Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 25

Search results for: HRQoL

25 Factors Influencing Health-related Quality of Life in Thai AMI Survivors

Authors: K. Masingboon, S. Duangpaeng, N. Chaiwong


Acute myocardial infarction (AMI) is the most common cause of death among Thai with coronary heart disease (CHD). Thai AMI survivors are most likely to have impaired health-related quality of life (HRQoL) due to their lifestyle, functional, and psychological problems. Guided by the Individual and Family Self-Management Theory, this study aimed to explore HRQoL and identify its predictors among Thai AMI survivors. 155 Thai AMI survivors were recruited by stratified random sampling from three hospitals located in eastern region of Thailand. HRQol was measured using the Short Form -12 Health Survey (SF-12). The Center for Epidemiologic studies Depression Scale (CES-D) was utilized to assess the presence of depression, and the Family Support questionnaire was administered to examine family support. Results revealed that 92 percent of Thai AMI survivors reported a generally high level of HRQoL and 80 percent of them reported higher level of HRQoL in physical health and mental health dimension. Depression and family support were significantly predicted HRQoL among Thai AMI survivors and accounted for 28.5 percent of variance (p < .001). Interestingly, depression was the most significant predictors of HRQoL (β = -.65, p < .001) In conclusion, depression is a significant predictor of HRQoL in Thai AMI survivors. Increasing awareness of depression among these survivors is important. Depressive symptoms in should be routinely assessed. In addition, intervention to improve HRQoL among Thai AMI survivors should be addressed through depressive symptom management and family collaboration.

Keywords: health-related quality of life, AMI survivors, predictors, collaboration

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24 Indicators of Value of Life in Children with Colorectal Illness

Authors: Enkelejda Shkurti, Diamant Shtiza


Background: Health-related quality of life (HRQoL) is a significant consequence in health care. The objective of our study was to recognize features related to lower HRQoL scores in children with anorectal malformation (ARM) and Hirschsprung disease (HD). Methods: Children younger than 18 years, with HD or ARM, that were assessed at our private clinic in Tirana, Albania, from December 2018 to October 2019, were acknowledged. The outcomes of broad questionnaires concerning diagnosis, symptoms, and preceding health/surgical history and authenticated tools to measure urinary status, stooling grade, and HRQoL were appraised. Results: In patients aged 0-6 years, vomiting and abdominal enlargement were allied with a substantial decrease in total HRQoL scores. In children > 6 years of age, vomiting, abdominal swelling, and abdominal discomfort were also linked to a considerably lower HRQoL. The main indicator of lower HRQoL scores on regression tree analysis in all age clusters was the occurrence of psychosomatic, behavioral, or progressive comorbidity. Conclusion: Children with both HD or ARM that have a psychosomatic, behavioral, or growing problem experience considerably lower HRQoL than patients deprived of such problems, proposing that establishment of behavioral/growing sustenance as part of the care of these patients may have a considerable influence on their HRQoL.

Keywords: anorectal malformation, Hirsch Sprung disease, quality of life, Albania

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23 Evaluating Health-Related Quality of Life of Lost to Follow-Up Tuberculosis Patients in Yemen

Authors: Ammar Ali Saleh Jaber, Amer Hayat Khan, Syed Azhar Syed Sulaiman


Tuberculosis (TB) is considered as a major disease that affects daily activities and impairs health-related quality of life (HRQoL). The impact of TB on HRQoL can affect treatment outcome and may lead to treatment defaulting. Therefore, this study aims to evaluate the HRQoL of TB treatment lost to follow-up during and after treatment in Yemen. For this aim, this prospective study enrolled a total of 399 TB lost to follow-up patients between January 2011 and December 2015. By applying HRQoL criteria, only 136 fill the survey during treatment. Moreover, 96 were traced and fill out the HRQoL survey. All eight HRQol domains were categorized into the physical component score (PCS) and mental component score (MCS), which were calculated using QM scoring software. Results show that all lost to follow-up TB patients reported a score less than 47 for all eight domains, except general health (67.3) during their treatment period. Low scores of 27.9 and 29.8 were reported for emotional role limitation (RE) and mental health (MH), respectively. Moreover, the mental component score (MCS) was found to be only 28.9. The trace lost follow-up shows a significant improvement in all eight domains and a mental component score of 43.1. The low scores of 27.9 and 29.8 for role emotion and mental health, respectively, in addition to the MCS score of 28.9, show that severe emotional condition and reflect the higher depression during treatment period that can result to lost to follow-up. The low MH, RE, and MCS can be used as a clue for predicting future TB treatment lost to follow-up.

Keywords: Yemen, tuberculosis, health-related quality of life, Khat

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22 Health-Related QOL of Motorists with Spinal Cord Injury in Japan

Authors: Hiroaki Hirose, Hiroshi Ikeda, Isao Takeda


The Japanese version of the SF-36 has been employed to assess individuals’ health-related QOL (HRQOL). This study aimed to clarify the HRQOL of motorists with a spinal cord injury, in order to compare these individuals' SF-36 scores and national standard values. A total of 100 motorists with a spinal cord injury participated in this study. Participants’ HRQOL was evaluated using the Japanese version of the SF-36 (second edition). The score for each subscale was standardized based on data on the Japanese population. The average scores for NPF, NRP, NBP, NGH, NVT, NSF, NRE, and NMH were 10.9, 41.8, 45.9, 47.1, 46.1, 46.7, 46.0, and 47.4 points, respectively. Subjects showed significantly lower scores for NPF and NRP compared with national standard values, which were both ≤ 45.0 points, but relatively normal scores for the other items: NBP, NGH, NVT, NSF, NRE and NMH (> 45.0 points). The average scores for PCS, MCS and RCS were 21.9, 56.0, and 50.0 points, respectively. Subjects showed a significantly lower PCS score (≤ 20.0 points); however, the MCS score was higher (> 55.0 points) along with a relatively normal RCS score in these individuals (= 50.0 points).

