Development of the Parental Experience with Care for Children with Serious Illnesses (PRECIOUS) quality of care measure.

BACKGROUND: Parent-reported experience measures are part of pediatric Quality of Care (QoC) assessments. However, existing measures were not developed for use across multiple healthcare settings or throughout the illness trajectory of seriously ill children. Formative work involving in-depth interviews with parents of children with serious illnesses generated 66 draft items describing key QoC processes. Our present aim is to develop a comprehensive parent-reported experience measure of QoC for children with serious illnesses and evaluate its content validity and feasibility. METHODS: For evaluating content validity, we conducted a three-round Delphi expert panel review with 24 multi-disciplinary experts. Next, we pre-tested the items and instructions with 12 parents via cognitive interviews to refine clarity and understandability. Finally, we pilot-tested the full measure with 30 parents using self-administered online surveys to finalize the structure and content. RESULTS: The Delphi expert panel review reached consensus on 68 items. Pre-testing with parents of seriously ill children led to consolidation of some items. Pilot-testing supported feasibility of the measure, resulting in a comprehensive measure comprising 56 process assessment items, categorized under ten subthemes and four themes: (1) Professional qualities of healthcare workers, (2) Supporting parent-caregivers, (3) Collaborative and holistic care, and (4) Efficient healthcare structures and standards. We named this measure the PaRental Experience with care for Children with serIOUS illnesses (PRECIOUS). CONCLUSIONS: PRECIOUS is the first comprehensive measure and has the potential to standardize assessment of QoC for seriously ill children from parental perspectives. PRECIOUS allows for QoC process evaluation across contexts (such as geographic location or care setting), different healthcare workers, and over the illness trajectory for children suffering from a range of serious illnesses.

A Community-Based Intervention for Managing Hypertension in Rural South Asia.

BACKGROUND: The burden of hypertension is escalating, and control rates are poor in low- and middle-income countries. Cardiovascular mortality is high in rural areas. METHODS: We conducted a cluster-randomized, controlled trial in rural districts in Bangladesh, Pakistan, and Sri Lanka. A total of 30 communities were randomly assigned to either a multicomponent intervention (intervention group) or usual care (control group). The intervention involved home visits by trained government community health workers for blood-pressure monitoring and counseling, training of physicians, and care coordination in the public sector. A total of 2645 adults with hypertension were enrolled. The primary outcome was reduction in systolic blood pressure at 24 months. Follow-up at 24 months was completed for more than 90% of the participants. RESULTS: At baseline, the mean systolic blood pressure was 146.7 mm Hg in the intervention group and 144.7 mm Hg in the control group. At 24 months, the mean systolic blood pressure fell by 9.0 mm Hg in the intervention group and by 3.9 mm Hg in the control group; the mean reduction was 5.2 mm Hg greater with the intervention (95% confidence interval [CI], 3.2 to 7.1; P<0.001). The mean reduction in diastolic blood pressure was 2.8 mm Hg greater in the intervention group than in the control group (95% CI, 1.7 to 3.9). Blood-pressure control (<140/90 mm Hg) was achieved in 53.2% of the participants in the intervention group, as compared with 43.7% of those in the control group (relative risk, 1.22; 95% CI, 1.10 to 1.35). All-cause mortality was 2.9% in the intervention group and 4.3% in the control group. CONCLUSIONS: In rural communities in Bangladesh, Pakistan, and Sri Lanka, a multicomponent intervention that was centered on proactive home visits by trained government community health workers who were linked with existing public health care infrastructure led to a greater reduction in blood pressure than usual care among adults with hypertension. (Funded by the Joint Global Health Trials scheme; COBRA-BPS ClinicalTrials.gov number, NCT02657746.).

Improvements in work productivity among patients with inflammatory arthritis and osteoarthritis in the first six months after diagnosis: an inception cohort study.

