentences are within the 20-30 words range and, at the same time, maintain the intended meaning.

 something seems to be missing in the sentence in line 529-530.

Effectively, again there was a mistake, and several words were missing. We have corrected the sentence as follows:

Original: “Therefore, although the education program was, there are still specific areas that may require further strengthening”

Revised: “Therefore, although the education program was successful in improving self-efficacy, there are still specific areas that may require further strengthening.

Reviewer 4 Report (New Reviewer)

Comments and Suggestions for Authors

The results and their interpretation should be reconsidered.

Comments for author File: Comments.pdf

Author Response

COMMENTS TO REVIEWER 4.

(The reviewer’s comments are highlighted in bold characters, and the replies are written in italic characters).

Why used the difference knowledge to classify participants, due to baseline knowledge may be the confounding factor. Should mention about your reason for this selection method.

There are several aspects to consider in this regard:

Purpose of the study: The main objective of our research was to evaluate whether an educational intervention targeting physicians with lower levels of knowledge about type 2 diabetes could improve the clinical outcomes of their patients. This question is relevant from both a scientific and practical point of view, given that, in clinical practice, continuing education programs are usually directed at those professionals who show greater deficiencies in their knowledge. The question of whether an educational intervention can benefit those with limited knowledge more than those with more robust knowledge is precisely at the heart of the hypothesis we suggest in this study.

Justification for the intervention: The educational and medical training literature suggests that an improvement in knowledge, and therefore in clinical practice, is more likely to be observed in those professionals who initially have greater deficiencies. This is consistent with the fundamental principles of health education and teaching in general, where groups with a lower starting level tend to show greater absolute improvements after receiving an adequate intervention.

Sensitivity analysis: To address your concern regarding the comparability of the groups, we have added a Propensity Score Matching in our work. The results of this analysis were consistent with the main findings, reinforcing our conclusion that the educational intervention had a positive effect on the patients.

Each score should be descriptive. What does a score of 0 mean—does it indicate 'false'? And what does a score of 7 represent?

We regret this lack of information. We have included the meaning of the scores in the revised version of the paper.

 They are either rating scales or true/false questions. If they are true/false questions, the KR-20 or KR-21 should be used for the reliability test. However, for rating scales, Cronbach's alpha with a value above 0.70 is recommended.

This is an interesting remark by the reviewer. The questionnaire was developed like an exam with multiple option questions. Therefore, the questions are not true or false, but they do not have the conventional structure of a test either. Therefore, we consider that Cronbach's alpha test would be adequate. On the other hand, it is true that a value of 0.7 would be better, although different authors comment that a value higher than 0.6 would be adequate. This aspect has also been commented on in the reviewed article.

 Did not significant (referring to Hba1C levels).

Effectively, since there were no baseline differences, we have rewritten this sentence to avoid confusion in this regard.

Why you did not mention about this result? Why you did not mention about Duration of DM (referring to Table 1 data)

We regret the lack of information on this regard. We have included such information in the revised paper.

SBP,DBP,Trigly,Choles,LDL,Non-HDL were not dereference in both group. Pls recheck the results and your interpretation.

We regret the potential confusion in this section. Regarding metabolic parameters, as described in the original paper, both control and experimental groups experienced an improvement in most metabolic parameters. These data are shown in Supplementary Table S1. However, to better compare if the intervention was more effective that the control, we compare changes through a Forest plot, a procedure commonly employed to compare interventions (For instance: Muñoz, J. G., Gallego, M. G., Soler, I. D., Ortega, M. B., Cáceres, C. M., & Morante, J. H. (2020). Effect of a chronotype-adjusted diet on weight loss effectiveness: A randomized clinical trial. Clinical Nutrition, 39(4), 1041-1048.)

This paragraph should serve as a description above Figure 4, and the figure should be renamed accordingly.

We believe that the reviewer is making reference to the fact that the caption of the figure was so long. We have shortened and clarified the information of the figure.

Pls check your presentation of df. (referring to Table 2).

Attending to the explanation of the biostatistics that have collaborated with this analysis, in classical statistical models, degrees of freedom (df) are often exact integers determined by the number of observations and the number of estimated parameters. However, in mixed linear models:

• The fixed effects component behaves similarly to ordinary linear models, where the df relate to the number of observations minus the number of fixed parameters being estimated.
• The random effects add complexity because they introduce variance components and correlation structures that impact the effective sample size for inference.

Thus, the calculation of df in mixed models accounts for both fixed and random effects, which often leads to fractional (non-integer) degrees of freedom.

In this work, df were calculated following the residual Maximum Likelihood (REML) Degrees of Freedom, which estimates random effects and can yield approximate df that depend on the variance components.

Then, in mixed models, df can and often do have decimals. This is because the methods used (e.g., Kenward-Roger, Satterthwaite) yield approximations that reflect the effective sample size rather than the raw number of observations.

