Abstract
Objective
To describe the prevalence of menstrual problems (heavy menses bleeding, dysmenorrhoea and oligomenorrhoea) and its impact towards quality of life among adolescents in Klang Valley, Malaysia.
Design
Cross-sectional study.
Setting
Adolescent girls at secondary schools in the Klang Valley, Malaysia.
Population
729 adolescents aged between 13 and 18 years.
Method
A questionnaire survey using Menorrhagia Questionnaire and Paediatric Quality of Life-Teen Report Ages 13–18 (PedsQL).
Main outcome measures
Self reports of menstrual bleeding patterns, morbidities and effect on quality of life.
Results
The prevalence of menstrual problems among adolescents was 63.9% in the Klang Valley. Adolescents with menstrual problems had significant lower mean total score of PedsQL (70.23±13.53 vs 76.36±14.93, p=0.001), physical health summary score (74.10±16.83 vs 79.00±15.86, p<0.001) and psychosocial health summary score (68.05±14.27 vs 73.21±13.09, p=0.001) compared with those without menstrual problem. Adolescents experiencing heavy menses bleeding had the lowest physical and emotional function. Those with oligomenorrhoea had the lowest social function, whereas those with dysmenorrhoea had the lowest school function. Cigarette smoking, alcohol and medical illness had lower health-related quality of life, whereas taking oral contraceptive pills for menstrual problems was associated with higher scores in these adolescents.
Conclusion
Menstrual problems among adolescents have a significant impact on their quality of life. It is probably wise to screen them at the school level, to identify those with low functional scores and to refer them for proper management at a tertiary adolescent gynaecology centre.
Keywords: reproductive medicine, community gynaecology, epidemiology
Strengths and limitations of this study.
This was the largest school population-based cross-sectional study been conducted to evaluate the quality of life of adolescents with menstrual problems in Malaysia.
This was the first study conducted in Malaysia among adolescents using Paediatric Quality of Life-Teen Report Ages 13–18 (PedsQL).
This study used PedsQL, a better tool to reflect impact of menses problems to adolescents, particularly in social and school function.
Confounding factors were further analysed to give a clearer picture regarding the impact on health-related quality of life among adolescents with menstrual problems.
The study focused only at urban area, and the findings might not be applicable to the whole adolescents’ population in Malaysia.
Introduction
Menstrual problems among adolescent females are common. It is estimated that 75% of them would experience some disorders associated with menstruation.1 The most common menstrual problems among adolescents worldwide are heavy menses bleeding (HMB), oligomenorrhoea, dysmenorrhoea, amenorrhoea and premenstrual syndrome.
HMB is defined as excessive blood loss more than 80 mL per menses and accounts for a substantial proportion of healthcare resources among females of reproductive age. Although approximately 30% of adult females reported problem of HMB, its prevalence among adolescents varied worldwide, ranged from 10% to 30%.2 3 HMB requires medical intervention as increased blood loss may be indicative of a serious disease that requires urgent intervention. However, even in the absence of a medical problem, help is warranted because of the disability that a woman experiences as a consequence of menstrual periods.
Dysmenorrhoea affects 60%–93% of adolescents and is characterised by recurrent cramping abdominal pain associated with nausea.4 5 More than half of these girls missed school as a consequence of this problems.5 Dysmenorrhoea and HMB were associated with poor academic performance and limitation in outdoor activities whereas amenorrhoea was associated with low self-esteem.6–10
Although effective therapies for menstrual disorders exist, most of adolescents do not recognise their menses problems as a treatable medical conditions and do not always discuss their problems with healthcare providers.11 Only about 2% of teenagers in USA received information regarding menstruation from their healthcare providers.12 In Malaysia, only 11.1% of adolescents sought medical consultation for their menstrual disorders.7
In recent times, the concept of ‘quality of life’ has been used to quantify the effect of disease to patients.13 Menstruation-related problems contribute to school absenteeism and significantly add to the problems faced by adolescents and their families during this complicated phase of development. The age of menarche continues to decrease in this population, and hence increase the possibility that menstrual-associated morbidities may have a greater negative impact in their lives.14 Hence, it is important to study the effects of menstrual disorders among adolescents.
