Does an educational leaflet improve self-reported adherence to therapy in osteoporosis? The OPTIMA study

Abstract

Introduction

Adherence to treatment in osteoporosis remains poor. The aim of this study was to evaluate the effects of an educational leaflet on adherence to medication and to assess the association between adherence and health-related quality of life (HRQOL).

Methods

A naturalistic, observational, multi-center, prospective study of 12 months’ follow-up was performed. Consecutive post-menopausal women aged 50 years to 86 years starting treatment with raloxifene according to daily practice were enrolled from 126 primary care offices in Spain. The women were assigned to two study groups. Group A received an educational leaflet with general information about osteoporosis; group B followed current practice. To assess adherence to medication and HRQOL, the Morisky test and the EuroQoL questionnaire were administered. A total of 745 post-menopausal women (group A, n=366; group B n=379), with a mean age of 62 years, were included.

Results

Most patients in both study groups showed high adherence to raloxifene at the 3-month visit: 56.3% vs 62.7% for groups A and B, respectively; this proportion at the 12-month visit was 47.4% (P=0.15) and 52.5% (P=0.02), respectively. At baseline, “pain/discomfort” was the dimension showing the highest percentage of women reporting problems: 86.4% vs 83.2% in groups A and B, respectively (P=0.22). HRQOL improved in both groups throughout the study, with an overall mean increment in the EuroQoL visual analog scale (EQ VAS) of 9.2 at 12 months (P<0.01). Correlations between adherence and HRQOL were weak. After receiving an educational leaflet, young post-menopausal women suffering osteoporosis did not show improvement in adherence to therapy. HRQOL improved at 12-month follow-up under treatment.

Conclusion

No consistent correlation between adherence and HRQOL was found.

