Nima Ameli^1*, Menna Brown²

¹School of Health and Social Care, Swansea University, Wales, United Kingdom

²Faculty of Medicine, Health and Life Sciences, Swansea University, Wales, United Kingdom

*Corresponding Author: Nima Ameli, School of Health and Social Care, Swansea University, Wales, United Kingdom.

Abstract
Introduction: Due to the adverse impacts of polycystic ovary syndrome (PCOS) on patients' health and well-being, it has received significant attention in developing optimal approaches for treatment. This study aimed to explore barriers and facilitators of PCOS treatment adherence amongst PCOS-diagnosed women in Mashhad, Iran.

Methods: Employing a qualitative approach, this study conducted semi-structured interviews with ten women (20 to 40 years old) diagnosed with PCOS for over a year.

Results: The findings revealed that barriers to PCOS treatment adherence include inadequate knowledge about PCOS symptoms among patients and their families, insufficient information from doctors, long waiting times at appointments and short consultation sessions, lack of empathy from doctors, personal time constraints, social norms, side effects of the drugs, and lack of enjoyment of the treatment. Facilitators of PCOS treatment adherence included knowledge of PCOS consequences and remedies, family and peer support, social pressures, improved health outcomes, and personal improvement goals.

Conclusion: This study finds some key barriers and facilitators to treatment adherence in the context of Iran, which imply the need to increase PCOS awareness among girls, women, family members, and the general community, improve healthcare professionals' care (information provision, empathy, and prioritizing women's health), and enhance intrinsic motivation among PCOS-diagnosed women. These findings are among the first concerning facilitating and impeding factors associated with PCOS treatment adherence. The results relating to social pressure as a facilitator are novel in the broader context of the relevant literature.

Keywords: PCOS, Polycystic ovary syndrome, Barriers, Facilitators, Treatment, Adherence, Theoretical domains framework, lifestyle, lifestyle changes

1. Introduction
Polycystic ovary syndrome (PCOS) is recognized as a significant public health concern worldwide [1] and is one of the most common hormonal disorders occurring in women [2,3]. PCOS is characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphology - with excessive androgen production by the ovaries [4]. Subject to diagnostic criteria and study sample size, worldwide PCOS prevalence ranges from 6% to 20% of reproductive-aged women [5] and affects one in ten women of childbearing age [6]. In the short-term, PCOS leads to absent, infrequent, or irregular periods, hirsutism, androgenic alopecia, difficulty in weight management, acne, raised cholesterol, over or underactive thyroid, and infertility [7], which in turn could lead to mood swings, low self-esteem, and depression [7–9]. In the long-term, PCOS-diagnosed women suffer from being overweight and face a higher risk of developing diabetes, gestational diabetes, hypertension, heart disease, low HDL- cholesterol and high LDL-cholesterol, and sleep apnea [10].

Due to the adverse impacts of PCOS on patients' health and well-being, PCOS has received much attention in developing optimal pharmaceutical and lifestyle management treatment approaches using careful diagnosis [11]. The treatment models to improve symptoms of PCOS include medications (i.e., progesterone, oral contraceptives, anti-androgens, and metformin) and lifestyle management such as healthy diets, more physical exercise, and quitting smoking [12–14]. The effectiveness of these treatments in improving various symptoms of PCOS is well-documented across the literature. For instance, drug treatments such as insulin-sensitizing medications positively affect insulin resistance, irregular menstrual, anovulation, hirsutism, and obesity [15]. In addition, lifestyle management is found to improve insulin resistance and lead to weight loss, enhancing PCOS features, including psychological, cardio-metabolic, endocrine, and reproductive features [16,17]. However, the effectiveness of these treatments is highly reliant on persistent adherence from the patients [11,18], where the term adherence recognizes the patient's right to choose whether they follow the treatment plan suggested by the doctors [19]. Therefore, given the impact of PCOS on women's lives and the substantial role of adherence in the effectiveness of PCOS treatments, it is essential to investigate factors that facilitate or prevent patients' PCOS treatment adherence. Key barriers and facilitators to PCOS treatment adherence observed across the literature are individual-level (e.g., time and financial pressure, psychological comorbidities, and lack of motivation for maintaining a healthy lifestyle) [20,21], treatment-related (e.g., high cost and long duration of treatment, and no relief of symptoms), system-level (e.g., lack of professional support and empathy, and unavailability of allied health professionals) [19,20], and environmental barriers (e.g., lack of social support and exercise environment) [21].

