Assessment of Quality of life (QoL) in postmenopausal osteoporosis in the Lublin region DOI: / JHPOR - PDF

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1/2016: Assessment of Quality of life (QoL) in postmenopausal osteoporosis in the Lublin region 67 Assessment of Quality of life (QoL) in postmenopausal osteoporosis in the Lublin region DOI: /
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1/2016: Assessment of Quality of life (QoL) in postmenopausal osteoporosis in the Lublin region 67 Assessment of Quality of life (QoL) in postmenopausal osteoporosis in the Lublin region DOI: / JHPOR Authors: Mariola Drozd1, Joanna Mazur2, Monika Szkultecka-Dębek3, Lucyna Bułaś4, Maria Jesiotr5, Rafał Filip6 1- Department of Applied Pharmacy, Medical University of Lublin 2- Department of Child and Adolescent Health, Institute of Mother and Child 3- Department of Dermatology, Military Institute of Medicine 4- School of Pharmacy with the Division of Laboratory Medicine in Sosnowiec, Department of Applied Pharmacy, Institute of Pharmaceutical Technology, Medical University of Silesia in Katowice 5- Department of Applied Pharmacy, Medical University of Lublin 6- Medical Department, University of Rzeszów Keywords: Postmenopausal osteoporosis, quality of life, questionnaire Qualeffo-41 68 Abstract Introduction: Postmenopausal osteoporosis is related to the changes in female body during menopause. The aim was to assess the quality of life of women in the Lublin region suffering from postmenopausal osteoporosis. Methods: Data was obtained from standardized osteoporosis QoL questionnaire Qualeffo-41. The survey was conducted in April 2013 in a group of women with postmenopausal osteoporosis treated in ambulatory setting. Results: In total 55 QoL questionnaires were collected. The mean age was 70 years. The last declared menstruation was between 40 and 56 years. City inhabitants included 41 women, while 14 women inhabited rural areas. There were 28 married women, 25 widows and 2 maidens. The respondents weight was between kg. The shortest subject was 147 cm tall and the tallest cm. The results of QoL were at The results of the individual domains of the questionnaire indicate that the lowest rating was for physical function mean of Mental functions were assessed on average at Pain assessment resulted on average at The functioning during free time and opportunities for social contact were rated on average at The highest result was for overall health with a mean value of Conclusion: The analysis showed that Polish women suffering from postmenopausal osteoporosis have a low quality of life. The results suggest further research to test QoL at the beginning of the therapy and to monitor it during treatment, analyzing the domains that need the most improvement. Background Menopause can be defined as a period of transition from a reproductive period to the advanced age. This period is characterized by hormonal changes in the female body which are associated with different diseases and symptoms. Due to their influence the quality of life as well as the interactions with the environment can deteriorate. Many women begin to develop diseases such as obesity, hypertension, diabetes and osteoporosis [1,2]. Osteoporosis as defined by the World Health Organization (WHO, 1994) is skeletal systemic disease characterized by low bone mass, microarchitectural deterioration and fragility and a bone density 2.5 standard deviations below the mean for young white adult women at lumbar spine, femoral neck or forearm [3]. In 2001, the National Osteoporosis Foundation (NOF) and the National Institutes of Health in the USA developed a different definition describing osteoporosis as a skeletal disorder characterized by compromised bone strength predisposing to an increased risk of fracture [4]. In 2013 Clinician's Guide to Prevention and Treatment of Osteoporosis was developed. In this Guide NOF in collaboration with experts from different fields of medicine indicate the latest advice on prevention, risk assessment, diagnosis and treatment of osteoporosis in postmenopausal women and men over the age of 50 years. According to the authors of the guide osteoporosis is a silent disease until it is complicated by fractures fractures that occur following minimal trauma or, in some cases, with no trauma [5]. In 2014 Polish guidelines were compared with other international guidelines in terms of diagnostic measures, pharmacotherapy and calcium and vitamin D supplementation [6]. Depending on the cause of osteoporosis development we can differentiate primary and secondary osteoporosis. Most frequent (80%) is the primary disease and can be idiopathic or involutional. The idiopathic form is rather rare and usually affects young people without a known cause. The involutional form can be postmenopausal or senile. The form we predominantly observe is the postmenopausal type (80%) [7,8]. Osteoporosis is considered to be a social disease because of the incidence of the disease and the consequences. It is estimated that, due to complications within six months after the