Intermittently scanned continuous glucose monitoring provides no benefit over structured self-monitoring of blood glucose in type 2 diabetes not on prandial insulin, in the context of diabetes self-management education: GLucose monitoring programme SingaporE (GLiMPSE).

OBJECTIVE: We evaluated the impact of intermittently scanned continuous glucose monitoring(is-CGM)over self-monitoring of blood glucose(SMBG) in the context of diabetes self-management education (DSME) in sub-optimally controlled type 2 diabetes(T2D) in a multi-ethnicsetting. RESEARCH DESIGN AND METHOD: Randomized-controlled, open-label trial (NCT04564911), of T2D with HbA1c ≥ 7.5-≤10 %, on oral agents with/without basal insulin was carried out. Intervention arm received 6 weeks(w) continuous is-CGM, followed by one is-CGM/month till 24w. Control arm was advised to perform 4 SMBG/day. Educationwas delivered at weeks 0, 2, 8, 16. PRIMARY OUTCOME: Change in HbA1c from baseline at 24w. Modified intention-to-treat (mITT) analysis with linear mixed-effect model for repeated measurementswas performed. RESULTS: 176 subjects, age 55 ± 10.7 years(y), DM duration 11 ± 7.3y, BMI 27.8 ± 5.9 kg/m2, 58 % Male, 29.5 % basal insulin users were analysed. Within each arm,from baseline to 24w, mean HbA1c decreasedby -0.6 % (-6.6.mmol/mol, p-value < 0.01)and weight decreased(isCGM: -1.44 kg; SMBG: -1.25 kg, both p < 0.01). These changes were sustained to one year. However, there wasno significant difference in these parameters between arms (p-value > 0.05). CONCLUSION: In the context of DSME, use of either SMBG or is-CGM led to improved glycaemia and reduced weight over a period of 24 weeks, sustained to one year.

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.

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.

PRECIOUS demonstrated satisfactory measurement properties for assessing the quality of care for children with serious illnesses.

OBJECTIVES: To determine the measurement properties of PaRental Experience with care for Children with serIOUS illnesses (PRECIOUS), a parent-reported measure of Quality of Care for seriously ill children across care settings and illness trajectories. STUDY DESIGN AND SETTING: Parents self-administered baseline and 2-week follow-up surveys online. Exploratory Factor Analysis was used to determine PRECIOUS's factor structure and select items. Internal consistency was evaluated with Cronbach's α, test-retest reliability with intraclass correlation coefficients, and convergent validity with Spearman's correlations between PRECIOUS scales and subscales of Measure of Processes of Care and Quality of Children's Palliative Care Instrument. RESULTS: Of 152 parents [108 (71%) mothers, 44 (29%) fathers] who completed the baseline survey, 123 (81%) completed follow-up. Exploratory Factor Analysis grouped PRECIOUS into five scales: collaborative and goal-concordant care (12 items), caregiver support and respectful care (15 items), access to financial and medical resources (five items), reducing caregiving stressors (nine items), and hospitalization-specific processes (four items). Root Mean Square Error of Approximation was 0.040 and Comparative Fit Index was 0.980. Cronbach's α ranged from 0.85 to 0.96. Intraclass correlation coefficients ranged from 0.72 to 0.86. Significant correlations with Measure of Processes of Care and Quality of Children's Palliative Care Instrument confirmed convergent validity. The original 56-item tool was reduced to 45 items. CONCLUSION: PRECIOUS demonstrates satisfactory measurement properties for assessing Quality of Care for seriously ill children.

Protocol update and baseline characteristics for the TRIal to slow the Progression of Diabetes (TRIPOD) randomized controlled trial.

