Adalimumab versus Infliximab Treatment Outcome in Ulcerative Colitis: Application of EQ-5D, Visual Analogue Scale, and IBDQ-9 Measures: A Prospective Observational Study.

BACKGROUND: Ulcerative colitis (UC) is a chronic global disease, and its incidence and prevalence are increasing worldwide. OBJECTIVE: Our objective was to compare the secondary outcome of treatment with Infliximab (IFX) and Adalimumab (ADA) in the UC patients. METHODS: This was a one-year prospective observational study of moderate- to -severe UC patients treated with ADA or IFX. Patients' secondary health outcomes were measured using the EQ-5D 3L, EQ-VAS, and IBDQ-9 tools. T-test, Mann-Whitney, chi-square, and Fisher's exact tests were used to compare health-related quality of life (HRQoL) among UC patients. HRQoL predictor variables were identified by multivariate linear regression and multivariate logistic regression. RESULTS: A total of 238 UC patients (patients taking IFX: 78, patients taking ADA: 160) with a mean age of 37.66 and a mean disease duration of 9.29 years were enrolled. The EQ-5D index, EQ-VAS, and IBDQ-9 scores of patients taking IFX were 0.65, 55.93 and, 37.42, respectively. Similarly, patients taking ADA were 0.68, 59.27 and, 36.61, respectively. The highest problem reports were in P/D: 86.1% and A/D: 73.5%. The main independent predictors of HRQoL were: education over 12 years (ß = 0.054 [EQ-5D index], ß = 13.63 [EQ-VAS], OR: 0.28 [MO], OR: 0.07 [SC]), education between 6-12 years (ß = 11.23 [EQ-VAS]), and having "other chronic diseases" (ß = -0.074 [EQ-5D index], ß = -5.29 [IBDQ-9], OR: 2.84 [UA], OR: 3.80 [A/D]). CONCLUSION: There was no significant difference between the effect of ADA and IFX on secondary health outcomes in patients with moderate-to-severe UC.

Methods for the health technology assessment of complex interventions: a protocol for a scoping review.

INTRODUCTION: In healthcare policy and economic literature, research on the health technology assessment (HTA) of complex interventions (CIs) is becoming increasingly important. In many developed countries, HTA guides decision-making to help achieve greater value for money when funding health care. However, research has yet to identify the forms of evidence and evaluation criteria that should be used in the HTA of CIs. Previous research has established that the HTA of CIs requires multiple factors to be evaluated but there is no agreement on which factors ought always to be considered. There is equally little agreement on which forms of evidence ought to be collected or synthesised and how. We plan to perform a systematic scoping review in order to identify the range of evaluation criteria and types of evidence currently used in the HTA of CIs. METHOD AND ANALYSIS: This protocol was developed to guide the methodological framework for the conduct of a scoping review on health technology assessment (HTA) of complex interventions (CIs), using the Joanna Briggs Institute guidelines and the six-stage framework proposed by Arksey and O'Malley, in addition to more recent innovations in scoping review methodology. A grey literature search will supplement the primary searches of seven electronic databases for studies available in English between January 2000 and August 2020. Two reviewers will independently screen all search results for inclusion and data will be extracted using a customised data extraction or charting form. Any dispute will be resolved by consensus or through arbitration by a third author. The mnemonic Population, Concept and Context will be adopted to establish criteria for selecting relevant literature, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: Extension for Scoping Review will be used for reporting the results. Several explanatory-descriptive methods will be used for analysing the extracted data including frequency and trend analyses as well as reflexive thematic coding and analysis.Mapping evidence on the HTA of CIs will allow us to gain a better understanding of both established and emerging practices, including the information types, requirements, values and parameters that are incorporated in the HTA of CIs. We also expect the findings of the scoping review to help identify research gaps that will guide future studies. As healthcare becomes more complex in its delivery, it is timely to determine how these complex interventions should be assessed so that policy decisions can be made about whether implementation and public funding is warranted. ETHICS AND DISSEMINATION: This scoping review will involve secondary analysis of already collected data, and thus, does not require ethics approval. The research findings will be submitted to peer-reviewed journals for publication and will also be disseminated at conferences and seminars.

Prevalence of Cigarette Smoking and Associated Factors among Male Citizens in Tehran, Iran.

