Is skin disinfection before subcutaneous injection necessary? The reasoning of Certified Nurses in Infection Control in Japan (2024)

Abstract

Nurses continue to disinfect the skin before administering subcutaneous injections as a standard process in clinical settings; despite evidence that disinfection is not necessary. To implement evidence-based practice, it is critical to explore why this gap between “evidence” and “practice” exists. This study aimed to describe the reasons offered by Certified Nurses in Infection Control (CNIC) in Japan for performing skin disinfection before subcutaneous injection. Adopting an inductive qualitative design, interviews were conducted with 10 CNIC in 2013. According to the participants, skin disinfection before subcutaneous injection: (a) was common practice; (b) may have been beneficial if it was omitted; (c) adhered to hospital norms; (d) prevented persistent suspicion of infection; (e) had no detrimental effect; (f) was an ingrained custom; and (g) involved a tacit approval for not disinfecting in home care settings. The themes (c) and (g) were cited as the main reasons affecting decision-making. The CNIC administered injections following skin disinfection in hospitals in accordance with hospital norms. On the contrary, outside the hospital, they administered subcutaneous injections without skin disinfection. All themes except (b) and (g) reflect the barriers and resistance to omitting skin disinfection, while (g) shows that it is already partly implemented in home care settings. It is necessary to create a guideline for skin disinfection before subcutaneous injection that considers the quality of life of patients at home, their physical conditions, and the surrounding environment at the time of injection, in addition to the guidelines applicable in hospitals.

Introduction

Disinfecting the skin before administering a subcutaneous injection is a standard procedure in clinical settings for nurses. The rationale behind this practice is that the needle breaks the skin barrier and increases the risk of introducing an infection [1]. However, the Forum for Injection Technique UK [2] and Tandon et al. [3] report that disinfection before subcutaneous injection of insulin is not necessary. The World Health Organization (WHO) Best Practices for Injections and Related Procedures Toolkit [4] recommends washing the skin with soap and running water before administering a subcutaneous injection. Although skin that is visibly soiled or dirty must be washed, swabbing a patient’s clean skin before giving an injection is unnecessary [5]. Furthermore, disinfection is usually burdensome and not required when injections are given in non-institutional settings such as homes, workplaces, or restaurants [6].

Dunleavy et al. and Hope, Hickman, Parry, and Ncube [7, 8] report that not using an alcohol swab is a risk factor for skin and soft tissue infections. In contrast, in some patients, unnecessary disinfection adds to the time needed for self-care. Patients with diabetes receive subcutaneous injections daily; they are hyperglycemic and have reduced function of various immunocompetent cells [9] and, therefore, need to take daily measures to prevent infection. Pre-injection skin disinfection is thus very important in patients with diabetes who self-inject insulin. However, studies dealing with patients with diabetes who self-inject insulin suggest no increased risk of infection when doses are given without skin preparation. In a pre-test/post-test design, Koivisto and Felig [10] study 13 patients who received over 1,700 insulin self-injections with and without skin preparation. No cases of local or systemic infections were found during the three-to-five-month study period. Similarly, McCarthy, Covarrubias, and Sink [11] study 50 patients who received 1,800 self-injections of insulin in a crossover trial of skin preparation with alcohol or tap water, or with no skin preparation, none of whom experienced injection site complications. Thus, skin disinfection before administration of subcutaneous injections is an unnecessary process, and it could burden patients who may not require disinfection. Fleming, Jacober, Vandenberg, Fitzgerald, and Grunberger [12] reported benefits, such as ease of procedure, when patients with diabetes omitted skin disinfection before administering subcutaneous injections, compared to those who disinfected their skin.

A study conducted in Greece by Theofanidis [13] indicates that nurses disinfect the skin before insulin injections as a longstanding medical ritual, although there is insufficient evidence on the need for disinfection. This is true in other parts of the world as well, including Japan [14]. Nurses who do not have extensive knowledge of infection control may assume that skin disinfection before administration of subcutaneous injections prevents infection. According to recent books published in Japan on nursing techniques and skills, disinfection is necessary, while only a few books have introduced studies verifying that it is unnecessary [15]. In contrast, Certified Nurses in Infection Control (CNIC) receive certification from the Japan Nursing Association for specializing in infection control and having advanced nursing skills. CNIC have more experience, skill, and knowledge-based perceptions than other nurses regarding skin disinfection before subcutaneous injection. In this study, the word “experience” is defined as “practical knowledge, skill, or practice derived from direct observation of or participation in events or in a particular activity” [16], while the word “perception” is defined as “The way in which something is regarded, understood, or interpreted” [17]. Describing CNIC’s experience and perception of skin disinfection before subcutaneous injection was considered suitable for this objective.

Although omitting skin disinfection before administering subcutaneous injections is safe, reduces the burden on patients, and likely reduces costs, it has still not become standard clinical practice. Exploring the reasons for this lack of adoption in clinical practice in Japan will help us address obstacles to the introduction of new evidence. Thus, we pose the following research question: why do Japanese nurses disinfect skin before administering subcutaneous injections? Based on this research question, the purpose of this study was to describe, using a qualitative design, CNIC’s reasoning for disinfecting or not disinfecting the skin before administering a subcutaneous injection.

Methods

Study design

An inductive qualitative design was used. The participants’ perceptions and experiences of the phenomena under examination are described under a qualitative descriptive approach [18], which produces a straightforward explanation of participants’ experiences in their own words [19]. The aim of a qualitative description is not thick description (ethnography), theory development (grounded theory), or interpretative meaning of an experience (phenomenology), but a rich, straight description of an experience or an event [18].

Participants and data collection

To meet conditions similar to the skills required for a subcutaneous injection, the participant selection criteria were as follows: (1) worked as a staff nurse with more than 10 years of experience and (2) acquired CNIC qualification. We adopted convenience sampling. The first author contacted the director of nursing at the hospitals in which the CNIC worked. The researchers asked a total of 10 nursing department directors of hospitals with over 300 hospital beds to be introduced to the CNIC by telephone and letter. The director of one hospital’s nursing department declined to cooperate because the significance of the study was not understood. Nine directors of hospital nursing departments agreed to participate, and introduced their hospital’s CNIC to the researchers one by one. One nursing manager introduced two CNIC from her hospital there are usually only one or two such nurses in a hospital. The researchers visited the 10 CNIC, explained the purpose of the study to them, and sought their voluntary participation. To ensure that the study ideas did not influence the participants, the researchers did not disclose their own views on skin disinfection before subcutaneous injection.

The 10 CNIC agreed to participate in the study. Each of them had 15–26 years of nursing experience and 3–7 years of experience as CNIC. They worked primarily in non-profit hospitals, and seven of them worked in hospitals with bed numbers ranging from 300 to 500. The remaining three nurses worked in 500- to 900-bed hospitals. One of the ten nurses was a ward head nurse, and one was a staff nurse. The other eight were not assigned to a ward, but were assigned to a department for which they worked across the hospital departments as infection control specialists. The CNIC had all worked in several wards as staff nurses for more than 10 years. Therefore, although there were participants who did not intervene frequently in their colleagues’ work, all participants were in a position to instruct nurses on infection control measures, including skin disinfection before injection.

Data were collected from August to November, 2013 using individual semi-structured interviews. Data collection and analysis were performed simultaneously. After interviewing five participants individually, analysis and categorizations were made. After each interview, an analysis confirmed the emergence of new categories. Up to the eighth participant, a new category was identified each time; hence, more interviews were conducted with additional participants. Two more participants were interviewed, but no new categories emerged. Therefore, data collection was considered complete with 10 participants.

Each interview lasted 30 to 60 minutes. The interviews were held in a private room that allowed two people to converse calmly at a site with convenient participant access. All participants requested to be interviewed at the hospital where they worked, and the first author conducted their interviews accordingly. Using a semi-structured interview guide, questions were asked in the order shown in Table 1.

Table 1. Interview guide.

Questions
1	Do you disinfect the patient’s skin before subcutaneous injection?
2	Do you think that skin disinfection before a subcutaneous injection is necessary?
3	What is the evidence and reasoning behind these beliefs?
4	How do you perceive the reasons for skin disinfection in clinical practice?
5	What do you think about omitting skin disinfection?