OBJECTIVES: Reduced work productivity (WP), measured by work productivity loss (WPL) and work disability (WD), is common in patients with inflammatory arthritis (IA) and osteoarthritis (OA) but is not well characterised. We aimed to assess if there were any improvements in WP (WPL and WD) from diagnosis (T1) to six months later (T2) and to explore associations between WP at T2 and health status at T1 among these patients. METHODS: Patients were surveyed for work characteristics, work ability, WP and health status including physical functioning and vitality at T1 and T2. Associations between WP at T2 and health status at T1 were explored using regression models. RESULTS: Patients with IA (n=109) were younger than those with OA (n=70) (mean age: 50.5 vs. 57.7 years). The median WPL score decreased from 30.0 to 10.0 in patients with IA and from 20.0 to 0.0 in patients with OA, while the proportion reporting WD decreased from 52.3% to 45.3% in patients with IA and increased from 52.2% to 56.5% in patients with OA from T1 to T2. Physical functioning at T1 (coefficient = -0.35) was significantly associated with WPL at T2. Vitality at T1 (coefficient = 0.03) was associated with WD at T2. CONCLUSIONS: Greater improvements in WP were observed among patients with IA than those with OA in the first six months after diagnosis. This provides a basis for healthcare professionals to aim for greater improvements in work and health status for patients with IA.

Investigating 5-Level EQ-5D (EQ-5D-5L) Values Based on Preferences of Patients With Heart Disease.

OBJECTIVES: Several studies have shown that patients with heart disease value hypothetical health states differently from the general population. We aimed to investigate the health preferences of patients with heart disease and develop a value set for the 5-level EQ-5D (EQ-5D-5L) based on these patient preferences. METHODS: Patients with confirmed heart disease were recruited from 2 hospitals in Singapore. A total of 86 EQ-5D-5L health states (10 per patient) were valued using a composite time trade-off method according to the international valuation protocol for EQ-5D-5L; 20-parameter linear models and 8-parameter cross-attribute level effects models with and without an N45 term (indicating whether any health state dimension at level 4 or 5 existed) were estimated. Each model included patient-specific random intercepts. Model performance was evaluated for out-of-sample and in-sample predictive accuracy in terms of root mean square error. The discriminative ability of the utility values was assessed using heart disease-related functional classes. RESULTS: A total of 576 patients were included in the analysis. The preferred model, with the lowest out-of-sample root mean square error, was a 20-parameter linear model including N45. Predicted utility values ranged from -0.727 for the worst state to 1 for full health; the value for the second-best state was 0.981. Utility values demonstrated good discriminative ability in differentiating among patients of varied functional classes. CONCLUSIONS: An EQ-5D-5L value set representing the preferences of patients with heart disease was developed. The value set could be used for patient-centric economic evaluation and health-related quality of life assessment for patients with heart disease.

Parent-Reported Experience Measures of Care for Children With Serious Illnesses: A Scoping Review.

OBJECTIVE: This scoping review aimed to: 1) identify parent-reported experience measures (PaREMs) for parents of children with serious illnesses from peer-reviewed literature, 2) map the types of care experience being evaluated in PaREMs, 3) identify and describe steps followed in the measure development process, including where gaps lie and how PaREMs may be improved in future efforts, and 4) help service providers choose a PaREM suitable for their service delivery setting and strategy. DATA SOURCES: Relevant articles were systematically searched from PubMed, CINAHL, and Scopus EBSCOhost databases until June 10, 2021, followed by a manual reference list search of highly relevant articles. STUDY SELECTION: Abstracts were screened, followed by a full-text review using predetermined inclusion and exclusion criteria. DATA EXTRACTION: A standardized data extraction tool was used. DATA SYNTHESIS: Sixteen PaREMs were identified. There were large variances in the development processes across measures, and most have been developed in high-income, English-speaking Western countries. Most only assess the quality of acute inpatient care. Few measures can be used by multiple service providers or chronic care, and many do not capture all relevant domains of the parent experience. CONCLUSIONS: Service providers should integrate PaREMs into their settings to track and improve the quality of care. Given the multidisciplinary nature of pediatric care and the often-unpredictable disease trajectories of seriously ill children, measures that are applicable to multiple providers and varying lengths of care are essential for standardized assessment of quality of care and coordination among providers. To improve future PaREM development, researchers should follow consistent and methodologically robust steps, ideally in more diverse sociocultural and health systems contexts. Future measures should widen their scope to be applicable over the disease trajectory and to multiple service providers in a child's network of care for a comprehensive evaluation of experience.

Population Segmentation Based on Healthcare Needs: Validation of a Brief Clinician-Administered Tool.

