Measurement of the major ignored burden of multiple myeloma, pernicious anaemia and of other haematological conditions on partners and family members: A cross-sectional study.

BACKGROUND: Having a haematological condition can adversely affect the quality of life (QoL) of family members/partners of patients. It is important to measure this often ignored burden in order to implement appropriate supportive interventions. OBJECTIVE: To measure current impact of haematological conditions on the QoL of family members/partners of patients, using the Family Reported Outcome Measure-16 (FROM-16). METHODS: A cross-sectional study, recruited online through patient support groups, involved UK family members/partners of people with haematological conditions completing the FROM-16. RESULTS: 183 family members/partners (mean age = 60.5 years, SD = 13.2; females = 62.8%) of patients (mean age = 64.1, SD = 12.8; females = 46.4%) with 12 haematological conditions completed the FROM-16. The FROM-16 mean total score was 14.0 (SD = 7.2), meaning 'a moderate effect on QoL'. The mean FROM-16 scores of family members of people with multiple myeloma (mean = 15.8, SD = 6.3, n = 99) and other haematological malignancies (mean = 13.9, SD = 7.8, n = 29) were higher than of people with pernicious anaemia (mean = 10.7, SD = 7.5, n = 47) and other non-malignant conditions (mean = 11, SD = 7.4, n = 56, p < .01). Over one third (36.1%, n = 183) of family members experienced a 'very large effect' (FROM-16 score>16) on their quality of life. CONCLUSIONS: Haematological conditions, in particular those of malignant type, impact the QoL of family members/partners of patients. Healthcare professionals can now, using FROM-16, identify those most affected and should consider how to provide appropriate holistic support within routine practice.

Mapping of Family Reported Outcome Measure (FROM-16) scores to EQ-5D: algorithm to calculate utility values.

OBJECTIVE: Although decision scientists and health economists encourage inclusion of family member/informal carer utility in health economic evaluation, there is a lack of suitable utility measures comparable to patient utility measures such those based on the EQ-5D. This study aims to predict EQ-5D-3L utility values from Family Reported Outcome Measure (FROM-16) scores, to allow the use of FROM-16 data in health economic evaluation when EQ-5D data is not available. METHODS: Data from 4228 family members/partners of patients recruited to an online cross-sectional study through 58 UK-based patient support groups, three research support platforms and Welsh social services departments were randomly divided five times into two groups, to derive and test a mapping model. Split-half cross-validation was employed, resulting in a total of ten multinomial logistic regression models. The Monte Carlo simulation procedure was used to generate predicted EQ-5D-3L responses, and utility scores were calculated and compared against observed values. Mean error and mean absolute error were calculated for all ten validation models. The final model algorithm was derived using the entire sample. RESULTS: The model was highly predictive, and its repeated fitting using multinomial logistic regression demonstrated a stable model. The mean differences between predicted and observed health utility estimates ranged from 0.005 to 0.029 across the ten modelling exercises, with an average overall difference of 0.015 (a 2.2% overestimate, not of clinical importance). CONCLUSIONS: The algorithm developed will enable researchers and decision scientists to calculate EQ-5D health utility estimates from FROM-16 scores, thus allowing the inclusion of the family impact of disease in health economic evaluation of medical interventions when EQ-5D data is not available.

Stress perfusion cardiovascular magnetic resonance and serial fractional flow reserve assessment of the left anterior descending artery in patients undergoing right coronary artery chronic total occlusion revascularization.

