Knowledge and practice of home blood pressure monitoring 6 months after the risk and assessment management programme: does health literacy matter?

BACKGROUND: Little is known whether patients with lower health literacy could retain the practice and knowledge of home blood pressure monitoring (HBPM) after an educational programme. METHODS: A cluster randomised controlled trial in five primary care clinics recruited participants with uncontrolled hypertension. Clinics were randomised either to a HBPM group education (Risk Assessment and Management Programme (RAMP-group), or individual counselling of self-management (RAMP-individual). Health literacy was assessed by the Chinese Health Literacy Scale for Chronic Care. Practice and knowledge of HBPM were surveyed by a 10-item HBPM knowledge checklist and patient record review 6 months after interventions. Predictors for regular HBPM and good HBPM knowledge were assessed by multivariate logistic regression models. RESULTS: 287 participants (RAMP-group: 151; RAMP-individual: 136) were follow-up for 6 months. 272 participants completed the knowledge questionnaires (response rate 94.8%). 67.8% of the participants performed HBPM regularly, and there was no statistical difference between both interventions. Age more than 65 (adjusted odds ratios (aOR) 2.58, 95% CI 1.37 to 4.86, p=0.003), not working (aOR 2.34, 95% CI 1.10 to 4.97, p=0.027)and adequate health literacy (aOR 2.25, 95% CI 1.28 to 3.95, p=0.005) predicted regular HBPM. Participants in RAMP-group demonstrated a significant lower body weight than those in RAMP-individual (-0.3±2.0 kg vs +0.7 ±1.7 kg, p<0.001).The RAMP-group participants were eight times more likely to have full HBPM knowledge score than the RAMP-individual participants (aOR 8.46, 95% CI 4.68 to 15.28, p<0.001). CONCLUSION: Patients could retain HBPM knowledge better after RAMP-group than RAMP-individual. Older, retired and patients with adequate health literacy were more likely to continue weekly HBPM 6 months after education. TRIAL REGISTRATION NUMBER: NCT02551393.

Clinical Therapeutics in Hong Kong.

Hong Kong is a compact territory in Southern China that enjoys a high degree of autonomy. Despite its dense population and uneven wealth distribution, infant mortality is low and life expectancy is long. The health service is more hospital and clinic based than community based. This seems cost-effective while professional standards are high and rigorously maintained. Drug registration follows American and European requirements. Hong Kong is a part of the Pharmaceutical Inspection Cooperation Scheme, which brings a high standard of drug regulation. Hong Kong is a good choice for clinical trials because the subjects are Chinese and protocols in English do not need to be translated. There are also 2 well-established clinical trials centers in university hospitals that also run Phase I and clinical pharmacology studies.

Towards a Transparent, Credible, Evidence-Based Decision-Making Process of New Drug Listing on the Hong Kong Hospital Authority Drug Formulary: Challenges and Suggestions.

The aim of this article is to describe the process, evaluation criteria, and possible outcomes of decision-making for new drugs listed in the Hong Kong Hospital Authority Drug Formulary in comparison to the health technology assessment (HTA) policy overseas. Details of decision-making processes including the new drug listing submission, Drug Advisory Committee (DAC) meeting, and procedures prior to and following the meeting, were extracted from the official Hong Kong Hospital Authority drug formulary management website and manual. Publicly-available information related to the new drug decision-making process for five HTA agencies [the National Institute of Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), the Australia Pharmaceutical Benefits Advisory Committee (PBAC), the Canadian Agency for Drugs and Technologies in Health (CADTH), and the New Zealand Pharmaceutical Management Agency (PHARMAC)] were reviewed and retrieved from official documents from public domains. The DAC is in charge of systemically and critically appraising new drugs before they are listed on the formulary, reviewing submitted applications, and making the decision to list the drug based on scientific evidence to which safety, efficacy, and cost-effectiveness are the primary considerations. When compared with other HTA agencies, transparency of the decision-making process of the DAC, the relevance of clinical and health economic evidence, and the lack of health economic and methodological input of submissions are the major challenges to the new-drug listing policy in Hong Kong. Despite these challenges, this review provides suggestions for the establishment of a more transparent, credible, and evidence-based decision-making process in the Hong Kong Hospital Authority Drug Formulary. Proposals for improvement in the listing of new drugs in the formulary should be a priority of healthcare reforms.

Measuring non-polyaminated lipocalin-2 for cardiometabolic risk assessment.