BACKGROUND: As populations age with increasingly complex chronic conditions, segmenting populations into clinically meaningful categories of healthcare and related service needs can provide healthcare planners with crucial information to optimally meet needs. However, while conventional approaches typically involve electronic medical records (EMRs), such records do not always capture information reliably or accurately. OBJECTIVE: We describe the inter-rater reliability and predictive validity of a clinician-administered tool, the Simple Segmentation Tool (SST) for categorizing older individuals into one of six Global Impression (GI) segments and eight complicating factors (CFs) indicative of healthcare and related social needs. DESIGN: Observational study ( ClinicalTrials.gov , number NCT02663037). PARTICIPANTS: Patients aged 55 years and above. MAIN MEASURES: Emergency department (ED) subjects (between May and June 2016) had baseline SST assessment by two physicians and a nurse concurrently seeing the same individual. General medical (GM) ward subjects (February 2017) had a SST assessment by their principal physician. Adverse events (ED visits, hospitalizations, and mortality over 90 days from baseline) were determined by a blinded reviewer. Inter-rater reliability was measured using Cohen's kappa. Predictive validity was evaluated using Cox hazard ratios based on time to first adverse event. KEY RESULTS: Cohen's kappa between physician-physician, service physician-nurse, and physician-nurse pairs for GI were 0.60, 0.71, and 0.68, respectively. Cox analyses demonstrated significant predictive validity of GI and CFs for adverse outcomes. CONCLUSIONS: With modest training, clinicians can complete a brief instrument to segment their patient into clinically meaningful categories of healthcare and related service needs. This approach can complement and overcome current limitations of EMR-based instruments, particularly with respect to whole-patient care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02663037.

Improving sensitivity of the connective tissue disease screening questionnaire: A comparative study of various scoring methods.

OBJECTIVES: Early detection of autoimmune rheumatic diseases is crucial given their high morbidity and mortality and short window of opportunity to improve patient outcomes. Self-administered screening questionnaires such as the connective tissue disease screening questionnaire (CSQ) have been shown to promote early detection of autoimmune rheumatic diseases. However, optimal scoring of screening questionnaires may differ with prevalence of clinical features and changes in classification criteria. We compared the performance of 3 scoring methods for the CSQ for early detection of autoimmune rheumatic diseases in a multi-ethnic Asian population. METHODS: Patients who were newly referred for evaluation of possible autoimmune rheumatic diseases were invited to answer the cross-culturally adapted CSQ. Detection of autoimmune rheumatic diseases using 1) the original CSQ scoring, 2) a modified CSQ scoring and 3) a scoring based on current classification criteria, were compared to classification of autoimmune rheumatic diseases by classification criteria. RESULTS: Of 819 participants, 85 were classified as having autoimmune rheumatic diseases screened for by the adapted CSQ. The original CSQ scoring yielded relatively lower sensitivities in detecting both any and individual autoimmune rheumatic diseases (67% and 20-57%, respectively) compared to the modified CSQ scoring (81% and 60-73%, respectively) and the scoring based on current classification criteria (89% and 50-88%, respectively). CONCLUSION: The adapted CSQ with the classification criteria-based scoring achieved relatively high sensitivities in detecting autoimmune rheumatic diseases, suggesting this could be employed as the first step in population screening.

Impact of COVID-19 on health-related quality of life in patients with cardiovascular disease: a multi-ethnic Asian study.

BACKGROUND: Little is known about the impact of the global coronavirus disease-2019 (COVID-19) pandemic on patients with cardiovascular disease (CVD), the biggest global killer and major risk factor for severe COVID-19 infections. We aim to explore the indirect consequences of COVID-19 on health-related quality of life (HRQoL) of patients with CVD. METHODS: Eighty-one adult outpatients with CVD were assessed using the EQ-5D, a generic health status instrument with five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), before and during the pandemic. Changes in the EQ-5D dimensional responses were compared categorically as well as using the dimension-specific sum-score (range 1-3, with a higher score indicating worse health). The responses and sum-score were compared using the exact test of symmetry and the paired t-test, respectively. RESULTS: These patients [mean age (SD) 59.8 (10.5); 92.6% males; 56% New York Heart Association (NYHA) functional class I] had coronary artery disease (69%), heart failure (28%), or arrhythmias (15%). None experienced change in NYHA class between assessments. About 30% and 38% of patients reported problems with at least one of the EQ-5D dimensions pre-pandemic and during the pandemic, respectively. The highest increase in health problems was reported for anxiety/depression (12.5% pre-pandemic vs 23.5% during pandemic; p = 0.035) with mean domain-specific score from 1.12 (SD 0.33) to 1.25 (SD 0.46) (standardized effect size = 0.373, p = 0.012). There was no meaningful change in other dimensions as well as overall HRQoL. CONCLUSION: The COVID-19 pandemic is associated with a significant worsening of the mental health of patients with CVD.