BACKGROUND: Type 2 diabetes (T2D), a major risk factor for cardiovascular disease and other adverse health conditions, is on the rise in Singapore. TRIPOD is a randomized controlled trial aimed to determine whether complementing usual care with an evidence-based diabetes management package (DMP) -comprising access to an evidence-based app, health coaching, pedometer, glucometer and weighing scale, with or without a financial rewards scheme (M-POWER rewards), can improve mean HbA1c levels at months 6 and 12. METHODS: The protocol was published in Trials, accessible via https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3749-x 1. This manuscript updates the protocol with changes to the study design due to challenges with recruitment and presents baseline characteristics. Key updates include changing the arm allocation ratio from 1:1:1 (Arm 1-Usual Care: Arm 2-DMP: Arm 3-DMP+M-POWER rewards) to 10:1:10, the sample size from 339 to 269, the intervention period from two to one year, and the primary hypothesis to focus solely on differences between Usual Care and DMP+M-POWER rewards. Recruitment for the study began on 19 October 2019 and ended on 4 June 2022. RESULTS: The average age of participants was 55.0 (SD9.7) years old and 64.2% were male. The majority of participants (76.8%) were Chinese, 4.9% Malay and 18.3% Indian and of other ethnicities. 67.0% had a monthly household income of SGD$4000 or more. The mean baseline HbA1c was 8.10% (SD 0.95) and the mean body mass index was 26.8 kg/m2 (SD 5.3). DISCUSSION: The final participant completed month 12 follow-up data collection on 8 June 2023. All pre-planned analyses will be conducted and final results reported. TRIAL REGISTRATION: ClinicalTrials.gov NCT03800680 . Registered on 11 January 2019.

Comparison of Functional Health Status and Health Related Quality of Life Between Adult Patients With Fontan Procedure and Noncongenital Heart Diseases.

To compare functional health status and Health Related Quality of Life (HRQoL) between Fontan and non-congenital heart disease (CHD) patients in an Asian population. Functional health status and HRQoL (New York Heart Association (NYHA) functional class, Duke Activity Status Index (DASI), HeartQol and EQ-5D-5L) were measured. A total of 65 patients (twenty Fontan patients, mean age 28 ± 5; and 45 age-matched non-CHD patients, mean age 33 ± 5) were recruited. After adjustment for age, gender and ethnicity, there were no significant differences in functional health status and HRQoL between groups. In an Asian population, Fontan patients have similar functional health status and Health Related Quality of Life compared to non-CHD patients.

Measurement Properties of the 15-Item Singapore Caregiver Quality of Life Scale (SCQOLS-15) in Family Caregivers of Patients with Heart Diseases.

PURPOSE: To evaluate the measurement properties of the 15-item Singapore Caregiver Quality of Life Scale (SCQOLS-15) in family caregivers of patients with heart diseases. METHODS: The SCQOLS-15 survey was self-administered by family caregivers of patients with chronic heart diseases, at baseline and 1 week later. The criterion validity of SCQOLS-15 and its domain scores was assessed by calculating the Spearman correlation coefficient (ρ) with the Brief Assessment Scale for Caregivers (BASC), Caregiver Reaction Assessment (CRA), and their sub-scores. Known-group validity was assessed using the New York Heart Association (NYHA) functional class. Test-retest reliability was evaluated using the intraclass correlation coefficient (ICC). RESULTS: Of the 327 caregivers included, 65% were adult children and 28% were spouses. The distribution of NYHA classes of the patients was I: 27%, II: 40%, III: 24%, and IV: 9%. There was a positive correlation between the SCQOLS-15 and BASC total scores (ρ = 0.7). SCQOLS-15 domain scores were also correlated with BASC and CRA sub-scores as per a priori hypotheses, with absolute values of ρ ranging from 0.4 to 0.6. The mean values of SCQOLS-15 total and all domain scores were lower among caregivers of patients with NYHA class III/IV compared to those of class I/II patients (each P < 0.05). Among 146 caregivers who completed the follow-up and self-rated a stable quality-of-life, ICCs for test-retest reliability of SCQOLS-15 total and all domain scores were ≥ 0.8. CONCLUSION: The SCQOLS-15 is a valid and reliable instrument for measuring the quality of life in caregivers of heart disease patients.

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.

Baseline characteristics of participants in the Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) Program.