BACKGROUND: Fractional flow reserve (FFR) assessment of remote arteries, in the context of a bystander chronic total occlusion (CTO), can lead to false positive results. Adenosine stress cardiovascular magnetic resonance (CMR) evaluates perfusion defects across the entire myocardium and may therefore be a reliable tool in the work-up of remote lesions in CTO patients. The IMPACT-CTO study investigated donor artery invasive physiology before, immediately post, and at 4 months following right coronary artery (RCA) CTO percutaneous coronary intervention (PCI). The aim of this subanalysis was to assess the concordance between baseline perfusion CMR and serial FFR evaluation of left anterior descending artery (LAD) ischemia in patients from the IMPACT-CTO study. METHODS: Baseline adenosine stress CMR examinations from 26 patients were analyzed for qualitative evidence of LAD ischemia. The results were correlated with the serial LAD FFR measurements. RESULTS: The present findings demonstrated that before RCA CTO PCI, there was 62% agreement between perfusion CMR and FFR (ischemic threshold £ 0.8) in the assessment of LAD ischemia (k = 0.29; fair concordance). At 4 months after revascularization, there was 77% agreement (k = 0.52; moderate concordance) between the index CMR assessment of LAD ischemia and the follow-up LAD FFR. Concordance was improved at a LAD FFR ischemic threshold of £ 0.75. CONCLUSIONS: In this hypothesis generating study, baseline CMR assessment of LAD ischemia correlated better with the 4 months LAD FFR data (threshold £ 0.8) as compared to the FFR measurements taken prior to RCA CTO revascularization.

Family reported outcomes, an unmet need in the management of a patient's disease: appraisal of the literature.

BACKGROUND: A person's chronic health condition or disability can have a huge impact on the quality of life (QoL) of the whole family, but this important impact is often ignored. This literature review aims to understand the impact of patients' disease on family members across all medical specialities, and appraise existing generic and disease-specific family quality of life (QoL) measures. METHODS: The databases Medline, EMBASE, CINHAL, ASSIA, PsycINFO and Scopus were searched for original articles in English measuring the impact of health conditions on patients' family members/partner using a valid instrument. RESULTS: Of 114 articles screened, 86 met the inclusion criteria. They explored the impact of a relative's disease on 14,661 family members, mostly 'parents' or 'mothers', using 50 different instruments across 18 specialities including neurology, oncology and dermatology, in 33 countries including the USA, China and Australia. These studies revealed a huge impact of patients' illness on family members. An appraisal of family QoL instruments identified 48 instruments, 42 disease/speciality specific and six generic measures. Five of the six generics are aimed at carers of children, people with disability or restricted to chronic disease. The only generic instrument that measures the impact of any condition on family members across all specialities is the Family Reported Outcome Measure (FROM-16). Although most instruments demonstrated good reliability and validity, only 11 reported responsiveness and only one reported the minimal clinically important difference. CONCLUSIONS: Family members' QoL is greatly impacted by a relative's condition. To support family members, there is a need for a generic tool that offers flexibility and brevity for use in clinical settings across all areas of medicine. FROM-16 could be the tool of choice, provided its robustness is demonstrated with further validation of its psychometric properties.

In vitro Assessment of Tris Egg Yolk and Soybean Lecithin Based Extenders for Cryopreservation of Crossbred Ram Semen.

BACKGROUND: The replacement of egg yolk with alternative plant-derived soybean lecithin is gaining interest in both animal and human sperm cryopreservation owing to biosecurity issues with egg yolk based extenders. OBJECTIVE: To evaluate the comparative effect of egg yolk and soyabean lecithin based extenders on the quality of cryopreserved crossbred ram semen. METHODS: Pooled ejaculates (total ejaculates = 36) were divided into two aliquots and extended with Tris egg yolk extender (Tris extender) and soybean lecithin based commercial extender (Ovixcell) RESULTS: Among the two extenders, Ovixcell showed better sperm quality both at the pre-freeze (Sperm motility) and post-thaw stages. Lower malondialdehyde (MDA) level (nmol/mL) was observed in Ovixcell as compared to Tris extender. Both sperm quality and MDA level decreased significantly (P < 0.05) from pre-freeze to post-thaw in both the extenders. CONCLUSION: The findings of the present study indicate that Ovixcell is a comparable alternative to Tris extender for the cryopreservation of crossbred ram semen.

Structural racism, socio-economic marginalization, and infant mortality.