Keywords: health-related QOL, HRQOL, SF-36, motorist, spinal cord injury, Japan

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21 Psycho-Social Predictors of Health-Related Quality of Life among Persons Living with Benign Prostatic Hyperplasia in Ibadan, Nigeria

Authors: A. C. Obosi, H. O. Osinowo, L. I. Okeke


Benign prostatic hyperplasia (BPH) is one among other prostate diseases with an increasing public health concern. The prevalence and increased psychological distress of BPH among men negatively impact on their health-related quality of life (HRQoL). Although several biomedical factors have been implicated in poor HRQoL among people with BPH, there is a dearth of research on the psychosocial factors predicting HRQoL among them especially in developing climes. This study, therefore, examined the psychosocial (knowledge, perceived stigma, depression, anxiety, perceived social support and illness acceptance) predictors of health-related quality of life among persons living with BPH in Ibadan, Nigeria. Biopsychosocial model and Health-related Quality of life guided this study which utilized ex-post facto design. Eighty-seven males living with BPH were purposively selected and actively participated in the study. Participants’ mean age was 61.77 ± 15.80 years. A standardized questionnaire comprising Socio-demographics and measures of health-related quality of life (α = 0.47); knowledge (α = 0.72); psychological distress (α = 0.95); perceived social support (α = 0.96) and Illness acceptance (α = 0.89) scales was utilized in the study. Data were content analysed, while bivariate correlation, hierarchical multiple regression and t-test for independent samples were computed at p < 0.05. Results revealed that 42.5% of the respondents reported poor HRQoL. Furthermore, age, length of illness, perceived stigma, depression, anxiety, knowledge, perceived social support and illness acceptance jointly predicted HRQoL significantly (R2=0.33, F(9,75)=4.05) and accounted for 33% variance in the total observed variance on HRQoL, while Illness acceptance (β=0.43), anxiety (β=-0.54), and perceived social support (β=0.16) had significant independent contributions to the observed variance on HRQoL. Illness acceptance, knowledge, perceived social support and psychological distress such as anxiety, depression and perceived stigma are important predictors of HRQoL. Therefore, it was recommended that urgent psychological intervention targeted at improving the quality of life of these persons be undertaken.

Keywords: benign prostatic hyperplasia, Health-related quality of life, prostate disorders, psychosocial factors

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20 Quality of Life in People with Hearing Loss: A Study of Patients Referred to an Audiological Service

Authors: Peder O. Laugen Heggdal, Oyvind Nordvik, Jonas Brannstrom, Flemming Vassbotn, Anne Kari Aarstad, Hans Jorgen Aarstad


Background: Hearing loss (HL) affect people of all ages and stages in life. To author's best knowledge, if patients with an HL have reduced Generic Quality of life (QoL), has yet not been answered. Aim: The aim of the present study was to investigate the relationship between HL and generic and disease-specific Health Related Quality of Life (HRQoL) in adult patients (aged 18–78 years) with an HL, seeking Hearing Aid (HA). Material and Methods: 158 adult (aged 18-78 years) patients with HL, referred for HA fitting at Haukeland University Hospital in western Norway, participated in the study. Both first-time users, as well as patients referred for HA renewals, were included. First-time users had been pre-examined by an Ear Nose and Throat specialist. The questionnaires were answered before the actual HA fitting procedure. The pure-tone average (PTA; frequencies 0.5, 1, 2 and 4 kHz) was determined for each ear. The generic European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire general part and a shortened version of the Abbreviated Profile of Hearing Aid Benefit (APHAB) were answered. In addition, EORTC HRQoL answers from a general population and patients with former head and neck cancer served as comparison. Results: In general, no lowered HRQoL scores were determined among HL patients compared to the general population. Patients with unilateral HL to some extent showed lower HRQoL than those with bilateral HL (social function and fatigue). The APHAB scores correlated significantly with the EORTC HRQoL scores. By stepwise linear regression analysis, the APHAB scores were scored secondary to PTA (best ear), cognitive and physical function. Conclusion: HRQoL scores in HL patients, in general, seems to be at the population level, but the unilateral HL patients scored to some extent lower than the bilateral HI patients. APHAB and generic QoL scores levels are associated. Both HRQoL and APHAB scores are generated more complexly than anticipated.

Keywords: quality of life, hearing loss, hearing impairment, distress, depression, anxiety, hearing aid

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19 Cardiac Rehabilitation Program and Health-Related Quality of Life; A Randomized Control Trial

Authors: Zia Ul Haq, Saleem Muhammad, Naeem Ullah, Abbas Shah, Abdullah Shah


Pakistan being the developing country is facing double burden of communicable and non-communicable disease. The aspect of secondary prevention of ischemic heart disease in developing countries is the dire need for public health specialists, clinicians and policy makers. There is some evidence that psychotherapeutic measures, including psychotherapy, recreation, exercise and stress management training have positive impact on secondary prevention of cardiovascular diseases but there are some contradictory findings as well. Cardiac rehabilitation program (CRP) has not yet fully implemented in Pakistan. Psychological, physical and specific health-related quality of life (HRQoL) outcomes needs assessment with respect to its practicality, effectiveness, and success. Objectives: To determine the effect of cardiac rehabilitation program (CRP) on the health-related quality of life (HRQoL) measures of post MI patients compared to the usual care. Hypothesis: Post MI patients who receive the interventions (CRP) will have better HRQoL as compared to those who receive the usual cares. Methods: The randomized control trial was conducted at a Cardiac Rehabilitation Unit of Lady Reading Hospital (LRH), Peshawar. LRH is the biggest hospital of the Province Khyber Pakhtunkhwa (KP). A total 206 participants who had recent first myocardial infarction were inducted in the study. Participants were randomly allocated into two group i.e. usual care group (UCG) and cardiac rehabilitation group (CRG) by permuted-block randomization (PBR) method. CRP was conducted in CRG in two phases. Three HRQoL outcomes i.e. general health questionnaire (GHQ), self-rated health (SRH) and MacNew quality of life after myocardial infarction (MacNew QLMI) were assessed at baseline and follow-up visits among both groups. Data were entered and analyzed by appropriate statistical test in STATA version 12. Results: A total of 195 participants were assessed at the follow-up period due to lost-to-follow-up. The mean age of the participants was 53.66 + 8.3 years. Males were dominant in both groups i.e. 150 (76.92%). Regarding educational status, majority of the participants were illiterate in both groups i.e. 128 (65.64%). Surprisingly, there were 139 (71.28%) who were non-smoker on the whole. The comorbid status was positive in 120 (61.54%) among all the patients. The SRH at follow-up among UCG and CRG was 4.06 (95% CI: 3.93, 4.19) and 2.36 (95% CI: 2.2, 2.52) respectively (p<0.001). GHQ at the follow-up of UCG and CRG was 20.91 (95% CI: 18.83, 21.97) and 7.43 (95% CI: 6.59, 8.27) respectively (p<0.001). The MacNew QLMI at follow-up of UCG and CRG was 3.82 (95% CI: 3.7, 3.94) and 5.62 (95% CI: 5.5, 5.74) respectively (p<0.001). All the HRQoL measures showed strongly significant improvement in the CRG at follow-up period. Conclusion: HRQOL improved in post MI patients after comprehensive CRP. Education of the patients and their supervision is needed when they are involved in their rehabilitation activities. It is concluded that establishing CRP in cardiac units, recruiting post-discharged MI patients and offering them CRP does not impose high costs and can result in significant improvement in HRQoL measures. Trial registration no: ACTRN12617000832370

