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Advance Information Improves User Satisfaction With the Levonorgestrel Intrauterine System

From the Department of Obstetrics and Gynaecology, University Hospital, the Department of Biostatistics and Public Health, University of Turku, and Leiras Clinical Research, Turku; and Tampere School of Public Health, University of Tampere, Finland.

Address reprint requests to: Tiina Backman, MD, Turku University Hospital, Department of Obstetrics and Gynaecology, PO Box 52, FIN N-20510, Turku, Finland; E-mail: tiina. backman{at}nly.fimnet.fi.

	ABSTRACT

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
OBJECTIVE: To evaluate parameters associated with and the impact of advance information given in a regular outpatient setting on user satisfaction with the levonorgestrel-releasing intrauterine system.

METHODS: A questionnaire was sent to 23,885 women in Finland who had had a levonorgestrel intrauterine system inserted between 1990 and 1993. The number of returned questionnaires was 17,914 (response rate 75%). Cumulative logistic regression analysis was based on the five-grade scale of satisfaction as a dependent variable.

RESULTS: Most users of the levonorgestrel-releasing intra-uterine system (74%) were very or fairly satisfied with it, although over 70% of them had chosen it because of dissatisfaction with their previous method of contraception. User satisfaction increased with age and was associated with the amount of information about different symptoms (menstrual, greasiness of hair/skin, pregnancy, pelvic inflammatory disease, and missed periods) regardless of whether the symptom in question was actually experienced. The women who received information about the possibility of absence of menstruation were more satisfied than the less informed women (odds ratio 5.0, 95% confidence interval 4.1, 5.9).

CONCLUSION: Information received at the insertion visit is strongly associated with increased user satisfaction among the users of the levonorgestrel intrauterine system. The association between high user satisfaction and advance information was strongest regarding the possibility of missing periods.

Contraception and related counseling is an essential component of women’s health. If women are not satisfied with their contraceptive method or if they do not consider it safe, they will stop using it.¹ Adverse effects and health risks attributed to reliable contraceptive methods have been shown to make women decide against using them.^2–5 The ability to sustain continuous use of a contraceptive method is an ultimate measure of user satisfaction.⁶

Most clinical trials on the levonorgestrel-releasing intrauterine system have focused on the safety and effectiveness in preventing pregnancy, and user satisfaction has mostly been measured by continuation rates and/or reasons for discontinuation.^7–10 Even though the importance of counseling the users of the levonorgestrel-releasing intrauterine system has been emphasized by most of its investigators,^8,10–12 the quality and impact of information on user satisfaction has not been studied in detail.¹³ The purpose of this study was to evaluate the demographic parameters associated with user satisfaction with the levonorgestrel-releasing intrauterine system and to analyze how information given by the physician in a regular outpatient setting and perceived by its users is associated with user satisfaction.

	MATERIALS AND METHODS

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The levonorgestrel-releasing intrauterine system (Mirena, Levonova, Turku, Finland) was launched in Finland in 1990. Simultaneously, all women who had had their levonorgestrel-releasing intrauterine system inserted between April 1990 and December 1993 were asked to participate in an epidemiologic study. A consent form was filled in. The women were asked to fill in their identity number (unique for every Finnish citizen) and to consent for further collection of data by signing their initials. They were asked to return these forms to the manufacturer. The number of women who enrolled in the study was 26,630.

In April 1996, a questionnaire containing 75 questions was mailed to 23,885 women whose contact information was supplied from the Population Registry by using the social security numbers. After three reminders, 75% of questionnaires were returned. All unsigned questionnaires and those in which the date of birth, requested in the final questionnaire, did not match the social security codes, were excluded from the final analysis (n = 554). The final number of questionnaires for analysis was 17,360. All the women consented to further use of the information by signing the questionnaire. A more detailed description of the methods has been previously published.¹⁴ Approval for the study was obtained from the Ethics Committee of the Medical Faculty of Turku University.

The questionnaire included questions on reproductive and contraceptive history, on smoking habits (smoker or nonsmoker), and on alcohol consumption (beer, wine, and hard liquor, each asked separately). The mean age of the women was 40 years (standard deviation 6.4). Most of them had given birth (99.3%), predominantly to two or three children (78.1%). Eighty-three percent of the women were married or cohabiting. The number of women who had had spontaneous or medical abortions was 3523 (23%), and 670 (4.8%) had experienced ectopic pregnancies.

