Advantages of Transmuscular Quadratus Lumborum Block via Subfascial Approach Versus Extrafascial Approach for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Study.

OBJECTIVE: We aimed to compare the analgesic effect and incidence of lower limb weakness of transmuscular quadratus lumborum (TQL) block via subfascial approach with that via extrafascial after laparoscopic cholecystectomy (LC). METHODS: Eighty patients undergoing LC were randomized to receive ultrasound-guided bilateral TQL block via subfascial (subfascial group) or extrafascial (extrafascial group) using 30 mL of 0.33% ropivacaine unilaterally. Pain scores of port sites while rest and coughing at 1, 6, 12, 24, 36, and 48 hours postoperatively as primary outcome were compared. Modified Lovett Rating Scale, ambulatory dependency, and rescue analgesia requirement was also compared. RESULTS: The pain score of the subxiphoid and of the right subcostal port site for up to the postoperative 36 hours (2 [1 to 2]) and 24 hours (2 [2 to 3]) in the subfascial group was significantly lower than that in extrafascial group (2 [2 to 2] and 3 [2.25 to 4]). Up to postoperative 24 hours, the rescue analgesia requirement in subfascial group was significantly lower than that in extrafascial group, namely less fentanyl consumption and parecoxib (1.3 [±5.5] µg vs. 5.6 [±10.6] µg; 17.5% vs. 37.5%). The ratio of patients with LRS score of 6 at postoperative 1 hour (65.0%), and with dependent ambulation at postoperative 1 and 6 hours in subfascial group (15.0% and 0.0%) was significantly lower than that in extrafascial group (10.0%, 80.0%, and 17.5%). CONCLUSION: TQL block via subfascial had the advantages of better analgesic effect and less lower limbs weakness after LC over that via extrafascial.

A review of rotavirus vaccine use in Asia and the Pacific regions: challenges and future prospects.

INTRODUCTION: Rotavirus infection causes a significant proportion of diarrhea disease burden in children <5 years of age in Asia and the Pacific regions. The World Health Organization recommends that rotavirus vaccination should be included in national immunization programs to prevent rotavirus gastroenteritis (RVGE). AREAS COVERED: A literature review was performed to identify and summarize published evidence on RVGE epidemiology and status of rotavirus vaccine use, including the impact and cost-effectiveness of rotavirus vaccination programs in Asia and the Pacific regions (49 countries) during the period 2000-2018. EXPERT OPINION: Rotavirus vaccination programs have successfully reduced the burden of RVGE in many countries. However, such programs still do not exist in most Asia-Pacific countries, and therefore the burden of RVGE remains high in children <5 years of age. Challenges to vaccine implementation include a lack of surveillance data; safety concerns around intussusception; a general lack of awareness about RVGE disease epidemiology and vaccines among physicians, policy-makers, and parents; insufficient cost-effectiveness analyses; and potential issues with vaccine affordability including vaccination costs and lack of political will. Recommendations to overcome these challenges include developing cost-effectiveness analyses for more diverse national and regional settings, providing non-governmental support for low-income countries, and improving advocacy efforts.

PLAIN LANGUAGE SUMMARYWhat is the context?Rotavirus (RV) infection causes acute gastroenteritis (GE) in children under 5 years of age.Rotavirus vaccination (RVV) implementation has been slow in Asia and the Pacific (AP) regions, which could be responsible for the region falling behind in their fight against RVGE.What is new?RVV via national immunization programs (NIPs) is available in 8/49 countries and through the private market or non-governmental support in other countries. Coverage rates vary between countries, possibly driven by the mechanism through which RVV is available.A substantial positive impact of RVV on RVGE disease burden with a very low risk of intestinal intussusception for up to 7 days after RVV has been documented in the AP regions.Economic evaluation studies, mainly cost-effectiveness analyses, predict a significant reduction in treatment costs related to RVGE and its complications showing that RVV is good value for money.What is the impact?The prospect of continued safe and effective use of RVV in the AP regions is promising.Challenges to RVV implementation include establishing evidence of burden of disease, poor awareness of rotavirus vaccines, limited evidence from cost-effectiveness analyses from several countries, issues of affordability of the vaccine and a lack of political will.Recommendations for RVV implementation into the NIPs include conducting clinical and cost-effectiveness studies in countries where these are not available, establishing reliable surveillance mechanisms, providing non-governmental support for low-income countries and improving advocacy efforts.Maintenance of high vaccination coverage is needed in countries that have implemented national RVV programs.Graphical abstract[Formula: see text].

Cost-effectiveness evaluation of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine for children in Taiwan.