Validity and Utility of the Center for Epidemiological Studies Depression Scale for Detecting Depression in Family Caregivers of Persons with Dementia.

BACKGROUND/AIMS: The psychometric properties of Center for Epidemiological Studies Depression Scale (CES-D) have never been substantively investigated in caregivers of persons with dementia (PwD). We evaluated the validity and reliability of CES-D for detecting caregiver depression in dementia, and assessed whether CES-D could provide added utility beyond Zarit Burden Interview (ZBI). METHOD: Family caregivers of community-dwelling PwD (n = 394) completed self-administered questionnaires containing CES-D. Factorial validity was evaluated with confirmatory factor analysis; convergent and discriminant validity with Pearson's correlation coefficient; known-group validity by comparing across key variables; and internal consistency reliability with Cronbach's α. Cohen's κ was used to compare the agreement between those with depression (CES-D ≥16) and those with high caregiver burden (ZBI >60). RESULTS: CES-D demonstrated convergent, discriminant and known-group validity, consistent with a priori hypotheses. The original four-factor model of CES-D produced the best model-fit indices. Internal consistency reliability was good for the CES-D total scale (α = 0.92), but lower for the Positive affect and Interpersonal problems subscales (α = 0.70-0.74). Forty-five percent of the caregivers had depression as identified by CES-D (95% CI 40-50%), but most of them were not identified by high ZBI scores (κ = 0.16). CONCLUSIONS: CES-D is a valid and reliable scale for detecting caregiver depression in dementia. It has added utility, beyond that of a caregiver burden scale, in identifying a subgroup of caregivers with depression but not burden. However, two subscales (Positive affect and Interpersonal problems) may require caution in interpretation among non-Caucasian caregivers.

Valuation of Health States Considered to Be Worse Than Death-An Analysis of Composite Time Trade-Off Data From 5 EQ-5D-5L Valuation Studies.

OBJECTIVES: To evaluate the discriminative ability of negative values measured in 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L) value set studies. METHODS: This is a secondary analysis of EQ-5D-5L value set studies from Singapore, the Netherlands, China, Thailand, and Canada in which health state values were elicited from a general population sample using a composite time trade-off (TTO) method. Mean values were calculated for health states with same severity. The association between the mean values and severity was evaluated using Pearson correlation (r). A linear mixed model using severity as the fixed effect was fitted for values. The analyses were performed separately for positive values (from a conventional TTO for health states considered "better than death") and negative values (from a lead time TTO for health states considered "worse than death"). RESULTS: In Singapore (N = 1000; negative values 32.6%), the mean decreased with severity from 0.89 to 0.21 for positive values and increased with severity from -0.98 to -0.89 for negative values. The correlation between values and severity was much lower for negative values (r = -0.016) than for positive values (r = -0.614). The coefficient of severity in the linear mixed model for negative values was much smaller (coefficient = -0.009; pseudo-R2 < 0.001) compared with the model for positive values (coefficient = -0.041; pseudo-R2 = 0.337). Results using data sets from the other countries were similar. CONCLUSIONS: Negative values are not associated with severity of health states in EQ-5D-5L valuation studies, suggesting poor discriminative ability of the lead time TTO method in valuing health states considered worse than death.

Effectiveness of a Technology-Based Supportive Educational Parenting Program on Parental Outcomes (Part 1): Randomized Controlled Trial.

