Development and Effectiveness of a Patient Safety Education Program for Inpatients

Reviewer  Comment

Author Response to Comment

Changes made to Article

Page

Reviewer: 1

Point 1

1. Page 2/ line 6. At the end said “patien25t". I supposse that is a "finger fail".

As per your comment, we edit the error letter.

wherein education on patient safety~

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Point 2

2. Reference; Some of reference were works developed in Korea and published in korean journals, so I can read only an english abstract. That is not a real problem, but in two cases, I couldn't find the reference in the internet (Nº 35 and 38). It is a pity that this information cannot be accessed, especially when it is about the basis that explains the development of instruments that are used for measurement within your work.  I suggest you improve the reference in a way that the readers can access to that papers if they decide it. 

As per your comment, we amended the reference. But 35,36 is related to the development of tools to be used for domestic research participants, so it has been maintained.[ 35. Lee, J. The Knowledge and Attitude of Patient Safety of Hospitalized Patients. Catholic University, Seoul, 2019. 36. Kim, K. J.;  Lee, E. H.; Shin, S. H., Development and validation of the patient safety perception scale for hospitalized patients. Korean Journal of Adult Nursing 2018, 30 (4), 404-416.]

**Please be note the number of reference is changed due to the manuscript amendment.

Reference 38: Lee, K. Willingness toward patient participation in patient safety. Ulsan University, Ulsan, 2018.

è  Davis, R. E., Sevdalis, N., & Vincent, C. A. (2011). Patient involvement in patient safety: How willing are patients to participate?. BMJ quality & safety, 20(1), 108-114.

è Sahlström, M., Partanen, P., Azimirad, M., Selander, T., & Turunen, H. (2019). Patient participation in patient safety—An exploration of promoting factors. Journal of nursing management, 27(1), 84-92.

Point 3

3. Result_5.1. Verification of the sameness of the subjects; There is no mention about patient´s length of stay in any group. Were stay the patients by seven days, at least, as suggested in table 2?.

As per your comment, we inserted the patient staying period in table 3 and added the regarding description below table 3 among manuscript.

None

è  The duration of stay in hospitalization of the experimental group was at least 7 days, maximum of 39 days, and average 10.85 (±8.20) days, and the duration of stay in hospitalization of the control group was at least 5 days, maximum of 41 days, and average 8.92 (±4.29) days

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Point 4

4. Data collection and procedure / Discussion; May be the authors can consider explore the length of stay as a variable that could affect the patient safety perception or willingness to participate in patient safety, in a positive or negative manner.

In order to prevent the spread of the experiment in selecting the experimental group and the control subjects, pre-evaluation was performed on the day of hospitalization regardless of the length of stay at the hospital, and post tests were performed on the 5th to 7th day after hospitalization. It is believed that it will not affect the willingness to participate in patient safety. In order to match the pre-evaluation and post-evaluation of the experimental group and the control group, the same measurement point was applied. In the future, it is suggested that the study will be conducted in consideration of the length of stay in the hospital. In this section, the limitations of the study were not taken into account for the period of stay in the hospital.

As per your comment, we amended 4.4 Data collection and procedure and discussion part regarding study limitation.

4.4 Data collection and procedure

In order to prevent experimental expansion of the experimental and control groups, the study applied different data collection periods.

è  To prevent the spread of treatment effects between experimental and control groups, the study applied different data collection periods. One week after completing the control data collection, the experimental group's data collection proceeded.

6. Discussion

None

è Fourth, there is a limit to conducting the survey on the day of hospitalization and the 5th or 7th day of hospitalization without considering the length of the subject's stay in the hospital to confirm the effect of arbitration.

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Point 5

5. Discussion: There are no comments if there was a difference between the intervention and control groups considering the complaints or the incident report made by the patients. It is a small group of patients, it makes it unlikely that many incidents, complaints or lawsuits were presented, but the authors could mention it as a point for further studies.

As per your comment, we added the discussion part regarding study limitation.

None

è  Fifth, since a small number of hospitalized patients were conveniently extracted, there is a limitation that patient safety problems are unlikely to have been raised during the study period.

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Point 6

6. Discussion; The authors could also mention aspects related to the perception of health workers in charge of patients and how these could eventually change their relationship with more educated patients in terms of patient safety.

As per your comment, we added the discussion part regarding study limitation.

None

è  Also, reinforcement of patient safety education by medical personnel will be more helpful in improving the perception of patient safety among inpatients ^{50, 51}.