In summary, we wish to thank the reviewer for his/her feedback. As the comments were made directly on the PDF, we have carefully reviewed them and have made every effort to follow all the suggestions. However, if we have inadvertently missed any, please do not hesitate to let us know

This manuscript is a resubmission of an earlier submission. The following is a list of the peer review reports and author responses from that submission.

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

This manuscript describes the comparative effect of an advanced practice exercise  program on the metabolic control of patients diagnosed with type 2 diabetes. Overall, this is a well written article with conclusive evidence that appropriate education is imperative for the effective management of patients with type 2 diabetes. The manuscript has the following limitations:

1. Selecting providers with a lower knowledge score for the intervention and clinicians with higher knowledge scores introduces selective bias and does not provide a true control. This should be noted as a limitation.

2. The introduction mentions that type 2 diabetes is considered a trivial disease by some providers especially compared to patients under insulin therapy. Is this referencing type 1 diabetes or patients with type 2 diabetes on insulin? 

3. The ethics section mentions that cultural and social implications were considered. Please elaborate on how this was done. Is this referring to lifestyle interventions? Also, how were community representatives engaged and involved? 

4. The self efficacy section of the manuscript mentions that every patient with a new diagnosis must be referred to a nurse. Please elaborate on this finding.

5. Was the overall experience of the clinicians measured, such as years in medical practice or number of diabetes patients treated? 

6. A higher HbA1c group in the intervention group potentially represents another bias since this population has more room for improvement. Please list this as a limitation. 

Author Response

Article

Increasing self-efficacy for the management of patients with type 2 diabetes through an advanced practice education program for primary care professionals

Yunis et al.

REVIEWER 1. REPORT OF ANSWERS

This manuscript describes the comparative effect of an advanced practice exercise  program on the metabolic control of patients diagnosed with type 2 diabetes. Overall, this is a well written article with conclusive evidence that appropriate education is imperative for the effective management of patients with type 2 diabetes. The manuscript has the following limitations:

Comment #1: Selecting providers with a lower knowledge score for the intervention and clinicians with higher knowledge scores introduces selective bias and does not provide a true control. This should be noted as a limitation.

Response #1: We would like to express our gratitude for your valuable suggestion. We have given your comment the attention it deserves and concur with the importance of your observation. Consequently, we have incorporated the suggested modifications in the manuscript (discussion section, lines 522-534)

C#2: The introduction mentions that type 2 diabetes is considered a trivial disease by some providers especially compared to patients under insulin therapy. Is this referencing type 1 diabetes or patients with type 2 diabetes on insulin?

R#2. This is a good remark by the reviewer. Thank you for the appreciation. We referred to type 1 diabetes. It has been clarified in the text of the revised manuscript (line 50)

C#3: The ethics section mentions that cultural and social implications were considered. Please elaborate on how this was done. Is this referring to lifestyle interventions? Also, how were community representatives engaged and involved? 

R#3: We regret this misunderstanding. We originally referred that the patients’ care was developed following their cultural and social implications, especially regarding the obtention of the consent. We have modified this section to clarify this issue.

C#4: The self efficacy section of the manuscript mentions that every patient with a new diagnosis must be referred to a nurse. Please elaborate on this finding.

R#4: Again, we fully agree with the reviewer and included the following paragraph in the discussion section:

“The health professionals evaluated in the present work showed a high baseline level of self-efficacy, especially regarding the perception of the staff about the treatment of diabetes in the community, with variables like referring new diagnosed patients to a nurse. Since the reform of health systems carried out after the WHO conference in Alma Ata (1978), the strategy of Primary Care began to be developed almost worldwide, and specifically, to implement health programs to address chronic conditions (such as diabetes type 2), which would be developed by the Primary Care Team, with the doctor and nurse, being the basic core professionals assigned to each patient, for medium and long term control”.

C#5: Was the overall experience of the clinicians measured, such as years in medical practice or number of diabetes patients treated? 

R#5: We have the data about staff experience, and it has been included in the Methods section of the new version of the paper. However, we lack the precise data of number of patients treated. It is important to remind that several professionals had more than 20 years of experience, and, therefore, is quite difficult to obtain this data.

C#6: A higher HbA1c group in the intervention group potentially represents another bias since this population has more room for improvement. Please list this as a limitation. 

R#6: We thank you again for your contributions, which have helped to improve the quality and clarity of our work. We have incorporated the suggested modifications in the manuscript (discussion section, lines 526-530)

Author Response File: Author Response.pdf

Reviewer 2 Report

Comments and Suggestions for Authors

The work of the willing project group starts from a brilliant, extremely interesting and all in all little-studied idea: assuming that a training intervention on healthcare personnel can have important health consequences, the researchers implemented a professional improvement path on a group of doctors and nurses to then evaluate the repercussions of this intervention in terms of surrogate health endpoints and intermediate outcomes in patients assisted by these healthcare workers.

However, this work presents numerous critical points, one of which is fatal as it is expressed in a serious error in the assignment of the two groups.

