Displaying publications 1 - 20 of 284 in total

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  1. Langove N, Javaid MU, Ayyasamy RK, Ibikunle AK, Sabir AA
    Work, 2024;77(1):295-305.
    PMID: 37483056 DOI: 10.3233/WOR-230103
    BACKGROUND: Fear of losing psychological resources can lead to stress, impacting psychological health and behavioral outcomes like burnout, absenteeism, service sabotage, and turnover.

    OBJECTIVE: The study examined the impact of job stressors (time pressure, role ambiguity, role conflict) on employee well-being and turnover intentions. The study also investigated the mediating role of employee well-being between job stressors and turnover intention based on the conservation of resources (COR) theory.

    METHODS: Data from 396 IT executives in Malaysian IT firms were analyzed using the Partial Least Squares - Structural Equation Modeling (PLS-SEM) technique.

    RESULTS: Results confirmed a significant negative correlation between time pressure (-0.296), role ambiguity (-0.423), role conflict (-0.104), and employee well-being. Similarly, employee well-being showed a significant negative relationship with turnover intentions (-0.410). The mediation analysis revealed that employee well-being mediates the relationship between time pressure (0.121), role ambiguity (0.173), role conflict (0.043), and turnover intentions.

    CONCLUSION: This paper aims to manifest the importance of designing employee well-being policies by firms to retain employees. Findings reflect the role of the managerial approach towards ensuring employee well-being for employee retention, thereby reducing recruitment and re-training costs.

    Matched MeSH terms: Intention*
  2. Mahmud I, Sultana S, Rahman A, Ramayah T, Cheng Ling T
    Waste Manag Res, 2020 Dec;38(12):1438-1449.
    PMID: 32364437 DOI: 10.1177/0734242X20914753
    Each year Bangladesh produces around 400,000 metric tonnes of e-waste. E-waste accumulation is expected to increase by 20% annually. In order to facilitate e-waste recycling, it is crucial to identify the factors. In this study, building on the stimulus-organism-response framework, we develop a research model to explore the effect of information publicity, ascription of responsibility and convenience of recycling on the recycling attitude, subjective norm, personal norm and perceived behaviour control which lead to recycling intention. Data were gathered from 127 small and medium electronics store managers. The structural equation modelling technique was used to test the paths. The result suggests a significant influence of the element of stimulus (S) on the element of organism (O). The relationship between the element of organism (O) and the element of response (R) is partial. This paper contributes to the body of work dedicated to helping us better understand the recycling behaviour from the stimulus-organism-response perspective. From the viewpoint of practice, this research sheds light on some of the challenges that the implementer might face when making strategy and policy for e-waste management in Bangladesh.
    Matched MeSH terms: Intention
  3. Lin Y, Lin Z, He F, Hu Z, Zimet GD, Alias H, et al.
    Vaccine, 2019 10 16;37(44):6714-6723.
    PMID: 31548016 DOI: 10.1016/j.vaccine.2019.09.026
    BACKGROUND: Little research has been conducted on the intention to obtain HPV vaccine now that the vaccine is approved for use in China. Acceptance of the three HPV vaccines, which differ in valency and price, has never been investigated.

    METHODS: An online cross-sectional survey assessing female undergraduate students' intention to obtain the HPV vaccine and their acceptability of 2-, 4- and 9-valent HPV vaccines (2vHPV, 4vHPV, and 9vHPV, respectively).

    RESULTS: Of a total of 997 complete responses, 55.2% reported intent to obtain the HPV vaccine. Some of the significant factors exerting influence on intent to obtain HPV vaccination were high knowledge score (OR = 1.469, 95% CI:1.087-1.987), perceived high risk of HPV infection (OR = 1.466, 95%CI:1.017-2.114), perception of no serious side effects (OR = 1.562, 95%CI:1.150-2.121), and mass media exposure to HPV vaccination information (OR = 2.196, 95%CI: 1.625-2.966). Socioeconomic status indicators did not significantly influence intent to obtain the HPV vaccine. A higher proportion of respondents were willing to pay for 2vHPV (78.6%) and 4vHPV (68.0%) compared with 9vHPV (49.3%). Socioeconomic status indicators were the strongest correlates of acceptability for all the three vaccines. Exposure to mass media reporting about HPV vaccination is the factor which exerts the most influence on acceptance of 9vHPV after socioeconomic status indicators.