BACKGROUND: Transitioning into parenthood can be stressful for new parents, especially with the lack of continuity of care from health care professionals during the postpartum period. Short hospital stays limit the availability of support and time parents need to be well equipped with parenting and infant care skills. Poor parental adjustment may, in turn, lead to negative parental outcomes and adversely affect the child's development. For the family's future well-being, and to facilitate a smoother transition into parenthood, there is a need for easily accessible, technology-based educational programs to support parents during the crucial perinatal period. OBJECTIVE: This study aimed to examine the effectiveness of a technology-based supportive educational parenting program (SEPP) on parenting outcomes during the perinatal period in couples. METHODS: A randomized, single-blinded, parallel-armed, controlled trial was conducted. The study recruited 236 parents (118 couples) from an antenatal clinic of a tertiary hospital in Singapore. Eligible parents were randomly assigned to the intervention group (n=118) or the control group (n=118). The SEPP is based on Bandura's self-efficacy theory and Bowlby's theory of attachment. Components of the intervention include 2 telephone-based educational sessions (1 antenatal and 1 immediately postnatal) and a mobile health app follow-up for 1 month. The control group only received routine perinatal care provided by the hospital. Outcome measures including parenting self-efficacy (PSE), parental bonding, perceived social support, parenting satisfaction, postnatal depression (PND), and anxiety were measured using reliable and valid instruments. Data were collected over 6 months at 4 time points: during pregnancy (third trimester), 2 days postpartum, 1 month postpartum, and 3 months postpartum. Outcomes were standardized using baseline means and SDs. Linear mixed models were used to compare the groups for postpartum changes in the outcome variables. RESULTS: The intervention group showed significantly better outcome scores than the control group from baseline to 3 months postpartum for PSE (mean difference, MD, 0.37; 95% CI 0.06 to 0.68; P=.02), parental bonding (MD -1.32; 95% CI -1.89 to -0.75; P<.001), self-perceived social support (MD 0.69; 95% CI 0.18 to 1.19; P=.01), parenting satisfaction (MD 1.40; 95% CI 0.86 to 1.93; P<.001), and PND (MD -0.91; 95% CI -1.34 to -0.49; P<.001). Postnatal anxiety (PNA) scores of the intervention group were only significantly better after adjusting for covariates (MD -0.82; 95% CI -1.15 to -0.49; P<.001). CONCLUSIONS: The technology-based SEPP is effective in enhancing parental bonding, PSE, perceived social support and parental satisfaction, and in reducing PND and PNA. Health care professionals could incorporate it with existing hands-on infant care classes and routine care to better meet parents' needs and create positive childbirth experiences, which may in turn encourage parents to have more children. TRIAL REGISTRATION: ISRCTN Registry ISRCTN48536064; http://www.isrctn.com/ISRCTN48536064 (Archived by WebCite at http://www.webcitation.org/6wMuEysiO).

Factors influencing paternal involvement during infancy: A prospective longitudinal study.

AIMS: To explore factors influencing paternal involvement at 6 months postpartum and to detail the trend of these factors over a period of 6 months. BACKGROUND: There is a dearth of studies on paternal involvement during infancy in the unique Asian context. DESIGN: A prospective four-time point longitudinal design was adopted. METHODS: A total of 201 participants were recruited from a local hospital from May 2016 - December 2017 using convenience sampling. Self-administered questionnaires were used for data collection. Data were statistically analysed. RESULTS: Parenting self-efficacy at 6-month postpartum, paternal involvement, and paternal postnatal depression on the day of wife's hospital discharge, wife in paid work and wife's antenatal class attendance significantly influenced paternal involvement at 6 months postpartum. A sub-analysis of first-time and experienced fathers revealed that parenting self-efficacy at 6-month postpartum, paternal involvement on the day of wife's hospital discharge and wife in paid work were significant factors influencing paternal involvement for first-time fathers. Significant factors influencing paternal involvement for experienced fathers were paternal involvement on the day of wife's hospital discharge and wife's antenatal class attendance. CONCLUSION: Fathers (first-time and experienced) who were involved during their infant's birth were also involved at 6-month postpartum. Healthcare professionals may encourage paternal involvement through teaching fathers infant care skills during the antenatal period, especially first-time fathers as they may be lacking in such skills, which may hinder their parenting satisfaction. Paternal involvement throughout the perinatal period can be enforced by healthcare professionals to promote paternal involvement.

Iterating a framework for the prevention of caregiver depression in dementia: a multi-method approach.

