Caregivers of Neuromuscular Patients Living with Tracheostomy during COVID-19 Pandemic: Their Experience

Background: During a pandemic, tracheostomy management in neuromuscular disease (NMD) patients can be complex. Methods: Using a multicentre, multiple case study approach, we sought perspectives through semi-structured interviews via hybrid quali-quantitative analysis. The qualitative analysis involved a semi-structured interview and the quantitative analysis the completion of a battery of questionnaires. Aim: To investigate the caregivers’ experiences, burden and beliefs regarding tracheostomy during the Italian COVID-19 pandemic. The following instruments were administered: Connor and Davidson Resilience Scale (CD-RISC-25); Acceptance and Action Questionnaire-II (AAQ-II); State-Trait Anxiety Inventory (STAI); Langer Mindfulness Scale (LMS); Zarit Burden Interview (ZBI). Results: Fifty-three caregivers (62.3% female, mean age 52.2 (SD = 18.2)) participated in the study. The more resilient the carers, the more they were psychologically flexible (r = 0.380, p = 0.014) and able to cope adaptively with the emergency (r = 0.378, p < 0.006). Similarly, perceived control was higher the more resilient they were (r = 0.897, p < 0.001). The main emotions emerging were isolation and loneliness (15; 34.88%). The perception of tracheostomy meant that it could be seen as a lifesaver or as a condemnation. Similarly, the relationship with health professionals moves from satisfaction to a feeling of abandonment over the course of the pandemic. Conclusions: These findings offer a unique opportunity to understand the point of view of caregivers of NMD patients living with tracheotomy during the COVID-19 pandemic, when going to the hospital may have been hampered.


Introduction
Throughout their disease, patients suffering from NMD and chronic respiratory insufficiency may encounter the possibility of undergoing tracheotomy and invasive mechanical ventilation (IMV) for acute related complications or worsened respiratory insufficiency [1,2]. While prolonged respiratory failure is probably the most common reason for performing tracheostomy, other indications such as decreased level of consciousness, poor airway protective reflexes, difficult management of secretions, requests of patients on 24 h noninvasive ventilation, severe alterations in physiology associated with trauma and medical illness are also indications for tracheostomy. With the development of less invasive tracheostomy techniques that can be performed safely at the patient's bedside, the frequency

Objectives
The main aim of the present study was to explore the caregivers 'experiences of people with NMD, e.g., Amyotrophic Lateral Sclerosis (ALS), Spinal Muscular Atrophy (SMA), Duchenne Muscular Dystrophy (DMD)], or tetra-paresis, concerning tracheostomy management during the COVID-19 health emergency in Italy. Specific objectives included: (1) investigating whether resilience, flexibility and dispositional mindfulness were correlated with lower anxiety, stress and burden scores; (2) exploring the emotional experiences and management of the caregivers; (3) investigating whether a finding related to caregivers' emotional coping and experience, characterized by a higher number of positive terms and metaphors, is correlated with levels of resilience, flexibility, state anxiety and dispositional mindfulness.

Methods Ethics
This study received ethical approval from the Ethics Committee of the IRCCS Fondazione Don Carlo Gnocchi section of the IRCCS Regione Lombardia (reference: 8 September 2021) and the Ethics Committee of the Bari Policlinico University hospital (reference number 6747 of the 24 May 2021. Before the interview, participants provided their signed informed consent by mail. Oral consent was obtained also on the day of the interview.

Study Design and Methodological Orientation
A multicenter case series quanti-qualitative study was carried out according to the Consolidated Criteria for Reporting Qualitative Research Checklist (COREQ) [19].
The Interpretative Phenomenological Analysis (IPA) [20,21] was adopted as a paradigm to conduct the study. IPA focuses the attention on understanding the complex system of meanings related to a unique and subjective intimate phenomenon [22]. This inner phenomenon is characterized by the presence of beliefs and constructs made manifest or suggested by the interviewee's discourse and may represent a piece of his or her identity. In both cases, meaning is central and the aim is to try to understand the content and complexity of these meanings rather than to measure their frequency.