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An interview guide was developed for this study; it was pilot tested with two nurses. After evaluating their responses, a few questions were revised. One of the modifications was adding “evidence” to the third question to elicit concrete evidence. A second modification was the inclusion of the fifth question, broadly asking about participants’ ideas regarding omission of skin disinfection before subcutaneous injection. At the beginning of the interview, participants were asked about their years of experience as a nurse, their years of experience as a CNIC, and their department. They were also asked some follow-up questions such as “What do you mean?” to clarify some answers or “Can you explain further?” to encourage them to expound on their narrative. To ensure the consistency and accuracy of the data, the interviews were recorded with the participants’ permission. The first author who conducted the interviews transcribed them verbatim, and prepared field notes during and immediately after the interviews. There were no repeat interviews.

Data analysis

An inductive content analysis was used for our data analysis[20]. The researchers read each verbatim transcript several times to obtain an overall understanding of the content and gain a sense of the whole [21]. The meaning units in the interviews related to nurses’ reasoning process were identified and coded. The codes were sorted into subcategories based on similarities and differences [22]. Depending on the relationships among subthemes, a larger number of subthemes can be organized, or combined, into a smaller number of themes [22]. After assessments across subcategories, overarching themes were derived. When discrepancies in coding occurred, the researchers of this study discussed and resolved them through consensus. The process was repeated until the content of each interview was compared with the content of all other interviews. Through the process, emerging findings could be identified and comparative commonalities could be extracted. This series of analyses methods were performed by three researchers. Two of them are nurses with experience of working in hospitals; the other is an occupational therapist with experience in medical practice. All three are experienced in qualitative research.

Study rigor

Rigor was confirmed following Lincoln and Guba’s criteria [23]. The credibility of the research findings was established using member checking and peer debriefing. Transferability was ensured via detailed descriptions of the research process. Dependability was achieved by checking the consistency of the findings. The first author, who conducted the interviews, did not have a prior relationship with the participants, which helped participants to freely provide their opinions and perceptions, which were accurately transcribed to promote authenticity.

Ethical considerations

This study followed the guidelines set out by the 1975 Helsinki Declaration (2008 version). The study was approved by the Hokkaido University Graduate School of Health Sciences Ethics Committee and the ethics committee of the study site (13–51). When briefing potential participants, the researchers explained the purpose and requirements of the study, participants’ right to withdraw at any time without consequences, and possibility of the authors publishing the results. They were informed that personal information would be managed appropriately, and that colloquial and written data would be discarded at the end of the study. The above aspects were explained verbally and in writing, and written consent was obtained. After this, the researchers began to schedule interviews.

Results

The researchers conducted semi-structured interviews with 10 CNIC, followed by an inductive content analysis. Seven themes emerged around the rationale for why CNIC performed skin disinfection before administering subcutaneous injections, namely, “common practice,” “presumed merit of omitting disinfection,” “adherence to hospital norms,” “avoiding persistent suspicion of infection,” “no detrimental effect,” “ingrained custom,” and, “tacit approval for not disinfecting in home care settings.” The meaning of each theme is elaborated upon, using direct quotations from the participants in Table 2.

Table 2. Themes, subthemes, and quotations from the interviews.

Themes	Subthemes	Quotations
Common practice	Public perception of the need to disinfect before injection	• If the knowledge that there is no need to disinfect the skin before subcutaneous injection were to become widespread and accepted, I would consider omitting skin disinfection.
		• It is common practice now to disinfect before an injection, so we do it to provide care to patients in this situation.
		• I think the way of thinking will change a little if people are familiarized with the information that it is okay to not disinfect.
	Patient anxiety can occur by omitting disinfection	• If there is swelling that is caused by the local reaction of the injection, the patient may be worried that it may have been caused by not disinfecting.
		•I do not know if patients are convinced or not about omitting skin disinfection.
		・Omission of disinfection under current circumstances has psychological effects on patients.
Presumed merit of omitting disinfection	The certainty of the procedure is increased by simplifying the procedure if omitted	• The good thing for us is that the time taken for the treatment may be a little shorter. The reduction of one process can lead to operational efficiency. We will be able to focus on ensuring that patients’ injections are administered.
		• Because there is less to prepare, it becomes easier to do.
	Expected economic benefit if omitted	• Although garbage is a small issue, if we consider each patient individually, it becomes a big issue when considering many diabetes patients.
	Expected economic benefit if omitted	• Omitting this step can therefore help in cost reduction for the hospitals because the amount of antiseptic cotton purchased will be reduced.
	Decrease in harm to patients from alcohol	• There are many patients who are atopic. These patients have to tolerate skin pain from alcohol wipes. Most patients persevere by saying they are fine.
Adherence to hospital norms	Disinfection of skin in hospitals with no choice	• In the ordinary course of hospital work, the option for me or other healthcare professionals not to disinfect the patient is not up for debate.
	Adherence to the manual	• Disinfection is a standard nursing procedure in the hospital, and I believe it should be practiced as long as it remains so.
	Adherence to the manual	• I do not think disinfection will be done if the manual is revised.
	Difficulty to implement as CNIC	• Personally, I do not think skin disinfection before administering subcutaneous injection is necessary, but in my current position, I disregard my own opinion and follow the norm.
	Difficulty to implement as CNIC	• I am responsible for infection control in the hospital, but I do not think there is any need to change the practice or omit disinfection under the current circumstances.
Avoiding persistent suspicion of infection	Skin disinfection to remove risk of infection as much as possible	• The reason to carry out skin disinfection is that it minimizes the risk of causing an infection in the patient.
	Insufficient convincing evidence	• If the CDC guidelines say it is unnecessary, then I will definitely believe it, because those guidelines are based on a considerable evidence.
	Insufficient convincing evidence	• Previous foreign studies cannot be applied to Japanese people as they are. If there is evidence that Japanese people really do not have any trouble, I can do it.
	Difficulty in persuading CNIC to omit the practice of disinfection	• I thought that is one way to interpret it when I read the previous research that skin disinfection before subcutaneous injection is not always necessary. However that does not motivate me to change my behavior.
		• In my head, I knew that the pH under the skin is a pH that does not allow bacteria to grow, so it does not lead to infection.
	Perceived awareness of cleanliness	• If it is not necessary to disinfect the skin, it is important to instruct the patient to keep the skin clean. However, at present, the patient has not been instructed to do so.
	Perceived awareness of cleanliness	• If it is not necessary to disinfect skin before injection, awareness of cleanliness as a whole may be lowered, and washing hands may be neglected.
	Required ability to adequately determine whether disinfection is necessary	• I do not think the results of the previous study can be applied to patients with low immunity.
		• I am concerned about whether patients can judge if they need disinfection or not.
No detrimental effect	The absence of significant patient disadvantage caused by disinfection	• To be honest, I do not hear much about disinfection being detrimental to the patient.
		• Compared with other infection control issues, there are no major disadvantages for patients even if skin disinfection is continued.
	Minor problems with alcohol exposure	• The only harm to the patient is the redness of the skin caused by the accidental use of an alcohol swab to an alcohol-hypersensitive person.
Ingrained customs	Resistance to overturning a convention	• We have been in a situation where we have been disinfecting the skin before subcutaneous injections for a long time now. Hence, it is hard to teach everyone the rationale for why they do not have to do it in future.
	Resistance to overturning a convention	• There is concern that nurses may be confused if the need for skin disinfection differs depending on the injection.
	The education nurses have received about the need to disinfect	• The reason skin disinfection is always carried out in the clinical setting is that we all learned it from nursing skills textbooks. That is why there is no doubt in anyone’s mind.
Tacit approval for not disinfecting in home care settings	Acknowledgment of those who omit disinfection	• In the case of a person with dementia, I think the disinfection procedure may be forgotten before the self-injection of insulin. However, it is more important to inject insulin than to disinfect the skin.
	Acknowledgment of those who omit disinfection	• I believe it is okay to skip skin disinfection at home, because, unlike in a hospital, at home, the problem is restricted to just the person, and it becomes their responsibility.
	Unnecessary skin disinfection is a burden for patients at home	• I wonder if such a procedure is really necessary when the patient has to continue taking insulin at their home.
		• In the case of people who inject subcutaneously on a daily basis, omitting disinfection reduces the burden on the subject.

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Note: CNIC refers to the Certified Nurses in Infection Control in Japan.

Common practice

The decision to disinfect or not was influenced by perceptions and responses of the people who received care. One reason for skin disinfection before administering subcutaneous injections was that it is common practice. Participants worried that omitting this step would not be acceptable, and would instead induce anxiety in the patient. They also reported that they would agree to omit skin disinfection if it became a common practice with injection patients among the general public. Thus, disinfection was carried out owing to participants’ perception that it is a current common practice.