fracture of the femur, 20% of patients die and 50% die within the next year. It is estimated that since the number of hip fractures in 2000 was 1.6 million cases worldwide, then in 2025 it may reach 4 million, and in 2050 even 6 million [7, 9]. These fractures cause patient s immobilization, loss of independence and pain which results in reduction of the quality of life [10]. More than 30% of the vertebral body fractures do not cause clinical symptoms [11]. However all the other patients feel persistent pain and that affects significantly their quality of life [7]. Epidemiological data from 2008, related to Poland indicate that among people over 50 years, 165/ are experiencing osteoporotic fracture. In case of people over 85 years of age, the figure is 666 for men and for women per /year [9]. A study conducted in a Podlasie region showed that the proportion of women with fractures and without them at different ages, among whom a history of osteoporotic fractures occur in the 5th decade of life is reported in 20%, in the 6th %, in the 7th %, in the 8th %, and in the 9thdecade 44.4%. On average, in the whole population 27% of the women experienced in the past low-energy fractures [12]. In other study conducted in Poznan it was demonstrated that 40% of respondents after a fracture rated their quality of life as poor. Prior to the trauma, 8% of patients assessed 1/2016: Assessment of Quality of life (QoL) in postmenopausal osteoporosis in the Lublin region 69 their QoL as bad, while all the respondents consistently complained about a significant deterioration in relation to pain [13]. The aim of this study was to assess the quality of life in postmenopausal women suffering from osteoporosis. In addition, an attempt was made to verify the correlation between the place of residence, age, BMI, the occurrence of fractures and quality of life of patients. In recent years, it has been proven that there are needed questionnaires measuring health status for the research purposes and for clinical practice as well. The questionnaires are based on health status variables, such as mood, physical and social functioning and patient self-management. The general scales to measure health status are used to evaluate patients suffering from various diseases, however these scales are not measuring specific functioning in a given disease. Therefore it was necessary to construct a specific scale for osteoporosis. The questionnaire which is recommended by the International Osteoporosis Foundation (IOF) [14] is the called Quality of Life Questionnaire of the International Osteoporosis Foundation (Qualeffo-41) [15]. The questionnaire consists of 41 questions in the following 5 subscales: pain (5 questions), physical function (17 questions), social function (7 questions), general health perception (3 questions) and mental function (9 questions). When filling out questionnaires only one answer to each question should be selected. For the total score and subscores, 0 indicates a good health status, whereas 100 indicates a poor health status [16]. The studied material consisted of data of the interview conducted by the appropriately trained interviewer. The interviews were conducted among 55 patients undergoing a medical treatment at the clinic for osteoporosis treatment in April The interview included a questionnaire Qualeffo-41 with the addition of a special copyright questionnaire to characterize the studied group of patients. This additional questionnaire allowed us to collect information about age, weight, height, age of onset of the last menstrual period, the concomitant diseases and history of bone fractures. The interview lasted on average minutes. The study was conducted at two clinics treating osteoporosis in Lublin. There was a random selection of the studied group, which included women aged years, average 70 years (median 72 years). The age distribution of women in the study group is shown in Figure 1. The inclusion criterion was a history of menopause and osteoporosis diagnosed by the patient declared verbally and its written consent to participate in the study. The obtained data were compiled using MS Office Excel 2007, and the results are presented as descriptive statistics and as figures and tables. For the purpose of the statistical analysis the significance index and Pearson correlation and the index α-cronbach were used. The assumed level of statistical significance was α = The study received a positive opinion of the Bioethics Committee of the Medical University of Lublin. Material and Methods Figure 1. The number of women in the different age groups Results Taking into account 55 patients, it should be pointed out that they represented a diverse population of patients with postmenopausal osteoporosis. The assessment of the demographic data of women surveyed is shown in Table 1. characteristic Patients N=55 Place of residence Marital situation Weight Height Body mass index (BMI) Age at menopause Fracture coexisting diseases Urban Rural Married Widowed Single Mean Median Mean Median Mean Median SD Mean Median SD Yes No Yes No 41 (74.5%) 14 (25.5%) 28 (50.9%) 25 (45.5%) 2 (3.6%) 62 kg 60 kg 158 cm 160 cm years 50 years (38.2%) 34 (61.8%) 42 (76.4%) 13 (23.6%) Table 1. Socio-demographic characteristics of women with postmenopausal osteoporosis The fractures declared by women usually concerned the lower limbs (12 persons, 21.8%), including: ankle (3 people, 5.45%), the hip bone (1 person, 1.8%), the toes (3 women, 5.45%). Fractures of upper limbs were reported by12 people, representing 21.8% of the respondents, including: wrist (5 people, 9.1% of respondents), shoulder (2 women, 3.6% of respondents). Broken ribs was reported by 1 person (1.8% of respondents). Vertebral frac- 70 tures were experienced by 2 people (3.6% of respondents). Broken collarbone was reported by 1 person (1.8% of respondents). Patients also reported concomitant diseases: hypertension, neurological diseases, thyroid disease, rheumatoid arthritis, gallstones, or kidney stones, glaucoma and cataracts. In the first step, we analyzed the psychometric properties of the questionnaire Qualeffo-41 in the sample of 55 women. According to the analysis of reliability, four of the five dimensions of Qualeffo-41 questionnaire have good psychometric properties as α-cronbach ratio significantly exceeds the 0.7, which is considered as the threshold value. The best result concerns the physical functioning domain. The α-cronbach value below 0.7 was obtained for measuring mental functioning. The properties of this subscale are significantly improved by the elimination of question # 38 (Do you get annoyed by details?). Domain No of items Description Cronbach α Pain 5 Back pain; Sleep disturbance Physical function Social activities General health perception Mental function Activities of daily living; Jobs around the house; Mobility; Walking outside Sport; Gardening; Hobby; Theatre; Visiting friends; Intimacy General health; overall quality of life; Change in quality of life Fatigue; Depression; Loneliness; Energy; Hopefulness; Fear of becoming dependent Table 2. Description and reliability of Qualeffo The evaluation of the quality of life of women with postmenopausal osteoporosis was based on a standardized questionnaire Qualeffo-41. The results are summarized in Tables 3 and 4. It should be noted that the overall average quality of life of women surveyed is (SEM 15.46). However, in various domains of the questionnaire it was found that women assessed the overall health as the worst with an average of (SEM 1.80). There was even recorded a maximum value in case of 17 people, i.e. A very bad condition. The next step was to assess the functioning during free time and opportunities for social contact, rated on average at (SEM 2,35) at the lowest value of 0.0 in 2 patients, which can be explained as a lack of disruption in social activities and the highest of 90 in case of 4 women for whom the assessment has shown great difficulty in social activities. Feeling pain, was another domain with an average score of (SEM 2.40). In this case, the lowest value was observed in 5 women, which indicates the lack of pain, as well as the highest value recorded here was in 3 women, which is a significant perception of pain. The surveyed women found mental functions on average at (SEM 1.36), with the best value (1 woman) and the worst (3 women). However, despite significant pain, women gave the best rating in physical function - the average value is (SEM 1.69), which means that surveyed women had not significant difficulties in the physical functioning in relation to movement. Correlation between the assessment of the quality of life with the place of residence, age, marital status, BMI and a history of fractures indicated that there was no statistically significant difference in case of analysis in relation to place of residence, marital status, BMI and a history of fractures. Statistically significant differences were demonstrated in the analysis in relation to age and for marital status in the social activities domain. It was found that with age the quality of life should deteriorate, which results in a longer life with the disease. This study confirms that hypothesis. For the pain domain depending on the marital status, the value of calculated p is at borderline of statistical significance. We also decided to analyze the correlation between the five domains of the questionnaire. The results are summarized in Table 5. Correlation coefficients range from to 0.655, assuming that the highest value of correlation is for physical function and social activities. Also it is worth to pay attention to the high correlation (r = 0.610) between the two domains, which are more than any other domain for osteoporosis (pain and limitations in functioning). Qualeffo-41 domains Statistics Total General health Pain Physical function Social activities perception Mental function Mean Median Minimum Maximum SEM % CI Table 3. Results of quality of life measured with Qualeffo-41 1/2016: Assessment of Quality of life (QoL) in postmenopausal osteoporosis in the Lublin region 71 Total Pain Physical function Place of residence Qualeffo-41 