    CONCLUSIONS: It is important to improve knowledge and health beliefs, and to establish a mass media marketing strategy to promote HPV vaccination in order to enhance HPV vaccine uptake. Undergraduate female students should be provided with detailed information about the different valency vaccine choices to help them make informed decisions about immunization.

    Matched MeSH terms: Intention*
  4. Lin Y, Lin Z, He F, Chen H, Lin X, Zimet GD, et al.
    Vaccine, 2020 03 23;38(14):3021-3030.
    PMID: 32127227 DOI: 10.1016/j.vaccine.2020.02.042
    OBJECTIVE: This study aims to investigate acceptance and willingness to pay for HPV vaccination among adult women in China.

    METHODS: An online survey was sent to mothers aged 27-45 years of primary school pupils in the Fujian province, China. Participants completed questions about HPV related knowledge and health beliefs, intention to take the HPV vaccine and the willingness to pay for bivalent vaccine (2vHPV), quadrivalent vaccine (4vHPV), and 9-valent HPV vaccine (9vHPV).

    RESULTS: Of a total of 2339 complete responses, 58.3% reported intent to obtain HPV vaccine. Mothers who were younger in age, residing in urban, working in managerial or professional occupations, who knew someone with cervical cancer and who were able to make independent decisions about the HPV vaccine (vs. joint decision with spouse) were more likely to express intent to have HPV vaccination. Perceived barriers, cues to action and self-efficacy were three of the constructs in the health belief model that significantly influenced HPV vaccination intent. A higher proportion of participants expressed willingness to pay for 2vHPV (81.2%) and 4vHPV (75.9%), as compared to 9vHPV (67.7%).

    CONCLUSION: Adults women expressed moderate intention to receive the HPV vaccine. Intervention to address barriers to uptake of the HPV vaccine among adult women in China is warranted.

    Matched MeSH terms: Intention
  5. Mohammed AH, Hassan BAR, Wayyes AM, Gadhban AQ, Blebil A, Alhija SA, et al.
    Vaccine, 2022 Oct 26;40(45):6549-6557.
    PMID: 36207222 DOI: 10.1016/j.vaccine.2022.09.052
    BACKGROUND: The issue around vaccination of children has brought divergent opinions among the populations across the globe and among the Arab population. There has been a low response rate to the calls for vaccination of children and this is reflective of the sentiments which parents may have towards their children being vaccinated. This study aims to explore the parents' health beliefs, intentions, and strategies towards the COVID-19 vaccine for their children among Arab population.

    METHODS: A cross-sectional study using an online survey from October to December 2021, was carried out in five Arab countries in the Middle East. A reliable health belief model (HBM) including five domains: severity, susceptibility, benefits, barriers and cues to action, was adopted. Chi-square, Mann-Whitney test, and multivariable logistic regression were performed for data analysis.

    RESULTS: The survey response rate was 58 % (1154/2000). Only 56 % of Arab parents are intended to vaccinate their children against COVID-19. The mean scores of parental health belief are largely driven by their concern over the vaccine's side effect (p = 0.001) followed by its efficacy, safety (p 