OBJECTIVES: We examine associations between infant mortality rates (IMRs) and measures of structural racism and socio-economic marginalization in Chicago, Illinois. Our purpose was to determine whether the Index of Concentration at the Extremes (ICE) was significantly related to community-level IMRs. STUDY DESIGN: We use a cross-sectional ecological public health design to examine community-level factors related to IMRs in Chicago neighborhoods. METHODS: We use data from the Chicago Department of Public Health and the American Community Survey to examine IMR inequities during the period 2012-2016. Calculations of the ICE for race and income were undertaken. In addition, we calculated racialized socio-economic status, which is the concentration of affluent Whites relative to poor Blacks in a community area. We present these ICE measures, as well as hardship, percent of births with inadequate prenatal care (PNC), and the percent of single-parent households as quintiles so that we can compare neighborhoods with the most disadvantage with neighborhoods with the least. Negative binomial regression was used to determine whether the ICE measures were independently related to community IMRs, net of hardship scores, PNC, and single-parent households. RESULTS: Spearman correlation results indicate significant associations in Chicago communities between measures of racial segregation and economic marginalization and IMRs. Community areas with the lowest ICERace scores (those with the largest concentrations of Black residents, compared with White) had IMRs that were 3.63 times higher than those communities with the largest concentrations of White residents. Most associations between community IMRS and measures of structural racism and socioeconomic marginalization are accounted for in fully adjusted negative binomial regression models. Only ICERace remained significantly related to IMRs. CONCLUSIONS: We show that structural racism as represented by the ICE is independently related to IMRs in Chicago; community areas with the largest concentrations of Blacks residents compared with Whites are those with the highest IMRs. This relationship persists even after controlling for socio-economic marginalization, hardship, household composition/family support, and healthcare access. Interventions to improve birth outcomes must address structural determinants of health inequities.

Real-world bone turnover marker use: impact on treatment decisions and fracture.

The use of bone turnover marker (BTM) testing for patients with osteoporosis in the USA has not been well characterized. This retrospective US-based real-world data study found BTM testing has some association with treatment decision-making and lower fracture risk in patients with presumed osteoporosis, supporting its use in clinical practice. INTRODUCTION: The purpose of this study was to characterize bone turnover marker (BTM) testing patterns and estimate their clinical utility in treatment decision-making and fragility fracture risk in patients with osteoporosis using a retrospective claims database. METHODS: Data from patients aged ≥ 50 years with newly diagnosed osteoporosis enrolled in the Truven MarketScan® Commercial Claims and Encounters and Medicare Supplemental and Co-ordination of Benefits databases from January 2008 to June 2018 were included. Osteoporosis was ascertained by explicit claims, fragility fracture events associated with osteoporosis, or prescribed anti-resorptive or anabolic therapy. BTM-tested patients were 1:1 propensity score matched to those untested following diagnosis. Generalized estimating equation models were performed to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for testing versus no testing on both treatment decision-making and fragility fracture. RESULTS: Of the 457,829 patients with osteoporosis, 6075 were identified with ≥ 1 BTM test following diagnosis; of these patients, 1345 had a unique treatment decision made ≤ 30 days from BTM testing. The percentage of patients receiving BTM tests increased significantly each year (average annual % change: + 8.1%; 95% CI: 5.6-9.0; p = 0.01). Patients tested were significantly more likely to have a treatment decision (OR: 1.14; 95% CI: 1.13-1.15), and testing was associated with lower odds of fracture versus those untested (OR: 0.87; 95% CI: 0.85-0.88). CONCLUSION: In this large, heterogeneous population of patients with presumed osteoporosis, BTM testing was associated with treatment decision-making, likely leading to fragility fracture reduction following use.

Cardiometabolic disease in South Asians: A global health concern in an expanding population.