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Point 7

7. Overall

Please be noted, to continue consensus the term of patient's safety perception.

Awareness

è  Perception

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Reviewer  Comment

Author Response to Comment

Changes made to Article

Page

Reviewer: 2

Point 1

1. Abstract; You need to specify the statistic analyses that were used in this study

As per your comment, we added and amended the Abstract.

None

è  Data were analyzed using SPSS statistical program. The effectiveness of the experimental and control groups before and after education was analyzed using paired t-tests, and the difference in the amount of increase in the measured variables for each group was analyzed using independent t-tests.

1

Point 2

1. Introduction: Page 2: wherein education on patien25t safety was imparted using audiovisual…

→ …wherein education on patient safety was imparted using audiovisual…

As per your comment, we edit the error letter.

wherein education on patient safety~

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Point 3

2. Introduction; The patient safety in this section is vague. You may provide more information regarding the contents of patient safety to help reader conceptualize this abstract concept

Please be note the highlight part in the introduction regarding the explanation about patient safety.

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Point 4

3. Introduction; You need to do a thorough literature review to address why this research question is important. What were the contents of patient safety education from previous studies? What are the findings of prior research about the impact of education on patient safety? What the results of previous studies can’t be applied to people in Korean? Why is there a need to repeat the same study? What is the existing knowledge and gap of  education for patient safety? Your current introduction is too weak to show the value of this study, and you need to strengthen it.

As per your comment, we amended introduction.

Such educational interventions were effective in improving the patients’ knowledge and awareness on, and satisfaction with, patient safety.

è  However, rather than dealing with the overall contents of patient safety, the training focused on precautions, fall prevention, and postoperative self-management in accordance with the characteristics of the patient's disease ^24-27. In addition, the U.S. holds a campaign to allow patients to participate in patient safety through "speak-up" activities centered on medical institutions and actively report accidents to prevent patient safety accidents ²⁸. However, in Korea, there are no national campaigns as well as studies that have verified the effectiveness of patient safety education conducted on patients and carers.

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Point 5

1. Method: Please describe how you mapped the ADDIE model onto the patient safety education program in this study

As per your comment, we demonstrated figure 2 regarding program development according to the ADDIE model.

None

è   Figure 1 was added and inserted.

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Point 6

2. Method; How did you decide the constrcts and contens of the patient safety program? How ADDIE model inform you of the design of contents of the education program?.

As the design content of the ADDIE model, the composition and contents of the patient safety program are organized around  vulnerable parts related to patient safety based on the data identified through consideration of prior research, content validity verification of experts, and demand survey for 1000 people.

Please refer to the highlight of "Composition of educational contents” within manuscript.

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Point 7

3. Method: How did you identify and approach potential participants and perform the process of informed consent?

As per your comment, we amended the manuscript.

None

è  The number of samples was calculated through G-power verification during the research plan, and IRB approval was obtained from the relevant medical institution for the selection of research participants. The wards for which the study was conducted were selected as internal medicine and surgical wards with many inpatients for more than one week. The purpose of the study was explained to the subjects who expressed their intention to participate in the study during the hospitalization period through the recruitment announcement for research participation, and the research assistant received the consent form and screened whether it was suitable for the study. The main reasons for dropping out of the subject were early discharge, transferring other wards or hospitals. Researchers and research assistants conducted research on ethical principles, and three to four nurses participated in the study after receiving training on research purposes and patient safety education in advance in the ward. After conducting a preliminary survey on the day of hospitalization, we trained the use of the tablet PC for patient safety education, and visited the target person to repeatedly watch the training video on the 3rd and 5th day of hospitalization. Finally, after conducting a follow-up survey on the 7th day of hospitalization, we provided a reimbursement.

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Point 8

4. Method: How did you decide the participants were assigned to control or experimental groups?

As per your comment, we amended the manuscript.

4.4. Data collection and procedure

In order to prevent experimental expansion of the experimental and control groups, the study applied different data collection periods. Data of the control group was collected from July 20 to September 11, 2020, and the data of the experimental group was collected from September 20 to November 13, 2020 after completing the data collection of the control group.

è  To prevent the spread of treatment effects between experimental and control groups, the study applied different data collection periods. One week after completing the control data collection, the experimental group's data collection proceeded. . Data of the control group was collected from July 20 to September 11, 2020, and the data of the experimental group was collected from September 20 to November 13, 2020.