ABSTRACTBackground:Dementia caregiving is often stressful and depression in family caregivers is not uncommon. As caregiver depression can have significant effects, there is a need for preventive efforts which are consistent with the extensive literature. We sought to consolidate the wide range of evidence (using a multi-method approach) into a simple framework that can guide the prevention of caregiver depression. METHODS: Using multiple logistic regression, we derived the predictors of caregiver depression from an empirical dataset containing key information and depression scores (based on the Center-for-Epidemiological-Studies-Depression-Scale) of 394 family caregivers. We then chose an underpinning theory as the foundation of the framework, and conducted an umbrella systematic review to find possible links between the derived predictors and the theory. Last, we compared the iterated framework with known interventions for caregiver depression in recent literature to assess whether the framework could map meaningfully with the known interventions. RESULTS: Significant predictors of caregiver depression included primary caregiver (odds ratio, OR = 1.53), severe dementia (OR = 1.40), and behavioral problems (OR = 3.23), lower education (OR = 1.77), and spousal caregivers (OR = 1.98). The integrated framework derived focuses on four strategic areas: physical-care demands of persons with dementia (PWD), behavioral problems of PWD, caregiving competency, and loss and grief of caregivers. This framework is supported by known interventions for caregiver depression in recent literature. CONCLUSIONS: By consolidating a broad range of evidence, we iterated a framework to aid the understanding and prevention of caregiver depression in dementia. The framework offers an approach to prevention which is simple, systematic, and reflective of the extensive literature.

Sample size determination for EQ-5D-5L value set studies.

PURPOSE: The EuroQol 5-Dimension (EQ-5D) is a widely used health status instrument for cost-utility analysis of healthcare interventions. Recently, its 5-Level version (EQ-5D-5L) and a protocol for conducting valuation of its health states were developed. We propose four approaches for estimating the sample size for EQ-5D-5L valuation according to the standardized procedures of the protocol. METHODS: The first approach is for estimating mean health state utility values with a desired precision level using a regression model. The second approach, empirical in nature, determines a sample size based on mean absolute error in predicting health state values using a large-scale reference study. The last two approaches are for assessing the significance of regression coefficients of health state descriptors and to estimate the regression coefficients with a desired precision for predicting health state utility values. RESULTS: Using data from a Singaporean study, we estimated parameters that are useful for sample size determination, including the design effect. Each of the approaches was illustrated with examples and pragmatic recommendations were provided. CONCLUSIONS: Capitalizing on the EQ-5D-5L valuation protocol, we proposed four sample size estimation approaches which can help to decide an appropriate sample size for a value set study.

Comparison of health state values derived from patients and individuals from the general population.

PURPOSE: Utility values are critical for cost-utility analyses that guide healthcare decisions. We aimed to compare the utility values of the 5-level EuroQoL-5Dimension (EQ-5D-5L) health states elicited from members of the general public and patients with heart disease or cancer. METHODS: In face-to-face interviews with 157 heart disease patients, 169 cancer patients, and 169 members from the general population, participants valued 10 EQ-5D-5L health states using a composite Time Trade-Off method. RESULTS: Pooling utility values for all health states, heart disease patients and cancer patients had mean utility values lower by 0.11 points (P value = 0.014) and 0.06 points (P value = 0.148), respectively, compared to the general population. Adjusting for sociodemographic characteristics, differences in health state utility values between the patient and the general populations were rendered non-significant, except that heart disease patients gave higher utility values (mean difference = 0.08; P value = 0.007) to mild health states than the general population. Difference in utility values, defined as utility value of a better health state minus that of a poorer health state, was higher among heart disease patients compared to the general population, before and after adjusting for sociodemographic characteristics. CONCLUSIONS: Patients may differ from members of the general population in the strength of their preferences for hypothetical health states. Using utility values derived from the general population may under-estimate the comparative effectiveness of healthcare interventions for certain diseases, such as heart diseases.

Single administration of Selective Internal Radiation Therapy versus continuous treatment with sorafeNIB in locally advanced hepatocellular carcinoma (SIRveNIB): study protocol for a phase iii randomized controlled trial.

