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Needs and preferences of women users of oral contraceptives in selected countries in Central and Eastern Europe

Background The availability of various oral contraceptive (OC) pill formulations with different hormone compositions suggests that there is potential to align a particular product with an individual user’s needs and preferences. To explore this concept further, a survey was conducted of current users of OCs to define and confirm areas of specific needs, and to gain insight into their views and preferences for OC formulations. Methods During November and December 2015, women users (n=615) of OCs in five Central and Eastern European countries were surveyed in face-to-face interviews conducted by experienced interviewers. The survey questionnaire comprised 34 questions about the use of and specific needs for OCs. Results Four basic needs of women taking OCs were identified: reliable contraception, reversibility of contraception, no effect on body weight and safety. Overall, 85% of surveyed women indicated that prevention of pregnancy was the main reason for taking OCs. Weight gain was the side effect of greatest concern with OC use (46% spontaneous answer; 65% aided answer). Independent behavioural segmentation analysis identified four groups – Solved Cycle Problems (46% of participants), Low Hormone Content (22%), Lifestyle (17%) and Beauty (14%) – which characterised the women according to needs and preferences beyond the basic needs of OCs. Each group had unique features and distinct preferences for different formulations of OCs. Conclusions Aligning product advantages with specific individual needs may enhance users’ overall experience with OCs as a contraceptive option.


Introduction
Oral contraceptives (OCs) are a popular and non-invasive method of preventing pregnancy. OCs are highly effective when taken correctly and are rapidly reversible with normal ovulation typically restored within 2-3 months after discontinuation. OCs have a well-established safety profile in healthy, non-smoking, normotensive women [1,2].
Since the first regulatory approval in 1960 in the United States of an OC pill containing mestranol and norethisterone, OCs have steadily evolved and numerous formulations are currently on the market [3]. Main developments have been a dramatic lowering of the ethinylestradiol content and introduction of 17β estradiol, both in combination with a range of new-generation progestins developed to minimise or prevent androgenic, estrogenic or glucocorticoid related side effects [3][4][5]. Modernday OCs are used in some cases to treat acne, hirsutism and a range of menstrual-related conditions [2,4]. The wide array of OC formulations -in terms of hormone composition, hormone dosage and administration schedule -suggests that there is a product to suit the needs and preferences of almost every woman.
Worldwide data for 2015 estimated that two-thirds of married or in-union women of reproductive age (15-49 years) used some form of contraception, with OCs representing 9% of contraceptive prevalence globally and approximately ISSN: 1740-4398 ORIGINAL RESEARCH -Needs and preferences of OC users drugsincontext.com 20% of contraceptive prevalence in regions such as Europe and Oceania [6]. However, poor compliance and high discontinuation rates are well-known issues with OC use, frequently fuelled by media alarms about associated health risks and by side effects or women's fear of side effects [4]. Continued high rates of unintended pregnancy worldwide [7][8][9] emphasise the need to further promote uptake of highly effective contraceptive methods such as OCs and to eliminate any real or perceived barriers to their use [3]. Aligning a product's specific advantages with a woman's individual needs and preferences may enhance user satisfaction and encourage long-term use.
Although data are collected regularly about the prevalence of OC use, comparatively little is known in some countries about the needs and preferences of women taking OCs. Accordingly, this study was undertaken of women users of OCs in selected countries in Central and Eastern Europe in order to define and confirm areas of specific needs and to gain insight into their views and preferences for different OC formulations.