BACKGROUND: Streptococcus pneumoniae (S. pneumoniae) and non-typeable Haemophilus influenzae (NTHi) are substantial contributors to morbidity and mortality of diseases including invasive pneumococcal diseases (IPDs), pneumonia and acute otitis media (AOM) worldwide. In Taiwan, 10-valent pneumococcal polysaccharide and NTHi protein D conjugate vaccine (PHiD-CV) and 13-valent pneumococcal conjugate vaccine (PCV13) are licensed in children against pneumococcal disease. In addition to S. pneumoniae, clinical trials suggest efficacy of PHiD-CV against NTHi AOM. This study aims at evaluating the cost-effectiveness of a 2 + 1 schedule of PHiD-CV vs. PCV13 2 + 1 in the universal mass vaccination program of infants in Taiwan. METHODS: A published Markov cohort model was adapted to simulate the epidemiological burden of IPD, pneumonia and AOM for a birth cohort in Taiwan over 10 years. The probability of entering a specific health state was based on the incidence rate of the diseases. Only direct medical costs were included, and costs and outcomes were discounted annually. Vaccine efficacy assumptions were based on published data and validated by a panel of independent experts. Clinical, epidemiological, and serotype distribution data were based on locally published data or the National Health Insurance Research Database. Price parity of vaccines was assumed. Published pneumococcal disease-related disutility weights were used due to lack of local data. Incremental cost-effectiveness ratio was calculated and benchmarked against the recommended threshold in Taiwan. Extensive one-way sensitivity analysis, alternative scenarios and probabilistic sensitivity analysis were performed to test the robustness of the results. RESULTS: PHiD-CV would potentially reduce the number of NTHi-related AOM cases substantially and prevent comparable IPD and pneumonia-related cases and deaths compared to PCV13. Over a 10-year horizon, PHiD-CV is estimated to dominate PCV13, saving 6.7 million New Taiwan Dollars (NTD) and saving 21 quality-adjusted life years. The result was robust over a wide range of sensitivity analyses. The dominance of PHiD-CV was demonstrated in 90.5% of the simulations. CONCLUSIONS: PHiD-CV 2 + 1 would provide comparable prevention of IPD, pneumonia cases and additional reduction of NTHi-AOM cases, and is considered dominant compared with PCV13 2 + 1 in Taiwan.

Combined ultrasound and nerve stimulator-guided deep nerve block may decrease the rate of local anesthetics systemic toxicity: a randomized clinical trial.

BACKGROUND: Ultrasound guidance might decrease the incidence of local anesthetics systemic toxicity (LAST) for many peripheral nerve blocks compared with nerve stimulator guidance. However, it remains uncertain whether ultrasound guidance is superior to nerve stimulator guidance for deep nerve block of the lower extremity. This study was designed to investigate whether deep nerve block with ultrasound guidance would decrease the incidence of LAST compared with that with nerve stimulator guidance, and to identify associated risk factors of LAST. METHODS: Three hundred patients undergoing elective lower limb surgery and desiring lumbar plexus blocks (LPBs) and sciatic nerve blocks (SNBs) were enrolled in this study. The patients were randomly assigned to receive LPBs and SNBs with ultrasound guidance (group U), nerve stimulator guidance (group N) or dual guidance (group M). The primary outcome was the incidence of LAST. The secondary outcomes were the number of needle redirection, motor and sensory block onset and nerve distribution restoration time, as well as associated risk factors. RESULTS: There were 18 patients with LAST, including 12 in group U, 4 in group N and 2 in group M. By multiple comparisons among the three groups, we found that the incidence of LAST in group U (12%) was significantly higher than that in group N (4%)(P = 0.037) and group M(2%)(P = 0.006). The OR of LAST with hepatitis B (HBV) infection and the female sex was 3.352 (95% CI,1.233-9.108, P = 0.013) and 9.488 (95% CI,2.142-42.093, P = 0.0004), respectively. CONCLUSIONS: Ultrasound guidance, HBV infection and the female sex were risk factors of LAST with LPBs and SNBs. For patients infected with HBV or female patients receiving LPBs and SNBs, we recommended that combined ultrasound and nerve stimulator guidance should be used to improve the safety. TRIAL REGISTRATION: This study was approved by the Ethical Committee of the First Affiliated Hospital of Army Medical University. The protocol was registered prospectively with the Chinese Clinical Trial Registry ( ChiCTR-IOR-16008099 ) on March 15, 2016.

Economic Evaluation of Human Rotavirus Vaccine in Thailand.