OBJECTIVE: The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) Program is a diabetes prevention trial comparing the diabetes conversion rate at 3 years between the intervention group, which receives the incentivized lifestyle intervention program with stepwise addition of metformin, and the control group, which receives the standard of care. We describe the baseline characteristics and compare Pre-DICTED participants with other diabetes prevention trials cohort. RESEARCH DESIGN AND METHODS: Participants were aged between 21 and 64 years, overweight (body mass index (BMI) ≥23.0 kg/m2), and had pre-diabetes (impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT)). RESULTS: A total of 751 participants (53.1% women) were randomized. At baseline, mean (SD) age was 52.5 (8.5) years and mean BMI (SD) was 29.0 (4.6) kg/m2. Twenty-three per cent had both IFG and IGT, 63.9% had isolated IGT, and 13.3% had isolated IFG. Ethnic Asian Indian participants were more likely to report a family history of diabetes and had a higher waist circumference, compared with Chinese and Malay participants. Women were less likely than men to meet the physical activity recommendations (≥150 min of moderate-intensity physical activity per week), and dietary intake varied with both sex and ethnicity. Compared with other Asian diabetes prevention studies, the Pre-DICTED cohort had a higher mean age and BMI. CONCLUSION: The Pre-DICTED cohort represents subjects at high risk of diabetes conversion. The study will evaluate the effectiveness of a community-based incentivized lifestyle intervention program in an urban Asian context.

Early oral stepdown antibiotic therapy versus continuing intravenous therapy for uncomplicated Gram-negative bacteraemia (the INVEST trial): study protocol for a multicentre, randomised controlled, open-label, phase III, non-inferiority trial.

BACKGROUND: The incidence of Gram-negative bacteraemia is rising globally and remains a major cause of morbidity and mortality. The majority of patients with Gram-negative bacteraemia initially receive intravenous (IV) antibiotic therapy. However, it remains unclear whether patients can step down to oral antibiotics after appropriate clinical response has been observed without compromising outcomes. Compared with IV therapy, oral therapy eliminates the risk of catheter-associated adverse events, enhances patient quality of life and reduces healthcare costs. As current management of Gram-negative bacteraemia entails a duration of IV therapy with limited evidence to guide oral conversion, we aim to evaluate the clinical efficacy and economic impact of early stepdown to oral antibiotics. METHODS: This is an international, multicentre, randomised controlled, open-label, phase III, non-inferiority trial. To be eligible, adult participants must be clinically stable / non-critically ill inpatients with uncomplicated Gram-negative bacteraemia. Randomisation to the intervention or standard arms will be performed with 1:1 allocation ratio. Participants randomised to the intervention arm (within 72 h from index blood culture collection) will be immediately switched to an oral fluoroquinolone or trimethoprim-sulfamethoxazole. Participants randomised to the standard arm will continue to receive IV therapy for at least 24 h post-randomisation before clinical re-assessment and decision-making by the treating doctor. The recommended treatment duration is 7 days of active antibiotics (including empiric therapy), although treatment regimen may be longer than 7 days if clinically indicated. Primary outcome is 30-day all-cause mortality, and the key secondary outcome is health economic evaluation, including estimation of total healthcare cost as well as assessment of patient quality of life and number of quality-adjusted life years saved. Assuming a 30-day mortality of 8% in the standard and intervention arms, with 6% non-inferiority margin, the target sample size is 720 participants which provides 80% power with a one-sided 0.025 α-level after adjustment for 5% drop-out. DISCUSSION: A finding of non-inferiority in efficacy of oral fluoroquinolones or trimethoprim-sulfamethoxazole versus IV standard of care antibiotics may hypothetically translate to wider adoption of a more cost-effective treatment strategy with better quality of life outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05199324 . Registered 20 January 2022.

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.

The Associations Between Preoperative Anthropometry and Postoperative Outcomes in Infants Undergoing Congenital Heart Surgery.

