Displaying publications 1 - 20 of 284 in total

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  1. Cappellini MD, Viprakasit V, Taher AT, Georgiev P, Kuo KHM, Coates T, et al.
    N Engl J Med, 2020 03 26;382(13):1219-1231.
    PMID: 32212518 DOI: 10.1056/NEJMoa1910182
    BACKGROUND: Patients with transfusion-dependent β-thalassemia need regular red-cell transfusions. Luspatercept, a recombinant fusion protein that binds to select transforming growth factor β superfamily ligands, may enhance erythroid maturation and reduce the transfusion burden (the total number of red-cell units transfused) in such patients.

    METHODS: In this randomized, double-blind, phase 3 trial, we assigned, in a 2:1 ratio, adults with transfusion-dependent β-thalassemia to receive best supportive care plus luspatercept (at a dose of 1.00 to 1.25 mg per kilogram of body weight) or placebo for at least 48 weeks. The primary end point was the percentage of patients who had a reduction in the transfusion burden of at least 33% from baseline during weeks 13 through 24 plus a reduction of at least 2 red-cell units over this 12-week interval. Other efficacy end points included reductions in the transfusion burden during any 12-week interval and results of iron studies.

    RESULTS: A total of 224 patients were assigned to the luspatercept group and 112 to the placebo group. Luspatercept or placebo was administered for a median of approximately 64 weeks in both groups. The percentage of patients who had a reduction in the transfusion burden of at least 33% from baseline during weeks 13 through 24 plus a reduction of at least 2 red-cell units over this 12-week interval was significantly greater in the luspatercept group than in the placebo group (21.4% vs. 4.5%, P<0.001). During any 12-week interval, the percentage of patients who had a reduction in transfusion burden of at least 33% was greater in the luspatercept group than in the placebo group (70.5% vs. 29.5%), as was the percentage of those who had a reduction of at least 50% (40.2% vs. 6.3%). The least-squares mean difference between the groups in serum ferritin levels at week 48 was -348 μg per liter (95% confidence interval, -517 to -179) in favor of luspatercept. Adverse events of transient bone pain, arthralgia, dizziness, hypertension, and hyperuricemia were more common with luspatercept than placebo.

    CONCLUSIONS: The percentage of patients with transfusion-dependent β-thalassemia who had a reduction in transfusion burden was significantly greater in the luspatercept group than in the placebo group, and few adverse events led to the discontinuation of treatment. (Funded by Celgene and Acceleron Pharma; BELIEVE ClinicalTrials.gov number, NCT02604433; EudraCT number, 2015-003224-31.).

    Matched MeSH terms: Intention to Treat Analysis
  2. Manns M, Zeuzem S, Sood A, Lurie Y, Cornberg M, Klinker H, et al.
    J Hepatol, 2011 Sep;55(3):554-563.
    PMID: 21237227 DOI: 10.1016/j.jhep.2010.12.024
    BACKGROUND & AIMS: There is increasing interest in identifying patients with chronic hepatitis C genotype 2 or 3 infection in whom it is possible to lower the burden of therapy while retaining high levels of efficacy.

    METHODS: Treatment-naive patients with chronic hepatitis C genotype 2/3 infection were randomized to receive peginterferon alfa-2b (1.5μg/kg/wk) for 24weeks (group A); peginterferon alfa-2b (1.0μg/kg/wk) for 24weeks (group B); or peginterferon alfa-2b (1.5μg/kg/wk) for 16weeks (group C), each in combination with weight-based ribavirin (800-1200mg/d). The study population comprised two cohorts: the Hep-Net cohort enrolled in Germany and an International cohort enrolled at study sites throughout Europe and Asia. The primary end point was sustained virological response (SVR).

    RESULTS: The study included 682 patients; 80.2% had genotype 3 infection. In the intent-to-treat population, SVR rates were 66.5%, 64.3%, and 56.6% in groups A, B, and C, and were similar in Asian and white patients. Treatment differences (A vs. B and A vs. C) failed to reach the predefined margin for noninferiority of -10%; and thus groups B and C failed to show noninferiority relative to group A. Among patients with undetectable HCV RNA at week 4, SVR rates were 75.3%, 75.9%, and 72.4%, respectively. Relapse rates were 17.8%, 16.3%, and 29.3%, respectively. Treatment-emergent serious adverse events were highest in group A and lowest in group C, and adverse events leading to discontinuation were similar across treatment arms.