INTRODUCTION: Rotavirus gastroenteritis is the leading cause of severe diarrhoea among young children < 5 years old. Previous cost-effectiveness analyses on rotavirus (RV) vaccination in Thailand have generated conflicting results. The aim of this current study is to evaluate the economic impact of introducing RV vaccination in Thailand, using updated Thai epidemiological and cost data. METHODS: Both cost-utility analysis (CUA) and budget impact analysis (BIA) of human rotavirus vaccine (HRV) under a universal mass vaccination (UMV) programme were conducted. A published static, deterministic, cross-sectional population model was adapted to assess costs and health outcomes associated with RV vaccination among Thai children < 5 years old during 1 year for CUA and over a 5-year period (2019-2023) for BIA. Data identified through literature review were incorporated into the model after consultation with local experts. Base case CUA was conducted from a societal perspective with quality-adjusted life year (QALY) discounted at 3% annually. Scenario analyses as well as one-way and probabilistic sensitivity analyses were conducted to assess the robustness of the base case CUA results. Costs were updated to 2017. RESULTS: At 99% coverage, HRV vaccination would substantially reduce RV-related disease burden. With an incremental cost-effectiveness ratio (ICER) of Thai baht (THB) 49,923/QALY gained, HRV vaccination versus no vaccination was cost-effective when assessed against a local threshold of THB 160,000/QALY gained. Scenario and sensitivity analyses confirmed the cost-effectiveness with all resultant ICERs falling below the willingness-to-pay threshold. HRV use in the UMV programme was estimated to result in a net expenditure of about THB 255-281 million to the Thai government in the 5th year of the programme, depending on vaccine uptake. CONCLUSION: HRV vaccination is estimated to be cost-effective in Thailand. The budget impact following inclusion of HRV into the UMV programme is expected to be partially offset by substantial reductions in RV-related disease costs. FUNDING: GlaxoSmithKline Biologicals SA GSK STUDY IDENTIFIER: HO-17-18213.

A Cost-Effectiveness Analysis of the 10-Valent Pneumococcal Non-Typeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) Compared to the 13-Valent Pneumococcal Conjugate Vaccine (PCV13) for Universal Mass Vaccination Implementation in New Zealand.

OBJECTIVES: Invasive pneumococcal disease (IPD), pneumonia and acute otitis media (AOM) still represent a significant medical burden in children < 5 years of age in New Zealand (NZ), with marked disparities across socio-economic and ethnic groups. This cost-effectiveness evaluation aims to compare the potential impact of two childhood universal immunisation strategies: vaccination with a 3 + 1 schedule of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, Synflorix, GSK) and the 13-valent pneumococcal conjugate vaccine (PCV13, Prevenar 13, Pfizer). METHODS: A static Markov-process cohort model was used to simulate the epidemiological and economic burden of pneumococcal diseases on a single-birth cohort over its lifetime. Costs and outcomes were discounted annually at 3.5%. Epidemiological and cost inputs were extracted from the most recently available NZ data, or derived from the most relevant reference countries' sources. The most updated evidence on the efficacies of the corresponding vaccines were used, particularly the significant effectiveness for PHiD-CV against IPD caused by serotype 19A. RESULTS: The model estimated that both vaccines have a broadly comparable impact on IPD-related diseases and pneumonia. Due to the additional benefits possible through broader impact on AOM, PHiD-CV is estimated to potentially provide additional discounted cost offsets of approximately NZD 0.8 million over the lifetime of the birth cohort. CONCLUSIONS: To ensure health equity in children, given the substantial burden of pneumonia and AOM, decision-makers should also take into account the impact of PCVs on these diseases for decisions relating to routine infant immunization. GSK STUDY IDENTIFIER: HO-15-16775.

Burden of hospitalized childhood community-acquired pneumonia: A retrospective cross-sectional study in Vietnam, Malaysia, Indonesia and the Republic of Korea.

