Prevention of menstrual toxic shock syndrome by French health professionals Running head: Toxic shock syndrome prevention

Methods: Fourteen semi-structured interviews with health professionals involved in women’s health (midwives, school nurses, general practitioners, and obstetriciangynecologists) were conducted over a period of six months (March 2019 to September 2019) in the Ile-de-France region in France. Their ages ranged from 26 to 67 years. All the interviews were recorded and typed to extract a qualitative analysis.


Introduction
Toxic Shock Syndrome (TSS) is a severe infectious disease that can be caused by Staphylococcus aureus or superantigenic toxin-producing streptococci [1]. Half of the cases of Staphylococcus aureus TSS reported in the literature are associated with the use of internal intimate protection products (tampons and cups) and the production of the the disease: vaginal colonization by a toxigenic S. aureus strain, the production of the TSST-1 toxin, the penetration through the vaginal epithelium of a suffi cient quantity of TSST-1 to cause the pathology and the absence or insuffi cient titer of neutralizing antibodies to this toxin [6].
Although the pathology of menstrual TSS has received signifi cant media coverage in recent years, the ANSES emphasized in 2018, in its report entitled "Safety of intimate products" that TSS and the proper use of these protections are still largely unknown to the general public. Thus, despite the various TSS prevention measures already in place in France, misuse of periodic protection by French women persists, due to a lack of information among them ( Figure 1). The misuse of internal sanitary protection is one of the main risk factors associated with the occurrence of TSS. It is thus important to strengthen prevention efforts for women in this area [7].
According to the study conducted by ANSES, women unanimously expressed a desire for information on TSS, such as knowledge of symptoms, the composition of protection, hygiene measures, and methods of use. As a source of information, health professionals (general practitioners, school nurses, midwives, and obstetricians) are considered by women as "primary and trusted sources of information" [7].
It, therefore, seems relevant to understand how these health professionals are made aware of the TSS pathology and what advice they give to their patients on the use of intimate protection.
The objective of this work was to estimate the participation of health professionals in (i) education on the use of intimate protection products and (ii) the prevention of menstrual TSS among French women.

Methods
In this study, two hypotheses were posed to answer the research problem: -(i) Health professionals only occasionally provide their patients with advice on the proper use of menstrual protection during consultations, and this specifi cally when the patient presents a high infectious risk (e.g., a patient in postpartum care or with a history of TSS).
-(ii) Health professionals only partially address the subject of TSS with women (symptoms, risk of recurrence), specifi cally when women request it.

Study procedure
The method chosen for this study was to conduct semidirective interviews with health professionals involved in gynecological follow-up: midwives, school nurses, general practitioners, and obstetrician-gynecologists to obtain qualitative answers. The interviews lasted an average of 30 minutes and were recorded to correct the notes if necessary.

Variables studied
An interview grid (to be found in Appendix I) was developed that grouped all the variables studied and was based on the two hypotheses posed.
To avoid directing the interviewed professional in his/her answers, it was deliberately chosen to elaborate this grid in three parts:

1.
To get the interviewee to talk about his or her involvement with women in prevention in the broadest

Participant inclusion criteria
The criteria for inclusion of participants were all qualifi ed health professionals, registered with the departmental order of the profession concerned and practising in the Ile-de-France region in France. The health professionals chosen were found after a search in the Health Insurance directory or were met directly at hospital internships for French health students.

Qualitative exclusion criteria for participants
Health professionals who did not work directly with women (health executives without clinical activity, exclusive university teachers, and retired health professionals) were excluded from the study.

Description of health professionals who agreed to participate in the study
To carry out the study, professionals were initially contacted and then responded favorably or not to this current and innovative research topic ( Figure 2).
Of these caregivers, 14 agreed to participate in the study, including 5 midwives, 3 school nurses, 3 general practitioners, and 3 obstetric gynecologists.
Finally, the 6 health professionals who did not respond to the solicitation emails sent were 4 midwives and 2 general practitioners.
All the professionals interviewed were female except for one general practitioner who was male.
The 14 semi-structured interviews with professionals were conducted at their workplaces between March and September 2019 in the Ile-de-France region in France. The median age was 37 years (min: 26 years; max: 67 years).
According to means and time, researchers could carry 14 interviews.