Sampling
Participants were purposively sampled and recruited at the Heart and Respiratory Rehabilitation Unit of the IRCCS Fondazione Don Carlo Gnocchi of Milan, Centro Santa Maria Nascente and at the Cardio-Thoracic Unit of Policlinico of Bari. Each potential participant in the study was contacted by one of the researchers involved in the study by telephone call to present the purpose of the research and thus verify his/her availability. Then, at the time of the telephone call, arrangements were made to schedule a functional time and day for the caregiver for the next phase. The recruitment of participants proceeded until theoretical saturation of the sample, i.e., until a redundancy of themes was observed and no new themes emerged [23].

Inclusion and Exclusion Criteria
To take part in the study, participants had to be caregivers of people with a tracheostomy and a diagnosis of NMD such as ALS, SMA, DMD, or tetra-paresis. The requirements also included being a caregiver for at least two years (i.e., since the start of the COVID-19 pandemic) and being aware of the diagnosis and medical record of the family member for whom one is a caregiver. To avoid potential research bias, younger subjects (<18 years old) and those with recorded psychiatric disorders or cognitive impairment were excluded from the study.

Setting and Time
Data collection took place from January 2022 until March 2022. Questionnaires and interviews were carried out online or by telephone, because of the resurgence of infections at the time due to the pandemic, the distance of the researchers from the participants, and to accommodate the needs of the caregiver. All telephone interviews took place in a quiet room to ensure privacy and confidentiality.

Materials and Data Collection
The caregiver accessed via an online link, realized thanks to the use of Qualtrics' platform, to a series of questionnaires designed to investigate the variables of interest. If the caregiver was unable to fill them out directly, he/she was assisted by a qualified and trained psychologist in completing them. The questionnaires took on average a maximum of 30 min to complete.

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The following data were collected: -Socio-demographic and clinical data: gender, level of education, profession (current or previous), marital status, role, how long they have been caring for their loved one and for how many hours/weeks, drug therapy taken, pathologies and/or comorbidities (if any). -Psychological tests: (a) Connor and Davidson's Resilience Scale (CD-RISC-25) [24], designed to detect resilience. The CD-RISC consists of five factors: 1. personal competence and tenacity (8 items); 2. self-confidence and management of negative emotions (7 items); 3. positive acceptance of change and secure relationships (5 items); 4. control (3 items); 5. spiritual influences (2 items). The Connor Davidson-Resilience Scale is based on a 5-point Likert scale, ranging from 1 "totally false" to 5 "totally true". The Resilience Scale has good internal consistency with values of Cronbach's alpha varying across research from a minimum of 0.82 to a maximum of 0.93. Its stability was also measured using the retest method at 24 weeks with equally positive results.
Acceptance and Action Questionnaire-II (AAQ-II) [25], designed to detect flexibility. The AAQ-II was developed to establish an internally consistent measure of the mental health and behavioral effectiveness model of ACT. The AAQ-II began as a 10-item scale, but after the final psychometric analysis it was reduced to a 7-item scale (2011). It was designed to assess the same construct as the AAQ-I and the two scales are correlated at 0.97, but the AAQ-II has better psychometric consistency. (c) State-Trait Anxiety Inventory (STAI) [26], designed to detect trait anxiety. The State-Trait Anxiety Inventory (STAI) is a psychological questionnaire based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The ST,AI measures two types of anxiety-state anxiety, or anxiety about an event and trait anxiety, or level of anxiety as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety. Its most recent revision is Form Y and is offered in 40 languages. The internal consistency coefficients for the scale ranged from 0.86 to 0.95; test-retest reliability coefficients ranged from 0.65 to 0.75 over a range of 2 months. The test-retest coefficients for this measure in the present study ranged from 0.69 to 0.89. This offers considerable evidence of the scale's construct and concurrent validity.
Zarit Burden Interview (ZBI) [27], designed to detect caregiver burden. The Zarit Burden Interview (ZBI) is a 22-question questionnaire designed to measure the extent to which a caregiver perceives his or her level of burden because of caring for a person with a particular diagnosis. Initially developed to measure the stress associated with caring for elderly people living in the community, it has since been validated in many patient populations and is a common measure of caregiver burden. Based on the original 29-item scale, the ZBI has undergone several modifications that have led to the current 22-item assessment. The ZBI questions comprise 5 domains: (1) burden in the relationship (6 items), (2) emotional well-being (7 items), (3) social and family life (4 items), (4) finances (1 item) and (5) loss of control over one's life (4 items). Most items explore both personal stress (12 items) and role stress (6 items). The ZBI uses a 4-point ordinal scale describing the degree of load experienced from 0 = never to 4 = almost always and takes about 10 min to complete. The maximum score is 88 with higher scores indicating a greater load. (e) Langer Mindfulness Scale (LMS) [28], to measure dispositional mindfulness. This is a questionnaire with 21 questions to be used as a training, self-discovery and research tool. It assesses four domains associated with mindfulness thinking: novelty seeking, engagement, novelty production and flexibility. An individual who seeks novelty perceives every situation as an opportunity to learn something new. An individual who scores high in engagement is likely to notice more details about his or her specific relationship with the environment. An individual who produces novelty generates new information to learn more about the current situation. Flexible people welcome a changing environment rather than resist it. The LMS has proven to have good test-retest reliability, factor validity and construct validity.
Furthermore, at the end of the previous phase, the participant underwent an ad hoc semi-structured interview (Table 1) aimed at investigating the experience of their loved ones' tracheotomy itself and the period before and after it happened. Moreover, the management of the tracheostomy, and the burden and emotional experiences over the COVID-19 period were also explored. The researcher used recognized qualitative techniques, such as returning and facilitating dialogue and useful memos were collected to account for that contextual information (such as relationships, pauses and/or interruptions in speech). This interview, subject to consent and whether the participant showed signs of fatigue, was conducted in a second meeting without taking more than 30 min. It should also be noted that both the above-mentioned tests and the semi-structured interview were administered with the support of a researcher by telephone if the participant did not have digital means or had difficulties using them.