To date, most published literatures looked into the prevalence of menstrual disorders among adolescents. However, only a few studies have investigated the quality of life of adolescents with menstrual disorders.15–17 These studies used the Medical Outcome Survey 36-item short form health survey and Child Health Questionnaire—Child Self Report Form to assess the quality of life among young females with specific menstrual problems. Although they demonstrated the negative impact on their lives, neither of these tools included the impact on school performance and activities, which is an integral part of an adolescent’s life.
Therefore, this study was designed to determine the prevalence of menstrual disorders and to evaluate the quality of life scores among adolescents with menstrual problems at Klang Valley in Malaysia. Besides that, the study also aimed to identify predictors of low quality of life scores in these adolescents. This may help clinicians to identify adolescents at risk of poor quality of life and improve the identified modifiable predictors or factors.
Methods
Participants and recruitment
The study was conducted over a period of 1 year, involving 1050 adolescents aged 13–18 years old from 20 selected secondary schools in Klang Valley, Malaysia. The 20 schools were randomly selected from 207 schools by computer generated randomisation. Sample size was calculated by using Kish formula with prevalence of menstrual disorder among adolescents of 75%. The total sample required was 750 adolescents. The study was conducted in the selected schools with the permission of the school principal and class teachers. The adolescents were selected by simple randomisation method. They were given the information sheet and parental consent form 1 week before the questionnaire was provided. Only those who returned the parental consent form were recruited. They were given 30 min to complete the self-administered questionnaire. Those with intellectual disability, inadequate reading skills or significant psychiatric problem, and those who were known to be pregnant or had previously been pregnant were excluded from this study.
Questionnaire
For the purpose of this study, the original Menorrhagia Questionnaire (MQ) in English was translated into three languages (Bahasa Malaysian, Mandarin and Tamil) by the Malaysian Translators Association, a certified professional body in Malaysia for the purpose of translation or interpretation of any document into multiple languages. The Paediatric Quality of Life-Teen Report Ages 13–18 (PedsQL) has a validated questionnaire in Malay, Mandarin and Tamil. It was used with the permission of the Mapi Research Trust, Lyon, France.
The MQ is a 13-items questionnaire designed by Ruta et al.18 However, only the first seven questions of this tool were used to classify the type of menstrual problem in this study. The PedsQL is a brief 23-item multidimensional instrument designed by Varni et al for measuring paediatric health-related quality of life (HRQL).19 It consists of four parts: (1) physical functioning with eight items, (2) emotional function with five items, (3) social function and (4) school function, both with five items, respectively. The validity of PedsQL is well established.20 The instructions asked how much a problem each item posed over the past month. The response scale used a 5-point Likert-type format ranging from 0 to 4, in which 0 indicated never a problem while 4 indicated almost always a problem. The raw score for each item was reverse-scored (0=100, 1=75, 2=50, 3=25 and 4=0) and transformed to a scale of 0–100, with higher scores indicating better HRQL.20 The total score was presented as mean score, computed as the sum of items divided by the number of items assessed by all scales. The Physical Health Summary score consisted of 8 items as similar as physical function part, while the Psychosocial Health Summary score included 15 items from emotional function, social and school function.
Data on the demographic information were incorporated into the questionnaire. The data collection process was piloted with 50 adolescents at a secondary school selected at random. This was undertaken to confirm the length of time required to complete the questionnaire and to refine the contents and process based on feedback from the participants. From the pilot study, the Cronbach alpha was 0.812 with no negative feedback received. The questionnaire took about 20 min to complete with no difficulties. Therefore, the study was commenced 1 week after the pilot test.
Data analysis
All data were collected in an electronic database and analysed using SPSS V.23.0. Mean was used for normally distributed continuous variables and analysis of variance test was used to compare mean score for PedsQL. SD, a summary measure of the differences of each observation from the mean, was also calculated. Logistic regression analysis was used to determine the predictor factors for HRQL.
Patient and public involvement
Patients or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this study.
Results
A total of 1050 adolescents were approached with all parent consented to participate in this study. Only 729 adolescents (69.4%) completed and returned the questionnaire for analysis. A total of 89 adolescents (8.5%) did not return the questionnaire and 232 (22.1%) returned incomplete questionnaire.
The demographic characteristics of sample population are presented in table 1. The majority of the sample population were Malays (62.1%), followed by Chinese (28.8%), Indian (7.8%) and others (1.2%). Surprisingly, more than half (59%) of the respondents were underweight, with only 31% of them had a normal body mass index (BMI). About 5.3% of the sample population were working part-time to support the family, after school and during the weekends.