Keywords: cardiovascular diseases, cardiac rehabilitation, health-related quality of life, HRQoL, myocardial infarction, quality of life, QoL, rehabilitation, randomized control trial

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18 Is Socio-Economic Characteristic is Associated with Health-Related Quality of Life among Elderly: Evidence from SAGE Data in India

Authors: Mili Dutta, Lokender Prashad


Introduction: Population ageing is a phenomenon that can be observed around the globe. The health-related quality of life (HRQOL) is a measurement of health status of an individual, and it describes the effect of physical and mental health disorders on the well-being of a person. The present study is aimed to describe the influence of socio-economic characteristics of elderly on their health-related quality of life in India. Methods: EQ-5D instrument and population-based EQ-5D index score has been measured to access the HRQOL among elderly. Present study utilized the Study on Global Ageing and Adult Health (SAGE) data which was conducted in 2007 in India. Multiple Logistic Regression model and Multivariate Linear Regression model has been employed. Result: In the present study, it was found that the female are more likely to have problems in mobility (OR=1.41, 95% Cl: 1.14 to 1.74), self-care (OR=1.26, 95% Cl: 1.01 to 1.56) and pain or discomfort (OR=1.50, 95% Cl: 1.16 to 1.94). Elderly residing in rural area are more likely to have problems in pain/discomfort (OR=1.28, 95% Cl: 1.01 to 1.62). More older and non-working elderly are more likely whereas higher educated and highest wealth quintile elderly are less likely to have problems in all the dimensions of EQ-5D viz. mobility, self-care, usual activity, pain/discomfort and anxiety/depression. The present study has also shown that oldest old people, residing in rural area and currently not working elderly are more likely to report low EQ-5D index score whereas elderly with high education level and high wealth quintile are more likely to report high EQ-5D index score than their counterparts. Conclusion: The present study has found EQ-5D instrument as the valid measure for assessing the HRQOL of elderly in India. The study indicates socio-economic characteristics of elderly such as female, more older people, residing in rural area, non-educated, poor and currently non-working as the major risk groups of having poor HRQOL in India. Findings of the study will be helpful for the programmes and policy makers, researchers, academician and social workers who are working in the field of ageing.

Keywords: ageing, HRQOL, India, EQ-5D, SAGE, socio-economic characteristics

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17 Determinants of Quality of Life in Patients with Atypical Prarkinsonian Syndromes: 1-Year Follow-Up Study

Authors: Tatjana Pekmezovic, Milica Jecmenica-Lukic, Igor Petrovic, Vladimir Kostic


Background: A group of atypical parkinsonian syndromes (APS) includes a variety of rare neurodegenerative disorders characterized by reduced life expectancy, increasing disability, and considerable impact on health-related quality of life (HRQoL). Aim: In this study we wanted to answer two questions: a) which demographic and clinical factors are main contributors of HRQoL in our cohort of patients with APS, and b) how does quality of life of these patients change over 1-year follow-up period. Patients and Methods: We conducted a prospective cohort study in hospital settings. The initial study comprised all consecutive patients who were referred to the Department of Movement Disorders, Clinic of Neurology, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade (Serbia), from January 31, 2000 to July 31, 2013, with the initial diagnoses of ‘Parkinson’s disease’, ‘parkinsonism’, ‘atypical parkinsonism’ and ‘parkinsonism plus’ during the first 8 months from the appearance of first symptom(s). The patients were afterwards regularly followed in 4-6 month intervals and eventually the diagnoses were established for 46 patients fulfilling the criteria for clinically probable progressive supranuclear palsy (PSP) and 36 patients for probable multiple system atrophy (MSA). The health-related quality of life was assessed by using the SF-36 questionnaire (Serbian translation). Hierarchical multiple regression analysis was conducted to identify predictors of composite scores of SF-36. The importance of changes in quality of life scores of patients with APS between baseline and follow-up time-point were quantified using Wilcoxon Signed Ranks Test. The magnitude of any differences for the quality of life changes was calculated as an effect size (ES). Results: The final models of hierarchical regression analysis showed that apathy measured by the Apathy evaluation scale (AES) score accounted for 59% of the variance in the Physical Health Composite Score of SF-36 and 14% of the variance in the Mental Health Composite Score of SF-36 (p<0.01). The changes in HRQoL were assessed in 52 patients with APS who completed 1-year follow-up period. The analysis of magnitude for changes in HRQoL during one-year follow-up period have shown sustained medium ES (0.50-0.79) for both Physical and Mental health composite scores, total quality of life as well as for the Physical Health, Vitality, Role Emotional and Social Functioning. Conclusion: This study provides insight into new potential predictors of HRQoL and its changes over time in patients with APS. Additionally, identification of both prognostic markers of a poor HRQoL and magnitude of its changes should be considered when developing comprehensive treatment-related strategies and health care programs aimed at improving HRQoL and well-being in patients with APS.

Keywords: atypical parkinsonian syndromes, follow-up study, quality of life, APS

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16 Study on Quality of Life among Patients Undergoing Hemodialysis in National Kidney Centre, Banasthali, Kathmandu

Authors: Tara Gurung, Suprina Prajapati


Health and well being of people is a crucial for accomplishing sustainable development goals of any country. The present study focuses on quality of life of patients undergoing hemodialysis. Hemodialysis is a life sustaining treatment for patients with end stage renal disease (ESRD). Hemodialysis can bring about significant impairment in health related quality of life (HRQOL). The purpose of this study was to assess the quality of life of hemodialysis patients undergoing hemodialysis. A descriptive cross-sectional research design was utilized in total 100 samples using random sampling technique. The findings revealed that the total quality of life of the patients was 30.41±3.99 out of 100. The total physical component score was statistically significant with education status of the patients where p value for t test was 0.03 (p=0.03) and occupation of the patients where p value for the ANOVA test was 0.007 (p=0.007). The study recommended that it would be better if awareness programs regarding chronic kidney disease and life style modification in hemodialysis patients is given to the patients so that it would help patients to maintain the HRQOL.