In the context of Iran, a country with 3% to 19% PCOS prevalence [22,23] and where barriers to treatment adherence may be exacerbated by its developing status and foreign sanctions that impact its medical field [24], documenting barriers and facilitators to PCOS treatment adherence can help identify practical gaps and recommendations in designing culturally appropriate healthcare for PCOS-diagnosed women. However, to our knowledge, only Bazarganipour et al. [19] investigated facilitating and inhibiting factors related to treatment adherence in the Iranian context. The study sample included 20 PCOS-diagnosed Iranian women (21 – 34 years old) and found impeding factors to have financial issues, patient-related (perception and knowledge), disease-related (side effects of medication and long treatment time), and healthcare provider-related factors (lack of informational support and absence of holistic care). In contrast, social factors (family, friends, and peers) were found to be both facilitating and inhibiting.

Thus, to enrich this strand of literature and expand the evidence in the Iranian context, the present study explores facilitators and barriers to PCOS treatment adherence in a sample of ten PCOS-diagnosed women (18 to 45 years old) from Mashhad, Iran.

2. Materials and Methods
This study used semi-structured interviews to explore barriers and facilitators to PCOS treatment adherence; purposive sampling was utilized. This study was approved by the Research Ethics Committee, School of Health and Social Care, Swansea University (Reference Number: 180722; Date: 04/08/2022). Informed consent was obtained from all the participants and two gynecologists from the target clinics. The participants included ten women (18 to 45 years old) diagnosed with PCOS for more than one year and who reside in the city of Mashhad in Iran. The age range is appropriate to reduce the potential confounding effects of menopause [25] and other associated hormonal and metabolic changes [26]. In addition, since symptoms of PCOS are familiar with some other disorders, such as adrenal hyperplasia, the syndromes of severe insulin resistance, androgen- secreting neoplasms, hyperprolactinemia, and thyroid abnormalities [27], the participants with a history of such disorders were excluded. Data were collected using one-to-one semi-structured interviews. The interviews were conducted between 19th August and 2nd September 2022. Thematic analysis was used to analyze the data. This involved identifying, analyzing, and reporting themes and patterns in the data [28,29]. To systematically structure the report, articles relating to barriers and facilitators of PCOS treatment adherence were compared against the validated version of the Theoretical Domains Framework (TDFv2) as developed by Michie et al. [30]. See Appendix A for tabulated TDFv2 mapping of the observations of the present study. The use of this framework in developing interventions consists of a theory-based and systematic approach that aligns with the recommendations of the Medical Research Council on intervention programs [31]. The use of this approach in investigating barriers and facilitators of PCOS treatment adherence is also prevalent across the literature; see Pirotta et al. [20].

3. Results
3.1 Sample Characteristics
Ten PCOS-diagnosed female residents of Mashhad, Iran, participated in online interviews, each lasting 25 to 45 minutes (mean duration 40 mins). The mean age of the sample was 29.7 years (SD = 6.12), with a minimum age of 20 and a maximum of 40. See (Table 1) for a summary of the participants' characteristics.

Two themes were developed: barriers and facilitators. They are outlined in the following section and supported by participant extracts. Several sub-themes were developed for each.

Table 1: Summary of Participant Characteristics

3.2 Barriers to PCOS Treatment Adherence
This theme captured factors that act as an impediment to patients' adherence to PCOS treatment. Factors identified were matched to five TDFv2 sub-themes, including Inadequate knowledge about PCOS symptoms, environmental context and resources, social norms, side effects of PCOS medication, and lack of enjoyment.​

3.2.1 Sub-theme 1: Inadequate Knowledge about PCOS Symptoms
Participants identified inadequate knowledge about early PCOS symptoms as the main barrier to delayed diagnosis.

'I had symptoms but did not know anything about this disease. At that time, I gained much weight and had unexpected hair fall. Most of that I thought was because of the high amount of stress from work, so I just tried to take more rest and did not check up the symptoms soon.'– Participant 1, Page 3

Participant 1 had symptoms and from an early age, but she normalized them by relating them to work matters, therefore underestimating the severity of their symptoms, and did not opt for diagnosis. Like Participant 1, participant 7 also normalized PCOS symptoms to stress, while Participant 4 thought these symptoms were common for her age.

Several participants recalled a lack of support from family, inhibiting their pursuance of treatment.