BACKGROUND: Cigarette smoking is as the leading cause of cancer mortality and other chronic diseases in males worldwide. The prevalence of cigarette smoking is different across and within countries by age, education level, occupation, and so on. This study aimed to determine the prevalence of cigarette smoking and its relationship with individuals' demographic factors and BMI in adolescent men living in Tehran, Iran. MATERIALS AND METHODS: This study involved secondary analysis of the 'Urban Health Equity Assessment and Response Tool-2' survey conducted in Tehran, Iran, among men aged 20+, 2011-2012. Using a multistage sampling method, 45,990 men were included in the study. The cigarette smoking status, BMI and demographic factors measured through a self-administered questionnaire. Chi-square, t-test, and logistic regression model were used to examine the relationships between the independents variables and cigarette smoking behavior, using SPSS software version 21. RESULTS: In the total of 45,990 men, the overall prevalence of cigarette smoking was 14.6% (CI 95%: 14.29- 14.94). Age (OR=0.96; CI 95%:0.94-0.98), house ownership (OR=0.68; CI 95%: 0.64-0.72), job status (OR=0.60; CI 95%: 0.46-0.86), marital status (OR=0.42; CI 95%: 0.39-0.47) and educational levels (OR=0.50; CI95%: 0.45-0.54) were associated with the prevalence of cigarette smoking. However, associations with BMI, family size, residency years, and district were not statistically significant. CONCLUSIONS: Given the relatively high prevalence of cigarette smoking in the study population, policy interventions are required to address this major public health issue, with a focus on the population demographic influences.

Association between social capital, health-related quality of life, and mental health: a structural-equation modeling approach.

AIM: To explore the association(s) between demographic factors, socioeconomic status (SES), social capital, health-related quality of life (HRQoL), and mental health among residents of Tehran, Iran. METHODS: The pooled data (n=31519) were extracted from a population-based survey Urban Health Equity Assessment and Response Tool-2 (Urban HEART-2) conducted in Tehran in 2011. Mental health, social capital, and HRQoL were assessed using the 28-item General Health Questionnaire (GHQ-28), social capital questionnaire, and Short-Form Health Survey (SF-12), respectively. The study used a multistage sampling method. Social capital, HRQoL, and SES were considered as latent variables. The association between these latent variables, demographic factors, and mental health was determined by structural-equation modeling (SEM). RESULTS: The mean age and mental health score were 44.48±15.87 years and 23.33±11.10 (range, 0-84), respectively. The prevalence of mental disorders was 41.76% (95% confidence interval 41.21-42.30). The SEM model showed that age was directly associated with social capital (P=0.016) and mental health (P=0.001). Sex was indirectly related to mental health through social capital (P=0.018). SES, HRQoL, and social capital were associated both directly and indirectly with mental health status. CONCLUSION: This study suggests that changes in social capital and SES can lead to positive changes in mental health status and that individual and contextual determinants influence HRQoL and mental health.

Empowerment assessment and influential factors among patients with type 2 diabetes.

BACKGROUND: Diabetic patients need high awareness of disease prevention to adopt self-management behaviors in their daily life. Central to this activity is patients' empowerment. Current study was conducted to assess empowerment score and its related factors among type 2 diabetic patients. METHOD: A cross-sectional study carried out over a period of nine months during 2010-2011. All patients with a diagnosis of type 2 diabetes including those referring to four hospitals affiliated with Tehran University of Medical Sciences were recruited. A total of 688 diabetic patients were identified who met the inclusion criteria and were all included in the study. Patients' empowerment was measured by Diabetes Empowerment Scale reflecting three dimensions including managing psychosocial aspect of diabetes, assessing dissatisfaction and readiness to change and Setting and achieving diabetes goal. Collected data was analysed using SPSS software version 11.5. RESULTS: As total, 688 were available for analysis, ranging from 37-81 years old with mean of 54.41 years (SD = 8.22). The Mean duration of the disease was approximately 6.67 years (SD = 4.58). Dimensions of 'managing the psychosocial aspect of diabetes', 'assessing dissatisfaction and readiness to change' and 'setting and achieving diabetes goal' were all measured and scored for each patient. The mean score for each domain was 25.75 ± 5.55, 24.78 ± 7.54, 27.63 ± 7.90, respectively. Data analysis revealed a statistically significant reverse relationship between age and 'assessing dissatisfaction and readiness to change' and 'setting and achieving diabetes goal'. In addition, disease duration had a statistically significant reverse relationship with 'assessing dissatisfaction and readiness to change'. CONCLUSION: Patients with type 2 diabetes have the potential to be empowered to manage their chronic disease if they are actively informed and educated.

