DESIGN: AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT.
SETTING: Acute stroke units at 44 hospitals in 8 countries.
PARTICIPANTS: The first 20,000 patients screened for AVERT, of whom 1158 were recruited and randomised.
MODEL: We use the Proximal Similarity Model, which considers the person, place, and setting and practice, as a framework for considering generalisability. As well as comparing the recruited patients with the target population, we also performed an exploratory analysis of the demographic, clinical, site and process factors associated with recruitment.
RESULTS: The demographics and stroke characteristics of the included patients in the trial were broadly similar to population-based norms, with the exception that AVERT had a greater proportion of men. The most common reason for non-recruitment was late arrival to hospital (ie, >24 h). Overall, being older and female reduced the odds of recruitment to the trial. More women than men were excluded for most of the reasons, including refusal. The odds of exclusion due to early deterioration were particularly high for those with severe stroke (OR=10.4, p<0.001, 95% CI 9.27 to 11.65).
CONCLUSIONS: A model which explores person, place, and setting and practice factors can provide important information about the external validity of a trial, and could be applied to other clinical trials.
TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12606000185561) and Clinicaltrials.gov (NCT01846247).
DESIGN: This post hoc descriptive exploration of data from the large international very early rehabilitation trial (A Very Early Rehabilitation Trial (AVERT)) examined the four common post acute rehabilitation pathways (inpatient rehabilitation, home with community rehabilitation, inpatient rehabilitation then community rehabilitation and home with no rehabilitation) experienced by participants in the 3 months post stroke and describes their 12-month outcomes.
SETTING: Hospital stroke units in AUS, UK and SE Asia.
PARTICIPANTS: Patients who had an acute stroke recruited within 24 hours who were ≤65 years.
RESULTS: 668 participants were ≤65 years; 99% lived independently, and 88% no disability (modified Rankin Score (mRS)=0) prior to stroke. We had complete data for 12-month outcomes for n=631 (94%). The proportion receiving inpatient rehabilitation was higher in AUS than other regions (AUS 52%; UK 25%; SE Asia 23%), whereas the UK had higher community rehabilitation (UK 65%; AUS 61%; SE Asia 39%). At 12 months, 70% had no or little disability (mRS 0-2), 44% were depressed, 28% rated quality of life as poor or worse than death. For those working prior to stroke (n=228), only 57% had returned to work. A noteworthy number of working age survivors received no rehabilitation services within 3 months post stroke.
CONCLUSIONS: There was considerable variation in rehabilitation pathways and post acute service use across the three regions. At 12 months, there were high rates of depression, poor quality of life and low rates of return to work.
TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12606000185561).
METHODS AND ANALYSIS: This two-phase sequential explanatory mixed-methods design, incorporating a quantitative design (phase I) and a qualitative study (phase II), is to be conducted in 4 government hospitals and 10 other non-governmental organisations or private dialysis centres within Klang Valley, Malaysia. A cross-sectional survey (phase I) will include 236 patient-caregiver dyads, while focus group discussions (phase II) will include 30 participants. The participants for both phases will be recruited purposively. Descriptive statistics, independent sample t-tests and multiple regression analysis will be used for analyses in phase I, and thematic analysis will be used in phase II.
ETHICS AND DISSEMINATION: Approval for the study has been obtained from the National Medical Research and Ethics Committee (MREC) (NMRR-21-1012-59714) and the Research Ethics Committee of Hospital Canselor Tuanku Muhriz UKM (UKM PPI/111/8/JEP-2021-078) and University of Malaya Medical Centre (MREC ID NO: 2 02 178-10346). Informed consent of the participants will be obtained beforehand, and no personal identifiers will be obtained from the participants to protect their anonymity. The findings will be published in peer-reviewed scientific journals and presented at national or international conferences with minimal anonymised data.
METHODS AND ANALYSIS: Scopus, CINAHL, Academic Search Complete, Cochrane Library, MEDLINE and Psychology and Behavioral Sciences Collection databases were selected. Screening was conducted independently by at least two authors and the decision for inclusion was done through discussion or involvement of an arbiter against a predetermined criteria. Included articles will be evaluated for quality using A MeaSurement Tool to Assess systematic Reviews and Risk of Bias in Systematic Review tools, while primary systematic review articles will be cross-checked and reported for any overlapping using the 'corrected covered area' method. Only narrative synthesis will be employed according to the predefined themes into two major dimensions-theory and knowledge generation (focusing on cognitive taxonomy due to its ability to be generalised across disciplines), and clinical-based competence (focusing on psychomotor and affective taxonomies due to discipline-specific influence). The type of technology used will be identified and extracted.