Methods
In this study, women users of OCs living in large cities in the Czech Republic, Poland, Romania, Russia and Slovakia were surveyed about their use of OCs and their needs and preferences for OCs. Face-to-face interviews were conducted by professional interviewers experienced in market research studies for the healthcare industry. The interviews took place between 25 November and 16 December 2015. In the Czech Republic, Poland, Romania and Slovakia, potential survey participants were put forward by doctors to ensure that the women were OC users. In Russia, potential survey participants were put forward by doctors and pharmacists (50:50), as OCs can be purchased without a prescription in Russia.
The questionnaire, which is provided in full in the Appendix, was divided into four sections: Section A: Experience with Contraceptive Pills (10 questions); Section B: Factors behind Product Choice (10 questions); Section C: Declaration of Switching from Drug Currently Taken (10 questions); Section D: Declaration of Interest in Selected Products (4 questions); and Respondent Details. Respondents' answers were collated and stratified by country of origin.
The questionnaire was compiled by IMS Health Consulting Sp. z o.o. (now Quintiles IMS) and accepted by Gedeon Richter. It was designed using established techniques to enhance the reliability and validity of the information collected. In some instances, similar questions, although phrased somewhat differently, were asked (e.g. questions A1, B1 and B4 for features of OCs of most importance to women; questions B2 and B3 for side effects of OCs of most concern to women).
The survey included openended questions where respondents were asked to provide a response in their own words (spontaneous answers) and closedended questions where respondents were asked to choose from a list of response choices (aided answers). Most questions had an opt-out option of 'hard to say' or 'none' as appropriate.
In Section D of the questionnaire, Declaration of Interest in Selected Products, five different OC products were presented and described to participants in order for them to select (hypothetically) the one that best reflected their individual needs and expectations towards a contraceptive pill. All products met the universal basic needs of women in terms of OC selection (reliable contraception, reversibility of contraceptive effect, no effect on body weight and good safety) but each provided different additional non-contraceptive features (Box 1).
The representative products were selected on the basis of their differing formulations (type of progestogen, hormone dosage and administration schedule) which confer non-contraceptive Box 1. Oral contraceptive products presented to survey participants in Section D: Declaration of Interest in Selected Products. After all collected data were analysed, an independent behavioural segmentation analysis was performed to create classification groups based on responses to question B4 (see Appendix) in which the women had been asked to rank, in order (1 = most important; 20 = least important), the key attributes of contraceptive pills of greatest importance to them in selecting a particular product. The analysis excluded the four basic needs of OCs as these are standard and focussed on other features of OCs able to address more specific needs and preferences of individual users.
The mean duration of current uninterrupted use of OCs was 22.1 months across the entire survey population. Per country, mean duration of current uninterrupted use was 56.2 months in Slovakia, 36.9 months in the Czech Republic, 23.6 months in Poland, 21.5 months in Romania and 11.4 months in Russia.
The majority of surveyed women (71%) reported that their current OC had been chosen by their gynaecologist; 24% indicated that the brand choice had been made in conjunction with their gynaecologist. The primary factors influencing brand choice were doctor's recommendation, price, better adjustment to the patient and lower risk of side effects.
Oral contraceptives features of greatest importance and concern Overall, women's responses to the survey reinforced that there are four basic needs with regard to OC selection: effective prevention of pregnancy, reversibility of the contraceptive effect, no effect on body weight and good safety.
Effective contraception: The most frequent response by surveyed women to question A1, 'What is the reason for you taking contraceptive pills?', was 'to prevent pregnancy' (85% of respondents; Figure 2). This basic need was further supported by women's responses to questions about the features of OCs of greatest importance to them (questions B1 and B4). Surveyed women indicated spontaneously (36%; Figure 3) and by aided Lack of effect on body weight: Although only 7% of surveyed women reported spontaneously that causing no weight gain or swelling was a feature of OCs of greatest importance to them ( Figure 3), during prompted questioning 34% of women chose the response 'has no effect on body weight' as an important feature of OCs ( Figure 4).
Further supporting the positioning of 'no weight gain' as a basic need of OCs, by spontaneous reporting (46% of surveyed answers (52%; Figure 4) that effective prevention of pregnancy was the attribute of OCs of highest importance to them.
Other frequent reasons women provided for current use of OCs were to regulate the menstrual cycle (32%), restore hormonal imbalance (26%) and alleviate the symptoms of PMS (21%) (Figure 2).
Reversibility of the contraceptive effect: Although surveyed women did not spontaneously mention reversibility of the contraceptive effect as a feature of OCs of greatest importance to them (Figure 3), during prompted questioning 46% of women    safety such as 'no effect on body weight' (34%) and 'low hormone dose' (31%) indicated that safety of OCs was an important consideration ( Figure 4). During prompted questioning, side effects apart from weight gain selected by a high proportion of respondents as being of greatest concern during OC use were venous thromboembolism (52%), neoplasm (52%), loss of libido (49%), haemorrhage (46%) and others ( Figure 6).