The women were asked whether they were satisfied with the levonorgestrel-releasing intrauterine system using a five-grade scale: "very satisfied," "fairly satisfied," "moderately satisfied," "fairly dissatisfied," and "very dissatisfied." Women were asked how easy it was to get information about the levonorgestrel-releasing intrauterine system before insertion. A question was asked about the amount of advance information concerning the risk of pregnancy, bleeding problems, occasional or total loss of menstruation, mood changes, pelvic inflammatory disease, and increased greasiness of hair and skin using a five-grade scale: "a lot of information," "quite a lot," "a moderate amount of information," "relatively little," or "very little information." They were asked about symptoms representing emotional distress (tiredness and overall lack of interest, nervousness, and tearfulness) when using the levonorgestrel-releasing intrauterine system. They were asked why they chose the levonorgestrel-releasing intrauterine system. The choices were: recommended by a physician, a friend’s recommendation, dissatisfaction with the previous method of contraception, and a desire to try a new method of contraception.

Background information on the women was cross-tabulated by variables describing user satisfaction. Cumulative logistic regression analysis was based on the five-grade scale of satisfaction as a dependent variable. The reference for comparisons with each symptom was the group of very poorly informed women. A model was constructed by a stepwise method. A variable was entered into the model if the significance level was less than 0.05. Independent variables in the cumulative logistic regression models were symptoms relevant to each specific information subtype. All analyses were done with and without the symptoms representing emotional distress. Age was divided into three groups as equal in size as possible: less than 33 years, 33–39, and 40 or older. The direct method of age-adjustment was used. In the analyses, body mass index, alcohol consumption, and smoking were classified on the basis of earlier experiences of relevant cutoff points. The amount of beer, wine, and spirits consumed (in a separate question) was converted to grams per month and divided into nonusers, below 500, and 500 g of alcohol or more per month. Statistical analysis was carried out using SAS software, 8.0 (SAS Institute, Cary, NC). All statistical tests were two-sided.

	RESULTS

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Table 1 shows age and age-adjusted demographic variables: education, contraception just before the insertion of the levonorgestrel-releasing intrauterine system, parity, and marital status by user satisfaction.

User satisfaction by different types of advance information is shown in Table 2. The cumulative odds ratios were adjusted by age, symptoms, and emotional distress. Adjusting the odds ratios with the symptom in question did not have association with the user satisfaction, indicating that advance information itself associates with higher user satisfaction regardless of experiencing the symptom or not. Most women (68.2%) had received a lot or quite a lot of information about bleeding problems (excessive bleeding or spotting) in contrast with 10% of women who received relatively little and very little information. The possibility of absence of menstrual bleeding was well explained (76.5%). Eight percent of the women considered that they had not gained information on this subject. Sixty-four percent (n = 10,933) of the women reported that they were very or fairly well informed about the risk of pregnancy. Six and ten percent reported that they received no or only little information of the risk of pregnancy, respectively. The proportion of women who were very or fairly well informed about the risk of mood changes, greasiness of the hair or skin, or pelvic inflammatory disease was 36.2%, 21.7%, and 31.3%, respectively.

The odds ratio for being satisfied with the levonorgestrel-releasing intrauterine system with a lot of advance information was 4.96 (95% confidence interval [CI] 4.15, 5.93). For women who said they were very well informed about bleeding problems, the odds ratio for being very satisfied with the levonorgestrel-releasing intrauterine system was 3.28 (95% CI 2.61, 4.10). The odds ratio for being satisfied with the levonorgestrel-releasing intrauterine system was 2.52 (95% CI 2.24, 2.82) in the group of women who said they were well informed about pelvic inflammatory disease. For greasiness of hair and skin, mood changes, or the risk of pregnancy, the odds ratios for high user satisfaction with good advance information were 2.35 (95% CI 2.09, 2.65), 2.32 (95% CI 2.06, 2.61), and 2.27 (95% CI 1.99, 2.59), respectively (Table 2). Adjusting the symptoms to indicate emotional stress did not change the results (Table 2). Education, marital status, or parity were not associated with user satisfaction, neither was smoking nor alcohol consumption.