Aim: We explored the association between preoperative anthropometry and biochemistry, and postoperative outcomes in infants with CHD after cardiac surgery, as infants with congenital heart disease (CHD) often have feeding difficulties and malnutrition. Methodology: This was a retrospective review of infants (≤ 1-year-old) who underwent congenital heart surgery. Preoperative anthropometryin terms of preoperative weight-for-age z-score (WAZ), length-for-age z-score (LAZ), as well as preoperative serum albumin and hemoglobin concentrations, were evaluated against 6-month mortality, and morbidity outcomes including postoperative complications, vasoactive inotrope score, duration of mechanical ventilation, length of stay in the pediatric intensive care unit and in hospital, using the logistic regression or median regression models accounting for infant-level clustering. Results: One hundred and ninety-nine operations were performed in 167 infants. Mean gestational age at birth was 38.0 (SD 2.2) weeks (range 26 to 41 weeks). Thirty (18.0%) infants were born preterm (<37 weeks). The commonest acyanotic and cyanotic lesions were ventricular septal defect (26.3%, 44/167), and tetralogy of Fallot (13.8%, 23/167), respectively. Mean age at cardiac surgery was 94 (SD 95) days. Feeding difficulties, including increased work of breathing during feeding, diaphoresis, choking or coughing during feeding, and inability to complete feeds, was present in 54.3% (108/199) of infants prior to surgery, of which 21.6% (43/199) required tube feeding. The mean preoperative WAZ was-1.31 (SD 1.79). Logistic regression models showed that low preoperative WAZ was associated with increased risk of postoperative complications (odds ratio 1.82; p = 0.02), and 6-month mortality (odds ratio 2.38; p = 0.008) following CHD surgery. There was no meaningful association between the other preoperative variables and other outcomes. Conclusion: More than 50% of infants with CHD undergoing cardiac surgery within the first year of life have feeding difficulties, of which 22% require to be tube-fed. Low preoperative WAZ is associated with increased postoperative complications and 6-month mortality.

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.

Protein supplementation versus standard feeds in underweight critically ill children: a pilot dual-centre randomised controlled trial protocol.

INTRODUCTION: Protein-energy malnutrition, increased catabolism and inadequate nutritional support leads to loss of lean body mass with muscle wasting and delayed recovery in critical illness. However, there remains clinical equipoise regarding the risks and benefits of protein supplementation. This pilot trial will determine the feasibility of performing a larger multicentre trial to determine if a strategy of protein supplementation in critically ill children with body mass index (BMI) z-score ≤-2 is superior to standard enteral nutrition in reducing the length of stay in the paediatric intensive care unit (PICU). METHODS AND ANALYSIS: This is a randomised controlled trial of 70 children in two PICUs in Singapore. Children with BMI z-score ≤-2 on PICU admission, who are expected to require invasive mechanical ventilation for more than 48 hours, will be randomised (1:1 allocation) to protein supplementation of ≥1.5 g/kg/day in addition to standard nutrition, or standard nutrition alone for 7 days after enrolment or until PICU discharge, whichever is earlier. Feasibility outcomes for the trial include effective screening, satisfactory enrolment rate, timely protocol implementation (within first 72 hours) and protocol adherence. Secondary outcomes include mortality, PICU length of stay, muscle mass, anthropometric measurements and functional outcomes. ETHICS AND DISSEMINATION: The trial protocol was approved by the institutional review board of both participating centres (Singhealth Centralised Institutional Review Board and National Healthcare Group Domain Specific Review Board) under the reference number 2020/2742. Findings of the trial will be disseminated through peer-reviewed journals and scientific conferences. TRIAL REGISTRATION NUMBER: NCT04565613.

Trajectories of Patient-Reported Outcomes After Palliative Gastrointestinal Surgery in Advanced Cancer: Is Good Quality of Life Sustainable?