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Point 9

5. Method; What was your rationale to measure these three constrcuts (i.e., patient safety knowledge, patient safety perception, and patient participation willingness) in this study?

As per your comment, we amended the manuscript within introduction part.

This is our answer for your review; In the case of prior research targeting patients on patient safety, increasing knowledge through patient safety education can change attitudes, and willingness to participate is an important variable related to the practice of direct action, so we chose as variables to verify the outcome of this study. In the necessity of the study, we presented the basis of previous research that patient safety education improves patient safety knowledge and awareness, and increases patient safety knowledge increase patient's willingness to participate. We also selected and measured patient safety knowledge, patient safety awareness, and willingness to participate in patient safety in order to verify the effectiveness of patient safety education according to the basis of previous studies.

None

è  In prior studies, patient safety education improved patient safety knowledge ^{13, 25, 29} and patient safety perception of subjects ²⁹ and increased communication skills ¹⁹. Inpatients who watched PINK videos increased their comfort in participating in patient safety activities ²¹, and changed their attitudes and capabilities in patient safety. As such, patient safety education will increase the willingness to participate by inducing improvements in knowledge and awareness and changes in attitudes^{13, 14, 17, 31} The willingness to participate in patient safety refers to the practice of direct health behavior, so it needs to be considered as an important variable to examine the effectiveness of patient safety education.

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Point 10

1. Discussion; The basedline scores of the constructs (i.e., patient safety knowledge and patient safety perception) were significantly different between participants of control and experimental groups. How can you prove the improvement in the scores of these two constructs resulted from the program but not individual differences?

As per your comment, we amended the manuscript within 5.2. Validating the effectiveness of the patient safety education program part.

This is our answer for your review; In the comparator's pre-homogeneity test of the experimental group, there was no significant difference at the 0.05 level statistically. Therefore, the experimental and control groups were assumed to be homogeneous. We analyzed whether there was a difference in the post-pre-score group between experimental groups and comparative groups, and analyzed whether there was a difference between groups through the change in scores. Therefore, the effectiveness of the program can be determined to be improved by the program, not by the individual difference.

5.2. Validating the effectiveness of the patient safety education program

None

è  In patient safety knowledge, the experimental group significantly increased the post-score compared to the pre-score (t=3.94 and p<.001), the control group showed no significant increase (t=1.35, p=.187).

è  In patient safety perception, the experimental group significantly increased the post-score compared to the pre-score (t=3.33, p=.002), the control group showed no significant increase (t=1.17, p=.251).

è  Subject's willingness to participate to patient significantly increased post-scores compared to pre-scores in the experimental group (t=3.78, p=.001), the control group also saw a significant increase in post-score (t=2.51, p=.017).

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Point 11

2. Discussion; You sample size for analyses was under power. As such, it risks the reliability of the statistical results. How did you justify this issue?

The selection of the number of participants was determined before the study began. According to Cohen's suggestion, the number of participants was determined based on power of .80 and effect size of .05. Calculating the power of the experimental group after arbitration, it was found that it exceeded over the power of the pre-design by showing patient safety knowledge .96, patient safety awareness .95, and patient safety willingness to participate.

None

Point 12

3. Discussion; The validity of the instruments used in this study raised a serious concern. If you can’t precisely measure outcomes of the study interest, the results generated are not reliable

As per your comment, we amended the manuscript within 4.3. Measurements part.

This is our answer for your review; The tools used in this study were verified for content validity, composition validity, and reference validity at the time of development of the tool, and the reliability and reliability of Cronbach's α for internal consistency were verified, so it was judged that the validity and reliability were secured. In each research tool part, the contents of validity and reliability verification performed during the tool development process were added and described.

4.3.1. Patient safety knowledge

The questionnaire was developed based on the cognitive knowledge items on patient safety presented in the studies of Lee 35 and An et al. ²⁹, validated with content validity verification for measuring patient safety knowledgevalidated with content validity verification for measuring patient safety knowledge.

4.3.2. Patient safety perception

None

è  The patient safety perception tool developed preliminary questions after verification of the content validity by experts at the time of development, and through the survey, it verified the construction feasibility, the referenced feasibility, and the reliability.

4.3.3. Patient participation willingness

None

è  The measuring instrument was used after obtaining the permission of the original author. The willingness to participate in patient safety was verified by experts for content validity for the developed items.

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Point 13

4. Discussion; There were ample limitations of study design that should be mentioned, such as sampling strategy, participant selection, measurement bias, etc. Please provide more information in this section

As per your comment, we added the discussion part regarding study limitation.