Keywords: health and well bing, hemodialysis, patients quality of life

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15 Metabolic Variables and Associated Factors in Acute Pancreatitis Patients Correlates with Health-Related Quality of Life

Authors: Ravinder Singh, Pratima Syal


Background: The rising prevalence and incidence of Acute Pancreatitis (AP) and its associated metabolic variables known as metabolic syndrome (MetS) are common medical conditions with catastrophic consequences and substantial treatment costs. The correlation between MetS and AP, as well as their impact on Health Related Quality of Life (HRQoL) is uncertain, and because there are so few published studies, further research is needed. As a result, we planned this study to determine the relationship between MetS components impact on HRQoL in AP patients. Patients and Methods: A prospective, observational study involving the recruitment of patients with AP with and without MetS was carried out in tertiary care hospital of North India. Patients were classified with AP if they were diagnosed with two or more components of the following criteria, abdominal pain, serum amylase and lipase levels two or more times normal, imaging trans-abdominal ultrasound, computed tomography, or magnetic resonance. The National Cholesterol Education Program–Adult Treatment Panel III (NCEP-ATP III) criterion was used to diagnose the MetS. The various socio-demographic variables were also taken into consideration for the calculation of statistical significance (P≤.05) in AP patients. Finally, the correlation between AP and MetS, along with their impact on HRQoL was assessed using Student's t test, Pearson Correlation Coefficient, and Short Form-36 (SF-36). Results: AP with MetS (n = 100) and AP without MetS (n = 100) patients were divided into two groups. Gender, Age, Educational Status, Tobacco use, Body Mass Index (B.M.I), and Waist Hip Ratio (W.H.R) were the socio-demographic parameters found to be statistically significant (P≤.05) in AP patients with MetS. Also, all the metabolic variables were also found to statistically significant (P≤.05) and found to be increased in patients with AP with MetS as compared to AP without MetS except HDL levels. Using the SF-36 form, a greater significant decline was observed in physical component summary (PCS) and mental component summary (MCS) in patients with AP with MetS as compared to patients without MetS (P≤.05). Furthermore, a negative association between all metabolic variables with the exception of HDL, and AP was found to be producing deterioration in PCS and MCS. Conclusion: The study demonstrated that patients with AP with MetS had a worse overall HRQOL than patients with AP without MetS due to number of socio-demographic and metabolic variables having direct correlation impacting physical and mental health of patients.

Keywords: metabolic disorers, QOL, cost effectiveness, pancreatitis

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14 Do Women with Endometriosis Have Higher Perceived Stress Levels than Healthy Women?

Authors: Jodie Hughes


Endometriosis affects 1 in 10 individuals that were born female globally. Endometriosis incidence rates peak between 30-40 year of age, in young women and adolescents it is a rarely suspected and often ill-diagnosed. The average cost of endometriosis is €9,579 per woman. More than 75% of women have reported being absent from work due to endometriosis, with 40% of women becoming unemployed due to the disease. 46% of patients with endometriosis need to have appointments with upward of five doctors to gain a correct diagnosis. Quantitative data were collected by way of an online PSS-10 survey that included demographic questions from two sample groups of females, group 1 was females with endometriosis, group 2 were healthy women. The data were scored using Cohens scoring system, overall scores were input to SPSS. A non-parametric Mann-Whitney U test and ANOVA was used to ascertain any differences between the PSS-10 scores of the two groups. A significance level of P<0.05 was adopted. Four women were invited to take part in a semi structured interview that was recorded, transcribed and coded using interpretive phenomenological analysis (IPA) using NVivo 12. Results showed that the PSS-10 scores were significantly higher in women with endometriosis compared to healthy women with a p=<0.005. Endometriosis affects all aspects of a patient’s life, to adequately diagnose and treat the condition and improve HRQoL there needs to be better understanding of the clinical symptoms and how they impact the lives of patients.

Keywords: endometriosis, HRQoL, perceived stress, women

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13 Personality, Coping, Quality of Life, and Distress in Persons with Hearing Loss: A Cross-Sectional Study of Patients Referred to an Audiological Service

Authors: Oyvind Nordvik, Peder O. L. Heggdal, Jonas Brannstrom, Flemming Vassbotn, Anne Kari Aarstad, Hans Jorgen Aarstad


Background: Hearing Loss (HL) is a condition that may affect people in all stages of life, but the prevalence increases with age, mostly because of age-related HL, generally referred to as presbyacusis. As human speech is related to relatively high frequencies, even a limited hearing loss at high frequencies may cause impaired speech intelligibility. Being diagnosed with, treated for and living with a chronic condition such as HL, must for many be a disabling and stressful condition that put ones coping resources to test. Stress is a natural part of life and most people will experience stressful events or periods. Chronic diseases, such as HL, are risk factor for distress in individuals, causing anxiety and lowered mood. How an individual cope with HL may be closely connected to the level of distress he or she is experiencing and to personality, which can be defined as those characteristics of a person that account for consistent patterns of feelings, thinking, and behavior. Thus, as to distress in life, such as illness or disease, available coping strategies may be more important than the challenge itself. The same line of arguments applies to level of experienced health-related quality of life (HRQoL). Aim: The aim of this study was to investigate the relationship between distress, HRQoL, reported hearing loss, personality and coping in patients with HL. Method: 158 adult (aged 18-78 years) patients with HL, referred for hearing aid (HA) fitting at Haukeland University Hospital in western Norway, participated in the study. Both first-time users, as well as patients referred for HA renewals were included. First-time users had been pre-examined by an ENT-specialist. The questionnaires were answered before the actual HA fitting procedure. The pure-tone average (PTA; frequencies 0.5, 1, 2, and 4 kHz) was determined for each ear. The Eysenck personality inventory, neuroticism and lie scales, the Theoretically Originated Measure of the Cognitive Activation Theory of Stress (TOMCATS) measuring active coping, hopelessness and helplessness, as well as distress (General Health Questionnaire (GHQ) - 12 items) and the EORTC Quality of Life Questionnaire general part were answered. In addition, we used a revised and shortened version of the Abbreviated Profile of Hearing Aid Benefit (APHAB) as a measure of patient-reported hearing loss. Results: Significant correlations were determined between APHAB (weak), HRQoL scores (strong), distress scores (strong) on the one side and personality and choice of coping scores on the other side. As measured by stepwise regression analyses, the distress and HRQoL scores were scored secondary to the obtained personality and coping scores. The APHAB scores were as determined by regression analyses scored secondary to PTA (best ear), level of neuroticism and lie score. Conclusion: We found that reported employed coping style, distress/HRQoL and personality are closely connected to each other in this patient group. Patient-reported HL was associated to hearing level and personality. There is need for further investigations on these questions, and how these associations may influence the clinical context.