BACKGROUND: Few studies describe the community-acquired pneumonia (CAP) burden in children in Asia. We estimated the proportion of all CAP hospitalizations in children from nine hospitals across the Republic of Korea (high-income), Indonesia, Malaysia (middle-income), and Vietnam (low/middle-income). METHODS: Over a one or two-year period, children <5 years hospitalized with CAP were identified using ICD-10 discharge codes. Cases were matched to standardized definitions of suspected (S-CAP), confirmed (C-CAP), or bacterial CAP (B-CAP) used in a pneumococcal conjugate vaccine efficacy study (COMPAS). Median total direct medical costs of CAP-related hospitalizations were calculated. RESULTS: Vietnam (three centers): 7591 CAP episodes were identified with 4.3% (95% confidence interval 4.2;4.4) S-CAP, 3.3% (3.2;3.4) C-CAP and 1.4% (1.3;1.4) B-CAP episodes of all-cause hospitalization in children aged <5 years. The B-CAP case fatality rate (CFR) was 1.3%. Malaysia (two centers): 1027 CAP episodes were identified with 2.7% (2.6;2.9); 2.6% (2.4;2.8); 0.04% (0.04;0.1) due to S-CAP, C-CAP, and B-CAP, respectively. One child with B-CAP died. Indonesia (one center): 960 CAP episodes identified with 18.0% (17.0;19.1); 16.8% (15.8;17.9); 0.3% (0.2;0.4) due to S-CAP, C-CAP, and B-CAP, respectively. The B-CAP CFR was 20%. Korea (three centers): 3151 CAP episodes were identified with 21.1% (20.4;21.7); 11.8% (11.2;12.3); 2.4% (2.1;2.7) due to S-CAP, C-CAP, and B-CAP, respectively. There were no deaths. COSTS: CAP-related hospitalization costs were highest for B-CAP episodes: 145.00 (Vietnam) to 1013.3 USD (Korea) per episode. CONCLUSION: CAP hospitalization causes an important health and cost burden in all four countries studied (NMRR-12-50-10793).

Cost-effectiveness analysis of infant pneumococcal vaccination with PHiD-CV in Korea.

BACKGROUND: Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) can cause invasive pneumococcal diseases (IPD), pneumonia, and acute otitis media (AOM). Both the 10-valent pneumococcal NTHi protein D conjugate vaccine (PHiD-CV) and the 13-valent pneumococcal conjugate vaccine (PCV-13) are included in the National Immunization Program for infants in Korea. This study aimed to evaluate the cost-effectiveness of the 3+1 schedule of PHiD-CV versus that of PCV-13 for National Immunization Program in Korea. METHODS: A published Markov model was adapted to evaluate the cost-effectiveness of vaccinating the 2012 birth cohort with PHiD-CV vs. PCV-13 from the Korean government perspective over 10 y. Best available published data were used for epidemiology, vaccine efficacy and disutilities. Data on incidence and direct medical costs were taken from the national insurance claims database. Sensitivity analyses were conducted to explore the robustness of the results. RESULTS: PHiD-CV was projected to prevent an additional 195,262 cases of pneumococcal diseases and NTHi-related diseases vs. PCV-13, with a substantially greater reduction in NTHi-related AOM and a comparable reduction in IPD and community-acquired pneumonia. Parity-priced PHiD-CV generated a health gain of about 844 quality-adjusted life years and a total cost-saving of approximately 4 million United States Dollars (USD) over 10 y. 93% of probabilistic simulations found PHiD-CV 3+1 to be the dominant vaccine option. CONCLUSION: Compared to PCV-13, PHiD-CV was projected to provide similar prevention against IPD and community-acquired pneumonia but would prevent more cases of AOM. Parity-priced PHiD-CV was anticipated to generate substantial cost-savings and health benefits vs. PCV-13 in Korea.

Cost-effectiveness analysis of a universal mass vaccination program with a PHiD-CV 2+1 schedule in Malaysia.

BACKGROUND: Currently, two pediatric pneumococcal conjugate vaccines are available in the private market of Malaysia-13-valent pneumococcal conjugate vaccine (PCV13) and pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). This study aimed to evaluate the cost-effectiveness of a universal mass vaccination program with a PHiD-CV 2+1 schedule versus no vaccination or with a PCV13 2+1 schedule in Malaysia. METHODS: A published Markov cohort model was adapted to evaluate the epidemiological and economic consequences of programs with no vaccination, a PHiD-CV 2+1 schedule or a PCV13 2+1 schedule over a 10-year time horizon. Disease cases, deaths, direct medical costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs) were estimated. Locally published epidemiology and cost data were used whenever possible. Vaccine effectiveness and disutility data were based on the best available published data. All data inputs and assumptions were validated by local clinical and health economics experts. Analyses were conducted from the perspective of the Malaysian government for a birth cohort of 508,774. Costs and QALYs were discounted at 3% per annum. One-way and probabilistic sensitivity analyses were performed. RESULTS: Compared with no vaccination, a PHiD-CV 2+1 program was projected to prevent 1109 invasive pneumococcal disease (IPD), 24,679 pneumonia and 72,940 acute otitis media (AOM) cases and 103 IPD/pneumonia deaths over 10 years, with additional costs and QALYs of United States dollars (USD) 30.9 million and 1084 QALYs, respectively, at an ICER of USD 28,497/QALY. Compared with a PCV13 2+1 program, PHiD-CV 2+1 was projected to result in similar reductions in IPD cases (40 cases more) but significantly fewer AOM cases (30,001 cases less), with cost savings and additional QALYs gained of USD 5.2 million and 116 QALYs, respectively, demonstrating dominance over PCV13. Results were robust to variations in one-way and probabilistic sensitivity analyses. CONCLUSIONS: A PHiD-CV 2+1 universal mass vaccination program could substantially reduce pneumococcal disease burden versus no vaccination, and was expected to be cost-effective in Malaysia. A PHiD-CV 2+1 program was also expected to be a dominant choice over a PCV13 2+1 program in Malaysia.