I will first list the potentially remediable critical points

First: the authors recruited 157 health professionals, adopting as a selection criterion having at least 50 diabetic patients in their care. However, of the 7850 expected patients, only 4099 were evaluated in the before-after analysis. The difference is probably explained by the fact that the patients not recruited were followed in a specialist setting but the authors should have illustrated the reasons for exclusion in detail. Therefore, from the published data, an average number of 26 patients per cluster emerges, identifying individual health professionals as clusters.

Second, the research could have been set up - more correctly - on a clustered randomized design: admitting an average number of 26 subjects per cluster, 77 vs 80 clusters in the intervention vs control group respectively, a coefficient of variation of the cluster size equal to 0.5 and a rho coefficient equal to 0.5 (proportion of variance explained by the clusters ) the study would have had 82% power to demonstrate a one percentage point difference in gHb with a standard deviation of 3.

Third, in line with what is specified in the previous point but also by simply adopting the allocation to the two arms performed by the authors, the statistical analysis should have been much more refined than a simple between groups comparison of before-after changes . In other words, the delta of the changes should have been studied with a multilevel approach (panel study) considering two separate sources of variance: that between clusters (i.e. between the individual operators) and those within clusters, i.e. that pertinent to the before-after analyses which concern the patients. It is clear that a traditional approach violates one of the most important statistical assumptions, that of independence between observations. In this case a simple test for paired data considers the within dependence but does not take into account in any way the fact that the patients followed by a single operator also have specific cluster characteristics in common, i.e. those linked to the single operator.  A panel study (e.g. mixed models) solves this problem through a random intercept and random slope approach.

Fourth (and last). However, the most important (and insoluble) problem concerns the strategy used by the authors in the allocation. Let's not forget that even if the outcomes are recorded on patients, what we wanted to evaluate in this research is the effectiveness on these endpoints of the training course applied to healthcare professionals. Therefore, the assignment of healthcare workers to the two arms should have ensured a sufficient balance between the intervention arm and the control arm of the baseline level of (presumed) performance in relation to diabetes management. It is completely incomprehensible to the writer why healthcare workers with lower basic performance were assigned to the intervention arm and those with better performance to the control arm. This creates a very serious selection bias that can skew the results toward the null. In other words, all healthcare workers enrolled in the research should have had an identical (e.g. mediocre) baseline level of performance: by allocating half to the training intervention and allocating the other half to the control arm, the effect measured on i patients would have reflected - other conditions being equal which would have been the subject of multivariate analysis - the intrinsic effectiveness of the training intervention itself. The results produced by the research - in the presence of an underlying imbalance of this magnitude - are most likely seriously undersized. It's a real shame because the commitment of human resources in this research was truly remarkable. With great regret I find myself forced to express a judgment of "unpublishability" of this research

Author Response

Article

Increasing self-efficacy for the management of patients with type 2 diabetes through an advanced practice education program for primary care professionals

Yunis et al.

Comment#1: The work of the willing project group starts from a brilliant, extremely interesting and all in all little-studied idea: assuming that a training intervention on healthcare personnel can have important health consequences, the researchers implemented a professional improvement path on a group of doctors and nurses to then evaluate the repercussions of this intervention in terms of surrogate health endpoints and intermediate outcomes in patients assisted by these healthcare workers.

Response#1: We want to thank the reviewer for its kind comments. We have tried to answer adequately the different questions.

C#2: However, this work presents numerous critical points, one of which is fatal as it is expressed in a serious error in the assignment of the two groups.

I will first list the potentially remediable critical points. First: the authors recruited 157 health professionals, adopting as a selection criterion having at least 50 diabetic patients in their care. However, of the 7850 expected patients, only 4099 were evaluated in the before-after analysis. The difference is probably explained by the fact that the patients not recruited were followed in a specialist setting but the authors should have illustrated the reasons for exclusion in detail. Therefore, from the published data, an average number of 26 patients per cluster emerges, identifying individual health professionals as clusters.

R#2: We regret the lack of information about this regard. The difference between the total number of patients and the estimated number of participants by your side depends on the permissions obtained during the first three months of 2022. As there was a longitudinal follow-up of participants, only those patients attending (programmed and/or by demand) to the centre during this period took part in the study. 

C#3: Second, the research could have been set up - more correctly - on a clustered randomized design: admitting an average number of 26 subjects per cluster, 77 vs 80 clusters in the intervention vs control group respectively, a coefficient of variation of the cluster size equal to 0.5 and a rho coefficient equal to 0.5 (proportion of variance explained by the clusters ) the study would have had 82% power to demonstrate a one percentage point difference in gHb with a standard deviation of 3.

R#3: This is a good remark, however, we wanted to remind that this was a quasi-experimental study, and no sampling procedure was carried out. As commented in the revised paper, we estimated the needed number of professional (48 in each group) with the GPower software. Later, all participants that consent to take part in the study were included in the present work.