    CONCLUSIONS: For patients with chronic hepatitis C genotype 2/3 infection, 24weeks of peginterferon alfa-2b (1.5μg/kg/wk) plus weight-based ribavirin remains a standard-of-care therapy; however, treatment for 16weeks may be considered for patients with undetectable HCV RNA at week 4 of the treatment.

    Matched MeSH terms: Intention to Treat Analysis
  3. Samah AA, Ahmadian M
    Asian Pac J Cancer Prev, 2014;15(21):9499-503.
    PMID: 25422246
    This study aimed to examine the relationship between body image satisfaction and breast self-screening behavior and intentions. The sample for this cross-sectional study consisted of 842 female university students who were recruited from a number of public and private universities. Data were obtained between the months of November and December, 2013, using multistage random cluster sampling. Main research variables were breast cancer screening behavior and intentions, demographic factors, and the total scores on each of the Multidimensional Body-Self Relations Questionnaire (MBSRQ-Appearance Scales) subscales. Results of multivariate analysis showed that having higher satisfaction and more positive evaluation of appearance were related to having performed breast self-examination more frequently in the last year and intending to perform breast self-examination more frequently in the next year. Longitudinal research can potentially provide detailed information about overall body image satisfaction and breast cancer screening behavior among various communities.
    Matched MeSH terms: Intention
  4. Kakkar AK, Cimminiello C, Goldhaber SZ, Parakh R, Wang C, Bergmann JF, et al.
    N Engl J Med, 2011 Dec 29;365(26):2463-72.
    PMID: 22204723 DOI: 10.1056/NEJMoa1111288
    BACKGROUND: Although thromboprophylaxis reduces the incidence of venous thromboembolism in acutely ill medical patients, an associated reduction in the rate of death from any cause has not been shown.
    METHODS: We conducted a double-blind, placebo-controlled, randomized trial to assess the effect of subcutaneous enoxaparin (40 mg daily) as compared with placebo--both administered for 10±4 days in patients who were wearing elastic stockings with graduated compression--on the rate of death from any cause among hospitalized, acutely ill medical patients at participating sites in China, India, Korea, Malaysia, Mexico, the Philippines, and Tunisia. Inclusion criteria were an age of at least 40 years and hospitalization for acute decompensated heart failure, severe systemic infection with at least one risk factor for venous thromboembolism, or active cancer. The primary efficacy outcome was the rate of death from any cause at 30 days after randomization. The primary safety outcome was the rate of major bleeding during and up to 48 hours after the treatment period.
    RESULTS: A total of 8307 patients were randomly assigned to receive enoxaparin plus elastic stockings with graduated compression (4171 patients) or placebo plus elastic stockings with graduated compression (4136 patients) and were included in the intention-to-treat population. The rate of death from any cause at day 30 was 4.9% in the enoxaparin group as compared with 4.8% in the placebo group (risk ratio, 1.0; 95% confidence interval [CI], 0.8 to 1.2; P=0.83). The rate of major bleeding was 0.4% in the enoxaparin group and 0.3% in the placebo group (risk ratio, 1.4; 95% CI, 0.7 to 3.1; P=0.35).
    CONCLUSIONS: The use of enoxaparin plus elastic stockings with graduated compression, as compared with elastic stockings with graduated compression alone, was not associated with a reduction in the rate of death from any cause among hospitalized, acutely ill medical patients. (Funded by Sanofi; LIFENOX ClinicalTrials.gov number, NCT00622648.).
    Note: Malaysia is a study site: participating investigators: Yaw Chong Hwa (WT Ma), Najihah I, SH How, Abdul Razak AM, Law WC (ST Tie), Bharathan T, Monniaty M, Aris Chandran, Ngau Yen Yew, Aziah AM, Irene Wong, CK Chuah, Rosemi S, KK Sia, Jeyaindran S, CY Leong
    Matched MeSH terms: Intention to Treat Analysis
  5. Lee WB, Fong GT, Zanna MP, Omar M, Sirirassamee B, Borland R
    Health Psychol, 2009 Jul;28(4):457-64.
    PMID: 19594270 DOI: 10.1037/a0014669
    OBJECTIVE: To test whether differences of history and strength in tobacco control policies will influence social norms, which, in turn, will influence quit intentions, by influencing smokers' regret and rationalization.
    DESIGN: The data were from the International Tobacco Control (ITC) Policy Evaluation Southeast Asia Survey, a cohort survey of representative samples of adult smokers in Thailand (N = 2,000) and Malaysia (N = 2,006). The survey used a stratified multistage sampling design.
    MAIN OUTCOME MEASURES: Measures included regret, rationalization, social norms, and quit intention.
    RESULTS: Thai smokers were more likely to have quit intentions than Malaysian smokers. This difference in quit intentions was, in part, explained by the country differences in social norms, regret, and rationalization. Reflecting Thailand's history of stronger tobacco control policies, Thai smokers, compared with Malaysian smokers, perceived more negative social norms toward smoking, were more likely to regret, and less likely to rationalize smoking. Mediational analyses revealed that these differences in social norms, accounted, in part, for the country-quit intention relation and that regret and rationalization accounted, in part, for the social norm-quit intention relation.
    CONCLUSION: The results suggest that social norms toward smoking, which are shaped by tobacco control policies, and smokers' regret and rationalization influence quit intentions
    Matched MeSH terms: Intention
  6. Wong LP, Atefi N, AbuBakar S
    BMC Public Health, 2016 08 12;16:780.
    PMID: 27520825 DOI: 10.1186/s12889-016-3409-y
    BACKGROUND: As there is no specific treatment for dengue, early detection and access to proper treatment may lower dengue fatality. Therefore, having new techniques for the early detection of dengue fever, such as the use of dengue test kit, is vitally important. The aims of the study were: 1) identify factors associated with acceptance of a home self-test kit for dengue fever if the dengue test is available to the public and 2) find out the characteristics of the test kits that influence the use of the dengue test kit.