domains Social activities General health perception Mental function Urban Mean SD Rural Mean SD p Marital status * married Mean SD widow Mean SD p Age (years) Mean SD Mean SD and older Mean SD p Body weight ** BMI BMI Mean SD Mean SD BMI 30 Mean SD p History of fractures yes Mean SD no Mean SD p Table 4. The average indexes of quality of life assessed by questionnaire Qualeffo-41 and selected characteristics of patients with osteoporosis * Due to small number single women were not included into calculations ** Due to small number of patients with BMI 18.5 not included into calculations Pain Pain Physical function Social activities General health perception Mental function Physical function Social activities General health perception Mental function Table 5. The correlation matrix between the five dimensions of the questionnaire Qualeffo -41 *In the top of the table is the Pearson correlation coefficient, in the lower its significance 72 Discussion Quality of life as defined by the World Health Organization, is an individual perception of their position in life, taking into account cultural conditions and a system of values in relation to individual objectives, standards, expectations and problems. QoL studies, in particular for diseases that cause an increase in pain suggest that such diseases significantly affect the deterioration of the mental and physical dimensions of quality of life [17]. A survey of one hundred postmenopausal women, aged 66 ± 8.7 years (age range 50-85), affected by osteoporosis with / or without fractures, done by the surgery clinic of the Instituto Italiano Auxologico for a period of about 4 months has shown that pain was present in 50% of cases and in 26% for more than 10 hours per day [18]. In the studies carried out in this work pain was present in 89%. The pain lasted 1-2 hours per day at 32.7%, 3-5 hours in 12.7%, and 6-10 hours at 3.6% of patients. Back pain lasting the whole day occurred in 40% of patients. In a study conducted at the clinic Instituto Italiano Auxologico, in the area of physical fitness, 46% of women under 65, and also 65% of people over 65 years declared significant changes [18]. For Polish women getting up from the chair causes difficulties in case of 62% of patients, bends - 64%, kneeling 67%, walking up the stairs 93%, walking 100 meters 51%. In the category of general health perception, according to a study in Italy, 58% of the women had poor well-being. In 21% of the 62 women, a reduction of their health perception was reported. Comparing their current level of health status with that of 10 years before, 58% of women aged below 65 indicate a deterioration, similarly as 83% of people aged 65 or more. Reduced quality of life was confirmed by 41% of women affected by osteoporosis [18]. According to research conducted for this study, most of the patients identified their health as fair % or poor %. In contrast, 21.8% described it as satisfactory. Most of the patients identified their overall quality of life as satisfactory (40%) and poor (34.5%). None of the patients defined quality of life as excellent. Satisfactory quality of life was reported by 34.5%. Comparing their current level of wellbeing with that of 10 years before, 91% of patients indicated its deterioration. In a study conducted in an Italian clinic, it was estimated that 40% of surveyed women had symptoms of depression [18]. According to our survey 100% of patients were experiencing fatigue. Also, as in the Italian study, we can conclude that approx. 40% of women have symptoms of depression, because they feel depressed, lonely, and only 40% of respondents thought indicated only sometimes with hope on the future response. Papaioannou, A. et al. believe that the experience of osteoporotic fracture has a negative impact on patient quality of life. The factors that play the biggest role is pain and disability, the ability to self-care and mobility [19,20]. Osteoporotic fractures lead to a reduction of efficiency and reduced quality of life and are associated with increased mortality. Because of the pain, impairment of movement and limitation in self-care activities, during the first months of the injury occur and a significant deterioration in QoL regardless of the location of the fracture [20]. The study by Abimanyi-Ochom J. et al. conducted using the EQ-5D questionnaire, found the average decrease in QoL for all fracture locations. Immediately after the injury decrease at an average of 51%, the largest decrease was recorded in the proximal femur fracture 69%, least (36%) of the radius bone. In the case of proximal femur and vertebral fractures, QoL did not return to the level from before the event even after 18 months, with 83-89% of the initial value [20,21]. In the Swedish study using the same protocol, O. Ström et al. obtained similar results [20,22]. The study in Lublin confirms the results obtained by A. Papaioannou, J. Abimanyi-Ochom and O. Ström et al. Polish women with osteoporotic fractures have reduced QoL. In the Outpatient Treatment of Oste
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