Epidemiology of burn injuries in south-eastern Iran: a retrospective study.

OBJECTIVE: To explore the epidemiology of burn injuries in Zahedan, Southeastern Iran. METHODS: A retrospective review of 730 medical records, of burnt patients, for a period of two years was done. Predesigned data recording forms were used to collect data. The SPSS-15 was used to analyze data. RESULTS: Overall, 713 medical records were analyzed: two-thirds (62.0%) were fire-related and one-third related to scalds (33.1%). Intentional self-harm injuries accounted for 14.3% of all admissions. A significant difference existed between patients' age or sex and the causes of burns (P < 0.001). Burns more than 60% closely correlated with death rate and hospital stay (P < 0.001). CONCLUSION: Lack of the necessary, socio-economic infrastructure, language and cultural barriers, low level of literacy, flammability of women's clothes and unsafe application/design of stove and heaters are likely to contribute to the high frequency of burn injuries in this area.

A study of serum levels of leptin, ghrelin and tumour necrosis factor-alpha in child patients with cyanotic and acyanotic, congenital heart disease.

OBJECTIVE: To investigate the serum levels of leptin, ghrelin and tumour necrosis factor-alpha in children with cyanotic and acyanotic congenital heart disease. METHODS: The prospective cohort study, was conducted at imam Ali Hospital, Zahedan University of Medical Sciences, Iran, in 2009-10 and comprised 64 subjects, including patients and controls. Using enzyme-linked immunosorpent assay kits, serum levels of ghrelin, leptin and tumour necrosis factor-alpha were measured and compared among patients (both cyanotic and acyanotic) and the controls, SPSS version 20 was used for statistical analysis. RESULTS: Of the 64 subjects, 24 (37.5%) were cyanotic, 21 (32.8%) were acynotic and 19 (29.68%) were healthy controls. The three groups were homogenous in terms of age and gender characteristics. There was no significant difference among the groups leptin, ghrelin and tumour necrosis factor-alpha serum levels (p > 0.05). There were also no significant differences in terms of weight, height and body mass index (P > 0.05). CONCLUSION: Serum levels of ghrelin, leptin and tumour necrosis factor-alpha did not change in acyanotic and cyanotic patients with congenital heart disease, suggesting that other crucial factors may regulate individuals' nutrient intake, growth, weight and energy intake and output.

A study on family communication pattern and parenting styles with quality of life in adolescent.

OBJECTIVE: To investigate the relationship between parenting styles and family communication patterns with adolescent's quality of life. METHODS: The cross-sectional study was carried out on 439 randomly selected adolescents in the city of Zahedan, Iran, from January to July 2011.The subjects were asked to complete the KIDSCREEN-52 health-related quality of life questionnaire, while their parents were asked to complete the Diana Brinder's Test to show their parenting styles. SPSS 15 was used to analyse data. RESULTS: Most parents had 'authoritative' parenting style (n = 380; 86.6%). Pluralistic (n = 170; 38.7%) and consensual (n = 152; 34.6%) patterns were the most frequent styles of communication in families. Data suggested a significant relationship between parenting style and some dimensions of quality of life, including physical well-being, psychological well-being, social support and peers, and autonomy (p < 0.05). There was also a significant relationship between family communication patterns and parent relation and home life (p < 0.001) as well as autonomy (p < 0.006). CONCLUSION: Families play a critical role in increasing adolescents' health-related quality-of-life. Effort should be made to address problems facing parents while raising their children.

Economics and resourcing of complex healthcare systems.

With rapid increases in healthcare spending over recent years, health economic evaluation might be thought to be increasing in importance to decision-makers. Such evaluations are designed to inform the efficient management of healthcare resources. However, research into health policy decisions often report, at best, moderate use of economic evaluation information, especially at the local level of administration. Little attention seems to have been given to the question of why economic evaluations have been underused and why they may yield different results in different contexts. There are many barriers to applying economic evaluations in situations which combine complexity with uncertainty. These barriers call for innovative and creative responses to economic evaluation of healthcare interventions. One response is to view economic evaluations in the context of complex adaptive systems theory. Such theory offers a conceptual framework that takes into account contextual factors, multiple input and output, multiple perspectives and uncertainty involved in healthcare interventions. This article illustrates how complexity theory can enrich and broaden policy-makers' understanding of why economic evaluations have not always been as successful as health economists would have hoped. It argues for health economists to emphasise contextual knowledge and relativist understanding of decision contexts rather than seeking more technically sound evidence-based reviews including economic evaluations.