C#4: Third, in line with what is specified in the previous point but also by simply adopting the allocation to the two arms performed by the authors, the statistical analysis should have been much more refined than a simple between groups comparison of before-after changes . In other words, the delta of the changes should have been studied with a multilevel approach (panel study) considering two separate sources of variance: that between clusters (i.e. between the individual operators) and those within clusters, i.e. that pertinent to the before-after analyses which concern the patients. It is clear that a traditional approach violates one of the most important statistical assumptions, that of independence between observations. In this case a simple test for paired data considers the within dependence but does not take into account in any way the fact that the patients followed by a single operator also have specific cluster characteristics in common, i.e. those linked to the single operator.  A panel study (e.g. mixed models) solves this problem through a random intercept and random slope approach.

R#4: This is a great comment by the reviewer. We have re-evaluated the clinical data of the participants regarding glucose and HbA1c according to your suggestions. The following information has been included in the Statistaical analysis section of the revised paper.

Since patients were grouped by Primary Care specialist, and this staff was divided into two groups (intervention and control), a mixed-effects model was conducted for capturing variability within Primary Care staff and between groups of patients. Health staff was considered as a random effect, while the educational intervention was considered as a fixed effect. To do this, change in metabolic parameters, in this case HbA1c was established as the dependent variable, and group of intervention was the fixed independent variable. The Primary Care staff was considered as the random variable. The mathematical model will be the next:

Where y_ij means the change in the metabolic parameter, β₀ is the mean change in HbA1c without intervention,  β₁  is the effect of educational intervention, u_j is the random effect for primary care staff j and ∈_ij is the residual error for patient ? of primary care staff j. To verify that the assumptions of normality were met in the adjusted model, a study of the residuals was carried out. In addition, a comparison analysis was performed with a null model (not including intervention groups), with a likelihood ratio to verify whether the inclusion of the group variable significantly improved the model.

C#4: Fourth (and last). However, the most important (and insoluble) problem concerns the strategy used by the authors in the allocation. Let's not forget that even if the outcomes are recorded on patients, what we wanted to evaluate in this research is the effectiveness on these endpoints of the training course applied to healthcare professionals. Therefore, the assignment of healthcare workers to the two arms should have ensured a sufficient balance between the intervention arm and the control arm of the baseline level of (presumed) performance in relation to diabetes management. It is completely incomprehensible to the writer why healthcare workers with lower basic performance were assigned to the intervention arm and those with better performance to the control arm.

R#4: We appreciate your comment on the staff allocation method. In our study, health professionals were divided based on their prior diabetes training to assess the impact of an educational intervention on clinical care in daily practice. We decided to allocate less-trained professionals to the intervention and more-trained staff to the control group, as we were specifically interested in seeing whether structured, diabetes-specific training led to improvements in patient care compared to those who already had extensive training and, in consequence, knowledge. We are aware that this allocation method is not random, which could be considered a limitation, but it is important to remind that this is a quasi-experimental study, as it has been originally described. Although a randomized trial may delve greater impact, this study design is also reliable, useful and reproducible. Therefore, we consider this strategy to be valid and appropriate for the purposes of this study, as it allows us to identify whether an educational intervention specifically targeting less-trained health professionals has a relevant clinical impact. This approach reflects standard practice where less experienced practitioners benefit from specific training interventions. That said, we acknowledge that non-randomization may introduce selection bias. We have therefore performed a statistical analysis adjusting for potential confounding variables and have included a detailed discussion of this limitation in the manuscript. We hope that with this justification, the choice of method and its relevance to the study objectives will be clearer.

The following article supports the idea of ​​continuing education and the impact of medical education on clinical practice [1]:

Reference:

1. Frenk, J.; Chen, L.; Bhutta, Z.A.; Cohen, J.; Crisp, N.; Evans, T.; Fineberg, H.; Garcia, P.; Ke, Y.; Kelley, P.; et al. Health Professionals for a New Century: Ttransforming Education to Strengthen Health Systems in an Interdependent World. The Lancet 2010, 376, 1923–1958.

This approach helps to frame the response within the logic of the study and acknowledges limitations.

C#5: This creates a very serious selection bias that can skew the results toward the null. In other words, all healthcare workers enrolled in the research should have had an identical (e.g. mediocre) baseline level of performance: by allocating half to the training intervention and allocating the other half to the control arm, the effect measured on i patients would have reflected - other conditions being equal which would have been the subject of multivariate analysis - the intrinsic effectiveness of the training intervention itself. The results produced by the research - in the presence of an underlying imbalance of this magnitude - are most likely seriously undersized.

