The Clinical and Cost-Effectiveness of an Individualized Nutritional CAre (INCA) Bundle versus Standard Care for Adults with Pressure Injuries Receiving Home Nursing Services: A Protocol for a Cluster Randomized and Pragmatic Clinical Trial with an Economic Evaluation.

BACKGROUND: Pressure injuries (PIs) represent a significant healthcare challenge in Singapore among the aging population. These injuries contribute to increased morbidity, mortality, and healthcare expenditure. Existing research predominantly explores single-component interventions in hospital environments, often yielding limited success. The INCA Trial aims to address this research gap by conducting a comprehensive, cluster randomized controlled trial that integrates education, individualized nutritional support, and community nursing care. This study is designed to evaluate clinical and cost-effectiveness outcomes, focusing on PI wound area reduction and incremental costs associated with the intervention. METHODS: The INCA Trial employs a two-group, non-blinded, cluster randomized, and pragmatic clinical trial design, recruiting 380 adult individuals (age ≥ 21 years) living in the community with stage II, III, IV, and unstageable PI(s) who are receiving home nursing service in Singapore. Cluster randomization is stratified by postal codes to minimize treatment contamination. The intervention arm will receive an individualized nutrition and nursing care bundle (dietary education with nutritional supplementation), while the control arm will receive standard care. The 90-day intervention will be followed by outcome assessments extending over one year. Primary outcomes include changes in PI wound area and the proportion of participants achieving a ≥40% area reduction. Secondary outcomes include health-related quality of life (HRQOL), nutritional status, and hospitalization rates. Data analysis will be conducted on an intention-to-treat (ITT) basis, supplemented by interim analyses for efficacy and futility and pre-specified sensitivity and subgroup analyses. The primary outcome for the cost-effectiveness analysis will be based on the change to total costs compared to the change to health benefits, as measured by quality-adjusted life years (QALYs). DISCUSSION: The INCA Trial serves as a pioneering effort in its approach to PI management in community settings. This study uniquely emphasizes both clinical and economic outcomes and melds education, intensive dietetic support, and community nursing care for a holistic approach to enhancing PI management.

Effectiveness of dietary counseling with or without nutrition supplementation in hospitalized patients who are malnourished or at risk of malnutrition: A systematic review and meta-analysis.

BACKGROUND: Nutrition support is associated with improved survival and nonelective hospital readmission rates among malnourished medical inpatients; however, limited evidence supporting dietary counseling is available. We intend to determine the effect of dietary counseling with or without oral nutrition supplementation (ONS), compared with standard care, on hospitalized adults who are malnourished or at risk of malnutrition. METHODS: We searched MEDLINE/PubMed, CINAHL, Embase, Scopus, The Cochrane Library, and Google Scholar for studies listed from January 1, 2011, to August 31, 2021. Meta-analysis was performed to obtain pooled risk ratios (RRs) and 95% CIs to estimate the effect. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was used to assess the certainty of the evidence. RESULTS: Sixteen studies were identified. Compared with standard care, dietary counseling with or without ONS probably does not reduce inpatient rates of 30-day mortality (RR = 1.24; 0.60-2.55; I2 = 45%; P = 0.56; moderate certainty), slightly reduces 6-month mortality (RR = 0.83; 0.69-1.00; I2 = 16%; P = 0.06; high certainty), reduces complications (RR = 0.85; 0.73-0.98; I2 = 0%; P = 0.03; high certainty), and may slightly reduce readmission (RR = 0.83; 0.66-1.03; I2 = 55%; P = 0.10; low certainty) but may not reduce length of stay (mean difference: -0.75 days; -1.66-0.17; I2 = 70%; P = 0.11; low certainty). Intervention may result in slight improvements in nutrition status/intake and weight/body mass index (low certainty). CONCLUSIONS: There is an increase in the certainty of evidence regarding the positive impact of dietary counseling on outcomes. Future studies should standardize and provide details/frequencies of counseling methods and ONS adherence to determine dietary counseling effectiveness.