Data Management
All interviews were audio-recorded, unwound and transcribed ad verbatim. The verbatim transcription took place in parallel with the collection of the interviews. To ensure anonymity, both questionnaires and interviews were pseudonymized with a subjectgenerated identification code (i.e., removing identifiable data to ensure privacy and confidentiality). Thus, no names were used during the later stages of the study. In particular, the uncoiling of the interviews was carried out respecting the criteria for the protection of anonymity, i.e., removal of first and last names, removal of names of places and people mentioned and removal of any details that might have made the study participants recognizable. In addition, the unwinding of all interviews took place under the supervision of the project doctor and was only carried out by the research team members. The interviews were then collected in a password-protected online file to which only the research team had access.

Data Analysis
Quantitative analyses were set up as statistical-descriptive to describe the sample. Based on the distribution of the variables of interest, parametric (or non-parametric) correla-tions were also carried out to identify the relationships between the experiences expressed in the semi-structured interviews, the specific characteristics of the sample and what emerged from the tests used. These analyses were conducted using Jamovi software (version 2.2.3).
Qualitative analyses were conducted on the semi-structured interviews, which will be audio-recorded, transcribed verbatim and anonymized, based on IPA, to identify themes, sub-themes, frequency of words used and metaphors. During the data analysis, which is flexible and dynamic, the IPA developers claim that researchers return to the interview data when necessary and that they focus on meanings during the analysis process. The main steps of analysis through IPA can be summarised as follows: reading and re-reading the text in depth; noting free associations and exploring semantic content; identifying themes and connections between them; identifying recurring sub-themes and their connections; noting idiosyncratic aspects of the interviews; noting metaphors and linguistic and temporal references. These analysis phases were followed by two of the group's independent researchers. To address issues of reliability and credibility, the emerging themes were constantly compared and contrasted during regular meetings and, in the event of disagreements, a third researcher was involved. The final categorization of themes and definitions was agreed upon by the entire research team and data saturation and triangulation of researchers were achieved [29]. These analyses were conducted using NVivo software (version 12, QSR international ® ).