    Matched MeSH terms: Intention
  6. KIEW CHEE CHING, ZUHA ROSUFILA ABU HASAN, NADIA ABU HASAN
    MyJurnal
    Shopee online has become increasingly popular among consumers for purchasing purposes as compared to brick-and-mortar retail due to the benefits and enjoyment that come with it. However, Shopee has facing intense competitive challenges with other competitors in Malaysia. In addition, it is also difficult for Shopee to compete with major leader of online shopping portal although this platform offers the same function and usage as its contender. Hence, it is important to understand consumer perceptions on the benefit and intention of using Shopee. This study examines consumer perceived usefulness, perceived ease of use, perceived price, perceived convenience and perceived trust adapted from the Technology Acceptance Model (TAM). 208 respondents who have experience online purchasing in East Cost of Malaysia were invited to participate in this study using online survey. Data were analyzed using descriptive, correlation and multiple regression analyses. The findings show that perceived convenience and perceived trust have strong influence towards consumer intention to use Shopee as platform to do online purchase. It is suggested that this study will help practitioners to understand consumer online shopping perception and intention in order to induce visitation and usage of Shopee.
    Matched MeSH terms: Intention
  7. NUR ERNA ERLIANA SAMSUDIN, AZWADI ALI, ROSHAIZA TAHA
    MyJurnal
    This study was conducted to assess how entrepreneurship experience, family background, and societal factors influence university students in Terengganu to embark on entrepreneurial activities. It cannot be denied that entrepreneurship exposure on campus may drive university students to engage in activities which may enhance their academic achievements in, boost confidence, and instill relevant qualities and skills to be successful graduates in the future. Such valuable experiences may be value added to the graduates. To see the impact of such an experience together with other relevant factors, this study has tested the relationship between entrepreneurship experience, family background, social factors and the subsequent effects among students of Universiti Malaysia Terengganu after graduation. The data were collected from 370 targeted respondents and were analysed using the multiple regression analysis. It was found that entrepreneurship experience and family background have significant relationships with entrepreneurship intention while societal factor was found to be insignificant.
    Matched MeSH terms: Intention
  8. YAP HUI YEE, SITI NUR'AFIFAH JAAFAR
    MyJurnal
    owadays the increasing prevalence of dietary disease has raised consumers’ awareness of healthy diet and lifestyle. The rise in the use of nutrition and health claims to promote health benefits in food products help consumers make effective food choices. There is very limited research regarding nutrition and health claims in Malaysia. This research focused on consumers’ knowledge, perception (i.e. perceived quality, perceived healthiness, perceived value, perceived importance, trust and perceived familiarity), and attitude towards nutrition and health claims on dairy products as well as their purchase intention towards the products, and examinethe relationship between these variables in Johor Bahru, Johor. All responses were collected by distributing questionnaire to convenience and quota sample (n=200). Data was analysed to obtain descriptive statistics and correlation analysis. The results showed that most of the consumers (46%) had moderate knowledge of nutrition and health claims on dairy products. Consumers generally had almost positive perception and attitude towards nutrition and health claims on dairy products and positive purchase intention towards dairy products. Almost all independent variables correlated with purchase intention towards dairy products. Consumer attitude had the strongest positive relationship with purchase intention (r=0.722), followed by moderate positive correlation between consumer perception and purchase intention (r=0.671), while consumer knowledge only had low relationship with purchase intention (r=0.299). This study added new knowledge regarding public purchasing behaviour towards dairy products with nutrition and health claims. This research also provided valuable information for both food manufacturers and companies to help them make effective decisions to improve the presentation of nutrition and health claims for better expression of information as well as the goodness of food products in order to attract the attention of health-conscious consumers.
    Matched MeSH terms: Intention
  9. 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
  10. Katijjahbe MA, Denehy L, Granger CL, Royse A, Royse C, Bates R, et al.
    Trials, 2017 06 23;18(1):290.
    PMID: 28645301 DOI: 10.1186/s13063-017-1974-8
    BACKGROUND: The routine implementation of sternal precautions to prevent sternal complications that restrict the use of the upper limbs is currently worldwide practice following a median sternotomy. However, evidence is limited and drawn primarily from cadaver studies and orthopaedic research. Sternal precautions may delay recovery, prolong hospital discharge and be overly restrictive. Recent research has shown that upper limb exercise reduces post-operative sternal pain and results in minimal micromotion between the sternal edges as measured by ultrasound. The aims of this study are to evaluate the effects of modified sternal precautions on physical function, pain, recovery and health-related quality of life after cardiac surgery.

    METHODS/DESIGN: This study is a phase II, double-blind, randomised controlled trial with concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. Patients (n = 72) will be recruited following cardiac surgery via a median sternotomy. Sample size calculations were based on the minimal important difference (two points) for the primary outcome: Short Physical Performance Battery. Thirty-six participants are required per group to counter dropout (20%). All participants will be randomised to receive either standard or modified sternal precautions. The intervention group will receive guidelines encouraging the safe use of the upper limbs. Secondary outcomes are upper limb function, pain, kinesiophobia and health-related quality of life. Descriptive statistics will be used to summarise data. The primary hypothesis will be examined by repeated-measures analysis of variance to evaluate the changes from baseline to 4 weeks post-operatively in the intervention arm compared with the usual-care arm. In all tests to be conducted, a p value <0.05 (two-tailed) will be considered statistically significant, and confidence intervals will be reported.

    DISCUSSION: The Sternal Management Accelerated Recovery Trial (S.M.A.R.T.) is a two-centre randomised controlled trial powered and designed to investigate whether the effects of modifying sternal precautions to include the safe use of the upper limbs and trunk impact patients' physical function and recovery following cardiac surgery via median sternotomy.

    TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry identifier: ACTRN12615000968572 . Registered on 16 September 2015 (prospectively registered).

    Matched MeSH terms: Intention to Treat Analysis
  11. Hossain Parash M, Suki NM, Shimmi SC, Hossain ABMT, Murthy KD
    Transfus Clin Biol, 2020 Apr;27(2):70-77.
    PMID: 32139133 DOI: 10.1016/j.tracli.2020.02.002
    OBJECTIVE: This study aims to examine the behavioural intention of students to make voluntary blood donations. Moreover, it uses a theory of planned behaviour as its guiding principle and does so within the context of Malaysia, a developing nation.

    METHODS: Data were collected via a self-administered questionnaire from a sample of 500 students at a public higher learning institution in Malaysia. Structural equation modelling approach (SEM) was performed to assess the strength of the hypothesized relationships of the proposed model simultaneously via the two-stage model-building process.

    RESULTS: The SEM approach revealed that knowledge was the most influential predictor of students' intention to make a voluntary blood donation. With the knowledge that the more blood they donate, the more lives will be saved, the inclination to donate blood is intensifying among students. Moreover, all of the TPB constructs applied were also seen to significantly influence students' response to voluntary blood donation.

    CONCLUSIONS: The nexus of attitude, subjective norm, perceived behavioural control, and knowledge about students' intention to perform voluntary blood donation are evidenced in a developing nation. The implications of the study and directions for future research are provided.

    Matched MeSH terms: Intention*
  12. Qazi A, Raj RG, Tahir M, Waheed M, Waheed M, Khan SU, et al.
    ScientificWorldJournal, 2014;2014:872929.
    PMID: 24711739 DOI: 10.1155/2014/872929
    Existing opinion mining studies have focused on and explored only two types of reviews, that is, regular and comparative. There is a visible gap in determining the useful review types from customers and designers perspective. Based on Technology Acceptance Model (TAM) and statistical measures we examine users' perception about different review types and its effects in terms of behavioral intention towards using online review system. By using sample of users (N = 400) and designers (N = 106), current research work studies three review types, A (regular), B (comparative), and C (suggestive), which are related to perceived usefulness, perceived ease of use, and behavioral intention. The study reveals that positive perception of the use of suggestive reviews improves users' decision making in business intelligence. The results also depict that type C (suggestive reviews) could be considered a new useful review type in addition to other types, A and B.
    Matched MeSH terms: Intention*
  13. Mustapa MAC, Amin L, Mahadi Z
    Pharmacogenomics J, 2020 12;20(6):801-812.
    PMID: 32457399 DOI: 10.1038/s41397-020-0167-0
    Pharmacogenomics (PGx) testing, which aims to identify the genes that affect our responses to drugs, has been favoured by healthcare professionals as a means of maximising drug efficacy and improving the safety and cost-effectiveness of healthcare. Support from the public is needed to determine the successful development of this technology and its implementation in society. Therefore, the objective of this paper was to analyse factors that influence stakeholders' intentions to adopt pharmacogenomic testing in Malaysia. A validated instrument was administered through face-to-face interviews with a total of 421 adult respondents who were stratified according to 2 stakeholder groups: healthcare providers (n = 221) and patients/family members (n = 200). The data were then analysed using SPSS® version 24 software and the advanced multivariate statistical approach of Partial Least Square (PLS) path modelling in order to analyse the complex relationships among variables. Results of the studies indicated that the Malaysian stakeholders had a high amount of trust in the key players (mean score of 5.31), perceived high benefits (mean score of 5.53) and claimed to have high intentions of adopting PGx (mean score of 5.39). The majority of the predictors have significant direct relationships with the intention to adopt PGx, with the exception of moral concerns. Perceived benefits appeared to be the most important direct predictor of the intention to adopt PGx testing (ß = 0.371, P 
    Matched MeSH terms: Intention*
  14. 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
  15. Jalalian M, Latiff L, Hassan ST, Hanachi P, Othman M
    PMID: 20578556
    University students are a target group for blood donor programs. To develop a blood donation culture among university students, it is important to identify factors used to predict their intent to donate blood. This study attempted to develop a valid and reliable measurement tool to be employed in assessing variables in a blood donation behavior model based on the Theory of Planned Behavior (TPB), a commonly used theoretical foundation for social psychology studies. We employed an elicitation study, in which we determined the commonly held behavioral and normative beliefs about blood donation. We used the results of the elicitation study and a standard format for creating questionnaire items for all constructs of the TPB model to prepare the first draft of the measurement tool. After piloting the questionnaire, we prepared the final draft of the questionnaire to be used in our main study. Examination of internal consistency using Chronbach's alpha coefficient and item-total statistics indicated the constructs "Intention" and "Self efficacy" had the highest reliability. Removing one item from each of the constructs, "Attitude," "Subjective norm," "Self efficacy," or "Behavioral beliefs", can considerably increase the reliability of the measurement tool, however, such action is controversial, especially for the variables "attitude" and "subjective norm." We consider all the items of our first draft questionnaire in our main study to make it a reliable measurement tool.
    Matched MeSH terms: Intention
  16. Bukar Ali, Bularafa, Abdul Rashid, Abdullah
    MyJurnal
    Unemployment and poverty are seriously issue of concern globally, especially in developing countries like Nigeria. Unemployment and poverty among university graduates in Nigeria, the trends on rising every year, major corporations are cutting down jobs and graduates who were interested to work can’t seem to find a job. However, entrepreneurship and business formation have been recognised around the World as a remedy for unemployment and pivotal for economies to grow. Therefore, promotion of entrepreneurial activity becomes the most top priority on the government agenda. Despite the unique role played by entrepreneurship to the economy as a whole and to the person that established business, in Nigeria, the rate of university graduates in entrepreneurship is far below expected. This led to many research efforts on factors that are having an effect on student’s entrepreneurial intentions. This review paper proposed the intention to be an entrepreneur can be explained by Ajzen, (1991) theory of planned behaviour, institutional, and core self-evaluation theories. Psychological (self-efficacy, risk-taking propensity, locus of control, innovativeness, need for achievement) and institutional (university environment, government support programmes) factors will have an effect on attitudes, subjective norms, perceived behavioural control. Consequently, the study predicted the entrepreneurial intentions of the Nigerian university students.
    Matched MeSH terms: Intention
  17. 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
  18. 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
  19. Shehabi Y, Howe BD, Bellomo R, Arabi YM, Bailey M, Bass FE, et al.
    N Engl J Med, 2019 Jun 27;380(26):2506-2517.
    PMID: 31112380 DOI: 10.1056/NEJMoa1904710
    BACKGROUND: Dexmedetomidine produces sedation while maintaining a degree of arousability and may reduce the duration of mechanical ventilation and delirium among patients in the intensive care unit (ICU). The use of dexmedetomidine as the sole or primary sedative agent in patients undergoing mechanical ventilation has not been extensively studied.