Cardiovascular disease (CVD) is one of the main causes of mortality and morbidity worldwide. As an emerging population, South Asians (SAs) bear a disproportionately high burden of CVD relative to underlying classical risk factors, partly attributable to a greater prevalence of insulin resistance and diabetes and distinct genetic and epigenetic influences. While the phenotypic distinctions between SAs and other ethnicities in CVD risk are becoming increasingly clear, the biology of these conditions remains an area of active investigation, with emerging studies involving metabolism, genetic variation and epigenetic modifiers (e.g., extracellular RNA). In this review, we describe the current literature on prevalence, prognosis and CVD risk in SAs, and provide a landscape of translational research in this field toward ameliorating CVD risk in SAs.

Effect of Lung Transplantation on Health-Related Quality of Life in the Era of the Lung Allocation Score: A U.S. Prospective Cohort Study.

Under the U.S. Lung Allocation Score (LAS) system, older and sicker patients are prioritized for lung transplantation (LT). The impact of these changes on health-related quality of life (HRQL) after transplant has not been determined. In a single-center prospective cohort study from 2010 to 2016, we assessed HRQL before and repeatedly after LT for up to 3 years using the SF12-Physical and Mental Health, the respiratory-specific Airway Questionnaire 20-Revised, and the Euroqol 5D/Visual Analog Scale utility measures by multivariate linear mixed models jointly modeled with death. We also tested changes in LT-Valued Life Activities disability, BMI, allograft function, and 6-min walk test exercise capacity as predictors of HRQL change. Among 211 initial participants (92% of those eligible), LT improved HRQL by all 5 measures (p < 0.05) and all but SF12-Mental Health improved by threefold or greater than the minimally clinically important difference. Compared to younger participants, those aged ≥65 improved less in SF12-Physical and Mental Health (p < 0.01). Improvements in disability accounted for much of the HRQL improvement. In the LAS era, LT affords meaningful and durable HRQL improvements, mediated by amelioration of disability. Identifying factors limiting HRQL improvement in selected subgroups, especially those aged ≥65, are needed to maximize the net benefits of LT.

Assessment of obesity, overweight and its association with the fast food consumption in medical students.

INTRODUCTION: Obesity is a condition in which excess body fat accumulates, which leads to various adverse effects on health, particularly cardiovascular diseases (CVDs), which reduce life expectancy and/or increase health problems. Fast food consumption is one of the factors which have been reported as a cause of obesity. Body mass index (BMI) is used to assess obesity and overweight, which can be calculated by using the formula, weight in kg, divided by square of height in metres. AIM: This study focused on the relationship of body mass index with fast food consumption, associated soft drink consumption and physical activity. METHODS: Descriptive cross-sectional study was conducted in Department of Biochemistry, SBKS MI and RC, and Sumandeep Vidyapeeth. This study was approved by the ethical review board .One hundred and forty seven medical students from 1(st) year MBBS course were included in this study. Self-structured questionnaire was used, which contained several data like information on age, height, weight, education level. The formula used for calculating BMI was, weight in kg, divided by square of height in metres (Kg/m(2)). RESULTS: In our study, out of 147 students, a total of 138 students (more than 90%) used to have fast food. Among these, a total of 47 students (34.05%) were pre-obese and obese. Out of 147 students, 87 students (59.18%) were in normal weight range, while 13 (8.84%) students were underweight. STATISTICAL ANALYSIS: Data was compiled in an Excel worksheet and it was analyzed for percentages and proportions. Chi-square and Pearson's correlation test were also applied wherever they were applicable and Alpha error was set at a 5% level. CONCLUSION: In our study, a significant relationship was found between BMI and fast food consumption, less physical activity, and intake of soft drinks.

An International Menopause Society study of climate, altitude, temperature (IMS-CAT) and vasomotor symptoms in urban Indian regions.