Willingness to change OC
Overall, 82% of surveyed women indicated that they were very unlikely or rather unlikely to switch to another brand of OC in the near future. Only 57 respondents (9%) indicated a probable or definite preference to switch brands, mainly because of 'a desire to try something new' (33% of the 57 respondents). Survey participants reported a high or reasonably high level of satisfaction with the attributes of the contraceptive pills they were currently using (Figure 7).
Across participating countries, the average cost for one pack of OCs in current use by the women was USD$12, lower in Poland (USD$7) and Romania (USD$6) and higher in the Czech Republic (USD$20) and Slovakia (USD$26). Only 24% of patients indicated a willingness (definitely 6%; probably 18%) to change to a cheaper product if such an option was available to them. Figure 5. Side effects of greatest concern with oral contraceptives: spontaneous responses (indicated by ≥2% of women women; Figure 5) and prompted questioning (65% of surveyed women; Figure 6), study participants indicated that weight gain was the feature of OCs of greatest concern to them. Per country, the proportion of women who indicated weight gain as the side effect of greatest concern with OCs ranged from 39% in Romania to 80% in Russia.

Good safety profile:
Although only 5% of survey participants spontaneously mentioned safety as a feature of OCs of greatest importance to them (Figure 3), during prompted questioning the frequent selection of features strongly associated with ISSN: 1740-4398 ORIGINAL RESEARCH -Needs and preferences of OC users drugsincontext.com  The Beauty segment comprised 14% of survey participants and, of the four classification groups, had the largest proportion of women aged ≤25 years (32%). Women in the Beauty segment were the most physically active, practicing sport on average four times a month, compared with three times per month in the other groups. Main drivers for current use of OCs were to prevent pregnancy (83%), regulate the menstrual cycle (35%), improve skin appearance (27%) and reduce symptoms of PMS (24%). The features of OCs of greatest importance to this group were to have a favourable effect on complexion and a favourable effect on hair/nails. The most common OC brands used by women in this group were 0.15 mg desogestrel + 0.03 mg ethinylestradiol (14%) and 2 mg cyproterone acetate + 0.035 mg ethinylestradiol (14%). Among the hypothetical product choices presented in Section D, the formulations that met the expectations of the largest proportion of women were 3 mg drospirenone + 0.02 mg ethinylestradiol (31%) and 2 mg chlormadinone + 0.03 mg ethinylestradiol (26%).