Table 1.
Demographic data of the study population (N=729)
| Variables | n | % |
| Race | ||
| Malay | 453 | 62.1 |
| Chinese | 210 | 28.8 |
| Indian | 57 | 7.8 |
| Others | 9 | 1.2 |
| Religion | ||
| Buddhist | 187 | 25.7 |
| Christian | 36 | 4.9 |
| Hindu | 48 | 6.6 |
| Islam | 457 | 62.7 |
| Sikh | 1 | 0.1 |
| Siblings | ||
| 0 | 25 | 3.4 |
| 1–3 | 326 | 44.7 |
| >3 | 378 | 51.9 |
| BMI | ||
| <20 underweight | 431 | 59.1 |
| 20–24.9 normal | 225 | 30.9 |
| 25–29.9 overweight | 54 | 7.4 |
| >30 obese | 19 | 2.6 |
| Job | ||
| Part-time | 39 | 5.3 |
| Not working | 690 | 94.7 |
All data are presented in frequency (%).
BMI, body mass index.
Table 2 shows the social characteristics of the study population. In the sample population, 95.6% did not smoke. The majority of them (93.0%) did not take alcohol in the past 2 weeks. Twenty-one adolescents (3%) from the sample population were involved in a sexual relationship. Only 5 (0.7%) of the sexually active adolescents practised contraception.
Table 2.
Social characteristics of the study population (N=729)
| Variables | n | % |
| Cigarette | ||
| Never | 697 | 95.6 |
| Once or twice | 11 | 1.5 |
| Once in a while but not regularly | 17 | 2.3 |
| Regularly in the past | 4 | 0.5 |
| Cigarette in 30 days | ||
| Not at all | 719 | 98.6 |
| Less than one cigarette per day | 5 | 0.7 |
| 1–5 cigarettes per day | 3 | 0.4 |
| 6–9 cigarettes per day | 1 | 0.1 |
| 20 or more cigarettes per day | 1 | 0.1 |
| Alcohol | ||
| Never | 678 | 93.0 |
| Once | 20 | 2.7 |
| Twice | 11 | 1.5 |
| 3–5 times | 9 | 1.2 |
| 6–9 times | 1 | 0.1 |
| 10 or more times | 10 | 1.4 |
| Involved in sexual relationship | ||
| Yes | 21 | 2.9 |
| No | 708 | 97.1 |
| Contraception | ||
| Yes | 5 | 0.7 |
| No | 724 | 99.3 |
| Taken oral contraception pills for menstrual problems | ||
| Yes | 28 | 3.8 |
| No | 701 | 96.2 |
All data are presented in frequency (%).
A large proportion of adolescents had learnt about menstruation from their mothers (78.3%) and from school (49.3%). About 25%–30% of them had gained knowledge from friends and books or magazines. The use of the internet among adolescents as the source of information was low at 3.4%, and a very small percentage (1.7%) learnt about menstruation from their fathers. The majority of the sample population (94%) had no medical problems. The most common medical problem seen was asthma (2.7%), followed by gastritis and anaemia (1.2% each). Others include heart disease, thalassaemia, anxiety disorder, recurrent urinary tract infection and orthopaedic-related problems.
Out of the total 729 adolescents who had menses, only 28 (4%) had taken oral contraceptive pills (OCPs) for menstrual problems. The mean age for menarche in the study population was 12.14±1.11 years old. The prevalence of menstrual problems was 63.9% (466) among the studied adolescents. The majority of them, 225 (30.9%) experienced dysmenorrhoea, followed by 205 (28.1%) had HMB, 33 (4.5%) had oligomenorrhoea and 3 (0.4%) with amenorrhoea.
The prevalence of adolescents with menstrual problems was 63.9% among the study population. The most common menstrual problem was dysmenorrhoea (30.9%), followed by HMB (28.1%) and amenorrhoea/oligomenorrhoea (4.9%). The sociodemographic characteristics of the adolescents with different menstrual problems are presented in table 3. There was a significant predisposition of dysmenorrhoea as the most common menstrual disorder across all ethnicities. Obesity (BMI>30) was also predominant in the dysmenorrhoea group. Among the sexually active group, 14 (66.7%) had menstrual problems and 7 (33.3%) had no menstrual problems.