OBJECTIVE: To examine the relationships between climate (season, temperature, humidity), lifestyle, health, mood and beliefs and experience of hot flushes and night sweats amongst mid-aged women living in eight urban Indian centers. METHODS: A total of 717 peri- and postmenopausal women, aged 45-55 years, from urban centers in different regions of India were included. Data were collected during both summer and winter months. Participants completed questionnaires eliciting information about sociodemographics, hot flushes (prevalence, frequency and problem-rating), health and lifestyle (body mass index, diet, exercise, alcohol use), mood (Women's Health Questionnaire) and attributions and beliefs (Menopause Representations Questionnaire). RESULTS: The prevalence of vasomotor symptoms was low, with 34% of the sample reporting hot flushes and/or night sweats. Seasonal variation in temperature was not associated with hot flush prevalence, frequency or problem rating. Hot flush prevalence was mainly associated with higher anxiety and intake of spicy foods, frequency with (older) age and (more) frequent exercise, while hot flushes were more problematic for women who reported poorer general health and more negative beliefs about menopause. CONCLUSIONS: In this study of Indian women, seasonal temperature variation did not appear to influence hot flush reporting. Health, mood, beliefs and lifestyle factors appear to explain some, but not all, of the variance in experience of menopausal symptoms.

A study of service provision in psychocutaneous medicine.

BACKGROUND: Psychocutaneous medicine concerns the recognition and treatment of psychological distress and psychiatric morbidity associated with dermatological diseases. A study in 2004 examining resources in the UK highlighted a number of deficiencies, and recommended that psychodermatology services be available, at least regionally, in the UK. Although there is now increased recognition of psychodermatology, this study of the availability of these services shows that provision has deteriorated since 2004. AIM: To study the service provision of psychocutaneous medicine in the UK. METHODS: Consultants in dermatology units across the UK were asked to take part in an online survey, accessible via an emailed link. This consisted of 10 questions concerning availability of psychodermatology services and psychological support for patients within their local trusts, both in adult and in child and adolescent medicine. Basic percentages were used to analyse quantitative data and content analysis for qualitative data. RESULTS: From 154 surveys, 127 responses were returned. The data indicated that despite frequently encountering patients who required psychological and psychiatric input, a large majority of UK dermatologists have inadequate access to appropriate support in their department. Importantly, this included the child and adolescent medicine and skin cancer departments, despite there being clear objectives for these services to be routinely available. CONCLUSIONS: A lack of resources in psychocutaneous medicine was highlighted in 2004, and the situation has not improved, or is, if anything, worse. Essential access to psychiatric and psychological support for patients is not currently available in most dermatology departments across the country.

The cost-effectiveness of drug regulation: the example of thorough QT/QTc studies.

We analyzed the cost-effectiveness of the International Conference on Harmonisation (ICH) E14 guideline that requires a thorough QT/QTc (TQT) study for all drugs under development. We compared two pharmacoeconomic scenarios: the health effects and costs resulting from implementing ICH E14 ("regulation" scenario) vs. not implementing ICH E14 ("no regulation" scenario). We used a dynamic population model to calculate the cost-effectiveness of ICH E14 for a prototype QT-prolonging antipsychotic drug entering the US and European markets. The incremental cost-effectiveness ratios of regulation vs. no regulation were ~€2.4 million per sudden cardiac death prevented and ~€187,000 per quality-adjusted life year (QALY) gained in users of antipsychotic drugs. The main driver of cost was the requirement for electrocardiogram (ECG) monitoring of users of QTc-prolonging drugs. Even when several of the assumptions in the model were varied, there were no results in favor of regulation. Our study shows that cost-effectiveness analysis of drug regulatory measures is feasible and should be considered before developing such measures.

Vascular access thrombosis and interventions in patients missing hemodialysis sessions.