Participant Demographics
The flow chart shows the process of recruitment and inclusion of the 53 participants ( Figure 1). Their socio-demographic features are shown in Table 2.
With an increase in dispositional mindfulness, there is also an increase in resilience (r = 0.380; p = 0.014). This finding is also useful in the face of the increase in resilience as the components of novelty producing (r = 0.502; p < 0.001) and novelty seeking (r = 0.427; p = 0.005) increase. In this regard, it is also worth noting that the increased presence of dispositional mindfulness is matched by an increase in tenacity (r = 0.343; p = 0.028) and self-confidence as well as tolerance of negative affect (r = 0.420; p = 0.006). In addition, as scores on the novelty-seeking component increased, so did tenacity (r = 0.345; p = 0.027) as well as confidence in one's own instincts and tolerance of negative affect (r = 0.477; p = 0.002) and readiness to accept change (r = 0.329; p= 0.036). The more novelty production increases, the more there is an increase in tenacity (r = 0.427; p = 0.005), confidence in one's instincts (r = 0.489; p = 0.001), ability to adapt to change (r = 0.312; p = 0.047) and control (r = 0.051; p = 0.003). Moreover, the greater the engagement, the greater the dispositional mindfulness (r = 0.556; p < 0.001) and psychological flexibility (r = 0.410; p = 0.008).

The Tracheostomy Experience through the Caregivers' Eye
The experience of the tracheotomy changed in many ways the life of both patients and caregivers. In Table 3, the most salient information gathered through the interview related to the tracheotomy itself and the period immediately before and after is grouped. As can be seen, many caregivers report an experience of a tracheostomy performed in an emergency, unexpectedly (13; 24.52%). The majority expected an improvement in the quality of life for their loved one following the operation (9; 16.98%), thinking that their loved one would be able to return to managing at least some of the activities of daily life (e.g., carrying out some office duties; going to a restaurant) and that it would slow down the evolution of the pathology. For five people, the interviews also reveal the need for a tracheostomy as a watershed between life and death. Following the tracheostomy of one's loved one, the panorama of experiences is multifaceted. Nine people (16.98%) emphasize an improvement in their quality of life, followed by eight (15.09%) who complain of being unable to communicate or to have lunch or dinner with their loved ones (8; 15.09%).
Twenty-three (53.48%; 25 references) caregivers referred to tracheostomy in positive terms: among them, the most stressed value is its power to save a life. On the other hand, 13 caregivers (30.23%; 15 references) describe it in negative terms, such as a great condemnation or suffering. The majority of caregivers referred to the tracheotomy of their beloved ones as to a saving anchor; therefore the most frequently words and metaphors used by the caregivers for describing tracheostomy are grouped in Figure 2, featuring an anchor.

Caregivers Confronted with Tracheostomy at the Time of the Pandemic: Semi-Structured Interviews
As reported earlier, data from 43 semi-structured interviews were analyzed. Each interview lasted between 5 and 20 min, regardless of the context in which it was conducted (online or by phone). In Table 4 are shown the superordinate themes, themes and sub-themes that emerged from the analysis conducted. In the supplement (Table S1) the full  table with examples of quotation is available. No answer 11 (20.75%) Twenty-three (53.48%; 25 references) caregivers referred to tracheostomy in positive terms: among them, the most stressed value is its power to save a life. On the other hand, 13 caregivers (30.23%; 15 references) describe it in negative terms, such as a great condemnation or suffering. The majority of caregivers referred to the tracheotomy of their beloved ones as to a saving anchor; therefore the most frequently words and metaphors used by the caregivers for describing tracheostomy are grouped in Figure 2, featuring an anchor.

Perceived Changes
One of the superordinate themes that emerged is inherent in the changes in health care received, which can be distinguished between those experienced during the period of lockdowns and related to the health emergency following them. In this regard, some found important differences, either precisely because of the absence of health personnel who could go to the home or because of the drastic decrease in contact with the home due to the lockdown (18 references; 324.29% coverage). For some, however, the differences were minimal because they covered short time brackets (e.g., of a few weeks) (16 references; 154.59% coverage) and, for others, no significant changes were seen because they did not have home care already in the pre-pandemic period (33 references; 301.8% coverage).

Coping Strategies
Another superordinate theme concerned coping strategies. Of these, the most widely used were those based on emotions (14; 32.55%; 26 references; 188.07% coverage), among which fear, anxiety and worry emerge most prominently, which either paralyze or cause caregivers to be activated in search of avoidance solutions to the dangers associated with contagion. This was followed by problem-based strategies (9; 20.93%; 16 references; 86.11% coverage) and, albeit to a lesser extent, those related to social support (5; 11.62%; seven references; 61.47% coverage) and passive adaptation (2; 4.65%; three references; 14.35% coverage; 61.47% coverage) ( Table 4).