Table 3.
Sociodemographic of adolescents with menstrual problems
| HMB (n=205) | Dysmenorrhoea (n=225) | Amenorrhoea/oligomenorrhoea (n=36) | P value | |
| Age (years) mean±SD | 15.71±1.41 | 15.81±1.69 | 15.42±1.40 | 0.608 |
| Ethnicity | ||||
| Malay | 140 (46.8%) | 140 (46.8%) | 19 (6.4%) | 0.047 |
| Chinese | 48 (41.1%) | 53 (45.2%) | 16 (13.7%) | |
| Indian | 16 (35.6%) | 28 (62.2%) | 1 (2.2%) | |
| Others | 1 (20.0%) | 4 (80.0%) | 0 (0.0%) | |
| BMI>30 | 5 (33.6%) | 9 (60.0%) | 2 (13.3%) | 0.023 |
| Job | ||||
| Part-time | 17 (46.0%) | 15 (40.5%) | 5 (13.5%) | 0.423 |
| Not working | 188 (43.8%) | 210 (49.0%) | 31 (7.2%) | |
| Alcohol | ||||
| Yes | 12 (41.4%) | 15 (51.7%) | 2 (6.9%) | 0.980 |
| No | 193 (44.1%) | 210 (48.1%) | 34 (7.8%) | |
| Smoking | ||||
| Yes | 12 (48.0%) | 11 (44.0%) | 2 (8.0%) | 0.719 |
| No | 193 (43.8%) | 214 (48.5%) | 34 (7.7%) | |
| Sexual | ||||
| Yes | 6 (42.9%) | 8 (57.1%) | 0 (0.0%) | 0.697 |
| No | 199 (44.0%) | 217 (48.0%) | 36 (8.0%) | |
| Taken OCPs for menstrual problems n (%) | ||||
| Yes | 15 (53.7%) | 11 (39.2%) | 2 (7.1%) | 0.388 |
| No | 191 (43.6%) | 214 (48.7%) | 34 (7.7%) | |
| Medical problem n (%) | ||||
| Yes | 15 (45.4%) | 16 (48.5%) | 2 (6.1%) | 0.946 |
| No | 190 (43.8%) | 209 (48.3%) | 34 (7.9%) | |
Analysis of variance test.
All data are presented in frequency (%).
BMI, body mass index.
Overall, adolescents with menstrual problems had significant lower mean total score of PedsQL (70.23±13.53 vs 76.36±14.93, p=0.001), physical health summary score (74.10±16.83 vs 79.00±15.86, p<0.001) and psychosocial health summary score (68.05±14.27 vs 73.21±13.09, p=0.001) compared with those without menstrual problem. There was a significant difference in all four domains of the PedsQL between adolescents with normal menses and those with menstrual problems. Adolescents with menstrual problem had lower scores compared with the normal population (table 4). Those with HMB have the lowest total score, and physical health functioning and the lowest psychosocial scores (table 5). HMB alone contributed to a lower physical score compared with dysmenorrhoea and amenorrhoea/oligomenorrhoea. Amenorrhoea/oligomenorrhoea had the lowest social function and dysmenorrhoea had the lowest school function. However, these differences were not statistically significant (table 5).
Table 4.
Comparison of Paediatric Quality of Life-Teen Report Ages 13–18 scores
| Normal (n=263) | Menstrual problems (n=466) | P value | |
| Physical | 79.00±15.86 | 74.10±16.83 | <0.001 |
| Emotional | 65.98±20.79 | 59.08±20.61 | <0.001 |
| Social | 82.29±16.42 | 78.03±17.70 | 0.001 |
| School | 74.97±15.78 | 70.94±17.44 | 0.002 |
| Total score | 76.36±14.93 | 70.23±13.53 | 0.001 |
Independent t-test.
All data are presented in mean±SD.
Table 5.
Paediatric Quality of Life-Teen Report Ages 13–18 scores among adolescents with menstrual problems
| HMB (n=205) | Dysmenorrhoea (n=225) | Amenorrhoea/oligomenorrhoea (n=36) | P value | |
| PH | 72.27±18.93 | 75.17±15.70 | 76.39±16.76 | 0.328 |
| PS | 67.96±15.18 | 69.79±15.07 | 68.80±17.38 | 0.621 |
| Emotional | 56.08±21.42 | 60.09±20.24 | 57.92±21.33 | 0.226 |
| Social | 76.48±17.93 | 79.31±17.82 | 75.83±18.69 | 0.441 |
| School | 71.32±18.10 | 69.98±16.46 | 72.64±18.95 | 0.665 |
| Total score | 69.46±14.54 | 71.35±12.65 | 71.44±15.51 | 0.534 |
Analysis of variance test.