Presumed merit of omitting disinfection

Some merits of omitting skin disinfection before subcutaneous injection as part of standard care were mentioned. These included the economic benefits of reducing the cost of purchasing cotton for disinfection and disposing of waste, reduction in labor by skipping one of the steps involved in administering injections, and avoidance of unnecessary irritation to the skin caused by disinfectant solutions. Although these are small benefits, they can aid in elevating the patients’ comfort level. As described above, the participants recognized the specific benefits of omitting skin disinfection before subcutaneous injection.

Adherence to hospital norms

Hospitals have standards that staff must follow to provide patients with a certain quality of care. Participants said that, because they worked in a hospital, they followed hospital norms. Even if they personally believed that skin disinfection was unnecessary, the hospital rule was to disinfect the skin before administering every injection. Hence, they had no option to skip the step of skin disinfection. Thus, one of the reasons nurses used skin disinfection before subcutaneous injection was adherence to hospital norms.

Avoiding persistent suspicion of infection

Participants were concerned about the risk of infection when skin disinfection was omitted before subcutaneous injection. They reported that the purpose of alcohol disinfection before administering subcutaneous injections was to remove bacteria from the skin and prevent infection. Disinfection may not completely prevent infection, but it is practiced on the assumption that the risk of infection can be reduced. Participants recognized that omission of skin disinfection before subcutaneous injection was unlikely to cause infection based on literature demonstrating that skin disinfection prior to subcutaneous injection was unnecessary and knowledge of subcutaneous anatomical physiology. However, they were still concerned about infection, and it was difficult for them to actually introduce the practice of omitting disinfection before subcutaneous injections. If omitting disinfection of the skin before subcutaneous injection became the standard, it was feared that disinfection might be omitted even in situations where disinfection was necessary. To avoid persistent suspicion of infection, the nurses continued the practice of skin disinfection before subcutaneous injection.

No detrimental effect

One reason considered by the participants for continuing disinfection was that it posed no significant harm to the patient. Although problems owing to exposure to alcohol could occur, they were not considered a significant disadvantage compared with many other infection control issues in hospitals. Participants perceived that it was not necessary to actively consider omitting the practice of disinfection prior to subcutaneous injections, as it is not detrimental for patients if continued.

Ingrained custom

The nurses were taught that disinfection before subcutaneous injection was necessary from the time they were students, and there was no opportunity to reflect upon the necessity of the practice even after they had started work. Nurses routinely administer injections after skin disinfection without questioning its scientific basis. Thus, it has become a deeply ingrained practice. They felt that it would be difficult to change this convention because it had become a custom. Another reason for performing skin disinfection before subcutaneous injections was that it was perceived as an ingrained practice.

Tacit approval for not disinfecting in home care settings

Participants believed that skin disinfection may not be necessary for patients at home because it places an extra burden on patients. When patients require injections in home care settings, it is important to ensure that the required dose is injected, and skipping skin disinfection is not considered a problem. In home care settings, nurses give tacit approval to the omission of disinfection because there are priorities over adhering to the norms of skin disinfection before subcutaneous injection.

Reasoning for disinfecting before subcutaneous injection

Seven themes emerged from the data examined in this study. Fig 1 shows the reasoning of the CNIC for disinfection skin before administering subcutaneous injections. Patients expect skin to be disinfected before a subcutaneous injection because it is “common practice.” Before administration, there was “presumed merit of omitting disinfection,” such as reduced patient burden for self-injection and streamlining and efficiency for nurses. However, because disinfection does not harm the patient, nurses continued the precedent to avoid any possible risk of infection; this concept was categorized as “ingrained custom,” “no precise effect,” and “avoiding persistent suspicion of infection.” In the hospital, CNIC, as hospital staff, must “adhere to hospital norms” and, thus, do not have the choice of omitting the practice of skin disinfection. Outside the hospital, on the contrary, CNIC are not obliged to follow these norms, and the need for skin disinfection was determined based on the priorities of individual self-injecting patients. Thus, there was “tacit approval for not disinfection in home care settings.”

Fig 1. Reasoning process for disinfecting skin before subcutaneous injection.

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The seven themes identified in this study are enclosed in squares. “Common practice” includes six other themes because they were based on common practice. The decision on whether to disinfect the skin before subcutaneous injection was made by going back and forth between the four themes: a positive theme of “presented merit of omitting disinfection,” and three other negative themes on the omission of said practice. In considering them, the decision was made in the presence of patients and/or injection providers. In the case of a hospital, the decision went through “adherence to hospital norms,” and then “always perform skin disinfection”; and if the patient was at home, it went through “tact approval for not disinfecting in home care settings,” and finally, “it depends on the patient’s situation.”

Discussion

The purpose of this study was to describe CNIC’ reasoning for disinfecting or not disinfecting skin before administering a subcutaneous injection. A qualitative inductive content analysis generated seven themes. Although extant research of the past 50 years has consistently shown that swabbing the skin with alcohol before administering a subcutaneous injection is unnecessary [11, 24, 25], in clinical settings, nurses continue to disinfect skin, as shown in the theme of “ingrained custom.” Thus, this practice can be described as based on tradition and habits.

The process of de-implementation is necessary to transform such a traditional and habitual practice. De-implementation is the process of identifying and removing practices based on tradition and habits that lack adequate scientific support [26]. In the pursuit of evidence-based health care, de-implementation of old routines is just as important as the implementation of new evidence [26]. In this study, “ingrained custom,” “common practice,” “adherence to hospital norms,” “avoiding persistent suspicion of infection,” and “no detrimental effect” were identified as barriers and resistance to the process of promoting de-implementation of skin disinfection before subcutaneous injections. It is expected that removing these barriers and resistances would result in updated evidence-based practices.

Notably, CNIC’s reasoning regarding disinfection differed between hospitals and home care settings. In the hospital, a nurse is a staff member, and nursing services are provided in accordance with hospital standards. Therefore, it is not possible to deviate from hospital rules. Participants were aware of the negative effects of skin disinfection on patients, such as increased pain [27] and skin stiffness [28]. However, even if individual nurses judge skin disinfection as unnecessary in individual cases, they do not have the authority or choice to omit the practice of disinfection in a hospital setting.

In contrast, as described in the theme of “tacit approval for not disinfection in home care settings,” CNIC opted to omit disinfection depending on the patient’s circumstances in home care settings because the mandatory norms did not need to be strictly followed there. It was suggested that the process of de-implementation may already be underway, in part, in home care settings wherein subcutaneous injections are implemented. Sexson, Lindauer, and Harvath [29] reported that skin disinfection before administering subcutaneous injections is not necessary in a home care setting. In fact, in people with diabetes who routinely self-administer subcutaneous insulin injections, the skin disinfection rate was only 16% in Spain [30] and 30% in Italy [31], and no major problems have been reported. Intermittent urethral catheterization is one example of a difference in medical technique required in the hospital and in home care settings. It is often self-administered by patients at home, and the use of antiseptic solutions during insertion has been a subject of much debate [32]. Although the risk of a urinary tract infection is always present at urethral catheterization, many recent studies support the use of a clean, rather than sterile technique when patients insert intermittent urethral catheterization in the home environment [33]. Considering the psychomotor and psychological burdens of patients who self-inject, as well as the patient’s family members who administer injections, there is no need to force disinfection before subcutaneous injection in the home environment. Nevertheless, introducing the decision to skip skin disinfection before subcutaneous injections is a concern in terms of infection. This concern can also be seen in the theme “avoid persistent suspicion of infection,” which is one factor influencing the decision to continue to disinfect the skin before administering subcutaneous injections. Skin commensal bacteria such as coagulase-negative staphylococci are major pathogens in the nosocomial setting [34]. An effective way to reduce the transmission of these health care-associated pathogens and the incidence of health care-associated infection is hand antisepsis [35]. When the omission of skin disinfection before subcutaneous injections is introduced to a patient, it is necessary to work even harder on hand hygiene to reduce concerns about infection among both nurses and patients.

Based on the results of this study and previous studies, evidence-based health care guidelines should be developed for skin disinfection before subcutaneous injections that consider the quality of life of patients at home, their physical conditions, and the surrounding environment at the time of injection.

In the UK, vaccine guidelines clearly state that disinfection is not required before administering vaccinations [36]. However, in Japan, official documents state that the skin must be disinfected before administering subcutaneous injections [37]. Karkos and Peters [38] and Schoonover [39] report that barriers to evidence-based practice that lack authoritative support ranked high against their introduction into clinical care. Even if nurses continue to update their knowledge and skills, the introduction of new ideas is difficult unless the authority of their facility/institution accepts those ideas.