R#5: Again, the comment of the reviewer is quite interesting, and in fact, we would like to have a clinical staff with similar knowledge (high or mediocre), but unfortunately, not all professionals are equally qualified. Precisely, for that reason, we designed (as commented above) a quasi-experimental design, not a randomized one. Regarding the statistical procedures, the data reflected in the paper followed the procedure carried out in other RCTs, and additionally, the inclusion of the mixed-effect model also increased the reliability of our observations, as described in the revised paper. Here we describe several previous works with a similar methodology [2-4]:

References:

2. Schachman, K.A.; Macomber, C.A.; Mitchell, M.L.; Brown, J.M.; Scott, J.L.; Darr, R.L.; Fabbro, M.A.; Morrone, W.R.; Peckham, K.A.; Charbonneau-Ivey, T.K. Gaining Recovery in Addiction for Community Elders (GRACE) Project: The Impact of Age-Specific Care on Clinical Outcomes and Health Care Resource Utilization in Older Adults With Substance Use Disorder in an Interprofessional Addiction Clinic. J Am Psychiatr Nurses Assoc 2024, doi:10.1177/10783903241261694.
3. Poza-Méndez, M.; Fernández-Gutiérrez, M.; Marín-Paz, A.J.; Sánchez-Sánchez, E.; Bas-Sarmiento, P. TikTok as a Teaching and Learning Method for Nursing Students: A Quasi-Experimental Study. Nurse Educ Today 2024, 141, doi:10.1016/J.NEDT.2024.106328.
4. Alhazmy, R.S.; Khalil, A.H.; Almutary, H. Effects of an Instructional WhatsApp Group on Self-Care and HbA1c among Female Patients with Type 2 Diabetes Mellitus. PLoS One 2024, 19, doi:10.1371/JOURNAL.PONE.0305845.

C#5: It's a real shame because the commitment of human resources in this research was truly remarkable. With great regret I find myself forced to express a judgment of "unpublishability" of this research.

R#5: We sincerely appreciate your comment regarding the commitment of the human resources involved in this research. The effort and dedication of our team, as well as the commitment of the participating professionals, have been fundamental to carry out this work, whose objective was to contribute to the improvement of clinical care through training interventions.

With due respect to your opinion, we believe that the study offers a significant contribution to the field of clinical education and diabetes management in primary care settings. Although we are aware of some limitations, such as the non-randomization of professionals in the groups, we have worked carefully to adjust for possible biases and confounding variables. These limitations are inherent to many intervention studies in real clinical settings, but do not invalidate the findings obtained.

We consider that the results of our study provide relevant and applicable information in clinical practice, especially in contexts where continuing education and the improvement of clinical skills in chronic diseases such as diabetes are crucial. The evaluation of the impact of specific training on less experienced physicians compared to those with more prior training is of particular interest, as it reflects common situations in daily practice.

We hope that, upon further review of the manuscript, the relevance and value of the study for the scientific community and clinical practice will be recognized, as well as its potential to open new lines of research in medical education and care for patients with chronic diseases.

Author Response File: Author Response.pdf

Reviewer 3 Report

Comments and Suggestions for Authors

Congratulations to the authors on their manuscript. They showed care in the preparation and execution of the study. Here are some considerations to complement the writing:

ABSTRACT: Inform in the methodology the period (year) in which the study took place. Inform the place where the study took place.

ABSTRACT: Include in the methodology the main way in which the results were analyzed.

METHODS: Include some details of how the training with the professionals took place. What teaching-learning methodology was applied, was it the expository method? Were the professional participants excluded from the study if they missed any of the days of the training, if so, indicate this in the methods. Considering that the target audience for the study was two professional classes (doctors and nurses), it is important to describe this process in order to clarify the approach taken with each one. This would make it clearer what was expected of each professional.

METHODS: In which city/country the data was collected. In what year or period was the data collected?

Table 1: As the study's target audience is professionals as well as patients with diabetes, I suggest emphasizing this in the title of the table.

DISCUSSION: I suggest that you address the repercussions of continuing health education. The education program in this study also functions as permanent health education. It promotes a sense of security among the professionals that their actions are more aligned, reinforcing their confidence in acting in accordance with the guidelines, and may even contribute to self-efficacy.

DISCUSSION - LINE 393: It points to information that professionals would be expected to know. This reinforces the need to include the importance of Permanent Health Education Policies in the discussion. As well as the repercussions when this is fragile.

DISCUSSION: Sometimes professionals and patients are unable to follow the guidelines very well due to limited social support, material resources or financial conditions. I didn't see this clearly in the text, was it possible to take this into account when interpreting the data?

The limitations and conclusions are consistent with the study's methodology and results.

Author Response

Article

Increasing self-efficacy for the management of patients with type 2 diabetes through an advanced practice education program for primary care professionals

Yunis et al.

REVIEWER 3. REPORT OF ANSWERS

Congratulations to the authors on their manuscript. They showed care in the preparation and execution of the study. Here are some considerations to complement the writing:

We thank the reviewer for his/her comments. We have tried to answer the different comments adequately. We considered that your comments has helped us to improve the paper.

Comment #1: ABSTRACT: Inform in the methodology the period (year) in which the study took place. Inform the place where the study took place.