Economic Evaluation of Nutrition Support in the Prevention and Treatment of Pressure Ulcers in Acute and Chronic Care Settings: A Systematic Review.

BACKGROUND: Recent developments in nutrition intervention indicated clinical effectiveness for pressure ulcer (PU) prevention and treatment, but it is important to assess whether they are cost-effective. The aims of this systematic review are to determine the cost-effectiveness and clinical outcomes of nutrition support in PU prevention and treatment. METHODS: A systematic search of randomized controlled trials, observational studies, and statistical models that investigated cost-effectiveness and economic outcomes for prevention and/or treatment of PUs were performed using standard literature and electronic databases. RESULTS: Fourteen studies met the inclusion criteria, which included 3 randomized controlled trials with their companion economic evaluations, 4 model-based, 2 cohort, 1 pre and post, and 1 prospective controlled trial. Risk of bias assessment for all of the uncontrolled or observational trials revealed high or serious risk of bias. Interventions that incorporated specialized nursing care appeared to be more effective in prevention and treatment of PUs, compared with single intervention studies. There is a trend of improved PU healing when additional energy/protein are provided. PU prevention ($250-$9,800) was less expensive than treatment ($2,500-$16,000). Nutrition intervention for PU prevention was cost-effective in 87.0%-99.99% of the simulation models. CONCLUSIONS: There is potential cost-saving and/or cost-effectiveness of nutrition support in the long term, as predicted by the model-based PU prevention studies in the review. Prevention of PU also appears to be more cost-effective than treatment. A multidisciplinary approach to managing PU is more likely to be cost-effective.

Green and black tea intake in relation to prostate cancer risk among Singapore Chinese.

PURPOSE: Tea is one of the most commonly consumed beverages worldwide. To date, observational data from prospective cohort studies investigating the relationship between green and black tea intake and prostate cancer risk are sparse and equivocal. In a population-based, prospective cohort study of Chinese men in Singapore, we investigated the relationship between green and black tea intake and prostate cancer risk. METHODS: Tea consumption data for 27,293 men were collected at baseline (between 1993 and 1998) using a validated food frequency questionnaire. After an average of 11.2 years of follow-up, 298 men had developed prostate cancer. Proportional hazards regression methods were used to assess the associations between tea intake and prostate cancer risk. RESULTS: There was no association between daily green tea intake and prostate cancer risk, compared with no green tea intake [hazard ratio (HR) = 1.08; 95 % confidence interval (CI) 0.79, 1.47]. For black tea, a statistically significant positive association and trend were observed for daily intake compared with no black tea intake (HR = 1.41, 95 % CI 1.03, 1.92; p for trend <0.01) CONCLUSIONS: Few prospective data are available from populations that have both a high level and wide range of black and green tea intake; this study represents a unique opportunity to evaluate their individual effects on prostate cancer risk. Our findings support the notion that green tea intake does not protect against prostate cancer and that black tea intake may increase prostate cancer risk.

Complementary and alternative medicine among Singapore cancer patients.

INTRODUCTION: This study evaluates determinants, expectations, association with quality of life (QOL) and doctor's awareness of Complementary and Alternative Medicine (CAM) use in Singapore cancer patients. MATERIAL AND METHODS: We interviewed 316 patients visiting the Cancer Centre of the National University Hospital on behaviour, attitudes and expectations towards CAM and assessed QOL via Euroqol Questionnaire (EQ-5D). Medical information was obtained from oncologists. RESULTS: One hundred and seventy-three patients (55%) reported CAM use after cancer diagnosis. Chinese ethnicity, tertiary education, age <65 years and previous CAM use were independent predictors of CAM use. Fifty-one per cent of CAM users informed their doctors about their use and 15% of doctors reported to be aware of CAM use in these patients. Thirty-seven per cent believed CAM to be equally or more effective than conventional cancer therapies and 78% expected at least basic knowledge about CAM from their oncologists. Twenty-fi ve per cent of patients reported concurrent use of oral CAM and chemotherapy, of which oncologists were unaware in 86% of cases. CAM users had higher EuroQol utility scores than non-CAM users (0.79 versus 0.73, respectively, P = 0.03), in particularly those aged >or=65 years and those with stage IV disease. CONCLUSION: Singapore cancer patients show high prevalence of CAM use, high expectations regarding its effectiveness and doctors' knowledge on CAM and many use it concurrently with chemotherapy or radiotherapy. Since oncologists are generally unaware of CAM use in their patients, doctor-patient communication on CAM use needs to be improved. The association of CAM use and higher QOL scores in some subgroups deserves further exploration.