BACKGROUND: Vascular access (VA) failure is a major complication in patients with end-stage renal disease (ESRD) receiving hemodialysis (HD). Thrombosis is the most common cause of VA dysfunction, but the risk factors for VA thrombosis are not well established. While the practice of missing HD sessions (HDs) is associated with increased morbidity and mortality, its impact on VA outcomes is unknown. We evaluated the impact of missing HDs on thrombosis and intervention rates in arteriovenous (AV) accesses. METHODS: Retrospective review of prevalent HD patients using AV access was done in 2 outpatient HD centers at The Ohio State University over a one-year period. RESULTS: A total of 142 patients underwent a total of 15,692 HDs, missing 1,602 HDs. Of the 78 patients who met the inclusion criteria, 50 patients missed at least 1 HD. Those with AVF demonstrated no significant association between missing HDs and VA thrombosis. Also, the incidence rate (IR) of intervention was not significantly different for those missing and not missing HDs. However, in the AVG group, those missing HDs were more likely to experience VA thrombosis (OR 9.48, p ≈ 0.041) and had a higher IR of intervention. CONCLUSION: The practice of missing HDs was prevalent. Those missing dialysis sessions with AVG were more likely to experience VA thrombosis and needed more interventions to maintain VA patency. Our study reveals a differential impact of missing HDs on thrombosis in AVG and AVF, depicting a need to explore mechanistic explanations that may eventually help develop specific preventive strategies.

Process analytical technology (PAT) for biopharmaceutical products: Part II. Concepts and applications.

Implementing real-time product quality control meets one or both of the key goals outlined in FDA's PAT guidance: "variability is managed by the process" and "product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other conditions." The first part of the paper presented an overview of PAT concepts and applications in the areas of upstream and downstream processing. In this second part, we present principles and case studies to illustrate implementation of PAT for drug product manufacturing, rapid microbiology, and chemometrics. We further present our thoughts on how PAT will be applied to biotech processes going forward. The role of PAT as an enabling component of the Quality by Design framework is highlighted. Integration of PAT with the principles stated in the ICH Q8, Q9, and Q10 guidance documents is also discussed.

Oman Eye Study 2005: prevalence and determinants of glaucoma.

This community-based study was carried out to estimate the prevalence and identify the determinants of glaucoma in the Omani population in 2005-06. Residents of 75 randomly selected houses in 25 clusters participated in the survey. We interviewed and examined 3324 individuals aged > or = 30 years in their homes and in eye clinics to note personal details, glaucoma status and presence of selected risk factors: 180 were diagnosed as having glaucoma. Projected prevalence of glaucoma among the Omani population > or = 30 years was 4.75%. Open angle and angle closure types of glaucoma contributed 40.6% and 37.8% respectively. History of hypertension was negatively, and older age and family history of glaucoma were positively, associated with glaucoma.

Asian Indian women: knowledge, attitudes and behaviors toward breast cancer early detection.

Education programs have been developed to promote adherence to recommended breast cancer screening guidelines. Few studies have assessed the degree to which ethnic subgroups are perceiving and acting on the proffered information. Such assessment is vital to the creation of efficient public health interventions. This paper describes the reported breast cancer knowledge, attitudes, and screening behaviors of 194 American Asian Indian women. While monthly breast self exam adherence was low, only 40.7%, 61.3% of women 40 and older, and 70% of women 50 and older, reported having had a mammogram within the past 12 months. These rates for annual mammography screening are high relative to many other ethnic groups. While the results are encouraging, the respondents may not be representative of all Asian Indian women. The majority of these women reported that their breast cancer knowledge is inadequate. They were willing to be called upon to share with others any knowledge they gained. There is a clear opportunity for public health nurses to provide Asian Indian women with a more comprehensive understanding of breast health and disease. Those women can then share their health knowledge with other women within their ethnic group.

Effects of age, sex, race, diagnosis-related group, and hospital setting on lipid management in patients with coronary artery disease.

Among 1,211 patients hospitalized with documented CAD at either a university hospital or a large suburban community hospital, 36% failed to receive appropriate evaluation and treatment for dyslipidemia. Younger patients, those admitted to a university hospital, and those undergoing percutaneous coronary intervention were substantially more likely to receive appropriate lipid management than other subgroups.