Keywords: coping, distress, hearing loss, personality

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12 Effectiveness of Mobile Health Augmented Cardiac Rehabilitation (MCard) on Health-Related Quality of Life among Post-Acute Coronary Syndrome Patients: A Randomized Controlled Trial

Authors: Aliya Hisam, Zia Ul Haq, Sohail Aziz, Patrick Doherty, Jill Pell


Objective: To determine the effectiveness of Mobile health augmented Cardiac rehabilitation (MCard) on health-related quality of life (HRQoL) among post-acute coronary syndrome(post-ACS) patients. Methodology: In a randomized controlled trial, post-ACS patients were randomly allocated (1:1) to an intervention group (received MCard; counseling, empowering with self-monitoring devices, short text messages, in addition to standard post-ACS care) or control group (standard post-ACS care). HRQoL was assessed by generic Short Form-12 and MacNew quality of life myocardial infarction (QLMI) tools. Participants were followed for 24 weeks with data collection and analysis at three-time points (baseline, 12 weeks and 24 weeks). Result: At baseline, 160 patients (80 in each group; mean age 52.66+8.46 years; 126 males, 78.75%) were recruited, of which 121(75.62%) continued and were analyzed at 12-weeks and 119(74.37%) at 24-weeks. The mean SF-12 physical component score significantly improved in the MCard group at 12 weeks follow-up (48.93 vs. control 43.87, p<.001) and 24 weeks (53.52 vs. 46.82 p<.001). The mean SF-12 mental component scores also improved significantly in the MCard group at 12 weeks follow-up (44.84 vs. control 41.40, p<.001) and 24 weeks follow-up (48.95 vs 40.12, p<.001). At 12-and 24-week follow-up, all domains of MacNew QLMI (social, emotional, physical and global) were also statistically significant (p<.001) improved in the MCard group, unlike the control group. Conclusion: MCard is feasible and effective at improving all domains of HRQoL. There was an improvement in physical, mental, social, emotional and global domains among the MCard group in comparison to the control group. The addition of MCard programs to post-ACS standard care may improve patient outcomes and reduce the burden on the health care setting.

Keywords: acute coronary syndrome, mobile health augmented cardiac rehabilitation (MCard), cardiovascular diseases, cardiac rehabilitation, health-related quality of life, short form 12, MacNew QLMI

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11 The Association between Health-Related Quality of Life and Physical Activity in Different Domains with Other Factors in Croatian Male Police Officers

Authors: Goran Sporiš, Dinko Vuleta, Stefan Lovro


The purpose of the present study was to determine the associations between health-related quality of life (HRQOL) and physical activity (PA) in different domains. In this cross-sectional study, participants were 169 Croatian police officers (mean age 35.14±8.95 yrs, mean height 180.93±7.53 cm, mean weight 88.39±14.05 kg, mean body-mass index 26.90±3.39 kg/m2). The dependent variables were two general domains extracted from the HRQOL questionnaire: (1) physical component scale (PCS) and (2) mental component scale (MCS). The independent variables were job-related, transport, domestic and leisure-time PA, along with other factors: age, body-mass index, smoking status, psychological distress, socioeconomic status and time spent in sedentary behaviour. The associations between dependent and independent variables were analyzed by using multiple regression analysis. Significance was set up at p < 0.05. PCS was positively associated with leisure-time PA (β 0.28, p < 0.001) and socioeconomic status (SES) (β 0.16, p=0.005), but inversely associated with job-related PA (β -0.15, p=0.012), domestic-time PA (β -0.14, p=0.014), age (β -0.12, p=0.050), psychological distress (β -0.43, p<0.001) and sedentary behaviour (β -0.15, p=0.009). MCS was positively associated with leisure-time PA (β 0.19, p=0.013) and SES (β 0.20, p=0.002), while inversely associated with age (β -0.23, p=0.001), psychological distress (β -0.27, p<0.001) and sedentary behaviour (β -0.22, p=0.001). Our results added new information about the associations between domain-specific PA and both physical and mental component scale in police officers. Future studies should deal with the same associations in other stressful occupations.

Keywords: health, fitness, police force, relations

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10 The Association Between Objectively Measured Physical Activity and Health-related Quality of Life, Life-space Mobility and Successful Aging in Older Indian Adults

Authors: Jeanne Grace, Jacqueline Naiker


Background: Longevity is increasing, accompanied by a rise in disability and chronic diseases with physical activity (PA) delaying disability, ensuring successful aging (SA) and independent living in older adults. Aim: This study aimed to determine objectively measured PA levels, health-related quality of life (HRQoL), life-space mobility, and successful aging (SA) of older adults in KwaZulu-Natal province, South Africa, as well as their mutual associations. Methods: A total of 210 older adults aged 65–92 years were purposively sampled and completed the Medical Outcomes Study 36-Item Short-Form Health Survey, the Life-Space Mobility, and Successful Aging questionnaires. PA levels were measured using an Omron Pedometer, which the participants wore for seven consecutive days. Results: The average number of steps taken per day for the seven days was 2025, with 98.6% of the entire study population classified as sedentary. The Vitality domain (one of 8 categorized) reflected the best health status (M = 59.9, SD ± 18.8), with a significant 93% of the participants indicating that they had not visited places outside their immediate neighborhood (P < 0.0005). A significant, negative association between the average number of steps taken in 7 days and all three SA variables – namely, the physical (r = –0.152, P = 0.027), sociological (r = –0.148, P = 0.032) and psychological (r = –0.176, P = 0.010), and a significant, positive association with life-space mobility (r = 0.224, P = 0.001) was noted. Conclusion: The majority of the elderly were sedentary, affecting their HRQoL, life-space mobility, and SA negatively.

Keywords: active life expectancy, geriatrics, nursing homes, well-being

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9 Effects of Turkish Classical Music on Cognitive Function, Depression and Quality of Life in Elderly

Authors: Rukiye Pinar Boluktas


According to 2015 statistics, in Turkey, 46% of older people live alone in their homes, 55% have poor health perceptions, 18% face poverty, and 43% are unhappy. Prevalence of depression is between 14% and 20%. In 2013, rate of suicide was 6.5. However, the most of older people prefer to live in their community although they are lonely, they face poverty, and face limitations as a result of chronic diseases and disabilities. Community based care for older people is also encouraged by Ministry of Health as it is more cost-effective. Music therapy is a simple, effective, safe, and nonpharmacologic intervention that may be used to decrease depression and to improve cognition, and health related quality of life (HRQOL). In Turkish culture, music is typically described as ‘food for soul’. This study aimed to investigate the effect of Turkish classical music songs in 32 community dwelling older people. Participants were received interventions two or three times per week, 50-60 min per session, for 8 weeks at a day health center. Each intervention session started listening music for 15-20 min to get remember songs, then followed singing songs as a group. Participants were assessed at baseline (week 0), and two follow-up at month 1 and month 2. Compared to baseline, at two follow-up, we observed that cognition improved, depression decreased, and SF-36 scores, including 8 domains and two summary scores increased. We conclude that an intervention comprising listening and singing Turkish classical music improve cognition, depression and HRQOL in older people.