 Response #1: The study was carried out in the Primary Health Centers of HMO Kupat Holim Meuhedet North District (Israel), from January 2022 to June 2023. We have made explicit reference in the acknowledgements to the management of this health district

C#2: ABSTRACT: Include in the methodology the main way in which the results were analyzed.

R#2: Following your indications, we have included this information.

C#3: METHODS: Include some details of how the training with the professionals took place. What teaching-learning methodology was applied, was it the expository method? Were the professional participants excluded from the study if they missed any of the days of the training, if so, indicate this in the methods. Considering that the target audience for the study was two professional classes (doctors and nurses), it is important to describe this process in order to clarify the approach taken with each one. This would make it clearer what was expected of each professional.

R#3: The information about the educational program was included in the supplementary materials. The learning methodology included theoretical exposition, flipped classroom, presentation and discussion of clinical cases and problem-based learning through workshops. The training programme comprised 8 sessions. It was mandatory for all participants to attend every session. In case of missing a session, the participant was not excluded from the study because he/she could attend the session with another group; a total of 4 educational programme groups were conducted on different dates.

It was recommended that the attending health professionals presented cases for consultation. It was recommended that health professionals apply the instructions and lessons learned during each session, commencing from the outset. Complex cases were presented for discussion as part of the training programme.

The venue and date of the events were as follows: The sessions were held on Mondays between 6:30 pm and 9:30 pm. Each session lasted three hours and was developed at the county executive office. The meetings were conducted by a provincial diabetes forum, which included the participation of diabetes consultants. After the conclusion of the course, a follow-up and a roundtable discussion were conducted.

The objective of the educational programme was to engage a cohort of medical professionals, comprising both doctors and nurses, in a collective learning experience. This was deemed essential to foster a collaborative approach, which is pivotal for effective chronic patient management within a healthcare context. Consequently, the programme integrated a joint follow-up and roundtable discussion at its conclusion. The rationale behind the training programme itself stipulates the necessity for joint training activities, rather than individual ones. This is due to the fact that the long-term follow-up of the patient represents a common objective shared by both professional profiles.

C#4: METHODS: In which city/country the data was collected. In what year or period was the data collected?

R#4: The study was carried out in the Primary Health Centers of  HMO Kupat Holim Meuhedet North District (Israel), between January 2022 and June 2023. We have made explicit reference in the acknowledgements to the management of this health district

C#5: Table 1: As the study's target audience is professionals as well as patients with diabetes, I suggest emphasizing this in the title of the table.

R#5: The clarification has been taken into account and added in the title of Table 1.

C#6: DISCUSSION: I suggest that you address the repercussions of continuing health education. The education program in this study also functions as permanent health education. It promotes a sense of security among the professionals that their actions are more aligned, reinforcing their confidence in acting in accordance with the guidelines, and may even contribute to self-efficacy.

R#6: This educational programme designed for primary healthcare professionals has been demonstrated to result in a notable improvement in the clinical parameters of their patients with type 2 diabetes.

Integrating such training programmes into continuous professional development is not only advantageous for improving patient control, reducing disease burden and comorbidities, lowering cardiovascular risk, and reducing the probability of patients developing complex chronic conditions, but also it encourages patients to assume greater responsibility for managing their chronic condition. The reinforcement of this efficacious educational programme in actual clinical practice would serve to enhance the self-efficacy of primary care teams, thereby increasing their capacity for problem-solving and reducing the necessity for specialist referrals. Consequently, this would result in a reduction in hospital resource consumption and an optimisation of the use of healthcare resources. In conclusion, this intervention provides primary care teams with additional tools for proactive intervention, enabling them to anticipate complications from complex chronic conditions and allowing patients to maintain higher levels of functionality and autonomy for longer periods.

In a previous study conducted by Almetahr et al. [1], notable enhancements were discerned in the evaluation of patients' glycosylated haemoglobin, foot care, dietary habits and physical activity (p < 0.05). Moreover, according to the results of Liu et al. [2], following the training program, there was a notable increase in the rate at which complications were identified, from 22.2% to 27.7% (p = 0.033). Additionally, there was an enhancement in the physicians' comprehension of diabetes management and the administration of medications for comorbidities, including hypertension and hyperlipidaemia. The study concluded that the most significant improvement in clinical care was observed following short-term intensive training.

The findings of both studies reinforce the significance of ongoing education in enhancing both medical expertise and clinical procedures, which has a beneficial effect on the self-efficacy and quality of care provided to patients with diabetes.

References:

1. Almetahr, H.; Almutahar, E.; Alkhaldi, Y.; Alshehri, I.; Assiri, A.; Shehata, S.; Alsabaani, A. Impact of Diabetes Continuing Education on Primary Healthcare Physicians’ Knowledge, Attitudes, and Practices. Adv Med Educ Pract 2020, 11, 781, doi:10.2147/AMEP.S275872.
2. Liu, H.; Hou, H.; Yang, M.; Hou, Y.; Shan, Z.; Cao, Y. The Role of Primary Physician Training in Improving Regional Standardized Management of Diabetes: A Pre-Post Intervention Study. BMC primary care 2022, 23, doi:10.1186/S12875-022-01663-5.