'I have been suffering from this disease for a year. I did not know anything about this disease. … At first, when I shared my problems with my mom, she did not consider it seriously. She just played it as having bad periods. This also discouraged me from looking more into it, so I also did not follow up much after that.' – Participant 4, Page 3

'Before diagnosis, I shared my concerns with my spouse, but he did not take my symptoms seriously and always brushed them off as normal mainly because he did not know much about this syndrome.' – Participant 9, Page 3

3.2.2 Sub-theme 2: Environmental Context and Resources
This sub-theme related to the role of environmental factors as either a facilitator or barrier to participants' PCOS treatment adherence. Need for more information, inconveniences in access to the health care provider, lack of health professional support, and time resource constraints were reported by participants.

Participants reported that their primary source of information had been their specialist doctor. However, participants expressed concerns about the insufficiency of data from the doctors. One participant highlighted a need for more specificity in the doctor's advice about the role of diet and exercise.

'My specialist doctor gave no exceptional advice regarding diet and exercise. I am still under treatment and still have irregular periods' – Participant 7, Page 3

Concerning inconveniences in access to the healthcare provider, while all the participants had access to a doctor at the time of the interview, they reported long waiting times and short consultation sessions as a barrier to treatment.

'Waiting time in doctor's offices is very long and tiring. Unfortunately, the sessions with the doctor were too short, and the doctor did not detail my condition because of many waiting patients. So, I didn't go to the doctor for two months.' – Participant 9, Page 3 Similarly, a lack of health professional support was reported, including a lengthy time diagnosis and a lack of empathy from the doctors.

'I went to a specialist doctor due to infertility, and at first, they did not diagnose PCOS … the previous doctor's diagnosis was that it was genetic. At first, the doctor wouldn't care to diagnose my condition further, and I didn't feel any support from her at all.' – Participant 9, Page 3

A lack of health professional support was also reported. This consisted of perceived inattention, quick dismissal, and lack of empathy from the doctor when first seeking the symptom diagnosis. Or failure to consider PCOS.

'First, when I had these symptoms, I shared them with a general practitioner. But at the time, I didn't get any serious attention and was told that there was "nothing wrong." So, I also thought the same.' – Participant 1, Page 3

Finally, although some participants identified the roles of exercise and a healthy diet in managing PCOS conditions, they expressed an inability to adhere to these treatments due to time constraints. For example, several participants reported difficulty making time for physical activity due to family responsibilities and employment. 'Taking care of my one-year-old child is full-time work for me, and I cannot make time to do exercise.' – Participant 7, Page 3

3.2.3 Sub-theme 3: Social Norms
Although highlighted by only one participant, the adverse impact of consuming traditionally recommended herbs delayed her diagnosis and worsened her symptoms.

'In the beginning, unfortunately, to deal with my irregular periods, at the suggestion of my mother and grandmother, I used herbal medicines such as "Aslab" and "Gol gav zaban" instead of going to the doctor, but with these herbal medicines, the situation worsened.' – Participant 5, Page 3​​​​​​​

3.2.4 Sub-theme 4: Side Effects of PCOS Medication
Negative experience related to treatment side effects was a significant barrier to treatment adherence. Participants reported avoiding medications because of side effects such as allergies, weight gain, morning sickness, and daily fatigue. Another discussed concerns about treatment and fertility, and another noted that the perceived ineffectiveness of therapy led to a complete halt in taking the medications.

'In the first phase of treatment, I took medicine to at least have a regular period. My thyroid was also affected, and I was not feeling well. I stopped the medicines and preferred to continue controlling this disease with exercise and diet.' – Participant 4, Page 3

'The drugs he prescribed for fertility affected period pains but did not affect fertility. … I was disappointed with the drugs that were prescribed for infertility and stopped them.'– Participant 9, Page 3

3.2.5 Sub-theme 5: Lack of Enjoyment
Participants discussed their discomfort and lack of enjoyment for various treatments as barriers to PCOS treatment adherence.

'Also, I don't find any interest in physical activities, and I don't feel comfortable doing exercise in the crowded gym center.'– Participant 7, Page 3

'But it is difficult to stop myself from snacking, especially when hanging out with friends or watching movies. So, I usually can't stick to a diet plan.' – Participant 5, Page 3​​​​​​​

3.3 Facilitators of PCOS Treatment Adherence
This second theme reflected factors that encouraged patients' adherence to PCOS treatment. Matched to four TDFv2 sub-themes, this theme includes knowledge about PCOS consequences and medicine, social factors, beliefs about the health benefits of treatment adherence, and personal goals.​​​​​​​

3.3.1 Sub-theme 1: Knowledge about PCOS Consequences and Treatment
Most participants (70%) identified the disease's various short- and long-term consequences, including depression, infertility, miscarriage, premature birth, diabetes during pregnancy, and, in advanced cases, uterine cancer. Understanding and awareness of such was a significant concern for most, motivating their action toward treatment adherence.