Response to Wu et al. - Cost-effectiveness analysis of infant pneumococcal vaccination in Malaysia and Hong Kong.

A recently published paper that assessed the comparative cost-effectiveness of the 2 pneumococcal conjugate vaccines (PCVs) in Malaysia and Hong Kong reported that the 13-valent PCV vaccine (PCV13) is a better choice compared to the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV or PCV10) from both a payer and societal perspective as well as under various scenarios. However, the analysis relied on a large number of assumptions that were either erroneous or did not take into account the most recent body of evidence available. A rigorous evaluation of the underlying assumptions is necessary to present a fair and balanced analysis for decision-making.

Cost-Effectiveness Analysis of Pneumococcal Vaccination with the Pneumococcal Polysaccharide NTHi Protein D Conjugate Vaccine in the Philippines.

OBJECTIVES: To compare the cost-effectiveness of a universal mass vaccination (UMV) program with a 2 + 1 schedule of a 10-valent pneumococcal polysaccharide nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) against two strategies: 1) a no-vaccination strategy and 2) a pneumococcal 13-valent conjugate vaccine (PCV13) 2 + 1 strategy in the Philippines. METHODS: A published Markov cohort model was adapted to simulate the epidemiological and economic burden of pneumococcal diseases (meningitis, bacteremia, pneumonia, and acute otitis media) within a projected birth cohort in 2012 of 1,812,137 newborns over lifetime. Analyses were conducted at an annual discount rate of 5% from the perspective of the Philippine government. The current evaluation was updated with the best available local/regional clinical epidemiological data and published efficacy evidence. RESULTS: Compared with the no-vaccination strategy, the PHiD-CV 2 + 1 UMV program was projected to prevent 3,343 deaths due to invasive pneumococcal diseases and pneumonia and 326,862 cases of pneumococcal diseases, resulting in an incremental cost-effectiveness ratio of 50,913 pesos/quality-adjusted life-year gained, which was considered to be highly cost-effective according to the threshold recommended by the World Health Organization. In comparison with the PCV13 2 + 1 strategy, the PHiD-CV 2 + 1 strategy was estimated to have a substantial reduction in acute otitis media (127,680 cases) and therefore a cost saving of potential 92.5 million pesos assuming price parity between PHiD-CV and PCV13 (US $1 = 42.13 pesos in 2012). CONCLUSIONS: The PHiD-CV 2 + 1 UMV program is projected to be cost-effective, compared with no vaccination, and would provide substantial savings with higher quality-adjusted life-year gains as compared with the PCV13 2 + 1 strategy in the context of the Philippines.

Health and economic burden of HPV-related diseases in Singapore.

OBJECTIVE: To assess the health and economic burden of human papillomavirus (HPV)-related diseases (cervical cancer, cervical intraepithelial neoplasia (CIN) 1/2/3, and genital warts) in Singapore over a period of 25 years beginning in 2008. METHODS: Incidence-based modeling was used to estimate the incidence cases and associated economic burden, with the assumption that age-stratified incidence rates will remain the same throughout the period of 25 years. The incidence rates in 2008 were projected based on data obtained from the National Cancer Registry for cervical cancer, and from a combination of published data and hospital registry review for CIN1/2/3 and genital warts. The population growth rate was factored into the projection of incidence cases over time. Direct cost data per cervical cancer and per CIN1/2/3 case were obtained from the financial database of large local hospitals while cost data for genital warts were obtained from the National Skin Center; these costs were multiplied by the number of incidence cases to produce an aggregate estimate of the economic burden over the 25-year period (in 2008 Singapore dollars) using a 3% discount rate. RESULTS: The total number of incidence cases of HPV-disease over 25 years beginning in 2008 was estimated to be 60,183, including 8,078 for cervical cancer, 11,685 for CIN 2/3, 8,849 for CIN1, and 31,572 for genital warts. The estimated total direct cost was 83.2 million Singapore Dollars over 25 years: 57.6 million attributable to cervical cancer, 13.0 million to CIN2/3, 6.83 million to CIN1, and 5.70 million to genital warts. CONCLUSION: HPV-related diseases are expected to impose significant health and economic burden on the Singapore healthcare resources in the next 25 years.