    METHODS: A national telephone survey was carried out with 2,512 individuals of the Malaysian public aged 18-60 years old. Individuals were contacted by random digit dialling covering the whole of Malaysia from February 2012 to June 2013.

    RESULTS: From 2,512 participants, 6.1 % reported to have heard of the availability of the dengue home test kit and of these, 44.8 % expressed their intention to use the test kit if it was available. Multivariate logistic regressions indicated that participants with primary (OR: 0.65; 95 % CI: 0.43-0.89; p = 0.02, vs. tertiary educational level) and secondary educational levels (OR: 0.73; 95 % CI: 0.57-0.90; p = 0.01, vs. tertiary educational level) were less likely than participants with a tertiary educational level to use a home self-testing dengue kit for dengue if the kit was available. Participants with lower perceived barriers to dengue prevention (level of barriers 0-5) were less likely (OR: 0.67, 95 % CI: 0.53-0.85, p 

    Matched MeSH terms: Intention
  7. Koo JH, Leong RW, Ching J, Yeoh KG, Wu DC, Murdani A, et al.
    Gastrointest Endosc, 2012 Jul;76(1):126-35.
    PMID: 22726471 DOI: 10.1016/j.gie.2012.03.168
    BACKGROUND: The rapid increase in the incidence of colorectal cancer (CRC) in the Asia-Pacific region in the past decade has resulted in recommendations to implement mass CRC screening programs. However, the knowledge of screening and population screening behaviors between countries is largely lacking.
    OBJECTIVE: This multicenter, international study investigated the association of screening test participation with knowledge of, attitudes toward, and barriers to CRC and screening tests in different cultural and sociopolitical contexts.
    METHODS: Person-to-person interviews by using a standardized survey instrument were conducted with subjects from 14 Asia-Pacific countries/regions to assess the prevailing screening participation rates, knowledge of and attitudes toward and barriers to CRC and screening tests, intent to participate, and cues to action. Independent predictors of the primary endpoint, screening participation was determined from subanalyses performed for high-, medium-, and low-participation countries.
    RESULTS: A total of 7915 subjects (49% male, 37.8% aged 50 years and older) were recruited. Of the respondents aged 50 years and older, 809 (27%) had undergone previous CRC testing; the Philippines (69%), Australia (48%), and Japan (38%) had the highest participation rates, whereas India (1.5%), Malaysia (3%), Indonesia (3%), Pakistan (7.5%), and Brunei (13.7%) had the lowest rates. Physician recommendation and knowledge of screening tests were significant predictors of CRC test uptake. In countries with low-test participation, lower perceived access barriers and higher perceived severity were independent predictors of participation. Respondents from low-participation countries had the least knowledge of symptoms, risk factors, and tests and reported the lowest physician recommendation rates. "Intent to undergo screening" and "perceived need for screening" was positively correlated in most countries; however, this was offset by financial and access barriers.
    LIMITATIONS: Ethnic heterogeneity may exist in each country that was not addressed. In addition, the participation tests and physician recommendation recalls were self-reported.
    CONCLUSIONS: In the Asia-Pacific region, considerable differences were evident in the participation of CRC tests, physician recommendations, and knowledge of, attitudes toward, and barriers to CRC screening. Physician recommendation was the uniform predictor of screening behavior in all countries. Before implementing mass screening programs, improving awareness of CRC and promoting the physicians' role are necessary to increase the screening participation rates.
    Matched MeSH terms: Intention
  8. WHO Solidarity Trial Consortium, Pan H, Peto R, Henao-Restrepo AM, Preziosi MP, Sathiyamoorthy V, et al.
    N Engl J Med, 2021 Feb 11;384(6):497-511.
    PMID: 33264556 DOI: 10.1056/NEJMoa2023184
    BACKGROUND: World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with coronavirus disease 2019 (Covid-19).