Further, general nurses are trained to follow guidelines. Nursing education requires education for clinical nurses and basic nursing education. Parallelly, with the development of the new guidelines for home care settings, it is essential to develop the ability to evaluate the patient’s skin condition from a multifaceted viewpoint from the stage of basic nursing education, and to emphasize the importance of not only following the guidelines, but also judging the necessity of skin disinfection in accordance with the individual patient’s situation and instructing the patient in future nursing education.

Limitations

The results of this study suggest that nurses have different reasoning for skin disinfection in home care settings than in hospitals. The participants in this study were experienced nurses who worked in hospitals. However, nurses who work in home care settings may have different reasoning on this issue. Further studies should consider the latter group to more deeply explore why nurses disinfect skin before administering subcutaneous injections. A quantitative survey will be required to clarify the actual status of skin disinfection before subcutaneous injections in home care settings when developing guidelines.

Conclusion

Our study described CNIC’s reasoning for disinfecting or not disinfecting skin before administering subcutaneous injections. Followed by an inductive content analysis, seven themes emerged: “common practice,” “presumed merit of omitting disinfection,” “adherence to hospital norms,” “avoiding persistent suspicion of infection,” “no detrimental effect,” “ingrained custom,” and, “tacit approval for not disinfecting in home care settings.” Participants in this study acknowledged practicing home care subcutaneous injections without prior skin disinfection. Within hospitals, however, compliance with hospital norms, rather than judgment about individual patient conditions, prevails. This study reveals the barriers and resistance to promoting evidence-based practice in skin disinfection before subcutaneous injections at clinical settings. Overall, hospital norms had the most influence on CNIC’s decision to disinfect.

Data Availability

The data for this study consists of transcripts of interviews with 10 participants and contain identifying items, and are therefore sensitive to privacy issues. As participants only allowed the interviews under promise of anonymity, we are expressly forbidden by the participants to make the full content of the interviews public. Anonymized excerpts from the full transcripts can be made available to qualified researchers by request to the ethical committee of the Faculty of Health Sciences, Hokkaido University, who can be contacted at shome@hs.hokudai.ac.jp.

Funding Statement

This study was supported by the Japan Society for the Promotion of Science, Tokyo, Japan (KAKENHI Grant Number JP26861850).

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PLoS One. doi: 10.1371/journal.pone.0245202.r001

Wen-Jun Tu

23 Jul 2020

PONE-D-20-14697

Is skin disinfection before subcutaneous injection necessary? The reasoning of certified nurses in infection control in Japan

PLOS ONE

Dear Dr. Yoshida,

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Academic Editor

PLOS ONE

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Reviewer #1:Dear Authors,

Thank you for your well written manuscript. The chosen theme is important, connected to the context, traditions and cultures in different countries. Hygienical care of the skin during subcutaneous injections seems to be a discussion theme that has no end. However, I would like to ask you how the theme of hand hygiene is raised when the nurses choose to protect the skin with or without disinfection? How do the nurses discuss the consequenses of skin hygiene during subcutaneous injections with the patient? These could be mentioned in the discussion part.

According to the method: The study is qualitative. It could be more clear if the comparative method that you used is also mentioned in the abstract. You also use content analysis in the study. Is this right method to this study (together with the comparative method)? The manuscript could be more clear if there is for example a table where you present the results of the comparative part.

The figure is missing a short explanation what it presents.

Reviewer #2:The review is uploaded as an attachment

Methods and Materials / Analysis

There are major flaws in the method part that need to be processed and written in a clearer way for the reader, please develop methods section for a better dependability and confirmability. Its most important for this studies credibility.

I cant’t follow you step by step in the preparation, organizing and resulting phases in the content analysis process. Qualitative content analysis process/method is not clear described, what design have used according to your references?

The material needs to be further processed - seven themes and no subcategories?

The results section and the tables must also be presented more clearly, sometimes too many and long quotes -see even over that part.

The results of the discussion must be problematized and developed further

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PLoS One. 2021 Jan 8;16(1):e0245202. doi: 10.1371/journal.pone.0245202.r002

5 Sep 2020

Sep 5, 2020

Dr. Wen-Jun Tu

Academic Editor

PLOS ONE

1160 Battery Street

Koshland Building East Suite 225

San Francisco、CA 94111 United States

Re: Manuscript ID: PONE-D-20-14697

Thank you very much for your e-mail and review of the manuscript (PONE-20-14697) that we sent on May 17, 2020. We would like to thank you and the two reviewers for providing constructive comments regarding the improvement of the original manuscript. All changes have been made in response to you and reviewers’ suggestions and itemized responses to the individual reviewer’s comments are also attached. In addition, the entire manuscript was revised to solve grammatical problems and improve readability through detailed English proofreading. These revisions are also colored in blue in the main document.

Reviewer #1:

Q1. The chosen theme is important, connected to the context, traditions and cultures in different countries. Hygienical care of the skin during subcutaneous injections seems to be a discussion theme that has no end. However, I would like to ask you how the theme of hand hygiene is raised when the nurses choose to protect the skin with or without disinfection? How do the nurses discuss the consequenses of skin hygiene during subcutaneous injections with the patient? These could be mentioned in the discussion part.

A1. We appreciate that helpful suggestion. As you advised, it is essential for both nurses and patients to maintain hand hygiene, whether disinfected or not prior to subcutaneous injection. In particular, after educating patients to ensure that they wash their hands for their own hand hygiene, nurses should assess the need for skin disinfection, explain the pros and cons of skin disinfection to patients, and make a decision after gaining their understanding. This point has been added to the revised draft. (P. 28-29 lines 418 – 428).

Q2. According to the method: The study is qualitative. It could be more clear if the comparative method that you used is also mentioned in the abstract. You also use content analysis in the study. Is this right method to this study (together with the comparative method)? The manuscript could be more clear if there is for example a table where you present the results of the comparative part.

A2. The phrase “comparative method” was not appropriate. I appreciate that you pointed this out. We have revised this term and discussed the inductive analysis; we also updated the references. We also modified abstract. In order to express clearly how the themes were extracted, we created a table 2 that includes the quotations from the participants, subcategories, and themes (P. 11 lines 164 – 175 and table 2).

Q３.The figure is missing a short explanation what it presents.

A３. A short explanation has been added to the figure’s legend. (P. 26-27 lines 379-388).

Reviewer #2:

Q1. There are major flaws in the method part that need to be processed and written in a clearer way for the reader, please develop methods section for a better dependability and confirmability. Its most important for this studies credibility.

The material needs to be further processed - seven themes and no subcategories?

The results section and the tables must also be presented more clearly, sometimes too many and long quotes -see even over that part.

A1. Thank you for pointing that out. As you said, the description of how the data were analyzed was inadequate, so we have revised the text. We analyzed the data inductively. We have modified the description of the analysis method, using references to follow the "content analysis process.” In order to express clearly how the themes were extracted, we have created a table that includes the quotations from the participants, subcategories, and themes. We also removed quotations from the participants in the results section. The quotations are shown in shorthand in Table 2 (P. 11 lines 164 – 175 and tabe2).

Q2. The results of the discussion must be problematized and developed further.

A2. In order to further develop the results of the discussion, we added the discussion as follows:

(1)Skin hygiene and patient instruction including hand antisepsis (P. 28-29 lines 418 – 428).

(2)About de-implementation (P. 30-31 lines 450-462).

(3)Nurse education related to the guidelines (P. 31 lines 463 – 467).

(4)The necessity for new guidelines at home care settings (P. 29 lines 428 – 431).

Academic Editor

Q1. Keywords: Please put the words in alphabetical order．

A1. We revised manuscript accordingly. (P. 4 line 41).

Q2. Clarify the design, inductive design?

A2. This study had an inductive design, so have I modified the text to reflect that. (P. 6 line 86).

Q3. More distinct written about the inclusion and exclusions criteria.

A3. We have added the inclusion criteria. The selection criteria were as follows: (1) worked as a staff nurse with more than 10 years of experience (2) acquired the CNIC qualification. We did not describe the exclusion criteria because there was no exclusions criteria. (P. 7 lines 97 – 100).

Q4. Convenience sampling ? pureposeful sampling?

A4. The data collection method of this research was convenience sampling, so we added that information. (P. 7 line 100).

Q5. How did you do when you contacted the nurses for asking them to participate? E-mail? Letter ? Phone call? How many nurses did you ask?

A5. To contact the study candidates, at first, we contacted the director of nursing at the hospital where the CNIC worked by telephone and postal mail. The directors of a hospital’s nursing department introduced their hospital's CNIC to us. And we visited with ten CNIC and explained the purpose of this study and asked them for cooperation in the research. (P. 7 lines 100-109).