'After diagnosing this disease, I got more information about polycystic ovary through the Internet…. If this disease is not controlled, it causes miscarriage, premature birth, infertility, diabetes during pregnancy, and in more advanced cases, it causes uterine cancer. I cannot imagine what kind of effect cancer will have on my life, so I always try to follow the treatment as I can.'–Participant 2, Page 2

'As per my doctor, PCOS can lead to some problems during pregnancy and can also have some serious problems like cancer. So I think we have to treat it carefully.' – Participant 5, Page 3 Participants also shared their understanding of the effectiveness of various treatment methods, including medicinal and lifestyle changes. Participants acknowledged the effectiveness of combining treatments to improve symptoms of PCOS.

'In my opinion, the combination of drug therapy, diet therapy, and exercise multiplies the effect of treatment. I have been trying to balance between these methods to realize the most benefit of the treatment.' – Participant 1, Page 3

'In my opinion … the treatment for this disease is long-term …. However, I still think these treatments are temporary, and the disease will return. So, I have to maintain my pace over time.'– Participant 3, Page 3

Exhibiting a good understanding of the duration of the PCOS treatment, one participant identified that PCOS treatments do not lead to a complete recovery, which motivated her persistent treatment. As such, knowledge about PCOS treatment methods facilitated patients' compliance with treatment.​​​​​​​

3.3.2 Sub-theme 2: Social Factors
This sub-theme emphasizes the role of social factors such as social support and social pressures in promoting PCOS treatment adherence among the participants. Most participants received support and encouragement from their families.

For example, participants emphasized that family members encouraged them to pursue and maintain treatment by supporting dietary changes. Eight participants reported family support to access the doctor for an initial consultation, and that family helped them to maintain physical activity, healthy diet, and medical treatments.

'My spouse and family have been very supportive to the extent that they have adapted their diet to encourage me to continue the treatment.' – Participant 4, Page 3

Two participants explored the role of social and cultural pressure to marry, conceive a child, and give birth as a driving factor to treatment adherence.

'Honestly, at that time, I felt like I was not a normal woman because my family and I think people believe women are important to give birth and continue the family. These factors push me to follow the treatment.' – Participant 3, Page 4​​​​​​​

3.3.3 Sub-theme 3: Beliefs about Health Benefits of Treatment Adherence
This sub-theme reflects the importance of the positive role of perceived health benefits and perceived improvements in health outcomes as a facilitator of treatment adherence. These improvements included improved menstrual cycles, pain reduction, and reduced heavy bleeding during menstruation, and a reduction in depressive symptoms and obesity was reported by participants.

'I got the fastest response from drug treatment. After taking the drug, I got my period immediately, and the menstrual period became somewhat more regular. The rest of the symptoms, such as depression and obesity, improved over a longer period with the help of diet and exercise. …, taking some Infertility pills gave me an acceptable response during one or two courses. …. I was always encouraged to continue treating this disease every time I took it ….'– Participant 1, Page 3​​​​​​​

3.3.4 Sub-theme 4: Personal Goals
​​​​​​​Personal goals were presented as intrinsic motivations for participants' treatment adherence.

For one participant, motivated by her social interactions, improving her appearance by losing weight encouraged her to partake in healthy lifestyle changes. For another, the desire to improve symptoms of PCOS (i.e., excess hair) to satisfy her spouse was highlighted as the motive for her commitment to drug therapy.

'… My job requires me to be involved in social contacts. Because of my obesity, I feel embarrassed in front of my customers. So, weight loss to have a fit body is my priority. Despite the challenges of strict diet and physical exercises, a good-looked appearance motivates me and keeps me on track.' – Participant 1, Page 3

'Personally, the symptoms of PCOS relating to excess hair are very concerning for me, and it has decreased my confidence, especially when I am with my husband... So, I want to try to reduce this symptom as much as possible.' – Participant 4, Page 3

As such, achieving a better physical appearance was highlighted as the personal goal that motivated treatment adherence.