Phase I study of weekly DN-101, a new formulation of calcitriol, in patients with cancer.

BACKGROUND: DN-101 is a new, high-dose, oral formulation of calcitriol under investigation for the treatment of cancer. We sought to evaluate the tolerability and pharmacokinetics (PK) of weekly doses of DN-101 in patients with advanced cancer. METHODS: Patients who completed a previously reported single dose escalation study of DN-101 [Beer et al. (2005) Clin Cancer Res 11:7794-7799] were eligible for this continuation weekly dosing study. Cohorts of 3-10 patients were treated at doses of 15, 30, 45, 60, and 75 microg calcitriol. Once 45 microg was established as the maximum tolerated dose (MTD), this cohort was expanded to include 18 patients. Dose limiting toxicity (DLT) was defined as > or =grade 2 hypercalcemia or > or =grade 3 persistent treatment-related toxicities. RESULTS: Thirty-seven patients were recruited. DLT of transient reversible grade 2 hypercalcemia (serum calcium of 11.6-12.5 mg/dL) occurred in two of six patients treated with 60 microg of DN-101. No DLT was observed in the 18 patients who received DN-101 weekly at 45 microg. Overall, DN-101 was well tolerated. The most frequent adverse events were fatigue (27%), hypercalcemia (19%, including five grade 1, two grade 2, and no grade 3 or 4 events), and grade 1 nausea (16%). PK parameters following repeat dosing were comparable to those for the initial dose (n = 4). CONCLUSION: The MTD for weekly DN-101 was established as 45 mug. The DLTs observed were two episodes of rapidly reversible grade 2 hypercalcemia in two of the six patients treated at 60 microg weekly. Repeat doses of DN-101 at 45 microg weekly are well tolerated and this dose is suitable for studies of weekly DN-101 in cancer patients.

Pharmacokinetics and tolerability of a single dose of DN-101, a new formulation of calcitriol, in patients with cancer.

BACKGROUND: Intermittent administration allows substantial dose escalation of calcitriol but limited bioavailability of the commercially available formulations at high doses is limiting. In this dose escalation study, we sought to evaluate the tolerability and pharmacokinetics of a single oral dose of DN-101, a high-dose calcitriol formulation. METHODS: DN-101 doses were escalated in sequential groups of three to six patients with advanced solid tumors. Dose-limiting toxicity was defined as grade > or =2 hypercalcemia or grade > or =3 persistent treatment-related toxicities. Single-dose administration of 15, 30, 60, 75, 90, 105, 135, and 165 mug was tested. RESULTS: Thirty-eight patients were enrolled in 2002 and 2003. The median age was 70 years (range, 44-91 years). Dose escalation was stopped at the 165 microg level when the number of capsules required at one time reached 11. No dose-limiting toxicities occurred. Transient and self-limited grade 3 toxicities were hyponatremia (2) and proteinuria (1). A dose-proportional increase in peak concentration (C(max)) and area under the concentration curve (AUC) was seen across the full range of DN-101 doses tested. At the 165 microg dose, C(max) was 6.21 +/- 1.99 ng/mL, AUC(0-24) was 41.3 +/- 9.77 ng h/mL, AUC(0-infinity) was 55.4 +/- 8.44, and half-life (T(1/2)) was 16.2 hours. CONCLUSIONS: At doses between 15 and 165 microg, DN-101 exhibits linear pharmacokinetics. At 165 microg, DN-101 achieves systemic exposure that is 5- to 8-fold higher than that achieved with commercial formulations of calcitriol, which makes DN-101 comparable to that required for antitumor activity in vivo in a murine squamous cell carcinoma model.