Analysis strategies
Once the verbatim statements of the caregivers interviewed had been transcribed, the interview framework was repeated and, for each question asked, the answers given by each participant were grouped. In addition, the answers obtained were classifi ed by hypothesis. An analysis of the feeling towards the questioning could be made (for example hesitations towards an answer, sighs, pauses, voice intonations). Finally, a correlation between the information obtained and the data in the literature was carried out.

Ethical and regulatory considerations
An oral (by telephone) and/or written (by e-mail) explanation of the study was given to the health professionals solicited who met the inclusion criteria.
At the beginning of the interview, the participant's oral consent was requested for the audio recording, and his anonymity was assured as well as the possibility of retracting at any time during the study. If the participant wished to withdraw or wanted more information about the survey, they could contact us.

(i) Involvement of professionals in providing advice on the choice and use of intimate protection products
The frequency of advice given by the professionals interviewed to women on the choice and use of intimate protection products is shown in Figure 3. It is observed that the advice given is infrequent and random. Indeed, of the 14 caregivers interviewed:  We can thus conclude that the information provided by professionals varies greatly depending on the professional and is not standardized.

(c). Three obstacles identifi ed by the professionals interviewed to the proper management of menstrual hygiene by women in France
The fi rst obstacle identifi ed is the "taboo" surrounding menstruation.
Health professionals have to initiate de discussion with their patients because it is delicate for women and especially young girls. Some professionals told us: "Young girls do not tell me that they are having their period, they come because they have a stomachache". Another health professional stated: "The subject of menstruation is often discussed very quickly because young girls are still very embarrassed to talk about menstruation, more so among middle school girls than high school girls, but the taboo surrounding menstruation still persists." The second obstacle identifi ed was economic diffi culties.
On this subject, one professional reported that "patients sometimes have little fi nancial means to have proper body hygiene, especially homeless patients. " Finally, the third and last obstacle is: environmental diffi culties, particularly those highlighted at school. One professional told us: "At school, there is not always enough to wash your hands". "The toilets are mixed and not always clean".

(ii) Involvement of the professionals interviewed in TSS prevention
Three of the 14 health professionals interviewed said that they were involved in preventing TSS in their patients, but not on a routine basis. They were not very involved in TSS prevention for various reasons.

(a). The reasons given by the professionals interviewed for not participating in TSS prevention
The fi rst reason given by the professionals (9/14) was the diffi culty of informing women "without alarming them".
For other professionals (6/14), the "rarity of the pathology associated with the lack of time" explains the lack of information given to patients about TSS. For most professionals (9/14), the "lack of theoretical knowledge" about the disease noted by the three school nurses interviewed, as well as three midwives, one obstetrician-gynecologist, and two general practitioners, was a hindrance to the explanation given to women. The last reason mentioned is the lack of concern of women for the pathology of menstrual TSS, as opposed to other potential risks such as the presence of endocrine disruptors in certain types of protection. Thus, a very large proportion of the professionals (11/14) interviewed told us that their patients did not ask questions about menstrual TSS pathology.

(b). Participation in TSS prevention in specifi c situations:
Professionals said that women using only tampons should be informed about menstrual TSS.
Another professional stated that he "does not name TSS, but always tells her patients to come and see him if something strange, abnormal or smelly appears".
Finally, one professional considered TSS prevention to be useful in "de-dramatizing the use of internal sanitary protection".
Although the health professionals interviewed were not very involved in the prevention of menstrual TSS, three main risks associated with tampon use were highlighted.
First, the "infectious risk" associated with menstrual TSS was the one cited most often (11/14).
Secondly, 2 professionals mentioned the risks of "redness and irritation", especially when using sanitary protection outside of menstruation.
Thirdly, the risks associated with the composition of tampons and the "presence of endocrine disruptors" were emphasized by one professional. He recommended to his patients "to avoid plastic fi lms and anti-odors because they are dangerous to health".