To evaluate the trajectories and sustainability of health-related quality of life (HRQoL) outcomes after palliative gastrointestinal (GI) surgery and perioperative factors associated with HRQoL improvement postsurgery. Background: Palliative patients face a wide range of physical, emotional, social, and functional challenges. In evaluating the efficacy of palliative surgical interventions, a major pitfall of traditional surgical outcome measures is that they fall short of measuring outcomes that are meaningful to patients during end-of-life. HRQoL tools may provide a more comprehensive assessment of the true value and impact of palliative surgery. Methods: We prospectively recruit advanced cancer patients undergoing palliative GI surgery. The Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire was administered before and at regular intervals after surgery. HRQoL improvement was defined as ≥4-points increment in FACT-G total score over baseline. Duration of sustained HRQoL improvement above this threshold and factors associated with varying extents of HRQoL change were evaluated. Results: Of the 65 patients, intestinal obstruction was the most common indication for surgery (70.8%). The mean baseline FACT-G total score was 70.7 (95% CI: 66.3-75.1). Forty-six (70.8%) patients experienced HRQoL improvement after surgery. This HRQoL improvement was sustained over a median duration of 3.5 months and was driven mainly by improvements in patients' physical and emotional well-being. Albumin was significantly associated with the extent of HRQoL improvements (P = 0.043). Conclusion: A clinically significant and sustained improvement in HRQoL was observed after palliative GI surgery. Patients with higher preoperative albumin levels were more likely to experience HRQoL improvements.

Early identification of axial spondyloarthritis in a multi-ethnic Asian population.

INTRODUCTION/OBJECTIVES: To address the diagnostic delay in axial spondyloarthritis (axSpA), we have cross-culturally adapted the Hamilton axSpA questionnaire, a self-administered screening questionnaire, in the Singapore population. In this study, we compared the performance of various scoring methods for this questionnaire in detecting axSpA. METHOD: The questionnaire was self-administered by eligible subjects. Scoring methods included method A, the original questionnaire scoring, and methods B-E, scoring developed based on the Assessment of SpondyloArthritis International Society (ASAS) criteria for inflammatory back pain (IBP) and the referral, classification and both referral and classification of axSpA, respectively. The reference standard was diagnosis by a rheumatologist. Since the ASAS criteria-based scoring methods were mainly based on clinical axSpA features, self-report and rheumatologist-assessment of clinical axSpA features were also compared in subjects with axSpA. RESULTS: Of 1418 subjects (age: 54 ± 14 years, female: 73%) recruited, 46 were diagnosed with axSpA by a rheumatologist. Sensitivities of methods A-E were 35%, 61%, 63%, 48% and 83%, respectively. Self-report of clinical axSpA features exceeded rheumatologist-assessment for arthritis (83 vs 26%), good response to NSAIDs (37 vs 30%), enthesitis (35 vs 30%), dactylitis (20 vs 2%) and family history for axSpA (13 vs 4%). The reverse was true for IBP (41 vs 63%) and uveitis (4 vs 15%). CONCLUSIONS: A self-administered questionnaire using the ASAS referral and classification criteria-based scoring yielded relatively high sensitivity in detecting axSpA in subjects newly referred to rheumatology clinics. This supports its evaluation as a screening and referral tool in the general population in future studies. Key Points • A self-administered questionnaire could be used as a screening and referral tool. • ASAS referral and classification criteria-based scoring yielded relatively high sensitivity. • Inaccurate perception of clinical axSpA features was observed in axSpA patients.

Impact of COVID-19 on Hepatocellular Carcinoma Management: A Multicountry and Region Study.