Keywords: cognitive function, depression, elderly, quality of life, Turkish classical music

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8 Tests for Zero Inflation in Count Data with Measurement Error in Covariates

Authors: Man-Yu Wong, Siyu Zhou, Zhiqiang Cao


In quality of life, health service utilization is an important determinant of medical resource expenditures on Colorectal cancer (CRC) care, a better understanding of the increased utilization of health services is essential for optimizing the allocation of healthcare resources to services and thus for enhancing the service quality, especially for high expenditure on CRC care like Hong Kong region. In assessing the association between the health-related quality of life (HRQOL) and health service utilization in patients with colorectal neoplasm, count data models can be used, which account for over dispersion or extra zero counts. In our data, the HRQOL evaluation is a self-reported measure obtained from a questionnaire completed by the patients, misreports and variations in the data are inevitable. Besides, there are more zero counts from the observed number of clinical consultations (observed frequency of zero counts = 206) than those from a Poisson distribution with mean equal to 1.33 (expected frequency of zero counts = 156). This suggests that excess of zero counts may exist. Therefore, we study tests for detecting zero-inflation in models with measurement error in covariates. Method: Under classical measurement error model, the approximate likelihood function for zero-inflation Poisson regression model can be obtained, then Approximate Maximum Likelihood Estimation(AMLE) can be derived accordingly, which is consistent and asymptotically normally distributed. By calculating score function and Fisher information based on AMLE, a score test is proposed to detect zero-inflation effect in ZIP model with measurement error. The proposed test follows asymptotically standard normal distribution under H0, and it is consistent with the test proposed for zero-inflation effect when there is no measurement error. Results: Simulation results show that empirical power of our proposed test is the highest among existing tests for zero-inflation in ZIP model with measurement error. In real data analysis, with or without considering measurement error in covariates, existing tests, and our proposed test all imply H0 should be rejected with P-value less than 0.001, i.e., zero-inflation effect is very significant, ZIP model is superior to Poisson model for analyzing this data. However, if measurement error in covariates is not considered, only one covariate is significant; if measurement error in covariates is considered, only another covariate is significant. Moreover, the direction of coefficient estimations for these two covariates is different in ZIP regression model with or without considering measurement error. Conclusion: In our study, compared to Poisson model, ZIP model should be chosen when assessing the association between condition-specific HRQOL and health service utilization in patients with colorectal neoplasm. and models taking measurement error into account will result in statistically more reliable and precise information.

Keywords: count data, measurement error, score test, zero inflation

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7 Comprehensive Literature Review of the Humanistic Burden of Clostridium (Clostridiodes) difficile Infection

Authors: Caroline Seo, Jennifer Stephens, Kirstin H. Heinrich


Background: Clostridiodes (formerly Clostridium) difficile infection (CDI) is an anaerobic, spore-forming bacterium with manifestations including diarrhea, pseudomembranous colitis and toxic megacolon. Despite general understanding that CDI may be associated with marked burden on patients’ health, there has been limited information available on the humanistic burden of CDI. The objective of this literature review was to summarize the published data on the humanistic burden of CDI globally, in order to better inform future research efforts and increase awareness of the patient perspective in this disease. Methods: A comprehensive literature review of the past 15 years (2002-2017) was conducted using MEDLINE, Embase and Cumulative Index of Nursing and Allied Health Literature. Additional searches were conducted from conference proceedings (2015-2017). Articles selected were studies specifically designed to examine the humanistic burden of illness associated with adult patients with CDI. Results: Of 3,325 articles or abstracts identified, 33 remained after screening and full text review. Sixty percent (60%) were published in 2016 or 2017. Data from the United States or Western Europe were most common. Data from Brazil, Canada, China and Spain also exist. Thirteen (13) studies used validated patient-reported outcomes instruments, mostly EQ-5D utility and SF-36 generic instruments. Three (3) studies used CDI-specific instruments (CDiff32, CDI-DaySyms). The burden of CDI impacts patients in multiple health-related quality of life (HRQOL) domains. SF-36 domains with the largest decrements compared to other GI diarrheal diseases (IBS-D and Crohn’s) were role physical, physical functioning, vitality, social functioning, and role emotional. Reported EQ-5D utilities for CDI ranged from 0.35-0.42 compared to 0.65 in Crohn’s and 0.72 in IBS-D. The majority of papers addressed physical functioning and mental health domains (67% for both). Across various studies patients reported weakness, lack of appetite, sleep disturbance, functional dependence, and decreased activities of daily lives due to the continuous diarrhea. Due to lack of control over this infection, CDI also impacts the psychological and emotional quality of life of the patients. Patients reported feelings of fear, anxiety, frustration, depression, and embarrassment. Additionally, the type of disease (primary vs. recurrent) may impact mental health. One study indicated that there is a decrement in SF-36 mental scores in patients with recurrent CDI, in comparison to patients with primary CDI. Other domains highlighted by these studies include pain (27%), social isolation (27%), vitality and fatigue (24%), self-care (9%), and caregiver burden (0%). Two studies addressed work productivity, with 1 of these studies reporting that CDI patients had the highest work productivity and activity impairment scores among the gastrointestinal diseases. No study specifically included caregiver self-report. However, 3 studies did provide mention of patients’ worry on how their diagnosis of CDI would impact family, caregivers, and/or friends. Conclusions: Despite being a serious public health issue there has been a paucity of research on the HRQOL among those with CDI. While progress is being made, gaps exist in understanding the burden on patients, caregivers, and families. Future research is warranted to aid understanding of the CDI patient perspective.

Keywords: burden, Clostridiodes, difficile, humanistic, infection

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6 Psychometric Properties of the Eq-5d-3l and Eq-5d-5l Instruments for Health Related Quality of Life Measurement in Indonesian Population

Authors: Dwi Endarti, Susi a Kristina, Rizki Noorizzati, Akbar E Nugraha, Fera Maharani, Kika a Putri, Asninda H Azizah, Sausanzahra Angganisaputri, Yunisa Yustikarini


Cost utility analysis is the most recommended pharmacoeconomic method since it allows widely comparison of cost-effectiveness results from different interventions. The method uses outcome of quality-adjusted life year (QALY) or disability-adjusted life year (DALY). Measurement of QALY requires the data of utility dan life years gained. Utility is measured with the instrument for quality of life measurement such as EQ-5D. Recently, the EQ-5D is available in two versions which are EQ-5D-3L and EQ-5D-5L. This study aimed to compare the EQ-5D-3L and EQ-5D-5L to examine the most suitable version for Indonesian population. This study was an observational study employing cross sectional approach. Data of quality of life measured with EQ-5D-3L and EQ-5D-5L were collected from several groups of population which were respondent with chronic diseases, respondent with acute diseases, and respondent from general population (without illness) in Yogyakarta Municipality, Indonesia. Convenience samples of hypertension patients (83), diabetes mellitus patients (80), and osteoarthritis patients (47), acute respiratory tract infection (81), cephalgia (43), dyspepsia (42), and respondent from general population (293) were recruited in this study. Responses on the 3L and 5L versions of EQ-5D were compared by examining the psychometric properties including agreement, internal consistency, ceiling effect, and convergent validity. Based on psychometric properties tests of EQ-5D-3L dan EQ-5D-5L, EQ-5D-5L tended to have better psychometric properties compared to EQ-5D-3L. Future studies for health related quality of life (HRQOL) measurements for pharmacoeconomic studies in Indonesia should apply EQ-5D-5L.