Q6. I want a flow chart showing how the participants were included in the study.

A6.The participant selection process was poorly documented. Therefore, we have described the selection process in detail. With this description, we decided that the flowchart was unnecessary. But if you disagree, I will respect your opinion and add a flowchart.

We added the following text: “The first author contacted the director of nursing at the hospital in which CNIC worked. We asked ten director of a hospital nursing department with over 300 hospital beds to introduce us to the CNIC by telephone and letter. One of the directors of a hospital’s nursing department declined to cooperate because the significance of the study was not understood. Eight directors of a hospital’s nursing department agreed to participate and introduced their hospital's CNIC to the researchers one by one. One Nursing Manager introduced two CNIC from her hospital. There are usually only one or two CNIC in hospitals. We visited with ten CNIC and explained the purpose of this study to the m and sought their voluntary participation.” (P. 7 lines 100-109).

Q7. In-depth interviews ? You write that semi-structured I. was used.

A7. Yes you are right. I conducted semi-structured interviews, so I deleted the phrase “in-depth” and I have added “semi-structured.” (P. 9 line 134).

Q8. References missing in text .

A8. We provided the missing references. (P. 11 lines 164-175).

Q9. Explaine more about the interview situation. Whitch demographic variables did you include in the questionnaire?

A9. We added the interview situation. All participants requested to be interviewed at the hospital where they worked, so the researchers conducted their interviews accordingly (P. 9-10 lines 145-147). We also added that demographic variables were collected to at the beginning of the interview (P. 10 lines 153-155).

Q10. Did you have any follow up questions? (To clarify some answers) like “Can you explain more?”, “How do you mean”? were asked. Did you ask the nurses the demographic questions before you started…

A10. Yes, we followed up questions were asked during the interview. Therefore, we added about the follow-up question to the new manuscript (P. 10 lines 155-157).

Q11. Who did the transcribed verbatim. The authors ? A secretary?

A11. It was done by the first author who was the interviewer of all the interviews. (P. 10 line 159).

Q12. Was the interview guide developed for this study?

A12. Yes, it was. So we added the following text: The interview guide was developed for this study (P.10 lines 148).

Q13. Make a nicer table –

A13. I remade Table 1.

Q14. I cant’t follow you step by step in the preparation, organizing and resulting phases in the content analysis process. Qualitative content analysis process/method not clear described, what design have used according to your references?

A14. We did not clearly describe process of content analysis in detail. The revised manuscript was described in detail with references as follow.

“This study used an inductive content analysis [18]. The researchers read each verbatim transcript several times to obtain an overall understanding of the content and gain a sense of the whole [20]. The meaning units in the interviews related to nurses’ reasoning process were identified and coded. The codes were sorted into subcategories based on similarities and differences [19]. Depending on the relationships between subcategories, researchers can combine or organize them into larger headings [19].After assessing across subcategories, overarching themes were derived. When discrepancies in coding occurred, the investigators discussed and resolved them by consensus. The process was repeated until the content of each interview was compared with the content of all other interviews.” (P. 11 lines 164 – 175).

Q15. I want a table presenting examples of the analysis process ;themes, subthemes, and quotations from the interviews. You must describe the process how these seven themes arise (dependability) It must be transparent. The material needs to be further processed - seven themes and no subcategories?

A15. In order to understand the process of analysis of how the seven themes were extracted, the themes, subcategories, and quotations from interviews are shown in Table 2.

Q16. I prefer Demographic in the method section. In what kind of ward did the Participants work? How often did they administrate a subcutaneous injection ? seldom ? often ? education level?

A16. We have moved the description of the demographic to the methods section. And,　ｗe added the following in the method section: “One of the ten was a ward head nurse and one was a staff nurse. The other eight were not assigned to a ward but were assigned to a department that worked across the hospital as infection control specialists. The CNIC had all worked in several wards as staff nurses for more than ten years. Therefore, although there were participants who did not intervene frequently among co-workers, all participants were in a position to instruct nurses on infection control measures including skin disinfection before injection.” (P. 8 lines 112– 121).

Q17. The results section and the tables must also be presented more clearly, sometimes too many and long quotes -see even over that part. develop the flow chart and present this in the resultsection.

A17. We created Table 2 in the Results section. The Interview quotations in the results section have been omitted from the main text of the paper and described in a concise form in the Interview quotations section of the table.

Q18. I think you must discuss the importance of the nurses following guidelines or not and if you have any national guidelines to follow ?? in such cases how do you implement it? Suggestions for clinical implications?

A18. It’s a question of whether nurses follow the guidelines, we think they should follow the guidelines. However, this study found that nurses comply with the guidelines in hospitals, but not in home care environments. In other words, we thought it was necessary to discuss whether the guidelines in the hospital setting and the guidelines in the home care settings should be the same, or whether they need to be developed separately. This point has been added to the revised draft. (P. 31 lines 436 – 467; P. 29 lines 428 – 431).

Q19. In the ethical section discussion, were the participates informed that they could withdraw from the study at any time ?

A19. I did explain to the participants that they could decline to participate in this study at any time, and I clarified this in the ethical considerations section. (P. 8 lines 124 – 125).

Q20. What is your bullet points? What is new? knowledge gap ?

A20. What I would like to highlight the most was the following sentence in the first paragraph of the discussion. “Our study reviewed that CNIC's regarding registering disinfection different between hospitals and home care settings.” I have revised the first paragraph so that the reader can understand it. (P. 27 lines 398 – 400).

Q21. I think your results indicate a very important situation – however you must discuss your old references, today a very high figure with multi drug resistance exists when we discuss hospital and hospital care. Coagulase-negative staphylococci (CoNS) are the most abundant micro-organisms colonizing human skin and mucous membranes all been shown to alter the flora, reduce the variety of strains and result in accumulation of multi-drug-resistant CoNS, I think this can be discussed more, I’m not convinced that the same guidelines should prevail in hospitals as well as in homes and at homecaresttings. The conditions are completely different.. This is a new important point to discuss.

A21. Thank you for your very constructive advice. Based on the results of the seven themes of this study and the results of previous studies, we thought that a home version of the guidelines should be developed. It should take into account the patient's physical condition and the environment at the time of injection, in addition to the guidelines applied in hospitals. In a previous study, the participants were outpatients, not hospitalized patients. At present, it has been pointed out that it is unclear whether omitting skin disinfection before subcutaneous injection is applicable to all patients. I mentioned this point in the 6th paragraph of the discussion. (PP. 28-29 lines 418 – 431).

Q22. Discuss the nurse education in relation to guidelines?

A22. We believe that there is a need for education regarding the description of the guidelines for disinfection before subcutaneous injection. However, in addition to this, it is necessary to introduce evidence on the necessity of skin disinfection and to educate the patients on the merits and demerits of disinfection and the necessity of individual assessment. These aspects have been added to the manuscript. (P. 31 lines 463 – 467).

Q23. Discuss de-implementation - - it is very hard to change a behavior.. de-implementation is a process for identifying and removing practices based on tradition and habits which lack adequate scientific support. In the pursuit of evidence-based health care, de-implementation of old routines is just as important as the implementation of new evidence. (Upvall MJ, Bourgault AM. De-implementation: a concept analysis. Nurs Forum. 2018.) https://doi.org/10.1111/nuf.12256. was shown for the commonly used antibiotics.

A23. Thank you for your advice on de-implementation. I read the paper you recommended. Our results clearly demonstrate the barrier and resistance of de-implementation in skin disinfection prior to subcutaneous injection. We also thought it was important to educate nurses in order to advance the de-implementation process. These are added to the discussion section. (P. 30-31 lines 450 – 467 ).

Q24. Try to make the conclusion more spot on, I think it is too long.

A24. We shortened the conclusion. (P. 32-33 lines 486 – 499).

We have also modified the Data Availability statement.

We believe that we have addressed comments of editor and reviewers and hope that the revised manuscript is now acceptable publication in PLOS ONE. Thank you for your generous consideration.

Sincerely yours,

Yuko Yoshida

Hokkaido University, Faculty of Health Sciences,

Department of Fundamental Nursing

Kita 12 Nishi5, Kita-ku, Sapporo, Hokkaido 060-0812, Japan

Phone and FAX: +81-(0)11-706-3718

Email address: yuko790402@hs.hokudai.ac.jp

Attachment

Submitted filename: Response to Reviewers0906.docx

Click here for additional data file.^{(47.4KB, docx)}

PLoS One. doi: 10.1371/journal.pone.0245202.r003

Wen-Jun Tu

16 Sep 2020

PONE-D-20-14697R1

Is skin disinfection before subcutaneous injection necessary? The reasoning of Certified Nurses in Infection Control in Japan

PLOS ONE

Dear Dr. Yoshida,

Please submit your revised manuscript by Oct 31 2020 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

We look forward to receiving your revised manuscript.