Appendix 1: Leaflet text on general information regarding menopause

What is postmenopause?
As the name suggests, postmenopause is the time of life after the menopause (the end of menstruation). Taking care of your health is particularly important at this time because the changes brought about by postmenopause can lead to health risks.
What happens during postmenopause?
Postmenopausal women produce less female hormones (oestrogen), which means they are at a considerably higher risk of suffering osteoporosis or bone fractures and may contract cardiovascular diseases. It is therefore important to have regular medical check-ups in order to help avoid these risks and so that you can continue living life to the full.
Postmenopause is a danger to your bones
During postmenopause, bone decalcification increases which leads to the onset of osteoporosis. This means that the amount of bone we have per unit volume decreases and our bones become more fragile and easier to break. Without the right care, postmenopausal women may lose up to 5% of their bone mass every year during this stage in their lives. Although osteoporosis usually begins during menopause, bones are actually fractured many years later. The first bones to break are the spine and wrists, followed several years later by the hips. Because this is a silent illness, the first symptom you note could be the first fracture, when it may already be too late. This means that prevention is vital. If you are already suffering osteoporosis you may need to take medication in order to slow down the bone loss. Your GP will be able to tell you what the best course of medication is for you.
Are you at risk of osteoporosis or fractures?
Answer the following questions to find out.
1. Did you reach menopause before you were 40?	□YES	□NO
2. Are you thin and small-boned?	□YES	□NO
3. Do you have a family history of fractures?	□YES	□NO
4. Is your lifestyle sedentary or lacking in exercise?	□YES	□NO
5. Do you smoke and/or drink?	□YES	□NO
6. Do you eat few foods rich in calcium (milk/cheese/yogurt)?	□YES	□NO
The more ‘yes’ answers you have, the greater the risk of osteoporosis. See your GP.
Look after your heart
At this time of your life you are more likely to experience cardiovascular problems. This is because before the menopause your hormones protected you from harmful cholesterol. Now, because the oestrogen levels in your body are lower, hardening of the arteries, chest pains or a heart attack become more of a risk.
Are you in danger of suffering heart disease?
Answer the following questions to find out.
1. Do you have a family history of heart disease?	□YES	□NO
2. Do you have high cholesterol?	□YES	□NO
3. Do you smoke and/or drink?	□YES	□NO
4. Do you have a hectic lifestyle?	□YES	□NO
5. Are you overweight?	□YES	□NO
6. Are you diabetic?	□YES	□NO
If your answer to any of these questions is ‘yes’, you are at more risk of heart disease. Keeping an eye on how much salt you eat, getting physical exercise and following your GP’s advice will all help to prevent heart disease at this time in your life.
Protect your breasts and uterus
After the menopause there is also a higher risk of breast cancer and cervical tumors. This is why regular medical check-ups are essential - they are the only way to protect yourself from possible risks. This is particularly true in the case of breast cancer which is the most common kind of cancer among women and causes no initial symptoms or pain.
Do you have regular medical check-ups?
□ NO If you don’t see your GP regularly, we advise you to do so. Your GP can give you advice on your diet so that you can stay healthy.
□ YES Keep having check-ups in order to protect yourself from possible complications related to postmenopause.
C for Calcium
It is very important to have a healthy, balanced diet in order to help check the effects of the menopause, particularly osteoporosis. The first step to take is to increase your calcium intake.
A diet that is rich in calcium is essential to help you prevent osteoporosis.
It is also a good idea to consult your GP about possible additional preventative treatment, since calcium tablets are very often needed to supplement the diet. Remember also that skimmed dairy produce contains the same amount of calcium as full-fat products.
Is your diet right for your bones at this new stage in your life?
Fill in the questionnaire below to find out if you are eating the most suitable kind of food.
1. Do you drink at least 2 or 3 glasses of milk a day?	□YES	□NO
2. Do you eat yogurts, custards and so on at least 2 or 3 times a week?	□YES	□NO
3. Do you eat cheese at least 2 or 3 times a week?	□YES	□NO
4. Do you regularly eat other foods (blue fish, nuts, etc.)?	□YES	□NO
If you have answered ‘NO’ to most of these questions you should be eating a more balanced diet in order to minimize the risk of osteoporosis. See your GP.
If you have answered ‘YES’ to most of these questions your diet is suitable to prevent health risks such as osteoporosis.
Your spine is pivotal
A bit of physical exercise or the right sport will help you stay in shape and prevent and slow down osteoporosis and bone fractures, as well as making your heart strong.
It is very important that the exercise you do does not bend or twist your spine too much, or expose you to possible falls. For instance, a half-hour brisk walk every day may be enough.
There are several very appealing sports and activities that are particularly suited to this time of life and that will help to strengthen your bones and protect them from osteoporosis, such as walking, cycling, swimming and dancing. The activities that are most commonly linked to spinal fractures are those carried out at home or in the workplace.
Are you aware of your posture in your day-to-day life?
Answer the following questions to find out.
1. Do you sit with your feet resting on the ground and your back and neck in a straight line?	□YES	□NO
2. Do you sleep on your back or your side on a firm mattress and use a light pillow?	□YES	□NO
3. When you pick something up off the floor, do your bend your hips and knees with your back straight and keep the object close to your body?	□YES	□NO
If you have answered ‘NO’ to any of these questions you should correct your posture and look after your spine more. Try to keep your back straight whenever you bend down and when you move or push objects.
Your GP can advise you
Your GP knows most about any problems you may experience as a postmenopausal woman and is the only person who can tell you what treatment is best suited to you and your needs.
In your case, your GP has chosen raloxifene (which is not a hormone) because it is ideal for preventing and treating osteoporosis, as well as for avoiding other possible health risks linked to postmenopause.
In addition, raloxifene will not cause any blood loss or staining, increase your weight or cause tenderness in your breasts, and you will be at no greater risk of breast or cervical cancer.
Follow your treatment exactly
Unless you take your medication regularly, your treatment will be less effective. Bear in mind the following points:
•Take one tablet a day. It doesn’t matter if you take it with food or not, but taking it at the same time every day will help you to remember it.
•If you forget to take a tablet, take it as soon as you remember and continue the treatment as normal. If you are several hours late, wait until the following day to continue treatment. Nothing will happen if you miss one day.
•Swallow the tablet whole with any kind of drink.
•Try not to abandon treatment unless your GP tells you to.
•If you have any questions, speak to your GP.