Emotions
The main emotion that emerged from the interviews was a sense of isolation and loneliness (15; 34.88%) together with a sense of abandonment (19; 44.18%). Significant, in particular, was the emotion of fear, which was connoted in three distinct modes: fear for the health of one's loved one (10; 23.25%; 13 references; 72.29% coverage); fear of the unknown (2; 4.65%; two references; 5.95% coverage); and fear related to virus infection (16; 37.20%; 20 references; 94.95% coverage). Other emotions were referred to as worry, general anxiety, anger, distress and anxiety specifically related to the mass media's information (Table 4).

Relationships
The superordinate theme for relationships (Table 4) was characterized by the presence of references to the absence of support (9; 20.93%; 12 references; 82.44% coverage), thus recalling the previously mentioned themes, such as the sense of protection and anxiety perceived by health care personnel (23; 53.48%; 37 references; 186.97% coverage), especially during the lockdown period.

Satisfaction
Few references are made to satisfaction concerning the care services received during the period of emergency health care. Only in a few cases are they described as very poor (1; 2.32%; 1 reference; 5.37% coverage) or as having improved (1; 2.32%; 1 reference; 1.94% coverage), while in most references caregivers stated that they felt no change (3; 6.97%; three references; 6.23% coverage) ( Table 4).

Tracheo's Changes
Few emotions (2; 4.65%; three references; 17.42% coverage) related to the changes introduced by tracheostomy were reported, while many were the reported changes in life and daily management (15; 34.88%; 34 references; 420.21% coverage) ( Table 4). Main emotions include the fear of making a mistake, not arriving on time and not understanding the needs of one's loved one.
Finally, a higher number of positive terms and metaphors was correlated with higher levels of resilience, flexibility, state anxiety and dispositional mindfulness.