C#7: DISCUSSION - LINE 393: It points to information that professionals would be expected to know. This reinforces the need to include the importance of Permanent Health Education Policies in the discussion. As well as the repercussions when this is fragile.

R#7: We fully agree with the reviewer’s comment. The clarification has been taken into account and added in the discussion, as follows:

“Nevertheless, evidence of the efficacy of training for health professionals and its impact on the metabolic control of their patients is gradually becoming available. The continuous education of healthcare professionals is crucial, especially when evidence starts demonstrating the effectiveness of training programs in improving the metabolic control of patients with type 2 diabetes. Studies have shown that structured educational interventions for healthcare providers lead to significant improvements in clinical outcomes, including better management of glycemic levels, increased adherence to treatment guidelines, and enhanced patient self-management skills. Regularly incorporating continuous education into the professional development of healthcare workers ensures that the latest evidence-based practices are implemented in clinical settings, thus contributing to long-term benefits in patient care. Normalizing such training not only reinforce healthcare providers with the necessary tools to address the complexities of diabetes care but also fosters a proactive approach to preventing complications and reducing the overall disease burden”

C#8: DISCUSSION: Sometimes professionals and patients are unable to follow the guidelines very well due to limited social support, material resources or financial conditions. I didn't see this clearly in the text, was it possible to take this into account when interpreting the data?

R#8: Lack of social support can affect primary care teams' adherence to training programmes. In this case, for example, the training sessions took place outside working hours, for three hours per week. The inability to integrate training into regular working hours is a significant limitation, as it can have a negative impact on health professionals' participation in continuing education programmes. This issue may be a consequence of the fact that the study did not receive any financial support, making it more difficult to incentivise participation. In addition, social determinants or a lack of social support can negatively influence adherence to treatment recommendations in people with type 2 diabetes, exacerbating the difficulties in managing the disease effectively. The intersection of professional constraints and patient challenges highlights the need for structural changes to fit education into work schedules and to address broader social barriers to adherence.

A comment about this regard has been included as a limitation of the study.

C#9: The limitations and conclusions are consistent with the study's methodology and results.

R#9: Thank you very much for your appreciation

Author Response File: Author Response.pdf

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

Believe me, I'm really sorry to have to confirm my previous objection: . The attribution to the study of the qualification of "quasi-experimental research" does not exempt the authors from the need to guarantee at all costs - as in any other Non-Randomized Research - the balance of the groups compared for all the basic characteristics capable of influencing the result. In this case, even in the absence of randomization, it would have been possible to balance the two groups by comparing them - using adequate methods - for the average level of knowledge and awareness regarding diabetes management, then administering the intervention only to one of the two groups and using the other group as control.

You insist a lot on underlining the non-randomized nature of the research but this is not the biggest problem. In fact the problem - and I am firmly convinced in this sense - is intrinsically linked to the nature of the comparison.

The effectiveness of an intervention must be studied by comparing groups with the same initial level of knowledge. Instead, you compared a group with low initial knowledge to another group with a high level of initial knowledge.

This is not a good reason as there is no plausible reason to think that an intervention applied to a deficient group will produce greater results than those obtained by a non-deficient group. Any observational or - in general - "Non-randomized" research must face the same problem using methods capable of guaranteeing the balance of the arms as much as possible: and the moment of allocation is in this sense the most critical moment.

 I had clarified the irrevocability of my opinion both to you and - separately - to the publisher. Nonetheless, the publisher, completely ignoring my clarification, sent me this research a second time for re-evaluation. I think it is in Your best interest, if You disagree with my opinion, to pressure the editor to consult another reviewer.

Author Response

Reviewer comments:

Believe me, I'm really sorry to have to confirm my previous objection: . The attribution to the study of the qualification of "quasi-experimental research" does not exempt the authors from the need to guarantee at all costs - as in any other Non-Randomized Research - the balance of the groups compared for all the basic characteristics capable of influencing the result. In this case, even in the absence of randomization, it would have been possible to balance the two groups by comparing them - using adequate methods - for the average level of knowledge and awareness regarding diabetes management, then administering the intervention only to one of the two groups and using the other group as control.

You insist a lot on underlining the non-randomized nature of the research but this is not the biggest problem. In fact the problem - and I am firmly convinced in this sense - is intrinsically linked to the nature of the comparison.

The effectiveness of an intervention must be studied by comparing groups with the same initial level of knowledge. Instead, you compared a group with low initial knowledge to another group with a high level of initial knowledge.

This is not a good reason as there is no plausible reason to think that an intervention applied to a deficient group will produce greater results than those obtained by a non-deficient group. Any observational or - in general - "Non-randomized" research must face the same problem using methods capable of guaranteeing the balance of the arms as much as possible: and the moment of allocation is in this sense the most critical moment.