4. Discussion
This study explored factors that inhibit and facilitate PCOS treatment adherence of PCOS-diagnosed women in Mashhad, Iran. The semi-structured interview revealed that barriers to PCOS treatment adherence included inadequate knowledge about PCOS symptoms among patients and their families, insufficient information from doctors, long waiting times at appointments and short consultation sessions, lack of empathy from doctors, personal time constraints, social norms, side effects of the drugs, and lack of enjoyment of the treatment. Facilitators of PCOS treatment adherence included knowledge of PCOS consequences and remedies, family and peer support, social pressures, improved health outcomes, and personal improvement goals. These findings align with the existing literature, including relating to the facilitating roles of patients’ positive experience of medication and lifestyle management [20,32] and support from families, partners, or friends to consult a doctor and take up lifestyle changes [19,20], and inhibiting roles of inadequate knowledge about early PCOS symptoms among participants and their parents, leading to delayed diagnosis [33,34], the experience of side effects of the medications resulting in drug avoidance [18,19], personal time constraints to take up lifestyle changes such as exercise [20,35], lack of enjoyment in taking drugs and disinterest in physical exercise [20,35], long waiting time for short consultation sessions [19], lack of empathy and dismissal from their doctor [19,33], lack of informational support [19,20], and inefficacy in engaging in healthy lifestyle changes such as avoiding unhealthy foods [20].

These findings can be mapped to the health belief model (HBM) [36], widely used to explain and predict the changes in individuals’ health behaviors [36]. Perceived susceptibility relates to the participants’ perceived risk of getting diagnosed with PCOS, which is expected to lead to high treatment compliance. Perceived benefits are captured by the participants’ reports of taking medications associated with maintaining regular periods and exercise and diet-based being linked with improvements in depressive symptoms and obesity. About half of the participants also stated that these improvements in their health encouraged them to stay committed to the treatments. Perceived barriers to PCOS treatment adherence included inadequate knowledge about PCOS symptoms among patients and their families, participants’ concern about side effects of PCOS medicines, time constraints, lack of enjoyment, inconveniences in access to the healthcare provider, and lack of health professional support, and social norms. Concerning cues to action, while social support and social pressure encouraged treatment adherence, insufficient information resulted in the opposite. Finally, a lack of self- efficacy resulted from a participant’s inability to engage and commit to a healthy diet. Appendix B discusses these findings in more detail. The study incorporates some limitations. First, a small sample was selected, which impedes generalisability. However, this is expected of qualitative research to provide a deeper understanding of topics, in this case, knowledge, experience, and barriers and facilitators of PCOS among Iranian women. Second, participants were educated, with some even having medical backgrounds; thus, the results do not capture a socioeconomically diverse group of women.

5. Conclusion
By conducting semi-structured interviews with ten PCOS-diagnosed women (mean age of 29.7 years), this study examined the barriers and facilitators of PCOS treatment adherence amongst PCOS-diagnosed women in Mashhad, Iran. Barriers to PCOS treatment adherence included inadequate knowledge about PCOS symptoms among patients and their families, insufficient information from doctors, long waiting times at appointments and short consultation sessions, lack of empathy from doctors, personal time constraints, social norms, side effects of the drugs, and lack of enjoyment of the treatment. On the other hand, factors such as knowledge of PCOS consequences and treatments, family and peer support, social pressures, improved health outcomes, and personal improvement goals facilitated PCOS treatment adherence. These findings are among the first in the context of Iran, thus laying the foundation for future empirical examinations of factors in the context of Iran. More notably, the findings relating to social influences (i.e., social pressure and social norms) are novel in the current study.

The study findings lead to some key recommendations. First, timely diagnosis can be encouraged through increased awareness about the syndrome [37,38], reduced stigma surrounding the disease [39], and enhanced social support [38]. These can be achieved through education and public health interventions [34,37]. Second, healthcare professionals should be encouraged and trained to provide patients with more informational support relating to PCOS [37] and trained not to dismiss and ignore patients and their symptoms [37]. Finally, a healthy lifestyle can be encouraged by reinforcing intrinsic motivation among PCOS-diagnosed women by encouraging them to partake in physical activities they enjoy [40].

Conflict of Interest: None

Author’s Contribution
Nima Ameli
As the primary researcher, Dr. Nima Ameli designed this research project, including various survey forms and data collection and analysis procedures; conducted interviews; cleaned and analyzed the data; and interpreted and reported the results based on extensive research.

Menna Brown
Dr. Meena Brown supervised the whole research process; revised the survey forms and data collection and analysis procedures to ensure compliance with the committee standards; reviewed, revised, and edited the research drafts, finalizing the research outcomes and attaining research objectives.

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