AIMS: Lipocalin-2 is a pro-inflammatory molecule characterized by a highly diversified pattern of expression and structure-functional relationships. In vivo, this molecule exists as multiple variants due to post-translational modifications and/or protein-protein interactions. Lipocalin-2 is modified by polyamination, which enhances the clearance of this protein from the circulation and prevents its excessive accumulation in tissues. On the other hand, animal studies suggest that non-polyaminated lipocalin-2 (npLcn2) plays a causal role in the pathogenesis of obesity-associated medical complications. The present study examined the presence of npLcn2 in samples from healthy volunteers or patients with cardiac abnormalities and evaluated npLcn2 as a biomarker for cardiometabolic risk assessment. METHODS AND RESULTS: Immunoassays were developed to quantify npLcn2 in blood and urine samples collected from 100 volunteers (59 men and 41 women), or venous plasma and pericardial fluid samples obtained from 37 cardiothoracic surgery patients. In healthy volunteers, npLcn2 levels in serum are significantly higher in obese and overweight than in lean subjects. After adjustment for age, gender, smoking, and body mass index (BMI), serum npLcn2 levels are positively correlated with heart rate, circulating triglycerides, high-sensitivity C-reactive protein (hsCRP), and creatinine in plasma. The npLcn2 levels in urine are significantly increased in subjects with metabolic syndrome and positively correlated with BMI, heart rate, circulating triglycerides, and urinary aldosterone. In cardiothoracic surgery patients, the circulating concentrations of npLcn2 are higher (more than two-fold) than those of healthy volunteers and positively correlated with the accumulation of this protein in the pericardial fluid. Heart failure patients exhibit excessive expression and distribution of npLcn2 in mesothelial cells and adipocytes of the parietal pericardium, which are significantly correlated with the elevated plasma levels of npLcn2, total cholesterol, and creatinine. CONCLUSIONS: Quantitative and qualitative evaluation of npLcn2 in human biofluid samples and tissue samples can be applied for risk assessment of healthy individuals and disease management of patients with obesity-related cardiometabolic and renal complications.

Cost-Effectiveness of Apixaban versus Warfarin in Chinese Patients with Non-Valvular Atrial Fibrillation: A Real-Life and Modelling Analyses.

OBJECTIVES: Many of the cost-effectiveness analyses of apixaban against warfarin focused on Western populations but Asian evidence remains less clear. The present study aims to evaluate the cost-effectiveness of apixaban against warfarin in Chinese patients with non-valvular atrial fibrillation (NVAF) from a public institutional perspective in Hong Kong. METHODS: We used a Markov model incorporating 12 health state transitions, and simulated the disease progression of NVAF in 1,000 hypothetical patients treated with apixaban/warfarin. Risks of clinical events were based on the ARISTOTLE trial and were adjusted with local International Normalized Ratio control, defined as the time in therapeutic range. Real-life input for the model, including patients' demographics and clinical profiles, post-event treatment patterns, and healthcare costs, were determined by a retrospective cohort of 40,569 incident patients retrieved from a Hong Kong-wide electronic medical database. Main outcome measurements included numbers of thromboembolic and bleeding events, life years, quality-adjusted life years (QALYs) and direct healthcare cost. When comparing apixaban and warfarin, treatment with incremental cost-effectiveness ratio (ICER) less than one local GDP per capita (USD 33,534 in 2014) was defined to be cost-effective. RESULTS: In the lifetime simulation, fewer numbers of events were estimated for the apixaban group, resulting in reduced event-related direct medical costs. The estimated ICER of apixaban was USD 7,057 per QALY at base-case analysis and ranged from USD 1,061 to 14,867 per QALY under the 116 tested scenarios in deterministic sensitivity analysis. While in probabilistic sensitivity analysis, the probability of apixaban being the cost-effective alternative to warfarin was 96% and 98% at a willingness to pay threshold of USD 33,534 and 100,602 per QALY, respectively. CONCLUSIONS: Apixaban is likely to be a cost-effective alternative to warfarin for stroke prophylaxis in Chinese patients with NVAF in Hong Kong.

Non-vitamin K Oral Anticoagulants Versus Warfarin for Patients with Atrial Fibrillation: Absolute Benefit and Harm Assessments Yield Novel Insights.