An exploratory study of response shift in health-related quality of life and utility assessment among patients with osteoarthritis undergoing total knee replacement surgery in a tertiary hospital in Singapore.

OBJECTIVE: To investigate the influence of response shift (RS) on health-related quality of life (HRQOL) and utility assessment among patients undergoing total knee replacement. METHODS: Consenting patients undergoing total knee replacement were interviewed to determine their HRQOL by using the six-dimensional health state short form, derived from SF-36, and the EuroQol five-dimensional questionnaire at baseline (pretest 1) and the six-dimensional health state short form, derived from SF-36, at 6 (pretest 2) and 18 months after surgery (post-test). RS was studied by using a "then-test" approach by contacting participants 18 months after surgery and asking them to evaluate their HRQOL at baseline (then-test 1) and at 6 (then-test 2) and 18 months after surgery. RS was calculated as the score difference between pretest and then-test scores for a given time point. Relationships between RS and external variables were explored by using univariate and multiple liner regression analyses. RESULTS: In 74 subjects (63% response rate, median age 68 years), median (interquantile range) six-dimensional health state short form, derived from SF-36, scores for then-tests at baseline (0.48 [0.42-0.49]) and at 6 months (0.72 [0.66-0.79]) after surgery were significantly different from respective pretest scores (0.61 [0.58-0.68] at baseline, P = 0.000; 0.69 [0.63-0.72] at 6 months, P = 0.000), showing RS at both time points. RS at baseline (0.14 [0.08-0.20]) was significantly larger than that at 6 months (-0.05 [0.14 to 0.00], P = 0.000). EuroQol five-dimensional questionnaire pretest and then-test scores at baseline also differed significantly (0.69 [0.17-0.73] vs. -0.18 [-0.23 to 0.00], P = 0.000). RS at baseline was not affected by assessed demographic or medical variables. RS at 6 months was greater in subjects with more years of education (16% of variance in multiple liner regression, P < 0.01). CONCLUSION: RS was present and impacted HRQOL and utility assessment among patients undergoing total knee replacement before and 6 months after surgery.

Aprepitant for Patients Receiving Highly Emetogenic Chemotherapy: An Economic Analysis for Singapore.

BACKGROUND: Aprepitant (a neurokinin 1 receptor antagonist), in combination with a serotonin receptor antagonist (5-HT3 RA) and dexamethasone, has demonstrated superior efficacy on end points related to chemotherapy-induced nausea and vomiting (CINV) compared with standard care (combination 5-HT3 RA and dexamethasone). OBJECTIVE: To determine the cost-effectiveness of an aprepitant-containing regimen compared with current clinical practice for the prevention of CINV in patients receiving highly emetogenic chemotherapy (HEC) in Singapore. METHODS: A decision-analytic model was constructed to assess the costs and outcomes associated with an aprepitant-containing regimen compared with standard care in the prevention of CINV following HEC. Three scenarios were modeled on the basis of results of four double-blind randomized clinical trials of aprepitant. CINV event probabilities were calculated on the basis of the occurrence of nausea and vomiting and the need for rescue medication in the 5 days following a single cycle of HEC. The analysis was conducted from the Singapore health care system perspective. RESULTS: Aprepitant reduced emesis and nausea, resulting in small but clinically important improvements when measured in quality-adjusted life-years. The aprepitant-containing regimen was associated with higher acquisition costs but lower costs relating to patient management, hospitalization, and use of rescue medication. Across the scenarios, the incremental cost per emetic event avoided ranged from cost saving to Singapore $63 (US $51). The incremental cost-effectiveness ratio ranged from cost saving to Singapore $49,800 per quality-adjusted life-year gained (US $40,600). The analysis was relatively insensitive to changes in the inputs. CONCLUSIONS: Aprepitant is a clinically important and cost-effective therapy for the prevention of CINV in patients treated with HEC in Singapore.

Are English and Chinese Versions of the Audit of Diabetes-Dependent Quality of Life Equivalent? An Exploratory Study Based on the Universalist Approach.