Kind regards,

Wen-Jun Tu

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1:All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1:Partly

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1:Yes

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4. Have the authors made all data underlying the findings in their manuscript fully available?

Reviewer #1:Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

Reviewer #1:Yes

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6. Review Comments to the Author

Reviewer #1:Dear Authors,

Thank you for the possibility to review this paper again. I can see that a lot of work have been done, but I feel there is lot to still do. I wonder if the whole research group participated to R1 or was it only the first author of this paper?

Abstract: Start the A. by going straigt, with 1-2 sentences, to the corn substance, not to previous litterature. Include: The study was done in autumn 2013. Please revise the A. The study does not "explain" you need to use "describe". Same words that you have in the text. A. needs much more stringency. "However" is not a good word in the abstact. Keywords: several missing: Japan, s.c injections (not only inj), content analysis. "Bake in Qualitative" into the A.

Introduction: Use same words throughout the whole paper. Now you use respondent, informant and participant at the same time, also interviewer and researcher. This is confusing. Reduce the use of the word "participant" and "therefore" (in the whole paper).

What is the main research question in this study? This should be clearly written.

Methods: Datacollection (DC). What about having a separate part for the study design and putting together DC and participants as a overhead. Now this text is mixed. Generally now its more clear. I think that you do not need a flow chart according to the participants.

Ethical considerations (E): This part should be moved before the results part. Now it confuses the reader in the method part. Keep it as a separate part for to make the paper clear. You need references to the E. since human beings participated. Use for example Helsinki Declaration and some local ethical committee descriptions from Japan. This is important.

Line 103-104 p. 6 is unclear.

Line 107, p. 6: ...were willing to participate in the survey... Do you mean in the study or what?

Line 135-137. p. 8. This is irrelevant info. Please remove curriculum vitae information from the manuscript.

Results: Where did the results come from? Please shortly introduce this in the ingress. Did the previous studies influence the results? Or the interviews with participants? What about your method?

The results part has in general stepped backwords and it feels that the you have lost the abstraction level. The text is now repeating the figure and the table. Please go back to your original manuscript and discuss the presentation of the results in your research group. This needs stringency and revision.

Discussion: This part includes also many repeatings. Here you should raise the level of abstaction even more and discuss the paper in whole. Please discuss this part with your reseach group and revise the text.

Line 365, p. 23. Is this necessary to mention? Many readers know this.

Line 382, p 23. NB, the English Language.

In general: I recommend you to use a professional English Language control.

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1:No

PLoS One. 2021 Jan 8;16(1):e0245202. doi: 10.1371/journal.pone.0245202.r004

31 Oct 2020

Oct 31, 2020

Dr. Wen-Jun Tu

Academic Editor

PLOS ONE

Re: Manuscript ID: PONE-D-20-14697R1

Dear Editor:

Thank you very much for your e-mail and review of the manuscript (PONE-20-14697R1) that we sent on Sep 5, 2020. We are very grateful for your constructive and insightful comments regarding the improvement of the revised manuscript. All changes have been made in response to your and the reviewers’ suggestions and itemized responses to the individual reviewer’s comments are also attached herewith. In addition, the entire manuscript was revised to resolve grammatical issues and improve readability through detailed proofreading. These revisions are also highlighted in red in the main document.

I look forward to working with you and the reviewers to move this manuscript closer to publication in PLOS ONE. Thank-you for your consideration. I look forward to hearing from you.

Sincerely,

Yuko Yoshida

Hokkaido University Faculty of Health Sciences

Address: Kita 12 Nishi 5, Kita-ku, Sapporo, Hokkaido 060-0812, Japan

Tel.:+81-011-706-3718

Fax: +81-011-706-3718

Email: yuko790402@hs.hokudai.ac.jp

Question1:

Response1:

We modified the sentence in the first line, deleted the section on previous literature, and added the following: “even though there is insufficient evidence on the need for disinfection.” We added that “interviews were conducted with 10 CNIC in 2013.” We also corrected and used the term “describe” instead of “explain,” Additionally, we reviewed the entire paper and avoided the use of the word “explain.” We have changed the expression from “however” to “on the contrary” in the abstract. We have made the above modifications to improve the stringency of abstract.

Question2:

Keywords: several missing: Japan, s.c injections (not only inj), content analysis. "Bake in Qualitative" into the A.

Response2:

We added “Japan,” “subcutaneous injections,” “content analysis” as keywords. We were not sure what the phrase “Bake in Qualitative” into the A. means. Thus, we have not been able to correct for this. We are sorry to trouble you; we request you to kindly explain what you meant further. We will correct this as soon as you let us know.

Question3:

What is the main research question in this study? This should be clearly written.

Response3:

We apologize for the confusion caused by the use of “respondent,” “informant,” and “participant” interchangeably; we have corrected them all to “participant.” In addition, the term “interviewer” has been changed to “researcher” to make it easier to follow. We reduced the usage of “participant” and “therefore” throughout the paper (participant:41→38, therefore:11→6). Special attention was paid to the use of unified terms and selection of conjunctions while proofreading.

We have modified our research question in the introduction as follows. “The research questions in this study were why Japanese nurses are performing skin disinfection before subcutaneous injections and what is the background to the practice. Based on this research question, the purpose of this study was to describe nurses’ reasoning for disinfecting or not disinfecting the skin before administering a subcutaneous injection, using a qualitative design.” (P. 4 lines 78-82).

Question4:

Response4:

Thank you for your advice. We outlined the “study design” in one section and then delineated the “participants and data collection” section together.

Question5:

Response5:

We removed the ethical considerations section before the Results part and have added it as a separate section. We added the following sentence: “This study followed the guidelines set out by the 1975 Helsinki Declaration (2008 version). The study was approved by the Hokkaido University Graduate School of Health Sciences Ethics Committee and the ethics committee of the study site (13-51).” (P. 9 lines 177-185).

Question6:

Line 103-104 p. 6 is unclear.

Response6:

We believe our intended meaning was not conveyed due to a spelling error. We have corrected it; kindly let us know if you seek further clarity.

(Before) We visited with ten CNIC and explained the purpose of this study to the m and sought their voluntary participation.

(After) The researchers visited the 10 CNIC, explained the purpose of the study to them, and sought their voluntary participation. (P. 5 lines 110-P.6 lines111).

Question7:

Line 107, p. 6: ...were willing to participate in the survey... Do you mean in the study or what?

Response7:

We apologize for the confusion; we have revised “survey” to “study.”

(Before) Ten CNIC were willing to participate in the survey.

(After) The 10 CNIC agreed to participate in the study. (P. 6 line 144).

Question8:

Line 135-137. p. 8. This is irrelevant info. Please remove curriculum vitae information from the manuscript.

Response8:

We have deleted the section in adherence with your comment.

Question9:

Results: Where did the results come from? Please shortly introduce this in the ingress. Did the previous studies influence the results? Or the interviews with participants? What about your method?

Response9:

We added the information you require in the beginning of the Results section.

“The researchers conducted semi-structured interviews with 10 CNIC and performed an inductive content analysis. Seven themes emerged around the rationale of why CNIC performed skin disinfection before administering subcutaneous injections: ‘common practice,’ ‘adherence to hospital norms,’ ‘ingrained custom,’ ‘no detrimental effect,’ ‘presumed merit of omitting disinfection,’ ‘avoiding persistent suspicion of infection,’ and ‘lowered adherence to norms in home care settings.’ The meaning of each theme is elaborated upon, using direct quotations from the participants in Table 2.” (P. 9 lines 188-194).

Question10:

Response10:

We have tried to use subcategory-based descriptions for each theme’s description to provide a convincing explanation of how the theme was generated. As a result, we believe the contents of the table were repeated many times and the abstraction level was lost. We discussed this again in the research group and in the main text; we have modified the main text to describe the essential meaning of each theme, avoiding simple repetition of the table contents as much as possible. In addition, for the item “Reasons to perform skin disinfection before subcutaneous injection,” the number of repeats of legend in Fig. 1 increased. We have made revisions to minimize the duplication of descriptions between the two.

Question11:

Response11:

We deleted the repetition of the sentence. To increase the level of abstraction, we rethought the structure of the discussion section and rewrote it. The content of the structure is as follows: (1) summary of the results of this study; (2) comparison of the concept of de-implementation with the results of this study; (3) reference to the de-implementation of skin disinfection observed in some cases at home; (4) justification of the de-implementation of skin disinfection at home; and (5) development of guidelines to facilitate the de-implementation process of skin disinfection before subcutaneous injections.