All data are presented in mean±SD.
PH, physical health summary score; PS, psychosocial health summary score.
Table 6 summarises the influence of demographic, clinical status and social factors on HRQL. In the linear regression, cigarette smoking, alcohol and medical illness had negative relationships with HRQL. This indicates that the more the adolescents smoked, drank alcohol and had medical problems, the lower the functional scores. Similarly, there was positive relationship with taking oral contraceptive pills for menstrual problems.
Table 6.
Predictors for health-related quality of life
| Unstandardised coefficients β |
95% CI for β | P value | ||
| Lower bound | Upper bound | |||
| Age | −0.091 | −0.706 | 0.523 | 0.771 |
| BMI | −0.126 | −0.433 | 0.182 | 0.423 |
| Race | 1.113 | −0.634 | 2.861 | 0.211 |
| Job | 1.673 | −0.627 | 3.972 | 0.154 |
| Cigarette | −4.652 | −7.610 | −1.693 | 0.002 |
| Alcohol | −2.870 | −4.673 | −1.067 | 0.002 |
| Sexual | 7.402 | 0.133 | 14.672 | 0.052 |
| Contraception | 11.040 | −2.433 | 24.512 | 0.108 |
| Taken oral contraception pills for menstrual problems | 7.976 | 2.691 | 13.260 | 0.003 |
| Medical problem | −2.712 | −4.551 | −0.874 | 0.004 |
Simple logistic regression.
Dependent variable: total score.
BMI, body mass index.
Discussion
The study revealed that the prevalence of menstrual disorders in the Klang Valley was 63.9%. The most common menstrual problem seen in the study population was dysmenorrhoea (30.9%), followed by HMB (28.1%), oligomenorrhoea (4.5%) and amenorrhoea (0.4%). This was similar to other studies performed in the past.7 11 12 21 The mean age of adolescents at menarche in this study was 12.14±1.11, which was also similar to most the previous studies.11 22
HMB was found in 28.1% of adolescents. This was much higher compared with only 18% of the sample population suffering from HMB in previous literature.7 This could be attributed to the sedentary life-style, increasing obesity and stress level among adolescents.23–26 HMB often occurred after menarche due to anovulatory cycles with an immature hypothalamic–pituitary–ovarian axis.27 HMB could be an emotional stress as evidenced by lowest mean emotional function score among the studied adolescents. This finding was similar compared with other studies.16 28 In the present study, adolescents often felt depressed, helpless and worried with their HMB. These emotional feelings had direct negative impact to their school and social performance. Pawar et al found that more than half of adolescents were reported missing from school due to HMB.29 Unfortunately, these debilitating psychosocial implications are often overlooked and neglected as clinicians always focus on restoring the normal menses cycle flow. The present study provides a new insight and need for clinicians to incorporate the psycho-emotional evaluation into routine care for adolescents with HMB.
Interestingly, adolescents with HMB in this study demonstrated lower mean physical health summary score compared with previous study using the similar PedsQL questionnaire.16 The body habitus, region and ethnicity of the studied population could be the contributing factors for this difference. Adolescents with HMB often felt tired, easily fatigue and had difficulty in performing sports activities. Wang et al demonstrated that 79.2% of adolescents reported that HMB severely affected their ability to participate in sports or physical activities.30 This inadvertently resulted to more sedentary life-style and increase obesity among adolescents, leading to a vicious cycle of worsening HMB.
The prevalence of dysmenorrhoea was 30.9%, which constituted moderate, severe and very severe abdominal cramps in this study population. Worldwide, the prevalence ranged from 50% to 80% and more than 15% reported severity which disrupt their daily activities.11 31 In studies carried out in Australia, the prevalence was reported to be as high as 94% in school populations.5 22 Dysmenorrhoea occurred commonly in midadolescents and late adolescents with established ovulatory cycles.27 32 In this study, adolescents with dysmenorrhoea were found to be more obese. This was in contrast to other published trials that showed dysmenorrhoea to be inversely related to BMI.33–35 However, other studies revealed that dysmenorrhoea occurred more frequently among obese adolescents.36 37 Obese adolescents are associated with increased adipose tissue and circulating oestrogen, which resulted in oestrogen dominance diseases, and increased prostaglandins which caused dysmenorrhoea.