	DISCUSSION

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We conclude that user satisfaction is strongly associated with information given at the time the levonorgestrel-releasing intrauterine system is inserted. User satisfaction increased with advance information with all six symptoms (bleeding problems, possibility of pregnancy, mood changes, greasiness of hair and/or skin, pelvic inflammatory disease, and total or occasional absence of menstruation) regardless of whether the symptom in question was experienced. The adjustment of symptoms indicating emotional stress (tiredness, overall lack of interest, nervousness, and tearfulness) did not change the results. The symptoms, except pregnancy, are the most common reasons for discontinuing use of the levonorgestrel-releasing intrauterine system.^7–9,11

We are not aware of similar studies on user satisfaction with IUDs. Focused counseling has been presented as a solution to the problem of very early discontinuation of the copper IUD.^5,12 In earlier studies, previous users of copper IUDs were more satisfied with the levonorgestrel-releasing intrauterine system.^6,10 The proportions of women being very or fairly satisfied with the levonorgestrel-releasing intrauterine system were 75.6% for prior users of copper IUDs, 77.3% for prior users of condoms, and 73.3% for prior users of oral contraceptives. This indicates that the method of contraception just before the insertion of the levonorgestrel-releasing intrauterine system does not have a strong impact on user satisfaction. The symptoms representing emotional stress were included in the analysis because they might indicate an overall dissatisfaction with life and not dissatisfaction with the levonorgestrel-releasing intrauterine system itself. The importance of counseling about compliance with triphasic oral contraceptives,^3,7,15–17 user satisfaction with progestin-only injectable contraception,¹⁸ or levonorgestrel-releasing implants^19,20 was also emphasized.

In our study, the strongest association between appropriate advance information about the levonorgestrel-releasing intrauterine system and user satisfaction was found in the case of the possibility of absence of bleeding. Previous studies have shown that a gross removal rate because of absence of menstrual bleeding varied from 6 to 19.7 per 100 women after 5 years,^{7–9,21,22,23} thus suggesting that counseling is very important.^14,22 Results from the Netherlands indicate that 50% of women of reproductive age want and accept no menstrual bleeding.^12,24 Thus, a contraceptive resulting in much less bleeding could satisfy a large proportion of users when properly counseled. The results of our study suggest that discontinuation due to absence of bleeding decreases with information about the benign nature of the symptom. User satisfaction increased significantly with the amount of information with all six symptoms, irrespective of whether the symptom in question was experienced.

In our study, user satisfaction increased with age, which has also often been the case in studies on other contraceptive methods^21,25–28 and in patient satisfaction surveys in general.²⁹ In some studies on other contraceptives, low parity and higher education were associated with higher removal rates, but in others there was no association.^4,28 In contrast, education, marital status, or parity were not associated with user satisfaction in this study.

The women said they were well informed about the possibility of their menstrual pattern changing. On the other hand, they were considerably less well informed about symptoms, which might seem less significant to doctors, for example, greasiness of hair or skin and mood changes.

Users of long-acting methods of contraception have been reported to be satisfied with their method.^14,26,30 The levonorgestrel-releasing intrauterine system can be used by women who have had problems with other contraceptive methods.¹¹ It is worth noticing that in our study over 70% of the women stated that they were dissatisfied with their previous method of contraception. Still, the satisfaction rate with the levonorgestrel-releasing intrauterine system was 74%.

Most users of the levonorgestrel-releasing intrauterine system were very or fairly satisfied with it. User satisfaction increased with age. Dissatisfaction with the previous method of contraception was the reason for choosing the levonorgestrel-releasing intrauterine system for 74% of the women. However, 74% of the users were very or fairly satisfied with their levonorgestrel-releasing intra-uterine system. User satisfaction increased with better information received at the insertion visit. The association was strongest in the case of getting information about missing periods.

	Footnotes

 
This study has been sponsored by an unrestricted grant by Leiras Oy, Finland. Three of the authors also received some financial support from the company.

PII S0029-7844(01)01764-1

Received July 23, 2001. Received in revised form November 7, 2001. Accepted November 19, 2001.

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