Adaptive decision-making: how Australian healthcare managers decide.

Despite many calls for the utilisation of research evidence in health policy-making, it is not widely practised, and little is known about how decision-makers in healthcare organisations actually make decisions. We recruited a purposive sample of Australian healthcare decision-makers to complete a web-based survey. We then took a sub-sample from willing respondents for individual interviews. All interviews were audio-recorded, transcribed verbatim and coded thematically. We found that resource allocation decision-making varied greatly across the Australian healthcare system. Decision-making was highly dependent on the operational context in time, place and purpose, and that research evidence was rarely exploited to its full potential. Decision-making involved a multifaceted interplay of elements in situation of inquiry. All decisions were made by networks or collectives of people; and no instance of individual decision-making was reported. This varied, social and contextual nature of decision-making points to a complexity that is not reflected in systematic evidence-based reviews or evidence-based models for decision-making, and we did not discover an appropriate model to reflect this complexity in the health- related literature. We developed a model of 'adaptive decision-making' that has potential to guide robust decision-making in complex situations, and could have some value as an explanatory or theoretical model for teaching and practice.

Assessment of diabetic distress and disease related factors in patients with type 2 diabetes in Isfahan: A way to tailor an effective intervention planning in Isfahan-Iran.

BACKGROUND: The purpose of this study was to assess diabetes distress and its related factors among type 2 diabetic patients to better tailor intervention planning in Isfahan-Iran. METHODS: A cross-sectional study was conducted in 2011. Study population was patients with type 2 diabetes referring to Omolbanin, an outpatient diabetic center in Isfahan. 140 diabetic patients met the inclusion criteria and were all included in the study. Patient's diabetes distress was measured by DDS. A 17-item self-report diabetes distress scale was used with subscales reflecting 5 domains: 1) Emotional burden (5 items), 2) Physician distress (4 items), 3) Regimen distress (5 items) and 4) Interpersonal distress (3 items). The responses to each item were rated between 1 and 6 (1 = not a problem, 2 = a slight problem, 3 = a moderate problem, 4 = somewhat serious problem, 5 = a serious problem, 6 = a very serious problem). The minimum and the maximum of score in the scale were 17 and 114 respectively. Collected data was analyzed by using SPSS software version 11.5. RESULTS: Mean age of participants were 53.23 years (SD = 7.82). 54.3% was female, 97.1% was married, and 57.1% had education lower than diploma. The average score of total diabetes distress was 2.96 ± 0.83. The average score of each domain was (3.40 ± 1.18), (2.57 ± 0.88), (2.97 ± 0.90), (2.76 ± 0.91) respectively. 'Emotional Burden' was considered as the most important domain in measuring diabetes distress. Total diabetes distress had significant association with age (p = 0.02), duration of diabetes (p<0.001), marital status, comorbidity, complications (p<0.001), and history of diabetes (p = 0.01). Pearson correlation coefficient revealed that diabetes distress of type 2 diabetic patients has a linear and direct relation with HbAlc (r = 0.63, p<0.001). CONCLUSION: It seems some keywords have a main role in diabetes distress such as emotional support, communication with patient and physician, self-efficacy and social support. All of these points are achievable through empowerment approach in diabetes care plan.

Evaluation of self-care practices and relative components among type 2 diabetic patients.