PURPOSE: The COVID-19 pandemic has altered healthcare priorities which may adversely impact cancer management. We aimed to evaluate the impact of the pandemic on the diagnosis, treatment, and consultation methods for patients with hepatocellular carcinoma (HCC). PATIENTS AND METHODS: We conducted a survey among 27 hospitals from 14 Asia-Pacific countries, collecting hospital-level information on the number of newly diagnosed HCC cases during a pre-pandemic period (February to May 2019) and for the same period during the pandemic (February to May 2020). Information was also collected on delays in diagnosis and treatment, changes in treatment modalities and complication rates, changes in patient enrollment in clinical trials, and modes of patient consultation. The information was stratified by the Barcelona Clinic Liver Cancer (BCLC) stage. RESULTS: The survey included cohorts of 2789 and 2045 patients newly diagnosed with HCC during the pre- and pandemic period, respectively. A decline of 26.7% in new HCC cases was reported during the pandemic compared to the pre-pandemic. A sizable proportion of institutions reported delays in diagnosis (48.2% in BCLC 0/A/B and 51.9% in BCLC C), delays in treatment (66.7% in BCLC 0/A/B and 63.0% in BCLC C), changes in treatment modality (33.3% in BCLC 0/A/B and 18.5% in BCLC C), an increase in treatment complications (about 15% across all BCLC stages), and no growth in clinical trial enrollments during the pandemic. Furthermore, there was a decline of 27.3% in face-to-face patient consultations and an increase of 18.3% in video/telephonic consultations during the pandemic. A considerable variation in changes in HCC management was observed among countries. CONCLUSION: The COVID-19 pandemic has significantly impacted the management of HCC among Asia-Pacific countries. The impact varies according to the disease stage and country. Well thought-through long-term strategies are required to ameliorate the negative impact of the pandemic on HCC patients.

The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) program: study protocol for a randomized controlled trial.

BACKGROUND: Community-based diabetes prevention programs varied widely in effectiveness, and the intervention strategy consisting of lifestyle interventions, stepwise addition of metformin, and financial incentives has not been studied in real-world clinical practice settings. The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) trial is a pragmatic trial that aims to compare the effectiveness of a community-based stepwise diabetes prevention program with added financial incentives (intervention) versus the standard of care (control) in reducing the risk of type 2 diabetes over 3 years among overweight or obese individuals with pre-diabetes. METHODS: This is an open-label, 1:1 randomized controlled trial which aims to recruit 846 adult individuals with isolated impaired fasting glucose (IFG), isolated impaired glucose tolerance (IGT), or both IFG and IGT from Singapore. Intervention arm participants attend 12 group-based sessions (2 nutrition workshops, 9 exercise sessions, and a goal-setting workshop) delivered at community sites (weeks 1 to 6), receive weekly physical activity and nutrition recommendations delivered by printed worksheets (weeks 7 to 12), and receive monthly health tips delivered by text messages (months 4 to 36). From month 6 onwards, intervention arm participants who remain at the highest risk of conversion to diabetes are prescribed metformin. Intervention arm participants are also eligible for a payment/rewards program with incentives tied to attendance at the group sessions and achievement of the weight loss target (5% of baseline weight). All participants are assessed at baseline, month 3, month 6, and every 6 months subsequently till month 36. The primary endpoint is the proportion of participants with diabetes at 3 years. Secondary endpoints include the mean change from baseline at 3 years in fasting plasma glucose, 2-hour plasma glucose, HbA1c, body weight, body mass index, physical activity, and dietary intake. DISCUSSION: The Pre-DICTED trial will provide evidence of the effectiveness and feasibility of a community-based stepwise diabetes prevention program with added financial incentives for individuals with pre-diabetes in Singapore. The study will provide data for a future cost-effectiveness analysis, which will be used to inform policymakers of the value of a nationwide implementation of the diabetes prevention program. TRIAL REGISTRATION: ClinicalTrials.gov NCT03503942 . Retrospectively registered on April 20, 2018. Protocol version: 5.0 Date: 1 March 2019.

Interval between symptom onset and diagnosis among patients with autoimmune rheumatic diseases in a multi-ethnic Asian population.