Discussion
More than 600 women users of OCs from the Czech Republic, Poland, Romania, Russia and Slovakia were surveyed about their experience with and views of OCs. Estimated usage rates of OCs in 2015 among married or in-union women aged 15-49 in these countries varied considerably, from 48.4% in the Czech Republic to 17.2% in Romania and 13.2% in Russia [6]; specific data for Poland and Slovakia were not available. All women resided in large cities and the respective cohorts were reasonably homogeneous with regard to age.
Consistent with the established universal basic needs of OC users, survey participants indicated that the features of OCs of greatest importance to them were reliable contraception, reversible contraceptive effect and no effect on body weight. Although safety was not expressed directly as an important feature of OCs, it could be inferred from women's frequent selection of features strongly associated with safety such as 'no effect on body weight' and 'low hormone dose'. Interestingly, weight gain, venous thromboembolism and neoplasm were each selected by more than half the sample as features of OCs of greatest concern to them. Despite the minimal risks of such complications with modern-day OCs, it appears that misperceptions about OCs continue to prevail. Current contraindications of OCs include hypertension, migraine, breast cancer and risk of venous thromboembolism [2,35]. There is no evidence to suggest that current or former use of OCs or that use of specific OC formulations is linked to an increased risk of breast cancer [36,37]. Indeed, use of modern-day OCs offers several health benefits including a substantial decrease in the risk of ovarian, endometrial and colorectal cancers [4]. Greater efforts to dispel the myths surrounding OCs and communicate their advantages appear warranted.
Independent behavioural segmentation analysis classified study participants into four groups based on their selection of OC features of greatest importance to them. In all segments, the main reason for current use of OCs was to prevent pregnancy (83-91% of respondents across segments). Aside from the four basic needs of OCs, 46% of surveyed women indicated a preference for OCs to stabilize their menstrual cycle and solve cycle-related problems, 22% preferred OCs with a low hormone content to ensure that their bodies remain as natural as possible, 17% expressed a preference for OCs that would maintain their body weight without them having to make changes to their diet or lifestyle (e.g. amount of exercise) and 14% favoured OCs with a positive effect on their hair/beauty. With the wide array of OC formulations available, it seems highly probable that an OC product can be matched with a user to address her specific expectations and preferences.
The relative importance that women place on maintaining their libido during OC use was apparent from the relatively high proportion of surveyed women (49%) who selected 'loss of libido' among the side effects of greatest concern during OC use. Different OC formulations appear to have variable effects on libido. A systematic review of 36 studies (n=13,673 women) reported that sexual desire decreased only with OCs containing 0.015 mg ethinylestradiol; whereas, no significant changes were observed in the case of OCs containing 0.02-0.03 ethinylestradiol [38].
The study had limitations which should be mentioned. Modest sample sizes in some countries (Czech Republic, Romania and Slovakia) may have impacted on the representativeness of the results when stratified by country of origin. Conversely, the overall results may have been influenced by the proportionately larger sample of women from Russia (n=300) compared with other countries. In addition, it is possible that inter-country differences in access to OCs (e.g. brand choice, reimbursement policies) had an influence on women's responses. In terms of women's Declaration of Interest in Selected Products (Section D), the wording used to describe the non-contraceptive benefits of each product may have influenced selection. While acknowledging these limitations, the close alignment between women's responses to the questionnaire and the universal basic needs of OC users increases our level of confidence that the survey cohort is reasonably representative of the wider population of OC users in Central and Eastern Europe.
To the best of our knowledge, this is the first study of its type with the aim of defining and confirming areas of specific needs of OC users, and gaining insight into their views and preferences for various OC formulations, conducted in Central and Eastern Europe.
The decision to use OCs as the contraceptive of choice is multifactorial (e.g. social, cultural and economic) and also reflects a woman's personal attitudes towards OCs. The high proportion of women in Russia and Slovakia who perceived weight gain, venous thromboembolism and neoplasms to be major concerns of OC use suggests the need for greater awareness of the improved safety of modern-day OCs. The behavioural segmentation analysis highlighted additional features of OCs of importance to women beyond the core features of reliable contraception and reversibility of effect. Knowledge of the therapeutic advantages associated with various OC formulations might assist physicians in selecting a product best suited to the specific needs and expectations of individual patients.
This market research could be extended to other countries in Europe in order to inform awareness and educational programmes tailored to a country's specific needs.

Conclusions
All modern OCs are designed to meet the universal basic needs of users: reliable contraception, reversibility of contraceptive effect, no effect on body weight and good safety. On the basis of their hormone composition, certain OC formulations offer additional benefits that can be individualized per patient. Greater promotion of these benefits, and careful alignment of a product's advantages with specific individual needs, may enhance users' overall experience with OCs as a contraceptive option and encourage long-term compliance, although this remains to be demonstrated conclusively, and in the absence of confounding factors such as cost. Our research highlights that considerable efforts are required to dispel lingering misperceptions about OCs, especially with regard to side effects, in order to increase the uptake of OCs as the contraceptive method of choice. ISSN: 1740-4398 ORIGINAL RESEARCH -Needs and preferences of OC users drugsincontext.com ISSN: 1740-4398 ORIGINAL RESEARCH -Needs and preferences of OC users drugsincontext.com