First, it is necessary to be cautious in generalizing the results of the study since only one hospital was selected as the study subjects.

è  The limitations of this study are as follows: First, this study selected subjects by voluntary participation through a recruitment announcement for inpatients in a hospital, but there are restriction in sampling and selection of participants, so it is necessary to be careful in generalization.

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Point 14

5. Discussion; What is the uniqueness generated from your study? What are your suggestions regarding implementations for daily practice and future study? You have to compare your findings to the existing literature and discuss more information relevant to your research question and provide concrete suggestions to enrich existing knowledge of patient care.

As per your comment, we amended and added discussion part.

None

è  We laid the foundation for the transition research from medical personnel-centered research to general patients, and it is expected to contribute to creating a patient-centered patient safety culture through the application and development of more diverse educational methods in the future.

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Reviewer  Comment

Author Response to Comment

Changes made to Article

Page

Reviewer: 3

Point 1

1. Abstract; The present study shows a well developed and clear academic structure. However, the abstract should follow a comprehensive structure of: Introduction, Objectives, Methods, Results and Conclusions. It is suggested to be rewritten following this structure for a better understanding.

è  As per your comment, we amended the Abstract.

None

è  Abstract: Background: Patient safety is considered an important issue in the field of healthcare, and most advanced countries.

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Point 2

2. Introduction: This is a compelling study that will certainly attract a high level of interest because of its topic. Introduction should include the increasing interest of the importance of training linked to health during COVID-19. Although patient safety education programs for inpatients constitutes an important issue, introduction does not highlight this specific importance.

As per your comment, we amended and added the Introduction.

None

è  At the time when non-face-to-face education is being activated due to the COVID-19 situation, developing a mobile-based patient safety education program will increase the use of education not only for hospital inpatients but also for targets in the community.

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Point 3

3. Discussion; The methodology is well developed and argued. Both the instruments and the sample are justified. The development of the program is extremely well explained. It is recommended to review the conclusions, as they are brief for the interesting results obtained. Please provide strengths and limitations section at the end of discussion it could improve the paper notoriously.

As per your comment, we amended the Discussion.

è  Also, reinforcement of patient safety education by medical personnel will be more helpful in improving the perception of patient safety among inpatients ^{40, 48}.

è  We laid the foundation for the transition research from medical personnel-centered research to general patients, and it is expected to contribute to creating a patient-centered patient safety culture through the application and development of more diverse educational methods in the future.

è  Fourth, there is a limit to conducting the survey on the day of hospitalization and the 5th or 7th day of hospitalization without considering the length of the subject's stay in the hospital to confirm the effect of arbitration. Fifth, since a small number of hospitalized patients were conveniently extracted, there is a limitation that patient safety problems are unlikely to have been raised during the study period. Therefore, in future studies, it is necessary to ensure generalization of research results by recognizing these limitations, expanding the recruitment of subjects from more diverse medical institutions, and conducting repeated studies to provide a basis. Furthermore, we propose a study that increases the stability and feasibility of measurement tools that evaluate patient safety in patients.

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Point 4

4. Introduction; No research questions were addressed, it could be interesting due the timely issue analyzed

As per your comment, we amended and added research questions in introduction.

None

è  The research questions derived from this study are as follows: 1. Does patient safety education increase patient safety knowledge of inpatients? 2. Does patient safety education increase patient safety awareness of inpatients? 3. Does patient safety education increase the willingness of inpatients to participate in patient safety?

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Point 5

5. Results: Page 9, Authors state “All statistical significance levels were set to .05.” for a better understanding of data it is suggested to express this significance below tables as p< .05

As per your comment, we amended table 3,4

None

è  p <.05

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Point 6

6. Reference; Please check the format of references in text, they should be referenced numbering them in order of appearance in text. Each number should appear in square brackets […]

Reference style derived from the ENDnote 9.3 version "ACS style".

If needed, it should be corrected by manual or technical support.

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Point 7

7. Introduction: Please carefully review all text that contains some grammatical errors (ex. p. 2 “wherein education on patien25t safety”)

As per your comment, we amended the manuscript.

è  wherein education on patient safety~

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Point 8

8. Reference: It is suggested to add the doi to all references in the References section

As per your comment, though we’ve tried to amend the reference style, when we applied ACS style, we cannot figure out doi number even though ENDnote reference information well equiptted. So, could you recommend appropriate reference style on ENDnote system?

if you need, I’ll send separate reference list file.

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