Studies had showed that dysmenorrhoea resulted in poor academic performance and social activities and directly caused the low school functioning scores.9 31 Similarly, the present study demonstrated that adolescents with dysmenorrhoea had the lowest mean score in school function as compare to other menstrual problems. A systemic review showed that nearly 25% of adolescents were absent from school and majority reported that their academic performance was severely affected by dysmenorrhoea.8 In order to overcome the disadvantage of dysmenorrhoea, there was an increased usage of non-steroidal anti-inflammatory drugs among adolescents with menstrual problems.
Oligomenorrhoea was associated with polycystic ovarian syndrome (PCOS) and these individuals were reported to have high levels of anxiety and depression.10 As the result, adolescents with oligomenorrhoea had lower psychosocial scores compared with menorrhagia and dysmenorrhoea group. It was noted that adolescents with PCOS were 3.4 times more likely to be concerned about their future fertility, leading to lower scores in all domains except physical functioning.15 Hence, early intervention and treatment should be provided to them as early as possible to improve their psychosocial scores.
This study illustrated the impact of menstrual problems on education among adolescents was significant. The disadvantages among those with menstrual problems were well demonstrated. School abstinence, disability to concentrate on studies, unable to participate in sports or school’s physical activities may have long-term consequences for adolescent girls with menstrual problems. These negative effects will start at school and continue unchanged throughout their life. Hence, it is important that their menstrual problems should be addressed properly from the beginning. Teachers should have knowledge about menstrual problem in order for them to be able to educate and provided better emotional support to adolescents. Besides that, teachers should have confidence in providing counselling regarding menstrual topics and refer adolescents who required further care to healthcare providers.38 This will ensure those required further attention will receive optimal care as early as possible.
Cigarette smoking, alcohol consumption and concurrent medical illness were all associated with lower quality of life among the study population. Adolescents on oral contraceptive pills for menstrual problems were found to have higher score of HRQL. Previous studies also reported the similar findings.39 40 Hence, contraceptive pills are one of the most effective treatments in HMB among young girls with menstrual problems to improve their quality of life.
Limitation
This study had several limitations. This study was conducted in secondary schools from the Klang Valley, where most of the students were residents of Selangor and Kuala Lumpur. Therefore, our findings may not be applicable to whole adolescents’ population in Malaysia. More extensive studies involving multiple schools throughout Malaysia are required to test the outcome of the current study. This was also a cross-sectional descriptive study; therefore, was only able to show the association of variables with functional scores, without allowing true causal relationships to be ascertained. Longitudinal studies would be more appropriate to probe into the cause and effect of each menstrual problem. Furthermore, there were no data regarding the norm for the Malaysian population to compare with the individuals with menstrual problems. This study highlights the need for normogram for the Malaysian population.
Conclusion
Menstrual problems among adolescents have a significant impact on their quality of life. Each menstrual problem affects each domain differently. This calls for a more comprehensive approach towards managing adolescents with menstrual problems. It is possibly wise to screen students at the school level, to identify those individuals with low functional scores and to refer them for proper management at a tertiary adolescent gynaecology centre.
Supplementary Material
Footnotes
Contributors: UM, AAZ and ZAM were involved in the proposal draft, data collection and analysis. KTC and NAAG were involved in original draft preparation. SG involved in finalising the manuscript. The preliminary data in this manuscript had been presented at the RCOG Conference 2012 in Kuching, Sarawak, Malaysia. The authors declare no conflict of interest. All authors are responsible for the content and writing of this paper. NAAG is responsible for the overall content as guarantor.
Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests: None declared.
Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review: Not commissioned; externally peer reviewed.
Data availability statement
No data are available.
Ethics statements
Patient consent for publication
Not applicable.
Ethics approval
This study involves human participants and was approved by Universiti Kebangsaan Malaysia Research Ethics Committee code of approval: FF-093-2012 and State Health District Office in Selangor and Kuala Lumpur, Malaysia. The study was conducted according to the guidelines of the Declaration of Helsinki. Participants gave informed consent to participate in the study before taking part.
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