(c). Impact of encountering a case of TSS during his professional activity on subsequent prevention practices:
During our interviews, we met a professional who, during his medical studies, met a patient who had suffered from TSS.
She had both arms and legs amputated. He confi ded to us that he did not participate in the prevention of TSS for women because he considered that the pathology was "rare and the pathophysiology poorly known". It was therefore "useless to alarm women".
Having met a case of menstrual TSS has not changed his professional practice. The two most appropriate times, according to the health professionals, to discuss menstruation and intimate protection are the gynecological prevention consultation and the emotional and sexual life programs carried out in secondary schools. These programs could provide an opportunity to defi ne menstruation and to present the different types of sanitary protection, explaining their use and the risks associated with misuse [16]. The preventive gynecology consultation could be an opportunity to supplement the information received in schools by taking into account the patient's psychological, social and cultural situation and preferences, as well as his or her lifestyle, in order to have a personalized discussion with the patient.
Three risks related to the use of tampons were highlighted by the professionals interviewed: the "infectious risk", the risks of "redness and irritation" and the risks associated with the "presence of endocrine disruptors". In the scientifi c literature, irritation is described with the use of intimate protection products. For sanitary towels, irritation phenomena were reported as early as 1981 in a study by Friedrich entitled "tampon effects on vaginal health" [17]. These irritations are related to the contact areas, which are the external genital mucosa or the skin of the genital region, as specifi ed in studies conducted by Farage in 2006, Stadler in 2006, and Xuemin et al. in 2011. Concerning the risks associated with the composition of tampons, no specifi c regulations are governing the composition, manufacture or use of intimate protection products. The ANSES has recommended the development of a more restrictive regulatory framework at the European level to limit the presence of these chemicals [7].
The mandatory information provided on all tampons boxes inform women of the risk of TSS associated with the misuse of internal intimate protection products. And yet, the ANSES published in 2018 that 73% of women do not know what menstrual TSS is [7].
It is therefore necessary to strengthen the information delivered on the pathology through health professionals in particular.
Most of the health professionals interviewed were aware of TSS through the media. The sources of information are often not very scientifi c. Indeed, the information relayed by the media does not always constitute complete information based on the data provided by scientifi c articles.
Initial and ongoing university training on the subject concerned only a few of the health professionals interviewed. It would therefore seem useful to develop French university training on the pathology of menstrual TSS.
The strengths of the study are fi rst of all the novelty of this qualitative study, which aimed to explore and understand the possible practices of education in the use of intimate protection products and the prevention of menstrual TSS. Indeed, most of the studies that have been conducted on menstrual TSS are quantitative and therefore based on a questionnaire, which does not allow for a precise exploration and understanding of the practices of health professionals. The fact that we were able to record all of the interviews made it possible to obtain the entirety of the exchanges. The choice of interviewees was made in an informed manner by trying to diversify the population as much as possible. To do this, we tried to recruit professionals of different ages and with different care activities. The 14 interviews allowed us to obtain different points of view and practices. The participants did not know the precise subject in advance, but were told that the subject of the study was "menstruation and intimate protection". This allowed for as many responses as possible with no preconceived notions, as caregivers were not able to discuss or research the topic with each other before participating.
The main limitations identifi ed were the small size of the study and the lack of male respondents. The results are from a qualitative survey based on a panel of 14 caregivers and therefore cannot be extrapolated to all caregivers. Similarly, it was not possible to study the results according to the gender of the professionals interviewed.
Finally, the decision to stop the interviews was made when the data was saturated, i.e., when no new elements were mentioned during the interviews. This saturation is diffi cult to defi ne; it was decided after transcribing and analyzing each of the interviews carried out when a redundancy in the comments without new elements appeared. However, it is impossible to say whether another element might have appeared if the interviews had continued. This work has highlighted the need to strengthen and standardize information for patients and health care professionals on promoting education on the use of intimate protection products and prevention of menstrual TSS ( Figure  4).
Among the different forms that information can take, the written word seems to be an adapted and recognized method to complement oral information in order to personalize the information given on menstrual hygiene. This is why we have chosen to produce an information leafl et for patients on our subject of study including the defi nition, epidemiology and signs suggestive of TSS as well as advice on the proper use of sanitary protection.
To conclude: health care professionals should be more