Question12:

Line 365, p. 23. Is this necessary to mention? Many readers know this.

Response12:

We deleted the points you deem unnecessary.

Question13:

Line 382, p 23. NB, the English Language.

Response13:

We deleted the points you have mentioned.

Question14:

In general: I recommend you to use a professional English Language control.

Response 14:

We shared your comments with a publication support services company and asked for an experienced proofreader to check the language.

Attachment

Submitted filename: Respons to Reviewers_SKINDISINFECTION.docx

Click here for additional data file.^{(31.3KB, docx)}

PLoS One. doi: 10.1371/journal.pone.0245202.r005

Wen-Jun Tu

16 Nov 2020

PONE-D-20-14697R2

Is skin disinfection before subcutaneous injection necessary? The reasoning of Certified Nurses in Infection Control in Japan

PLOS ONE

Dear Dr. Yoshida,

Please submit your revised manuscript by Dec 31 2020 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

We look forward to receiving your revised manuscript.

Kind regards,

Wen-Jun Tu

Academic Editor

PLOS ONE

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

Reviewer #1:All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1:Partly

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1:N/A

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

Reviewer #1:Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

Reviewer #1:Yes

**********

6. Review Comments to the Author

Reviewer #1:Dear Author(s),

Thank you once again for the possibility to take part in your manuscript. I can see that a lot of work is done and that the manus is now much better. However, I would like you to think over some important things and review these. There har been challenges to understand your track changes and two type of colouring the manuscript (red and blue) and what these mean and also the underlining in tables. There are a few grammatical problems and also words that need to be written correctly. If you could do the suggested changes and present the manus without track changes it would be easier to follow your thoughts.

Abstract (A): The first sentence is a result. I suggest that you remove the words "continue" and "even though". Could "evidence-based" research be possible to use to highlight research?

Read carefully the A once more and see if you could higher the abstraction level some more.

Introduction (I): Research question(s) are a bit unclear. You name two questions and write about one in same sentence. How many questions do you have in this study? This is very important that you write it/them clearly. I miss also the study context you are using. This could be a part of the research question(s). Use rather "is" than "were" in line 85. p 5.

Line 58. "Some studies..." You need a better start for the sentence. "Some" is coming also in next sentence.

Line 79. Please name the author.

Line 96 p.6. What is the difference between perception and experience? This could be explained in the indroduction (with references).

Lines 101-108 are a part of introduction.

Go straight to the participants under the heading on line 100.

Line 188: What do you mean with "larger headings"?

Line 190: Who were the "investigators"? Do you mean researchers of this study?

Ethical Considerations (EC): This part is much better now.

Line 214: "After this..." sentence is unnecessary here. Write 1-2 short sentencences in the end of EC about publishing the results, since you are now planning to publish this study. What did you explain about publishing to the participants?

Table 2. I advice you to think about to use the terms themes and subthemes or categories and sub-categories instead of mixing these with each other. It has been challenging to see the table through track changes.

Results (R): Line 307 p. 17. Are you sure this is a right heading here? I suggest to form this and think about the sub-theme here once again. So many track changes here has given challenges to understand the results.

Discussion (D): Start your discussion with your study objective to lead the readers back to your corn substance. I dont understand why the example of urinary tract infection and catheterization is here, line 400 p.26.

Lines 405-414 are marked with blue colour. Is there a special reason for this?

In the D: you should mention clearly your future visions about your study substance, what to do next?

Limitations: you could see a bit more for this and also the conclusion.

Good luck with your manuscript!

Best wishes from the reviewer 1.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1:No

PLoS One. 2021 Jan 8;16(1):e0245202. doi: 10.1371/journal.pone.0245202.r006

13 Dec 2020

Dec 13, 2020

Dr. Wen-Jun Tu

Academic Editor

PLOS ONE

Re: Manuscript ID: PONE-D-20-14697R2

Dear Editor:

Thank you for your e-mail and review of the manuscript (PONE-20-14697R2) that we sent on Oct 31, 2020. We are very grateful for your constructive and insightful comments regarding the improvement of the revised manuscript. All changes have been made in response to the reviewers’ suggestions and itemized responses to the reviewer’s comments are also attached herewith. In addition, the entire manuscript was revised to resolve grammatical issues and improve readability through detailed proofreading. Additions are marked in red, and deleted text is tracked via the ‘Track Changes’ function in Microsoft Word. The line numbers in this document are based on the main manuscript with the revision history and revisions shown in-line. These revisions are also highlighted in red in the main document.

I look forward to working with you and the reviewers to move this manuscript closer to publication in PLOS ONE. Thank you for your consideration. I look forward to hearing from you.

Sincerely,

Yuko Yoshida

Hokkaido University Faculty of Health Sciences

Address: Kita 12 Nishi 5, Kita-ku, Sapporo, Hokkaido 060-0812, Japan

Tel.:+81-011-706-3718

Fax: +81-011-706-3718

Email: yuko790402@hs.hokudai.ac.jp

Q1:There har been challenges to understand your track changes and two type of colouring the manuscript (red and blue) and what these mean and also the underlining in tables. There are a few grammatical problems and also words that need to be written correctly. If you could do the suggested changes and present the manus without track changes it would be easier to follow your thoughts.

A1: We would like to apologize for this confusion. We have improved the readability of the revised manuscript by unifying the color and using the track changes function in Word.

Q2:Abstract (A): The first sentence is a result. I suggest that you remove the words "continue" and "even though". Could "evidence-based" research be possible to use to highlight research?

Read carefully the A once more and see if you could higher the abstraction level some more.

A2: Thank you for your advice. I removed “continue” and “even enough” following your advice. To improve the abstract, we have modified the research background to highlight the significance of this research using the term “evidence-based.” The corrections and additions are in red.

Line 19-25

“Nurses continue to disinfect the skin before administering subcutaneous injections as a standard process in clinical settings; despite evidence that disinfection is not necessary. To implement evidence-based practice, it is critical to explore why this gap between “evidence” and “practice” exists. This study aimed to describe the reasons offered by Certified Nurses in Infection Control (CNIC) in Japan for performing skin disinfection before subcutaneous injection. Adopting an inductive qualitative design, interviews were conducted with 10 CNIC in 2013.”

In addition, the discussion section has been modified to describe the interpretation of the results using expressions that correspond to the expression of the research background.

Line 29-38

“The themes (c) and (g) were cited as the main reasons affecting decision-making. The CNIC administered injections following skin disinfection in hospitals in accordance with hospital norms. On the contrary, outside the hospital, they administered subcutaneous injections without skin disinfection. All themes except (b) and (g) reflect the barriers and resistance to omitting skin disinfection, while (g) shows that it is already partly implemented in home care settings. It is necessary to create a guideline for skin disinfection before subcutaneous injection that considers the quality of life of patients at home, their physical conditions, and the surrounding environment at the time of injection, in addition to the guidelines applicable in hospitals.”

Q3:Introduction (I): Research question(s) are a bit unclear. You name two questions and write about one in same sentence. How many questions do you have in this study? This is very important that you write it/them clearly. I miss also the study context you are using. This could be a part of the research question(s). Use rather "is" than "were" in line 85. p 5.

A3: Regarding the research question, we mentioned two in our previous manuscript: “Why Japanese nurses disinfect the skin before administering subsidiary injections and what is the background to this practice,” but deleted “what is the background to this practice,” and unified research question. The corrections and additions are in red.

Line 95-96

“Thus, we pose the following research question: why do Japanese nurses disinfect skin before administering subcutaneous injections?”

For the study context, we rewrote the following text before the text of the research question:

Line 91-95

“Although omitting skin disinfection before administering subcutaneous injections is safe, reduces the burden on patients, and likely reduces costs, it has still not become standard clinical practice. Exploring the reasons for this lack of adoption in clinical practice in Japan will help us address obstacles to the introduction of new evidence.”

Q4:Line 58. "Some studies..." You need a better start for the sentence. "Some" is coming also in next sentence.

A4: We have modified the sentence as per your suggestion, and now included a direct in-text citation as the beginning of the paragraph.

Lines 54-55

“Dunleavy et al. and Hope, Hickman, Parry, and Ncube [7,8] report that not using an alcohol swab is a risk factor for skin and soft tissue infections.”

Q5:Line 79. Please name the author.

A5: Following your advice, we have included the names of researchers.