    METHODS: We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry.

    RESULTS: At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan-Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P = 0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P = 0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P = 0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P = 0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration.

    CONCLUSIONS: These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ISRCTN83971151; ClinicalTrials.gov number, NCT04315948.).

    Matched MeSH terms: Intention to Treat Analysis
  9. Hock LK, Ghazali SM, Cheong KC, Kuay LK, Li LH, Huey TC, et al.
    Asian Pac J Cancer Prev, 2014;15(10):4359-66.
    PMID: 24935397
    Intention to smoke is a valid and reliable factor for predicting future smoking habits among adolescents. This factor, however, has received inadequate attention in Malaysia. The present paper elaborates the prevalence and factors associated with intent to initiate or to cease smoking, among adolescent nonsmokers and smokers in Kota Tinggi, Johor, Malaysia. A total of 2,300 secondary school students aged 13-16 years were selected through a two-stage stratified sampling method. A set of standardized questionnaires was used to assess the smoking behavior among adolescents and the inter-personal and intra-personal factors associated with smoking intention (intention to initiate smoking or to cease smoking). Multivariable logistic regression was used to identify factors related to smoking intention. The prevalence of intention to smoke in the future or to cease smoking among non- smoking adolescents and current smokers were 10.7% and 61.7% respectively. Having friends who smoke, social influence, and poor knowledge about the ill effects on health due to smoking showed significant relationships with intention to smoke in the future among non-smokers. Conversely, perceived lower prevalence of smoking among peers, weak contributory social influence, and greater awareness of the ill effects of smoking are factors associated with the intention to cease smoking sometime in the future. The study found that prevalence of intention to initiate smoking is low among non-smokers while the majority of current smokers intended to cease smoking in the future. Existing anti-smoking programmes that integrate the factors that have been identified in the current study should be put in motion to reduce the prevalence of intention to initiate smoking and increase the intention to cease smoking among adolescents.
    Matched MeSH terms: Intention
  10. Lim KH, Ibrahim N, Ghazali SM, Kee CC, Lim KK, Chan YY, et al.
    Asian Pac J Cancer Prev, 2013;14(2):805-10.
    PMID: 23621242
    Increasing the rate of smoking cessation will reduce the burden of diseases related to smoking, including cancer. Understanding the process of smoking cessation is a pre-requisite to planning and developing effective programs to enhance the rate of smoking cessation.The aims of the study were to determine the demographic distribution of smokers across the initial stages of smoking cessation (the pre-contemplation and contemplation stages) and to identify the predictors of smoking cessation among Malaysian adult smokers. Data were extracted from a population-based, cross-sectional survey carried out from April 2006 to July 2006. The distribution of 2,716,743 current smokers across the pre-contemplation stage (no intention to quit smoking in the next six months) or contemplation stage (intended to quit smoking in the next six months) was described. Multivariable logistic regression analysis was used to examine the relationship between socio-demographic variables and the stages of smoking cessation. Of the 2,716,743 current smokers, approximately 30% and 70% were in the pre-contemplative and contemplative stages of smoking cessation respectively. Multivariable analysis showed that male gender, low education level, older age group, married and those from higher income group and number of cigarettes smoked were associated with higher likelihood of pre-contemplation to cease smoking in the next six months. The majority of current smokers in Malaysia were in the contemplative stage of smoking cessation. Specific interventions should be implemented to ensure the pre-contemplative smokers proceed to the contemplative stage and eventually to the preparation stage.
    Matched MeSH terms: Intention
  11. Yeow PH, Yuen YY, Loo WH
    Appl Ergon, 2013 Sep;44(5):719-29.
    PMID: 22841592 DOI: 10.1016/j.apergo.2012.04.017
    Ever since the 9/11 terrorist attack, many countries are considering the use of smart national identity card (SNIC) which has the ability to identify terrorists due to its biometric verification function. However, there are many ergonomics issues in the use of SNIC, e.g. card credibility. This research presents a case study survey of Malaysian users. Although most citizens (>96%) own MyKad (Malaysia SNIC), many do not carry it around and use its applications. This defeats one of its main purposes, i.e. combating terrorism. Thus, the research investigates ergonomics issues affecting the citizens' Intention to Use (ITU) MyKad for homeland security by using an extended technology acceptance model. Five hundred questionnaires were collected and analysed using structural equation modelling. Results show that perceived credibility and performance expectancy are the key issues. The findings provide many countries with insights into methods of addressing ergonomics issues and increasing adoption of SNIC for homeland security.