BACKGROUND: Approximately 20 % of hepatocellular carcinoma (HCC) patients diagnosed in the early stages may benefit from potentially curative ablative therapies such as surgical resection, transplantation or radiofrequency ablation. For patients not eligible for such options, prognosis is poor. Sorafenib and Selective Internal Radiation Therapy (SIRT) are clinically proven treatment options in patients with unresectable HCC, and this study aims to assess overall survival following either SIRT or Sorafenib therapy for locally advanced HCC patients. METHODS: This investigator-initiated, multi-centre, open-label, randomized, controlled trial will enrol 360 patients with locally advanced HCC, as defined by Barcelona Clinic Liver Cancer stage B or stage C, without distant metastases, and which is not amenable to immediate curative treatment. Exclusion criteria include previous systemic therapy, metastatic disease, complete occlusion of the main portal vein, or a Child-Pugh score of >7. Eligible patients will be randomised 1:1 and stratified by centre and presence or absence of portal vein thrombosis to receive either a single administration of SIRT using yttrium-90 resin microspheres (SIR-Spheres®, Sirtex Medical Limited, Sydney, Australia) targeted at HCC in the liver by the trans-arterial route or continuous oral Sorafenib (Nexavar®, Bayer Pharma AG, Berlin, Germany) at a dose of 400 mg twice daily until disease progression, no further response, complete regression or unacceptable toxicity. Patients for both the Sorafenib and SIRT arms will be followed-up every 4 weeks for the first 3 months and 12 weekly thereafter. Overall survival is the primary endpoint, assessed for the intention-to-treat population. Secondary endpoints are tumour response rate, time-to-tumour progression, progression free survival, quality of life and down-staging to receive potentially curative therapy. DISCUSSION: Definitive data comparing these two therapies will help to determine clinical practice in the large group of patients with locally advanced HCC and improve outcomes for such patients. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01135056 , first received 24, May 2010.

Do chronic disease patients value generic health states differently from individuals with no chronic disease? A case of a multicultural Asian population.

BACKGROUND: There is conflicting evidence as to whether patients with chronic disease value hypothetical health states differently from individuals who have not experienced any long-lasting diseases. Furthermore, most studies regarding this issue have been conducted in western countries, with only one conducted in Asia. We aimed to evaluate possible systematic differences in the valuation of EuroQol Group five dimensions 3-level (EQ-5D-3L) health states by chronic disease patients and a population with no chronic disease in Singapore. METHODS: A face-to-face survey for the valuation of the 42 health states of the EQ-5D-3L using the visual analogue scale (VAS) method was conducted in Singapore. The survey also asked participants to report any chronic diseases they had. Ordinary least-square regression models were employed to assess possible differences in the valuation scores of all health states, severe health states and non-severe health states by individual chronic disease patient groups (diabetes, rheumatism, hypertension, heart diseases and lung diseases) and by a group of participants with no chronic disease. A difference of 4 to 8 points on the 100-point VAS was considered to be of practical significance. RESULTS: The analysis included 332 participants with at least one chronic disease and 651 participants with no chronic disease. After taking health state descriptors and covariates into account, mean valuation scores of the 42 health states by the heart disease group were higher by 4.6 points (p-value = 0.032) compared to the no chronic disease group. Specifically, the heart disease group valued severe health states 5.4 points higher (p-value = 0.025) than the no chronic disease group. There was no practically significant difference in the mean valuation score of non-severe health states between the heart disease group and the no chronic disease group. No practically significant differences were found in the mean valuation score of all health states, severe health states and non-severe health states between any other chronic disease group and the no chronic disease group. CONCLUSIONS: In Singapore, heart disease patients valued EQ-5D-3L severe health states differently from individuals with no chronic disease. Other chronic disease groups did not value EQ-5D-3L health states differently from the no chronic disease group.

How is the most severe health state being valued by the general population?

BACKGROUND: It has been reported that valuation of health states that are close to death, such as the most severe health state, can be affected by health state valuation procedure, and their utility values are difficult to predict. We examined how the most severe health states of Short Form-6 dimension (SF-6D) and EuroQoL-5 dimension-3 level (EQ-5D-3L) were valued by the Singapore general population. METHODS: Overall, 249 SF-6D and 42 EQ-5D-3L states were valued by two separate samples from the Singapore general population using the visual analogue scale (VAS) method. Ordinary least-square regression model was employed to explain deficit in the valuation of the most severe state using the health state descriptors. RESULTS: A total of 1021 participants from the SF-6D sample and 1015 participants from the EQ-5D-3L sample were included in the analysis. We observed that 67% of the SF-6D participants and 74% of the EQ-5D-3L participants considered the most severe state worse than dead. The most severe state had mean VAS valuation scores more than 20-25 points lower than the adjacent states that are better by only one level in only one dimension. SF-6D VAS valuation score for the most severe state was 27 points and 12 points lower than expected according to the health state descriptors among the participants who considered the most severe state worse than dead and better than dead, respectively. Similar results were found for the EQ-5D-3L valuation. CONCLUSIONS: The most severe health state was valued lower than expected according to its descriptors.