Keywords: EQ-5D, Health Related Quality of Life, Indonesian Population, Psychometric Properties

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5 An Exploratory Investigation into the Quality of Life of People with Multi-Drug Resistant Pulmonary Tuberculosis (MDR-PTB) Using the ICF Core Sets: A Preliminary Investigation

Authors: Shamila Manie, Soraya Maart, Ayesha Osman


Introduction: People diagnosed with multidrug resistant pulmonary tuberculosis (MDR-PTB) is subjected to prolonged hospitalization in South Africa. It has thus become essential for research to shift its focus from a purely medical approach, but to include social and environmental factors when looking at the impact of the disease on those affected. Aim: To explore the factors affecting individuals with multi-drug resistant pulmonary tuberculosis during long-term hospitalization using the comprehensive ICF core-sets for obstructive pulmonary disease (OPD) and cardiopulmonary (CPR) conditions at Brooklyn Chest Hospital (BCH). Methods: A quantitative descriptive, cross-sectional study design was utilized. A convenient sample of 19 adults at Brooklyn Chest Hospital were interviewed. Results: Most participants reported a decrease in exercise tolerance levels (b455: n=11). However it did not limit participation. Participants reported that a lack of privacy in the environment (e155) was a barrier to health. The presence of health professionals (e355) and the provision of skills development services (e585) are facilitators to health and well-being. No differences exist in the functional ability of HIV positive and negative participants in this sample. Conclusion: The ICF Core Sets appeared valid in identifying the barriers and facilitators experienced by individuals with MDR-PTB admitted to BCH. The hospital environment must be improved to add to the QoL of those admitted, especially improving privacy within the wards. Although the social grant is seen as a facilitator, greater emphasis must be placed on preparing individuals to be economically active in the labour for when they are discharged.

Keywords: multidrug resistant tuberculosis, MDR ICF core sets, health-related quality of life (HRQoL), hospitalization

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4 Evidence-Based in Telemonitoring of Users with Pacemakers at Five Years after Implant: The Poniente Study

Authors: Antonio Lopez-Villegas, Daniel Catalan-Matamoros, Remedios Lopez-Liria


Objectives: The purpose of this study was to analyze clinical data, health-related quality of life (HRQoL) and functional capacity of patients using a telemonitoring follow-up system (TM) compared to patients followed-up through standard outpatient visits (HM) 5 years after the implantation of a pacemaker. Methods: This is a controlled, non-randomised, nonblinded clinical trial, with data collection carried out at 5 years after the pacemakers implant. The study was developed at Hospital de Poniente (Almeria, Spain), between October 2012 and November 2013. The same clinical outcomes were analyzed in both follow-up groups. Health-Related Quality of Life and Functional Capacity was assessed through EuroQol-5D (EQ-5D) questionnaire and Duke Activity Status Index (DASI) respectively. Sociodemographic characteristics and clinical data were also analyzed. Results: 5 years after pacemaker implant, 55 of 82 initial patients finished the study. Users with pacemakers were assigned to either a conventional follow-up group at hospital (HM=34, 50 initials) or a telemonitoring system group (TM=21, 32 initials). No significant differences were found between both groups according to sociodemographic characteristics, clinical data, Health-Related Quality of Life and Functional Capacity according to medical record and EQ5D and DASI questionnaires. In addition, conventional follow-up visits to hospital were reduced in 44,84% (p < 0,001) in the telemonitoring group in relation to hospital monitoring group. Conclusion: Results obtained in this study suggest that the telemonitoring of users with pacemakers is an equivalent option to conventional follow-up at hospital, in terms of Health-Related Quality of Life and Functional Capacity. Furthermore, it allows for the early detection of cardiovascular and pacemakers-related problem events and significantly reduces the number of in-hospital visits. Trial registration: NCT02234245. The PONIENTE study has been funded by the General Secretariat for Research, Development and Innovation, Regional Government of Andalusia (Spain), project reference number PI/0256/2017, under the research call 'Development and Innovation Projects in the Field of Biomedicine and Health Sciences', 2017.

Keywords: cardiovascular diseases, health-related quality of life, pacemakers follow-up, remote monitoring, telemedicine

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3 A Cross-Cultural Validation of the Simple Measure of Impact of Lupus Erythematosus in Youngsters (Smiley) among Filipino Pediatric Lupus Patients

Authors: Jemely M. Punzalan, Christine B. Bernal, Beatrice B. Canonigo, Maria Rosario F. Cabansag, Dennis S. Flores, Paul Joseph T. Galutira, Remedios D. Chan


Background: Systemic lupus erythematosus (SLE) is one of the most common autoimmune disorders predominates in women of childbearing age. Simple Measure of Impact of Lupus Erythematosus in Youngsters (SMILEY) is the only health specific quality of life tool for pediatric SLE, which has been translated to different languages except in Filipino. Objective: The primary objective of this study was to develop a Filipino translation of the SMILEY and to examine the validity and reliability of this translation. Methodology: The SMILEY was translated into Filipino by a bilingual individual and back-translated by another bilingual individual blinded from the original English version. The translation was evaluated for content validity by a panel of experts and subjected to pilot testing. The pilot-tested translation was used in the validity and reliability testing proper. The SMILEY, together with the previously validated PEDSQL 4.0 Generic Core Scale was administered to lupus pediatric patients and their parent at two separate occasions: a baseline and a re-test seven to fourteen days apart. Tests for convergent validity, internal consistency, and test-retest reliability were performed. Results: A total of fifty children and their parent were recruited. The mean age was 15.38±2.62 years (range 8-18 years), mean education at high school level. The mean duration of SLE was 28 months (range 1-81 months). Subjects found the questionnaires to be relevant, easy to understand and answer. The validity of the SMILEY was demonstrated in terms of content validity, convergent validity, internal consistency, and test-retest reliability. Age, socioeconomic status and educational attainment did not show a significant effect on the scores. The difference between scores of child and parent report was showed to be significant with SMILEY total (p=0.0214), effect on social life (p=0.0000), and PEDSQL physical function (p=0.0460). Child reports showed higher scores for the following domains compared to their parent. Conclusion: SMILEY is a brief, easy to understand, valid and reliable tool for assessing pediatric SLE specific HRQOL. It will be useful in providing better care, understanding and may offer critical information regarding the effect of SLE in the quality of life of our pediatric lupus patients. It will help physician understands the needs of their patient not only on treatment of the specific disease but as well as the impact of the treatment on their daily lives.