OBJECTIVE: To translate and culturally adapt the UK English Audit of Diabetes-Dependent Quality of Life (ADDQOL) into Chinese for Singapore. METHODS: Translation was integrated into investigation of conceptual, item, semantic, and operation equivalence. Conceptual equivalence, item equivalence, and operation equivalence were assessed by literature review, expert judgment, and cognitive debriefing. Semantic equivalence was studied by using an optimized procedure including forward and backward translation, clinician review, and cognitive debriefings. Cognitive debriefings were done with five Chinese-speaking diabetic patients at polyclinics. Reliability, responsiveness, and construct validity tests were used to evaluate measurement equivalence. English- and Chinese-speaking diabetic patients by convenient sampling at a Diabetes Society of Singapore's public event were recruited for the measurement equivalence study. Mann-Whitney U tests, chi-square tests, and descriptive analyses were used for group comparisons and Spearman's correlation coefficients for construct validity tests. RESULTS: Forty-two English-speaking and 26 Chinese-speaking diabetic patients (45.5% females) with a mean age of 54.2 ± 10.07 years were recruited. Chinese-speaking respondents were more likely than the English-speaking group to be unemployed, less educated, and with poorer family functioning (P < 0.05). Conceptual equivalence, item equivalence, operation equivalence, and semantic equivalence were all demonstrated. Cronbach's alpha for internal consistency and intraclass correlation coefficient for test-retest reliability were 0.94 and 0.65, respectively. Distributions of responses were found to be similar except for some difference that can be justified by different demographic background. Convergent validity was suggested by weak to moderate correlations between "Present QOL" on the ADDQOL and EuroQol five-dimensional questionnaire (r = 0.268; P = 0.185) and six-dimensional health state short form (derived from short form 36 health survey) scores (r = 0.351; P = 0.078); divergent validity was shown by a weak correlation between ADDQOL average weighted impact (AWI) and ADDQOL "Present QOL" scores (r = 0.027, P = 0.896), a moderate correlation between ADDQOL AWI and six-dimensional health state short form (derived from short form 36 health survey) mental scores (r = 0.247; P = 0.224), and a positive correlation between ADDQOL AWI and family functioning scores (r = 0.288; P = 0.182). CONCLUSIONS: The ADDQOL has been translated and culturally adapted successfully into a Chinese version for Singapore. Our study provides justification for further research with large sample sizes among the Chinese-speaking population in Singapore.

Development and validation of a scale to measure patients' trust in pharmacists in Singapore.

OBJECTIVE: To develop and validate a scale to measure patients' trust in pharmacists for use as an outcomes predictor in pharmacoeconomic and pharmaceutical care studies. METHODS: Literature review, study team discussion and focus group discussions were conducted to generate items of a candidate version to be pilot-tested for content validity. An amended candidate version was then tested among eligible Singaporeans across different ethnic and age groups. Score distributions were assessed for discriminatory power and item analyses for finalizing items. Exploratory factor analysis was used to identify dimensionality and homogeneous items. Cronbach's alpha was measured for internal consistency and Pearson's correlation coefficients for convergent validity. RESULTS: Eighteen items were generated with good variability (SD > 1.0) and symmetry (means ranged from -1 to 1) for score distribution. After minor changes to improve content clarity, the amended questionnaire was self-administered among 1196 respondents [mean (SD) age: 38.6 (14.9) years, 51.6% female, 87% >6 years of education]. Six items were dropped due to inadequate item-total correlation coefficients, leaving 12-item scale for factor analysis. Three factors ("benevolence", "technical competence" and "global trust") were identified, accounting for 55% of the total variance. Cronbach's alpha was 0.83, indicating high internal consistency. Convergent validity was demonstrated by statistically significant positive correlations between trust and patients' satisfaction with pharmacists' service (r = 0.54), returning for care (r = 0.30) and preference of medical decision-making pattern (r = 0.16). CONCLUSION: The 12-item trust in pharmacists scale demonstrated high reliability and convergent validity. Further studies among other populations are suggested to confirm the robustness and even improve the current scale.

Development and validation of a functional health literacy test.