    METHODS: In an open-label, randomized trial, we enrolled critically ill adults who had been undergoing ventilation for less than 12 hours in the ICU and were expected to continue to receive ventilatory support for longer than the next calendar day to receive dexmedetomidine as the sole or primary sedative or to receive usual care (propofol, midazolam, or other sedatives). The target range of sedation-scores on the Richmond Agitation and Sedation Scale (which is scored from -5 [unresponsive] to +4 [combative]) was -2 to +1 (lightly sedated to restless). The primary outcome was the rate of death from any cause at 90 days.

    RESULTS: We enrolled 4000 patients at a median interval of 4.6 hours between eligibility and randomization. In a modified intention-to-treat analysis involving 3904 patients, the primary outcome event occurred in 566 of 1948 (29.1%) in the dexmedetomidine group and in 569 of 1956 (29.1%) in the usual-care group (adjusted risk difference, 0.0 percentage points; 95% confidence interval, -2.9 to 2.8). An ancillary finding was that to achieve the prescribed level of sedation, patients in the dexmedetomidine group received supplemental propofol (64% of patients), midazolam (3%), or both (7%) during the first 2 days after randomization; in the usual-care group, these drugs were administered as primary sedatives in 60%, 12%, and 20% of the patients, respectively. Bradycardia and hypotension were more common in the dexmedetomidine group.

    CONCLUSIONS: Among patients undergoing mechanical ventilation in the ICU, those who received early dexmedetomidine for sedation had a rate of death at 90 days similar to that in the usual-care group and required supplemental sedatives to achieve the prescribed level of sedation. More adverse events were reported in the dexmedetomidine group than in the usual-care group. (Funded by the National Health and Medical Research Council of Australia and others; SPICE III ClinicalTrials.gov number, NCT01728558.).

    Matched MeSH terms: Intention to Treat Analysis
  20. 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
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