BACKGROUND AND OBJECTIVES: Benefits and/or harms (including costs) of non-vitamin K oral anticoagulants (NOACs) versus warfarin therapy need appreciation in relative and absolute terms. METHODS: Accordingly, we derived clinically relevant relative and absolute benefit/harm parameters for NOACs (apixaban, dabigatran, rivaroxaban, edoxaban) compared to warfarin from four clinical trials involving atrial fibrillation (AF) patients. For each trial, we tabulated patient numbers enduring four important outcomes and calculated unadjusted relative risk reduction (RRR) and number needed to treat (NNT)/year values (and 95% confidence intervals) for the NAOC compared to warfarin. These outcomes were as follows: stroke/systemic embolism (primary endpoint), hemorrhagic stroke, major bleeds, and death. We also addressed drug acquisition costs. RESULTS: Each NOAC was noninferior to warfarin for primary-outcome prevention; RRRs were 12-33% and NNT/year values were 182-481, and all but one indicated statistically significant superiority. All the NOACs yielded statistically significant reductions in hemorrhagic stroke risk; RRRs were 42-74% and NNT/year values were 364-528. Major bleeding risk was comparable in both groups. Apixaban yielded a lower NNT/year for preventing death than for primary-outcome prevention. Compared to warfarin, NOAC acquisition costs were 70- to 140-fold greater. CONCLUSIONS: For the primary outcome, the absolute benefits of NOACs were modest (NNT/year values being large). Reduced hemorrhagic stroke rates with NOACs could be due to superior embolic infarct prevention and fewer consequential hemorrhagic transformations. Among apixaban recipients, the absolute mortality benefit exceeded that for the primary outcome, indicating prevention of additional unrelated deaths. The substantially greater NOAC acquisition costs need viewing against probable greater safety and the avoidance of monitoring bleeding risks.

Trends in C-reactive protein levels in US adults from 1999 to 2010.

C-reactive protein (CRP) is a well-known biomarker of systemic inflammation and cardiovascular disease. We investigated the trends in prevalence of elevated CRP levels (>3.0 mg/L) in a general population of US adults. Data from 27,214 subjects aged ≥20 years in the 1999-2010 National Health and Nutrition Examination Survey were analyzed. After adjustment for age, sex, race/ethnicity, body mass index (weight (kg)/height (m)(2)), and medications for lowering blood pressure, glucose, and lipids, the prevalence of elevated CRP decreased significantly from 36.7% in 1999-2002 to 32.0% in 2007-2010, corresponding to a decrease in mean CRP level from 1.92 to 1.66 mg/L (both P < 0.001). The trend remained significant after additional adjustment for several traditional cardiovascular risk factors and use of different medications, including statins. However, the decreasing trends were attenuated after additional adjustment for total bilirubin (P = 0.08 and 0.02), which increased from 0.62 to 0.73 mg/dL over 12 years (P < 0.001). The decreasing trend of CRP levels is encouraging and may be related to the increase in total bilirubin levels. Such trends may be explained in part by the increasing use of medications such as statins, which can increase bilirubin levels and decrease CRP levels.

Health promotion in older Chinese: a 12-month cluster randomized controlled trial of pedometry and "peer support".

PURPOSE: Aging, in conjunction with decreasing physical activity, is associated with a range of health problems. Simple, low-maintenance, population-based means of promoting activity to counteract the age-associated decline are required. We therefore assessed the effect of pedometry and buddy support to increase physical activity. METHODS: We undertook a clustered randomized trial (HKCTR-346) of 24 community centers involving 399 older Chinese participants (≥ 60 yr). Centers were randomly allocated to 1) pedometry and buddy, 2) pedometry and no buddy, 3) no pedometry and buddy, and 4) no pedometry and no buddy with a 2 × 2 factorial design. The trial simultaneously tested the individual and combined effects of the interventions. The intervention groups also received monthly organized group activities to provide encouragement and support. Outcome measures were assessed at 6 and 12 months, including physical fitness and activity and cardiovascular disease risk factors (anthropometry and blood pressure). RESULTS: From the 24 centers, 356 volunteers (89.2%) completed the study. Those receiving the interventions had higher mean physical activity levels at 12 months of 1820 (95% confidence interval (CI) = 1360-2290) and 1260 (95% CI = 780-1740) MET·min·wk(-1), respectively relative to the decrease in the control groups. The buddy peer support intervention significantly improved mean aerobic fitness (12% [95% CI = 4%-21%]) and reduced both body fat (-0.6% [95% CI = -1.1% to 0.0%]) and time to complete the 2.5-m get-up-and-go test (-0.27 [95% CI = -0.53 to -0.01] s). No other improvements in the cardiovascular disease risk factors were observed. The combination of motivational tools was no better than the individual interventions. CONCLUSIONS: Both motivational interventions increased physical activity levels, and the buddy style improved fitness. These tools could be useful adjuncts in the prevention of obesity and age-related complications.

Loading doses for costly cancer biologicals: sound pharmacology or unnecessary extravagance?

The rising cost of new molecularly-targeted anticancer drugs has become a major issue in oncology. One small but significant factor contributing to this problem is the routine co-administration of loading doses, which may inflate the cost of the first treatment by as much as US$1000. Here, we question the cost-effectiveness of this practice in cancer patients on several grounds, including non-urgent pace of disease, lack of evidence for survival benefit, weak dose-dependency of biopharmaceutical efficacy in cancer and the unproven validity of the 'volume of distribution' concept applied to target-specific drugs.