Are cash incentives always king? A randomized controlled trial evaluating hedonic versus cash incentives (TEH-C).

Introduction: Physical inactivity is a risk factor for obesity and non-communicable diseases. Despite myriad health and non-health benefits resulting from physical activity (PA), most individuals do not meet PA recommendations. Providing an incentive for meeting activity goals may increase activity levels. Classical economists argue that cash is the best incentive. Behavioral economists have posited that hedonic (pleasurable) incentives (e.g., massages, restaurant meals) may be superior to cash when incentives are offered over multiple time periods. To date, no studies have directly compared the effectiveness of cash versus hedonic incentives in promoting PA across multiple time periods. Methods: We conducted a two-arm, parallel, 4-month randomized controlled trial with healthy adults in Singapore where participants were randomized to either cash or hedonic incentives. Participants could earn up to SGD50 (≈USD37) in cash or hedonic incentives each month they met the study's step target of 10,000 steps daily on at least 20/25 days out of the first 28 days of a month. The primary objective was to compare the mean proportion of months that participants met the step target between the two arms. Results: By month 4, participants in the cash (N = 154) and hedonic incentive (N = 156) arms increased their mean daily steps by 870 (p < 0.001) and 1,000 steps (p < 0.001), respectively. The mean proportion of months the step target was achieved was 90.53 and 88.34 for participants in the cash and hedonic incentive arms respectively, but differences across arms were small and not statistically significant for this or any outcome assessed. Conclusion: Our findings suggest that both cash and hedonic incentives are effective at promoting physical activity but that neither strategy is clearly superior.Clinical trial registration: ClinicalTrials.gov, NCT04618757 registered on November 6, 2020.

Ambulatory blood pressure levels in individuals with uncontrolled clinic hypertension across Bangladesh, Pakistan, and Sri Lanka.

Hypertension is a leading risk factor for cardiovascular disease in South Asia. The authors aimed to assess the cross-country differences in 24-h ambulatory, daytime, and nighttime systolic blood pressure (SBP) among rural population with uncontrolled clinic hypertension in Bangladesh, Pakistan, and Sri Lanka. The authors studied patients with uncontrolled clinic hypertension (clinic BP ≥ 140/90 mmHg) who underwent ambulatory blood pressure monitoring (ABPM) during the baseline assessment as part of a community-based trial. The authors compared the distribution of ABPM profiles of patients across the three countries, specifically evaluating ambulatory SBP levels with multivariable models that adjusted for patient characteristics. Among the 382 patients (mean age, 58.3 years; 64.7% women), 56.5% exhibited ambulatory hypertension (24-h ambulatory BP ≥ 130/80 mmHg), with wide variation across countries: 72.6% (Bangladesh), 50.0% (Pakistan), and 51.0% (Sri Lanka; P < .05). Compared to Sri Lanka, adjusted mean 24-h ambulatory, daytime, and nighttime SBP were higher by 12.24 mmHg (95% CI 4.28-20.20), 11.96 mmHg (3.87-20.06), and 12.76 mmHg (4.51-21.01) in Bangladesh, separately. However, no significant differences were observed between Pakistan and Sri Lanka (P > .05). Additionally, clinic SBP was significantly associated with 24-h ambulatory (mean 0.38, 95% CI 0.28-0.47), daytime (0.37, 0.27-0.47), and nighttime SBP (0.40, 0.29-0.50) per 1 mmHg increase. The authors observed substantial cross-country differences in the distribution of ABPM profiles among patients with uncontrolled clinic hypertension in rural South Asia. The authors findings indicated the need to incorporate 24-h BP monitoring to mitigate cardiovascular risk, particularly in Bangladesh.