 I had clarified the irrevocability of my opinion both to you and - separately - to the publisher. Nonetheless, the publisher, completely ignoring my clarification, sent me this research a second time for re-evaluation. I think it is in Your best interest, if You disagree with my opinion, to pressure the editor to consult another reviewer.

Authors’ response:

First of all, we deeply appreciate the time you wasted reviewing our manuscript and, in particular, rereading it. We value your interest in ensuring the methodological soundness and quality of our research. We would like to respond to your last comment in a detailed and respectful manner, hoping to clarify the points that, from your perspective, still present important objections.

On the quasi-experimental nature of the study

First of all, we would like to reiterate that we are fully aware of the limitations inherent to any non-randomized study. From the beginning, we have been transparent about the quasi-experimental nature of our research, mentioning both in the introduction and in the discussion of the manuscript that the absence of randomization may introduce certain biases. However, we also consider this type of design to be valid and commonly used in studies where, for logistical, ethical or practical reasons, randomization is not feasible. Comparison between non-randomized groups, when properly managed, can provide useful and valuable information, as has been documented in numerous previous studies in the field of medical research. As the present work was based on an “educational intervention”, it was necessary to determine, a priori, the previous knowledge of Primary Care Professionals. 

Balancing the groups compared

You mention that "there is no ex post adjustment capable of remedying a selection bias." While we understand your concern in this regard, it is also relevant to mention that there are multiple statistical techniques specifically designed to address this type of bias in non-randomized studies. As we already discussed in our previous response, we have followed your initial recommendation and have incorporated a statistical analysis based on the propensity score matching method, with the aim of minimizing the initial differences between the groups of patients whose health staff received the educational intervention and those who did not receive it. This adjustment allows both groups to be matched based on the most relevant variables for the clinical outcome, such as age, gender, socioeconomic level and, of course, the initial clinical characteristics of the patients (such as glucose level, among others).

This type of adjustment is widely accepted in observational and quasi-experimental studies, and we believe it is a valid tool to address baseline differences between the groups being compared. We would like to emphasize that this analysis has been duly explained in the methods section and that the adjusted results are clearly presented in the results section.

Comparison of groups with different levels of initial knowledge

One of the central points of your criticism is the concern about the comparison between a group with a low level of initial knowledge (physicians who received the intervention) and another group with a higher level of knowledge (physicians who did not receive the intervention). In this regard, let us clarify some aspects:

Purpose of the study: The main objective of our research was to evaluate whether an educational intervention targeting physicians with lower levels of knowledge about type 2 diabetes could improve the clinical outcomes of their patients. This question is relevant from both a scientific and practical point of view, given that, in clinical practice, continuing education programs are usually directed at those professionals who show greater deficiencies in their knowledge. The question of whether an educational intervention can benefit those with limited knowledge more than those with more robust knowledge is precisely at the heart of the hypothesis we suggest in this study.

Justification for the intervention: You mention that there is no plausible reason to assume that an intervention applied to a deficient group will produce greater results than those obtained by a non-deficient group. However, the educational and medical training literature suggests the opposite: improvement in knowledge, and therefore in clinical practice, is more likely to be observed in those professionals who initially have greater deficiencies. This is consistent with the fundamental principles of health education and teaching in general, where groups with a lower starting level tend to show greater absolute improvements after receiving an adequate intervention.

Sensitivity analysis: To address your concern regarding the comparability of the groups, we have added a sensitivity analysis in our review, in which we exclude from the analysis Primary Care professionals with significantly higher levels of knowledge and compare only those with similar initial levels of knowledge. The results of this analysis were consistent with the main findings, reinforcing our conclusion that the educational intervention had a positive effect on the patients.

 On the tone of scientific debate

Finally, we would like to respectfully address your use of terms such as "irrevocable" or "unpublishable." We believe that scientific debate should be characterized by rigor, objectivity, and above all, a respectful exchange of ideas. We understand that you have a strong opinion about the limitations of our study, which we value and respect. However, we believe that the use of absolute terms, such as "irrevocable," may not be entirely appropriate in this context, since scientific research is based precisely on the principle that hypotheses and conclusions can be discussed, modified, and revised in light of new evidence and analysis.

We are also open to any additional recommendations on how we could further improve the presentation of our results, always with the aim of contributing to scientific knowledge in this field and contributing to the improvement of clinical practice in the management of type 2 diabetes.

In summary, we have implemented the adjustments suggested in your initial review and have added additional analysis to address potential concerns about the comparability of the groups. We would like to emphasize that we are completely open to continuing the academic debate in a constructive manner, and that we deeply value your expertise and input. However, we strongly believe that our research has merit and that, with the improvements we have introduced, it is ready to be evaluated for publication.

We thank you again for your time and hope that this response contributes to clarifying any misunderstandings or concerns. We remain at your disposal for any additional comments or clarifications you consider pertinent.

Yours sincerely.

Dr. Juan José Hernández Morante, on behalf of all my co-authors.