    Matched MeSH terms: Intention
  12. Tong SF, Low WY, Ismail SB, Trevena L, Willcock S
    Fam Pract, 2011 Jun;28(3):307-16.
    PMID: 21115986 DOI: 10.1093/fampra/cmq101
    BACKGROUND: Although prevalent in primary care settings, men's health issues are rarely discussed. Yet, primary care doctors (PCDs) are well positioned to offer health check-ups during consultations.
    OBJECTIVES: This study aims to develop a substantive theory to explain the process of decision making by which PCDs engage men in discussing health check-ups.
    METHODS: Grounded theory method was adopted. Data source was from 14 in-depth interviews and 8 focus group discussions conducted with a semi-structured guide. Interviews were recorded and transcribed verbatim for analysis. Initial open coding captured the concepts of processes from the data, followed by selective and theoretical coding to saturate the core category. Constant comparative method was used throughout the process to allow emergence of the theory.
    RESULTS: Fifty-two PCDs from private and public settings were interviewed. PCDs engaged male patients in health check-ups when they associated high medical importance with the relevant issues. The decision to engage men also depended on perceived chances of success in negotiations about health check-ups. A high chance of success, associated with minimal negotiation effort, is associated with men being most receptive to health check-ups. When doctors feel the importance of a particular health issue, they place less emphasis on their perceived men's receptivity to discuss that health issue in their intention to engage them in discussing it.
    CONCLUSIONS: Engaging male patients in appropriate health check-up activities requires a series of actions and decisions by the PCDs. The decision to engage the patient depends on the perceived balance between the receptivity of male patients and the medical importance of the issues in mind.
    Matched MeSH terms: Intention
  13. Polonsky M, Rozanova J, Azbel L, Bachireddy C, Izenberg J, Kiriazova T, et al.
    AIDS Behav, 2016 12;20(12):2950-2960.
    PMID: 27011378
    In this study, we use data from a survey conducted in Ukraine among 196 HIV-infected people who inject drugs, to explore attitudes toward drug addiction and methadone maintenance therapy (MMT), and intentions to change drug use during incarceration and after release from prison. Two groups were recruited: Group 1 (n = 99) was currently incarcerated and Group 2 (n = 97) had been recently released from prison. This paper's key finding is that MMT treatment and addiction recovery were predominantly viewed as mutually exclusive processes. Group comparisons showed that participants in Group 1 (pre-release) exhibited higher optimism about changing their drug use, were less likely to endorse methadone, and reported higher intention to recover from their addiction. Group 2 participants (post-release), however, reported higher rates of HIV stigma. Structural equation modeling revealed that in both groups, optimism about recovery and awareness of addiction mediated the effect of drug addiction severity on intentions to recover from their addiction.
    Matched MeSH terms: Intention
  14. Lee WB, Fong GT, Dewhirst T, Kennedy RD, Yong HH, Borland R, et al.
    J Health Commun, 2015;20(10):1166-76.
    PMID: 26054867 DOI: 10.1080/10810730.2015.1018565
    Antismoking mass media campaigns are known to be effective as part of comprehensive tobacco control programs in high-income countries, but such campaigns are relatively new in low- and middle-income countries and there is a need for strong evaluation studies from these regions. This study examines Malaysia's first national antismoking campaign, TAK NAK. The data are from the International Tobacco Control Malaysia Survey, which is an ongoing cohort survey of a nationally representative sample of adult smokers (18 years and older; N = 2,006). The outcome variable was quit intentions of adult smokers, and the authors assessed the extent to which quit intentions may have been strengthened by exposure to the antismoking campaign. The authors also tested whether the impact of the campaign on quit intentions was related to cognitive mechanisms (increasing thoughts about the harm of smoking), affective mechanisms (increasing fear from the campaign), and perceived social norms (increasing perceived social disapproval about smoking). Mediational regression analyses revealed that thoughts about the harm of smoking, fear arousal, and social norms against smoking mediated the relation between TAK NAK impact and quit intentions. Effective campaigns should prompt smokers to engage in both cognitive and affective processes and encourage consideration of social norms about smoking in their society.
    Matched MeSH terms: Intention
  15. Flaherty K, Bath PM, Dineen R, Law Z, Scutt P, Pocock S, et al.
    Trials, 2017 Dec 20;18(1):607.
    PMID: 29262841 DOI: 10.1186/s13063-017-2341-5
    RATIONALE: Aside from blood pressure lowering, treatment options for intracerebral haemorrhage remain limited and a proportion of patients will undergo early haematoma expansion with resultant significant morbidity and mortality. Tranexamic acid (TXA), an anti-fibrinolytic drug, has been shown to significantly reduce mortality in patients, who are bleeding following trauma, when given rapidly. TICH-2 is testing whether TXA is effective at improving outcome in spontaneous intracerebral haemorrhage (SICH).