Discussion
This study focused on assessing the experience of caregivers of NMD patients living with tracheotomies at home during the long pandemic period. To the best of our knowledge, no other study has ever focused on this topic. The decision of these researchers to carry this study toward the end of the series of pandemic waves was to collect as much information related to this long period of isolation as possible. This specific group of carers is often described as part of the NMD "family illness" [31] and may suffer intensively because of very demanding and overwhelming activities. Several studies have highlighted that they often experience heavy care burdens and psychological distress, so they need to implement coping strategies to manage or lighten stressful situations [32][33][34][35]. Since there are very few studies on the topic and in particular of carers of patients with NMD living with tracheotomy, this study is unique. Indeed, this is a very demanding role with heavy care burden which can be worsened by social isolation and fear of COVID-19 infection. During COVID-19 early stage of the pandemic, a previous study focused on evaluating the QoL of both ALS patients and caregivers and showed that while from one side there was not a significant reduction of QoL, for both people interviewed, on the other side the caregiver burden significantly increased mainly because of the reduction of family help for primary caregivers. Furthermore, the authors highlighted the importance of wide social support in the management of this clinical condition [36]. Given that this study was carried out towards the end of the COVID-19 pandemic waves, we decided instead not to focus on QoL but to understand the coping strategies that carers put in place. Interestingly, we found that, when the caregiver's overall burden is greater, resilience is also greater. Similarly, this tends to correlate positively with the components of tenacity, trust in one's instincts, control, adaptation to change and spiritual influences. Indeed, in our population, as psychological flexibility increases, the caregiver's burden decreases. Perceived emotional well-being tended to be higher in the presence of greater resilience, in particular, toughness, trust in one's instincts, tolerance of negative affect and a sense of control. Therefore, the prevalence of carers increased forced autonomy due to the pandemic and isolation improved their feeling of resilience. This was perceived despite most of the interviewed caregivers describing that there was no change in the real day-by-day management, therefore it was mainly a subjective perspective change. It was making a virtue of necessity via which carers escaped the worse. In terms of coping strategies, the most widely used by carers were those based on emotions, among which fear, anxiety and worry emerge most prominently, which either paralyse or cause caregivers to be activated in search of avoidance solutions to the dangers associated with contagion. This was followed by problem-based strategies and, to a lesser extent, those related to social support and passive adaptation. Interestingly a study by Siciliano et al. [37] described that ALS caregivers who adopted the emotion-oriented coping strategy were those with higher levels of psychological distress compared to those who adopted task-oriented strategies. However, when specific psychological interventions are offered to ALS caregivers they seem not to have any effect on psychological distress, burden, quality of life and on patients' psychological distress, although a significant positive effect was revealed on caregivers' feelings of control over caregiving [38]. Interestingly, very few studies have addressed the topic of psychological intervention in this specific population of people, therefore there is a much-needed research gap to bridge. The results of these small studies showed that shared experiences allowed participants to feel less alone, better understood and, more accepting of their beloved ones [39]. Interestingly, there was a long time-frame between the NIV initiation and the tracheotomy ( Table 2) which confirms the important value of NIV even for prolonged time during the day (more than 14 h); but also enhances the importance of a correct follow up (in person or in telemedicine) specifically in these patients [40,41]. The NIV success is related to the right choice of interface which may vary over the years of use and the strict follow up allow the right timing for transitioning to tracheotomy instead of an emergency procedure [42]. Indeed, the experience of the tracheotomy for a significant part of patients included in this study, almost 25%, was rushed and linked to an emergency procedure without much explanation of details. The perceived feeling of their caregivers was positive as it allowed the patient to survive, but on the other, the hand they describe a sudden change, worsening QoL for them and their loved ones. The reasons behind this sudden change may be found in the lack of usual respiratory follow-up during the pandemic period. Indeed, mouth patient facilities were not available as the majority of the respiratory healthcare providers were caring for the disproportioned number of sick patients with severe respiratory COVID-19 infection. Undoubtedly, the advent of telemedicine has lightened the burden and proved to be effective in CRF patients. However, most of the studies reported the lack of in-person visits as a disadvantage, probably due to the unique patient-doctor relationship that is encountered among this patient population. Globally, telemedicine helped patients and caregivers not to feel abandoned [39,[43][44][45][46][47]. The COVID-19 outbreak prompted wider use of telemedicine services, suggesting that telemedicine for NMD patients and carers may be used as replacement when the emergency requires it, but otherwise may become complementary to in-person care. This is true except for the most vulnerable patients, including those with tracheotomy and HIMV and their caregivers. In these categories, telemedicine may be considered to replace the usual in-person care in the referring center, depending on circumstances and patient/career preferences, with the help of structured integrated care with a multidisciplinary team of specialists and general physicians and local/home-based health care providers [39,48]. It is also to be considered that a diverse relationship between caregiver and patient (spouse vs. parent of the patient) may vary the approach to the problem and the related outcome. Despite this was not the aim of the present study, it offers a relevant insight for future studies and considerations.
While considering the relevant findings of this study, some limitations may be noted. First of all, IPA allows us to delve into people's subjective experiences, which would otherwise not be accessible. However, given the degree of depth, it requires a limited sample of people and the involvement of the researcher in the interpretation of experiences during data analysis. To minimize possible bias, as mentioned above, the analyses were conducted independently by two researchers and questionable topics were discussed with a third. Another limitation of the study is that it is descriptive and not interventionist. However, these results are necessary to create a snapshot of what happens when, in emergencies such as COVID-19, caregivers and their loved ones are objectively more isolated and have less opportunity to get out of the house and be welcomed in their needs. Structuring both longitudinal and randomized controlled trials would also help to improve healthcare management in high and urgent complex contexts. Finally, the small purposive sample limits the possibility of the generalizability of the results. However, given the rarity of the disease considered, a much larger population sample would be very difficult to achieve.
Continuous family interventions are needed, on a day-by-day basis about how to keep them informed, engaged and constantly supported by the different HCPs, even if in emergencies. Telehealth monitoring, as other studies have shown, could be relevant to sustain caregivers and should be incorporated into standard healthcare approaches.

Conclusions
This study purposed to give a snapshot of the role of the caregivers of NMD patients living with tracheotomy during the long pandemic period. The picture drawn is of people with a high burden of care which was worsened by the pandemic. Therefore, more support needs to be put in place to alleviate their stressors. Moreover, telemedicine needs to be implemented and focus not just on NMD and chronic respiratory failure patients but also on caregivers, and more studies should address effective intervention to lighten the burden of this "family illness" and its care. Data Availability Statement: The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request.

Acknowledgments:
The authors sincerely thank the caregivers who offered their help by sharing their experiences.

Conflicts of Interest:
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.