BACKGROUND: : Three validated functional health literacy tests (FHLTs) have been developed for use in healthcare settings. However, none of these tests has been shown to be readily applicable for use in the general public. OBJECTIVE: : To develop and validate an FHLT for screening the functional health literacy level of the general public and patients in healthcare settings. METHODS: : Maze procedure, expert judgment, and interviews with 55 respondents were used to develop the 21-item FHLT, which was modified from public health education material entitled Guidelines on Taking Medicines published by the Singapore Health Promotion Board. The finalized FHLT was then distributed by convenience sampling among eligible English-speaking respondents from the general public and rheumatic patients in Singapore. Descriptive analysis was used to summarize the sociodemographic characteristics and health status of the respondents. Cronbach's α was used to assess the reliability of the test. Partial correlation coefficients were used to investigate the convergent validity between scores on the FHLT and the Rapid Estimate of Adult Literacy in Medicine (REALM), and the divergent validity between the FHLT score and education level. Test-retest reliability was assessed by intraclass correlation coefficient (ICC). RESULTS: : Data were analyzed from 223 respondents from the general public (mean [SD] age: 43.8 [14.2] years, 49.3% female, 45.7% with >12 years of education) and 200 rheumatic patients (mean [SD] age: 46.6 [14.7], 70.5% female, 45.5% with >12 years of education). Cronbach's α for the FHLT was 0.72 and 0.68 for the general public and rheumatic patients, respectively, suggesting adequate reliability. Convergent validity was demonstrated with a strong correlation between scores on the FHLT and REALM (0.65 [p < 0.01] for the general public, 0.68 [p < 0.01] for rheumatic patients). Divergent validity was shown by the weak correlation between the FHLT score and education level (0.33 [p < 0.01] for the general public, 0.28 [p < 0.01] for rheumatic patients). Test-retest reliability of the FHLT among rheumatic patients (n = 112, response rate = 56%) was shown to be high (ICC = 0.95). ICC was not calculated for the test-retest reliability among the general public because of a poor response rate of 9%. CONCLUSIONS: : The 21-item FHLT has been shown to be a reliable and valid screening test for measuring functional health literacy levels of the general public as well as patients in healthcare settings. The availability of the FHLT would contribute to the effectiveness of health education programs and better health-related outcomes in the general population.

The impact of health literacy on health-related quality of life (HRQoL) and utility assessment among patients with rheumatic diseases.

OBJECTIVES: The objective of this study was to investigate the impact of health literacy (HL) on health-related quality of life (HRQoL) and utility assessment among patients with rheumatic diseases. METHODS: HL was measured by the rapid estimate of adult literacy in medicine (REALM) and was characterized as low or adequate. HRQoL and utility scores were assessed using the SF-36, SF-6D, and EQ-5D. Comparisons of sociodemographics and HRQoL in patients with low or adequate HL were made using t test, chi-square, or Mann-Whitney U tests. Spearman's correlation and partial correlations were used to study the relationship between HL, HRQoL, and utility scores, with significant correlations further explored using multiple linear regression models. RESULTS: Data were analyzed from 199 subjects. Patients with adequate HL had significantly higher education levels, better dwelling status, lower disease activity, and better physical functioning (PF). There was a significant although weak correlation between HL level and PF. After adjustment, HL level was shown to independently explain 3.7% of the variance in the PF score. Nevertheless, there was no impact of HL on utility assessment or other HRQoL domains. CONCLUSION: HL did not impact HRQoL in general, but was found to have a weak impact on the PF of patients with rheumatic diseases.

Validity, feasibility and acceptability of time trade-off and standard gamble assessments in health valuation studies: a study in a multiethnic Asian population in Singapore.

OBJECTIVES: To assess the validity, feasibility and acceptability of standard gamble (SG) and time trade-off (TTO) assessments in a multiethnic Asian population. METHODS: Through in-depth interviews performed among Chinese, Malay, and Indian Singaporeans (education >or= 6 years), we assessed validity of SG/TTO methods for eliciting health preferences by hypothesizing that 1) SG/TTO scores for three hypothetical health states (HS) would exhibit ranked order (decreasing scores with worse HS); and 2) more subjects would rate the most severe HS as worse than dead. Subjects also evaluated feasibility and acceptability of SG/TTO using a 10-point visual analog scale (VAS) and open-ended questions. Ratings were compared using Kruskal-Wallis, Wilcoxon signed-rank tests or tests of proportions. VALIDITY: In 62 subjects (90% response rate), as hypothesized, SG and TTO scores exhibited ranked order with increasing HS severity (SG: 0.85, 0.08, -19.00; TTO: 0.85, 0.00, -0.18). More subjects rated the most severe HS as worse than dead (SG: 8%, 39%, 59%; TTO: 8%, 45% and 62%). FEASIBILITY: Subjects felt SG and TTO were easy to understand (median VAS scores: 8.0 vs. 8.0, P = 0.87) and to complete (8.0 vs. 8.0, P = 0.84). Acceptability: SG and TTO were well accepted, with TTO less so than SG (median [interquartile range] offensiveness: 2.0 [0, 4.0] vs. 2.0 [0, 3.0], P = 0.045). Overall, subjects did not have a clear preference for SG/TTO (50% vs. 45%, P = 0.70). CONCLUSIONS: This study suggests the validity, feasibility and acceptability of SG and TTO for population-based HS valuation studies in a multiethnic Asian population.