    METHODS AND DESIGN: TICH-2 is a pragmatic, phase III, prospective, double-blind, randomised placebo-controlled trial. Two thousand adult (aged ≥ 18 years) patients with an acute SICH, within 8 h of stroke onset, will be randomised to receive TXA or the placebo control. The primary outcome is ordinal shift of modified Rankin Scale score at day 90. Analyses will be performed using intention-to-treat.

    RESULTS: This paper and its attached appendices describe the statistical analysis plan (SAP) for the trial and were developed and published prior to database lock and unblinding to treatment allocation. The SAP includes details of analyses to be undertaken and unpopulated tables which will be reported in the primary and key secondary publications. The database will be locked in early 2018, ready for publication of the results later in the same year.

    DISCUSSION: The SAP details the analyses that will be done to avoid bias arising from prior knowledge of the study findings. The trial will determine whether TXA can improve outcome after SICH, which currently has no definitive therapy.

    TRIAL REGISTRATION: ISRCTN registry, ID: ISRCTN93732214 . Registered on 17 January 2013.

    Matched MeSH terms: Intention to Treat Analysis
  16. Lin Y, Hu Z, Zhao Q, Alias H, Danaee M, Wong LP
    PLoS Negl Trop Dis, 2020 12;14(12):e0008961.
    PMID: 33332359 DOI: 10.1371/journal.pntd.0008961
    BACKGROUND: This study attempts to understand coronavirus disease 2019 (COVID-19) vaccine demand and hesitancy by assessing the public's vaccination intention and willingness-to-pay (WTP). Confidence in COVID-19 vaccines produced in China and preference for domestically-made or foreign-made vaccines was also investigated.

    METHODS: A nationwide cross-sectional, self-administered online survey was conducted on 1-19 May 2020. The health belief model (HBM) was used as a theoretical framework for understanding COVID-19 vaccination intent and WTP.

    RESULTS: A total of 3,541 complete responses were received. The majority reported a probably yes intent (54.6%), followed by a definite yes intent (28.7%). The perception that vaccination decreases the chances of getting COVID-19 under the perceived benefit construct (OR = 3.14, 95% CI 2.05-4.83) and not being concerned about the efficacy of new COVID-19 vaccines under the perceived barriers construct (OR = 1.65, 95% CI 1.31-2.09) were found to have the highest significant odds of a definite intention to take the COVID-19 vaccine. The median (interquartile range [IQR]) of WTP for COVID-19 vaccine was CNY¥200/US$28 (IQR CNY¥100-500/USD$14-72). The highest marginal WTP for the vaccine was influenced by socio-economic factors. The majority were confident (48.7%) and completely confident (46.1%) in domestically-made COVID-19 vaccine. 64.2% reported a preference for a domestically-made over foreign-made COVID-19 vaccine.

    CONCLUSIONS: The findings demonstrate the utility of HBM constructs in understanding COVID-19 vaccination intent and WTP. It is important to improve health promotion and reduce the barriers to COVID-19 vaccination.