BACKGROUND: The purpose of this study was to assess self-care practices and their relative components among type 2 diabetic patients. We hypothesized that some sociodemographic and health-related factors, high diabetes distress, and low self-efficacy would be associated with poorer self-care practices. MATERIALS AND METHODS: A cross-sectional study was conducted for a period of 6 months in 2011. Study population was type 2 diabetic patients referring to Omolbanin center, an outpatient diabetic center in Isfahan. One hundred forty diabetic patients met the inclusion criteria and were all included in the study. Patients' self-care practices were measured by Summary of Diabetes Self-care Activities (SDSCA) self-report scale that includes items on the following aspects of the diabetes regimen: General diet, specific diet, exercise, blood glucose testing, foot care, medications, and smoking. Diabetes distress measured by Diabetes Distress Scale (DDS) scale and Stanford diabetes self-efficacy scale was used for scoring this issue. Collected data were analyzed by using SPSS software version 11.5. RESULTS: Participants were between the ages of 37 and 75 years, with a mean of 53.23 years (SD=7.82). Fifty-four percent (n=76) were females; 97.1% were married (n=136), and 53.6% had education lower than diploma (n=75). Mean of duration of diabetes was 7.1 (SD=5.63) years. "Medications" subscale was considered as the most important one in measuring diabetes self-care practices (5.24 ± 2.38 days/week). Study findings revealed that general diet had significant relation with comorbidity, type of treatment, body mass index (BMI), fasting blood sugar (FBS), (Blood Sugar) (BS), waist circumference, diabetes distress, and self-efficacy. Specific diet had significant relation with comorbidity, education, triglyceride (TG), diastolic blood pressure (DBP), and low density lipoprotein (LDL). Exercise showed significant relation with history of diabetes, education, type of treatment, disease duration, TG, BMI, and BS. Also, blood glucose testing showed significant relation with disease duration, self-efficacy, TG, DBP, BS, LDL, and high density lipoprotein (HDL). On the other hand, foot care was related to age, diabetes distress, TG, BMI, HDL, and diabetes complications. Medications subscale as the most important subscale of self-care practices was relevant with age, disease duration, diabetes complications, type of treatment, FBS, HDL, and self-efficacy. The last subscale, smoking, had significant relation with sex, diabetes complications, diabetes distress, self-efficacy, TG, total cholesterol, BS, and HDL. CONCLUSION: This information should be used in clinical practice when targeting and designing educational and care plan for patients with type 2 diabetes.

The introduction of self-management in Type 2 Diabetes care: A narrative review.

Type 2 diabetes is one of the most life-threatening public health challenges in the world. It causes a high disease burden including increased disability, reduced life expectancy and ever-increasing costs of care in almost every country. The growing burden of diabetes along with rapid cultural changes, aging population, increasing urbanization, changes in nutritional habits, reduced physical activity, and improper lifestyle and behavior patterns would inexorably drive increased health care costs and demands. Several models of education have been proposed to reduce the complications of chronic diseases including diabetes. However, it is widely known and acknowledged that adopting self-care and self-management behaviors play a fundamental role in diabetes control and treatment. A non-systematic (narrative) search strategy was used to collect necessary data. Several models of diabetes care such as compliance-based or curative models exist. Neither the curative model nor the compliance/adherence model is rigorously effective in diabetes care. The model of self-empowerment - based on the three fundamental aspects of chronic illness care: choices, control, and consequences - is much more applicable in the management of diabetes. This point to an approach which recognizes that patients are responsible for their diabetes care. Self-empowerment model has the potential to place diabetes care into context - a context which is based on active involvement of patients and informed, proactive healthcare professionals in the process of care.

Resource allocation and economic evaluation in Australia's healthcare system.

OBJECTIVE: To explore dimensions and varieties of economic evaluations that healthcare decision-makers do or do not use. DESIGN: Web-based survey. SETTING AND PARTICIPANTS: A purposive sample of Australian healthcare decision-makers was recruited by direct invitation through email. All were invited to complete an online questionnaire derived from the EUROMET 2004 survey. RESULTS: A total of 91 questionnaires were analysed. Almost all participants were involved in financial resource allocations. Most commonly, participants based their decisions on patient needs, effectiveness of interventions, cost of interventions or overall budgetary effect, and policy directives. Evidence from cost-effectiveness analysis was used by half of the participants. Timing, ethical issues and lack of knowledge about economic evaluation were the most significant barriers to the use of economic evaluations in resource allocation decisions. Most participants reported being moderately to very familiar with the cost-effectiveness analysis. There was a general impression that evidence from economic evaluations should play a larger role in the future. CONCLUSIONS: Evidence from health economic evaluations may provide valuable information in some decisions; however, at present, it is not central to many decisions. The study suggests that, for economic evaluation to be helpful in real-life policy decisions, it has to be placed into context - a context which is complex, political and often resistant to voluntary change.