Lines 74-76

“A study conducted in Greece　by Theofanidis [13] indicates that nurses disinfect the skin before insulin injections as a longstanding medical ritual, although there is insufficient evidence on the need for disinfection.”

Q6:Line 96 p.6. What is the difference between perception and experience? This could be explained in the indroduction (with references).

A6: Thank you for your advice. The difference between “experience” and “perception” is now described in the introduction section, with quotations. Additionally, we included in the introduction section the reason for targeting CNIC’s “experience” and “perception.” The corrections and additions are in red.

Lines 77-99

“Nurses who do not have extensive knowledge of infection control may assume that skin disinfection before administration of subcutaneous injections prevents infection. According to recent books published in Japan on nursing techniques and skills, disinfection is necessary, while only a few books have introduced studies verifying that it is unnecessary [15]. In contrast, Certified Nurses in Infection Control (CNIC) receive certification from the Japan Nursing Association for specializing in infection control and having advanced nursing skills. CNIC have more experience, skill, and knowledge-based perceptions than other nurses regarding skin disinfection before subcutaneous injection. In this study, the word “experience” is defined as “practical knowledge, skill, or practice derived from direct observation of or participation in events or in a particular activity” [16], while the word “perception” is defined as “The way in which something is regarded, understood, or interpreted” [17]. Describing CNIC’s experience and perception of skin disinfection before subcutaneous injection was considered suitable for this objective.

Q7:Lines 101-108 are a part of introduction.

Go straight to the participants under the heading on line 100.

A7: Thank you for your comments. Lines 101–108 has been moved to the introduction section.

Lines 111-113

“To meet conditions similar to the skills required for a subcutaneous injection, the participant selection criteria were as follows: (1) worked as a staff nurse with more than 10 years of experience and (2) acquired CNIC qualification.”

Q8:Line 188: What do you mean with “larger headings”?

A8: We apologize for this expression. We have revised this sentence as follows.

Line 168-170

“Depending on the relationships among subthemes, a larger number of subthemes can be organized, or combined, into a smaller number of themes [22].”

Q9:Line 190: Who were the "investigators"? Do you mean researchers of this study?

A9: We have revised “investigators” to “researchers of this study.”

Lines 171-172

“When discrepancies in coding occurred, the researchers of this study discussed and resolved them through consensus.”

Q10:Ethical Considerations (EC): This part is much better now.

A10: Thank you for your comments. Following your advice, we deleted the sentence, and added more explanation on publishing the results to the participants.

Lines 192-194

“When briefing potential participants, the researchers explained the purpose and requirements of the study, participants’ right to withdraw at any time without consequences, and possibility of the authors publishing the results.”

Q11:Table 2. I advice you to think about to use the terms themes and subthemes or categories and sub-categories instead of mixing these with each other. It has been challenging to see the table through track changes.

A11: We apologize for the confusion. We attribute this issue to using Excel. The manuscript submitted the time before last one was made in Excel. Therefore, it was created by using Word from the previous manuscript. We have corrected the terminology and made all the tables more readable.

Q12:Results (R): Line 307 p. 17. Are you sure this is a right heading here? I suggest to form this and think about the sub-theme here once again. So many track changes here has given challenges to understand the results.

A12: Thank you for your comments. We have reconsidered the subtheme of “lowered adherence to norms in home care settings,” since it consists of subthemes “acknowledgment of those who omit disinfection” and “unnecessary skin disinfection is a burden for patients at home.” We believe “tacit approval for not disinfecting in home care settings” would be a suitable theme. This is because nurses in hospitals never think about complying with the norm; in situations where the norm in home care settings is lax, they start to consider other priorities, and it can be interpreted that they are hesitant and even partially acquiescing in omitting skin disinfection. This has been revised as follows.

“Tacit approval for not disinfecting in home care settings”

Q13:Discussion (D): Start your discussion with your study objective to lead the readers back to your corn substance. I dont understand why the example of urinary tract infection and catheterization is here, line 400 p.26.

A13: Thank you for your advice. We have revised the section as follows.

Lines 304-309

“The purpose of this study was to describe certified nurses’ reasoning for disinfecting or not disinfecting skin before administering a subcutaneous injection. A qualitative inductive content analysis generated seven themes. Although extant research of the past 50 years has consistently shown that swabbing the skin with alcohol before administering a subcutaneous injection is unnecessary [11, 24, 25], in clinical settings, nurses continue to disinfect skin, as shown in the theme of “ingrained custom.”

The reasons given for the example of urinary tract infection and catheterization are as follows. Intermittent urethral catheterization requires a strictly sterile technique in the hospital, but not at home. This issue is hotly debated. In case of skin disinfection before subcutaneous injection, sterile technique is only required in hospitals, but this process can be omitted at home. There is always a risk of infection if sterile techniques are not used; even so, sterile techniques are not required when intermittent urethral catheterization is performed at home. The example of urinary tract infection and catheterization was presented as a good example as a result. We have revised the description below to convey our intention.”

Lines 338-344

“Intermittent urethral catheterization is one example of a difference in medical technique required in the hospital and in home care settings. It is often self-administered by patients at home, and the use of antiseptic solutions during insertion has been a subject of much debate [32]. Although the risk of a urinary tract infection is always present at urethral catheterization, many recent studies support the use of a clean, rather than sterile technique when patients insert intermittent urethral catheterization in the home environment [33].”

Q14:Lines 405-414 are marked with blue colour. Is there a special reason for this?

A14: We apologize for the confusion. There was no difference in the message depending on the color. This mistake has been corrected.

Q15:In the D: you should mention clearly your future visions about your study substance, what to do next?

A15: Thank you for this input. We have revised the implications and future scope of the study as follows.

Lines 358-361

“Based on the results of this study and previous studies, evidence-based health care guidelines should be developed for skin disinfection before subcutaneous injections that consider the quality of life of patients at home, their physical conditions, and the surrounding environment at the time of injection.”

Q16:Limitations: you could see a bit more for this and also the conclusion.

A16: Thank you for your advice. The revised manuscript now includes the limitations, as shown below.

Lines 383-390

“The results of this study suggest that nurses have different reasoning for skin disinfection in home care settings than in hospitals. The participants in this study were experienced nurses who worked in hospitals. However, nurses who work in home care settings may have different reasoning on this issue. Further studies should consider the latter group to more deeply explore why nurses disinfect skin before administering subcutaneous injections. A quantitative survey will be required to clarify the actual status of skin disinfection before subcutaneous injections in home care settings when developing guidelines.”

We accordingly modified our conclusion as well:

Lines 388-395

“Our study described CNIC’s reasoning for disinfecting or not disinfecting skin before administering subcutaneous injections. Followed by an inductive content analysis, seven themes emerged: “common practice,” “presumed merit of omitting disinfection,” “adherence to hospital norms,” “avoiding persistent suspicion of infection,” “no detrimental effect,” “ingrained custom,” and, “tacit approval for not disinfecting in home care settings.” Participants in this study acknowledged practicing home care subcutaneous injections without prior skin disinfection. Within hospitals, however, compliance with hospital norms, rather than judgment about individual patient conditions, prevails. This study reveals the barriers and resistance to promoting evidence-based practice in skin disinfection before subcutaneous injections at clinical settings. Overall, hospital norms had the most influence on CNIC’s decision to disinfect.”

In addition, the entire manuscript was revised to resolve grammatical issues and improve readability through detailed English proofreading.

Attachment

Submitted filename: Respons to Reviewers_SKIN.docx

Click here for additional data file.^{(49.9KB, docx)}

PLoS One. doi: 10.1371/journal.pone.0245202.r007

Wen-Jun Tu

26 Dec 2020

Is skin disinfection before subcutaneous injection necessary? The reasoning of Certified Nurses in Infection Control in Japan

PONE-D-20-14697R3

Dear Dr. Yoshida,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Wen-Jun Tu

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

PLoS One. doi: 10.1371/journal.pone.0245202.r008

Wen-Jun Tu

2 Jan 2021

PONE-D-20-14697R3

Is skin disinfection before subcutaneous injection necessary?The reasoning of Certified Nurses in Infection Control in Japan

Dear Dr. Yoshida:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

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Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

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on behalf of

Dr. Wen-Jun Tu

Academic Editor

PLOS ONE

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Supplementary Materials

Attachment

Submitted filename: Review PLOS ONE 20200721 0517 skin disinfection before subcutaneous injection.docx

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Attachment

Submitted filename: Response to Reviewers0906.docx

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Attachment

Submitted filename: Respons to Reviewers_SKINDISINFECTION.docx

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Attachment

Submitted filename: Respons to Reviewers_SKIN.docx

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