    Matched MeSH terms: Intention
  17. Yang HK, Ji J, Han SU, Terashima M, Li G, Kim HH, et al.
    Lancet Gastroenterol Hepatol, 2021 02;6(2):120-127.
    PMID: 33253659 DOI: 10.1016/S2468-1253(20)30315-0
    BACKGROUND: Peritoneal recurrence of gastric cancer after curative surgical resection is common and portends a poor prognosis. Early studies suggest that extensive intraoperative peritoneal lavage (EIPL) might reduce the risk of peritoneal recurrence and improve survival. We aimed to evaluate the survival benefit of EIPL in patients with gastric cancer undergoing curative gastrectomy.

    METHODS: In this open-label, phase 3, multicentre randomised trial, patients aged 21-80 years with cT3 or cT4 gastric cancer undergoing curative resection were enrolled at 22 centres from South Korea, China, Japan, Malaysia, Hong Kong, and Singapore. Patients were randomly assigned to receive surgery and EIPL (EIPL group) or surgery alone (standard surgery group) via a web-based programme in random permuted blocks in varying block sizes of four and six, assuming equal allocation between treatment groups. Randomisation was stratified according to study site and the sequence was generated using a computer program and concealed until the interventions were assigned. After surgery in the EIPL group, peritoneal lavage was done with 1 L of warm (42°C) normal 0·9% saline followed by complete aspiration; this procedure was repeated ten times. The primary endpoint was overall survival. All analyses were done assuming intention to treat. This trial is registered with ClinicalTrials.gov, NCT02140034.

    FINDINGS: Between Sept 16, 2012, and Aug 3, 2018, 800 patients were randomly assigned to the EIPL group (n=398) or the standard surgery group (n=402). Two patients in the EIPL group and one in the standard surgery group withdrew from the trial immediately after randomisation and were excluded from the intention-to-treat analysis. At the third interim analysis on Aug 28, 2019, the predictive probability of overall survival being significantly higher in the EIPL group was less than 0·5%; therefore, the trial was terminated on the basis of futility. With a median follow-up of 2·4 years (IQR 1·5-3·0), the two groups were similar in terms of overall survival (hazard ratio 1·09 [95% CI 0·78-1·52; p=0·62). 3-year overall survival was 77·0% (95% CI 71·4-81·6) for the EIPL group and 76·7% (71·0-81·5) for the standard surgery group. 60 adverse events were reported in the EIPL group and 41 were reported in the standard surgery group. The most common adverse events included anastomotic leak (ten [3%] of 346 patients in the EIPL group vs six [2%] of 362 patients in the standard surgery group), bleeding (six [2%] vs six [2%]), intra-abdominal abscess (four [1%] vs five [1%]), superficial wound infection (seven [2%] vs one [<1%]), and abnormal liver function (six [2%] vs one [<1%]). Ten of the reported adverse events (eight in the EIPL group and two in the standard surgery group) resulted in death.

    INTERPRETATION: EIPL and surgery did not have a survival benefit compared with surgery alone and is not recommended for patients undergoing curative gastrectomy for gastric cancer.

    FUNDING: National Medical Research Council, Singapore.

    Matched MeSH terms: Intention to Treat Analysis
  18. Katijjahbe MA, Granger CL, Denehy L, Royse A, Royse C, Bates R, et al.
    J Physiother, 2018 04;64(2):97-106.
    PMID: 29602750 DOI: 10.1016/j.jphys.2018.02.013
    QUESTION: In people who have undergone cardiac surgery via median sternotomy, does modifying usual sternal precautions to make them less restrictive improve physical function, pain, kinesiophobia and health-related quality of life?

    DESIGN: Two-centre, randomised, controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis.

    PARTICIPANTS: Seventy-two adults who had undergone cardiac surgery via a median sternotomy were included.

    INTERVENTION: Participants were randomly allocated to one of two groups at 4 (SD 1) days after surgery. The control group received the usual advice to restrict their upper limb use for 4 to 6 weeks (ie, restrictive sternal precautions). The experimental group received advice to use pain and discomfort as the safe limits for their upper limb use during daily activities (ie, less restrictive precautions) for the same period. Both groups received postoperative individualised education in hospital and via weekly telephone calls for 6 weeks.

    OUTCOME MEASURES: The primary outcome was physical function assessed by the Short Physical Performance Battery. Secondary outcomes included upper limb function, pain, kinesophobia, and health-related quality of life. Outcomes were measured before hospital discharge and at 4 and 12 weeks postoperatively. Adherence to sternal precautions was recorded.