AIM: The interval between symptom onset and diagnosis (pre-diagnosis interval) can at times be longer than is ideal in patients with autoimmune rheumatic diseases (ARDs). In this study, we aimed to characterize this interval and to identify its associated factors. METHOD: We characterized pre-diagnosis interval into 4 intervals: Interval #1 between symptom onset and first visit to healthcare professionals; Interval #2 between first visit to healthcare professionals and rheumatology referral; Interval #3 between rheumatology referral and first rheumatology assessment; and Interval #4 between first rheumatology assessment and diagnosis. Median regression models were used to identify factors associated with longer pre-diagnosis interval and Interval #1. RESULTS: Among 259 patients (median age = 52.0 [41.6-61.9] years, 71% female, rheumatoid arthritis [n = 75], axial spondyloarthritis [axSpA] [n = 40] and psoriatic arthritis [n = 35]), median pre-diagnosis interval was 11.5 (4.7-36.0) months. Interval #1 (median = 4.9 months) was significantly longer than Intervals #2-#4 (median = 0.3, 1.5, and 0.0 months, respectively). Patients with axSpA had significantly longer pre-diagnosis interval (median = 38.7 months) and Interval #1 (median = 26.6 months) than patients with the other ARDs. Median regression suggested that patients referred from specialty care had significantly longer pre-diagnosis interval (median difference = 7.7 months) and Interval #1 (median difference = 6.4 months) compared to those referred from primary care. CONCLUSION: A long pre-diagnosis interval was observed among patients with ARDs (especially axSpA), due largely to a long interval between symptom onset and the first visit to healthcare professionals. This highlights the importance of interventions targeting patients prior to their first visit to healthcare professionals in reducing pre-diagnosis interval.

Budget impact and cost-effectiveness analyses of the COBRA-BPS multicomponent hypertension management programme in rural communities in Bangladesh, Pakistan, and Sri Lanka.

BACKGROUND: COBRA-BPS (Control of Blood Pressure and Risk Attenuation-Bangladesh, Pakistan, Sri Lanka), a multi-component hypertension management programme that is led by community health workers, has been shown to be efficacious at reducing systolic blood pressure in rural communities in Bangladesh, Pakistan, and Sri Lanka. In this study, we aimed to assess the budget required to scale up the programme and the incremental cost-effectiveness ratios. METHODS: In a cluster-randomised trial of COBRA-BPS, individuals aged 40 years or older with hypertension who lived in 30 rural communities in Bangladesh, Pakistan, and Sri Lanka were deemed eligible for inclusion. Costs were quantified prospectively at baseline and during 2 years of the trial. All costs, including labour, rental, materials and supplies, and contracted services were recorded, stratified by programme activity. Incremental costs of scaling up COBRA-BPS to all eligible adults in areas covered by community health workers were estimated from the health ministry (public payer) perspective. FINDINGS: Between April 1, 2016, and Feb 28, 2017, 11 510 individuals were screened and 2645 were enrolled and included in the study. Participants were examined between May 8, 2016, and March 31, 2019. The first-year per-participant costs for COBRA-BPS were US$10·65 for Bangladesh, $10·25 for Pakistan, and $6·42 for Sri Lanka. Per-capita costs were $0·63 for Bangladesh, $0·29 for Pakistan, and $1·03 for Sri Lanka. Incremental cost-effectiveness ratios were $3430 for Bangladesh, $2270 for Pakistan, and $4080 for Sri Lanka, per cardiovascular disability-adjusted life year averted, which showed COBRA-BPS to be cost-effective in all three countries relative to the WHO-CHOICE threshold of three times gross domestic product per capita in each country. Using this threshold, the cost-effectiveness acceptability curves predicted that the probability of COBRA-BPS being cost-effective is 79·3% in Bangladesh, 85·2% in Pakistan, and 99·8% in Sri Lanka. INTERPRETATION: The low cost of scale-up and the cost-effectiveness of COBRA-BPS suggest that this programme is a viable strategy for responding to the growing cardiovascular disease epidemic in rural communities in low-income and middle-income countries where community health workers are present, and that it should qualify as a priority intervention across rural settings in south Asia and in other countries with similar demographics and health systems to those examined in this study. FUNDING: The UK Department of Health and Social Care, the UK Department for International Development, the Global Challenges Research Fund, the UK Medical Research Council, Wellcome Trust.