Keywords: systemic lupus erythematosus, pediatrics, quality of life, Simple Measure of Impact of Lupus Erythematosus in Youngsters (SMILEY)

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2 Clinical Response of Nuberol Forte® (Paracetamol 650 MG+Orphenadrine 50 MG) For Pain Management with Musculoskeletal Conditions in Routine Pakistani Practice (NFORTE-EFFECT)

Authors: Shahid Noor, Kazim Najjad, Muhammad Nasir, Irshad Bhutto, Abdul Samad Memon, Khurram Anwar, Tehseen Riaz, Mian Muhammad Hanif, Nauman A. Mallik, Saeed Ahmed, Israr Ahmed, Ali Yasir


Background: Musculoskeletal pain is the most common complaint presented to the health practitioner. It is well known that untreated or under-treated pain can have a significant negative impact on an individual’s quality of life (QoL). Objectives: This study was conducted across 10 sites in six (6) major cities of Pakistan to evaluate the tolerability, safety, and the clinical response of Nuberol Forte® (Paracetamol 650 mg + Orphenadrine 50 mg) to musculoskeletal pain in routine Pakistani practice and its impact on improving the patient’s QoL. Design & Methods: This NFORT-EFFECT observational, prospective multicenter study was conducted in compliance with Good Clinical Practice guidelines and local regulatory requirements. The study sponsor was "The Searle Company Limited, Pakistan. To maintain the GCP compliances, the sponsor assigned the CRO for the site and data management. Ethical approval was obtained from an independent ethics committee. The IEC reviewed the progress of the study. Written informed consent was obtained from the study participants, and their confidentiality was maintained throughout the study. A total of 399 patients with known prescreened musculoskeletal conditions and pain who attended the study sites were recruited, as per the inclusion/exclusion criteria ( ID# NCT04765787). The recruited patients were then prescribed Paracetamol (650 mg) and Orphenadrine (50 mg) combination (Nuberol Forte®) for 7 to 14 days as per the investigator's discretion based on the pain intensity. After the initial screening (visit 1), a follow-up visit was conducted after 1-2 weeks of the treatment (visit 2). Study Endpoints: The primary objective was to assess the pain management response of Nuberol Forte treatment and the overall safety of the drug. The Visual Analogue Scale (VAS) scale was used to measure pain severity. Secondary to pain, the patients' health-related quality of life (HRQoL) was also assessed using the Muscle, Joint Measure (MJM) scale. The safety was monitored on the first dose by the patients. These assessments were done on each study visit. Results: Out of 399 enrolled patients, 49.4% were males, and 50.6% were females with a mean age of 47.24 ± 14.20 years. Most patients were presented with Knee Osteoarthritis (OA), i.e., 148(38%), followed by backache 70(18.2%). A significant reduction in the mean pain score was observed after the treatment with the combination of Paracetamol and Orphenadrine (p<0.05). Furthermore, an overall improvement in the patient’s QoL was also observed. During the study, only ten patients reported mild adverse events (AEs). Conclusion: The combination of Paracetamol and Orphenadrine (Nuberol Forte®) exhibited effective pain management among patients with musculoskeletal conditions and also improved their QoL.

Keywords: musculoskeletal pain, orphenadrine/paracetamol combination, pain management, quality of life, Pakistani population

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1 Profiling of the Cell-Cycle Related Genes in Response to Efavirenz, a Non-Nucleoside Reverse Transcriptase Inhibitor in Human Lung Cancer

Authors: Rahaba Marima, Clement Penny


The Health-related quality of life (HRQoL) for HIV positive patients has improved since the introduction of the highly active antiretroviral treatment (HAART). However, in the present HAART era, HIV co-morbidities such as lung cancer, a non-AIDS (NAIDS) defining cancer have been documented to be on the rise. Under normal physiological conditions, cells grow, repair and proliferate through the cell-cycle as cellular homeostasis is important in the maintenance and proper regulation of tissues and organs. Contrarily, the deregulation of the cell-cycle is a hallmark of cancer, including lung cancer. The association between lung cancer and the use of HAART components such as Efavirenz (EFV) is poorly understood. This study aimed at elucidating the effects of EFV on the cell-cycle genes’ expression in lung cancer. For this purpose, the human cell-cycle gene array composed of 84 genes was evaluated on both normal lung fibroblasts (MRC-5) cells and adenocarcinoma (A549) lung cells, in response to 13µM EFV or 0.01% vehicle. The ±2 up or down fold change was used as a basis of target selection, with p < 0.05. Additionally, RT-qPCR was done to validate the gene array results. Next, In-silico bio-informatics tools, Search Tool for the Retrieval of Interacting Genes/Proteins (STRING), Reactome, Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway and Ingenuity Pathway Analysis (IPA) were used for gene/gene interaction studies as well as to map the molecular and biological pathways influenced by the identified targets. Interestingly, the DNA damage response (DDR) pathway genes such as p53, Ataxia telangiectasia mutated and Rad3 related (ATR), Growth arrest and DNA damage inducible alpha (GADD45A), HUS1 checkpoint homolog (HUS1) and Role of radiation (RAD) genes were shown to be upregulated following EFV treatment, as revealed by STRING analysis. Additionally, functional enrichment analysis by the KEGG pathway revealed that most of the differentially expressed gene targets function at the cell-cycle checkpoint such as p21, Aurora kinase B (AURKB) and Mitotic Arrest Deficient-Like 2 (MAD2L2). Core analysis by IPA revealed that p53 downstream targets such as survivin, Bcl2, and cyclin/cyclin dependent kinases (CDKs) complexes are down-regulated, following exposure to EFV. Furthermore, Reactome analysis showed a significant increase in cellular response to stress genes, DNA repair genes, and apoptosis genes, as observed in both normal and cancerous cells. These findings implicate the genotoxic effects of EFV on lung cells, provoking the DDR pathway. Notably, the constitutive expression of this pathway (DDR) often leads to uncontrolled cell proliferation and eventually tumourigenesis, which could be the attribute of HAART components’ (such as EFV) effect on human cancers. Targeting the cell-cycle and its regulation holds a promising therapeutic intervention to the potential HAART associated carcinogenesis, particularly lung cancer.

Keywords: cell-cycle, DNA damage response, Efavirenz, lung cancer

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