    RESULTS: There were no statistically significant differences in physical function between the groups at 4 weeks (MD 1.0, 95% CI -0.2 to 2.3) and 12 weeks (MD 0.4, 95% CI -0.9 to 1.6) postoperatively. There were no statistically significant between-group differences in secondary outcomes.

    CONCLUSION: Modified (ie, less restrictive) sternal precautions for people following cardiac surgery had similar effects on physical recovery, pain and health-related quality of life as usual restrictive sternal precautions. Similar outcomes can be anticipated regardless of whether people following cardiac surgery are managed with traditional or modified sternal precautions.

    TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ANZCTRN12615000968572. [Katijjahbe MA, Granger CL, Denehy L, Royse A, Royse C, Bates R, Logie S, Nur Ayub MA, Clarke S, El-Ansary D (2018) Standard restrictive sternal precautions and modified sternal precautions had similar effects in people after cardiac surgery via median sternotomy ('SMART' Trial): a randomised trial. Journal of Physiotherapy 64: 97-106].

    Matched MeSH terms: Intention to Treat Analysis
  19. Aljaberi MA, Juni MH, Al-Maqtari RA, Lye MS, Saeed MA, Al-Dubai SAR, et al.
    BMJ Open, 2018 09 12;8(9):e021180.
    PMID: 30209153 DOI: 10.1136/bmjopen-2017-021180
    OBJECTIVE: The current study aimed to investigate the relationships among the perceived quality of healthcare services, satisfaction and behavioural intentions among international students in Kuala Lumpur, Malaysia.

    SETTING: A cross-sectional study on public universities in Kuala Lumpur, Malaysia.

    PARTICIPANTS: All participants in this study were international students joining public universities in Kuala Lumpur, Malaysia.

    PRIMARY INDEPENDENT VARIABLE: Perceived quality of healthcare services measured on a SERVQUAL scale.

    PRIMARY DEPENDENT VARIABLE: Participants' satisfaction of healthcare services assessed using five items.

    SECONDARY DEPENDENT VARIABLE: Behavioural intentions measured on six items.

    RESULTS: Of the 556 international students, 500 (90%) completed the survey. The study used structural equation modelling (SEM) through the AMOS (Analysis of Moment Structures) software to analyse the data. SEM analyses showed that the perceived quality of healthcare services significantly and directly affected satisfaction, with a value of 89% and an effect size of 0.78. It also had a significant indirect impact on the behavioural intentions (0.78) of international students. The results indicated that participants' satisfaction had a statistically significant impact on their behavioural intentions (0.77).

    CONCLUSION: Perceived quality of care is an important driver of international students' satisfaction and their behavioural intention with healthcare services. Such relations of effects among the three investigated factors were also positive and significant.

    Matched MeSH terms: Intention
  20. Mitra SR, Tan PY
    Br J Nutr, 2019 05;121(9):1002-1017.
    PMID: 30761964 DOI: 10.1017/S0007114519000345
    The aim of this study was to investigate the effectiveness of the Hipcref (high-protein, energy-restricted, high-vitamin E and high-fibre) diet in Malaysian adults on body composition and metabolic parameters after an intervention period of 6 months. Overweight/obese Malaysian adults (n 128; BMI≥23 kg/m2) were randomised to the Hipcref (n 65) or control diet (n 63). The intervention group received Hipcref diet charts based on their personal preferences. The control group followed a generalised dietary advice based on Malaysian Dietary Guidelines, 2010. All participants were responsible for preparing their own meals. There was a significant treatment group×time effect on anthropometric parameters (P<0·05) on an intention-to-treat basis. Pairwise comparisons revealed that Hipcref diet participants had significant reduction in weight, BMI, waist circumference, fat mass and percentage body fat at months 3 and 6 compared with baseline (P<0·001). The control group had significant increase in weight and BMI at months 3 and 6 compared with baseline (P<0·05). The Hipcref diet group had higher reduction in fasting insulin, insulin resistance and C-reactive protein levels compared with the control group at month 6 (P<0·05). Post-intervention, compared with the control group, the Hipcref diet group was found to consume significantly higher percentage energy from protein, and PUFA, higher energy-adjusted vitamin E (mg) and fibre (g), and lower total energy, lower percentage energy from fat and carbohydrate (P<0·05). The success of the Hipcref diet on overweight/obese Malaysian adults may be due to the combined effect of the nutrient composition of the Hipcref diet.
    Matched MeSH terms: Intention to Treat Analysis
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