ETHICS AND DISSEMINATION: The OoSR involves analysis of secondary data from published literature, thus ethical approval is not required. The findings will provide a valuable insight for policymakers, stakeholders, and researchers in terms of technology-based learning implementation and gaps identification. The findings will be published in several reports due to the extensiveness of the topic and will be disseminated through peer-reviewed publications and conferences.
PROSPERO REGISTRATION NUMBER: CRD4202017974.
SETTING: Pesticide poisoning database of Malaysia National Poison Centre (NPC) from 2006 to 2015.
PARTICIPANTS: Telephone enquiries regarding pesticide poisoning were made by healthcare professionals. Information received by the NPC was entered into a retrievable database of standardised Poison Case Report Form, as adapted from the World Health Organization (WHO).
OUTCOMES: The outcome of the study is to provide an overview of national epidemiological profile of pesticide poisoning. High-risk groups of people and their circumstances were also identified to ensure that appropriate measures are strategised.
RESULTS: Within the study period, a total of 11 087 pesticide poisoning cases were recorded. Sixty per cent of these cases were intentional in nature and most were found among male individuals (57%) of the Indian race (36.4%) aged between 20 and 29 years (25.5%), which occurred at home (90%) through the route of ingestion (94%). The highest number of poisoning was due to herbicides (44%) followed by agricultural insecticides (34%), rodenticides (9.9%), household insecticides (9.5%) and fungicides (0.5%). In addition, 93.6% of intentional pesticide poisoning cases were caused by suicide attempts. The results of this study show that there was an increasing trend in pesticide poisoning incidents over the 10-year duration. This indicates that pesticide poisoning is a prevalent public health problem in Malaysia, resulting in an average incidence rate of 3.8 per 100 000 population.
CONCLUSIONS: Deliberate pesticide ingestion as a method of suicide has become a disturbing trend among Malaysians. Therefore, regulation of highly hazardous pesticides must be enforced to ensure controlled and limited access to these chemicals by the public.
SETTING: A tertiary medical centre in Kuala Lumpur, Malaysia.
PARTICIPANTS: A total of 219 patients (range 23-80 years) who had received phosphodiesterase type-5 (PDE-5) inhibitors as ED treatment were evaluated.
INCLUSION CRITERIA: Adult patients aged ≥18 years, diagnosed with ED, and prescribed with sildenafil, tadalafil or vardenafil.
EXCLUSION CRITERIA: Patients diagnosed with ED but who did not receive any PDE-5 inhibitor, or those with missing data.
PRIMARY AND SECONDARY OUTCOME MEASURES: Factors associated with demographic and clinical characteristics as well as drug selection were assessed.
RESULTS: Ischaemic heart disease (p=0.025), benign prostatic hyperplasia (p<0.001), obesity (p=0.005), lower urinary tract symptoms (LUTS) (p=0.006) and α-blockers (p<0.001) were significantly associated with elderly patients with ED. Additionally, LUTS (p=0.038) and α-blockers (p=0.008) were significantly associated with the selection of PDE-5 inhibitor.
CONCLUSIONS: These data showed that elderly patients with ED were significantly associated with comorbidities and α-blockers, whereas LUTS and α blockers were associated with drug selection.
SETTING: Kelantan, Malaysia.
PARTICIPANTS: All breast cancer cases diagnosed in 2007 and 2011 identified from Kelantan Cancer Registry.
DESIGN: This retrospective cohort study used a relative survival approach to estimate the net survival of patients with breast cancer. Thus, two data were needed; breast cancer data from Kelantan Cancer Registry and general population mortality data for Kelantan population.
PRIMARY AND SECONDARY OUTCOME MEASURES: Net survival according to stage and age group at diagnosis at 1, 3 and 5 years following diagnosis.
RESULTS: The highest net survival was observed among stage I and II breast cancer cases, while the lowest net survival was observed among stage IV breast cancer cases. In term of age at diagnosis, breast cancer cases aged 65 and older had the best net survival compared with the other age groups.
CONCLUSION: The age at diagnosis had a minimal impact on the net survival compared with the stage at diagnosis. The finding of this study is applicable to other populations with similar breast cancer profile.
METHODS AND ANALYSIS: MERCURIAL is an ongoing multiyear prospective cohort study. Every year, for the next 5 years, a cohort of 1000 Hajj pilgrims was enrolled beginning in the 2016 Hajj pilgrimage season. Pre-Hajj and post-Hajj serum samples were obtained and serologically analysed for evidence of MERS-CoV seroconversion. Sociodemographic data, underlying medical conditions, symptoms experienced during Hajj pilgrimage, and exposure to camel and untreated camel products were recorded using structured pre-Hajj and post-Hajj questionnaires. The possible risk factors associated with the seroconversion data were analysed using univariate and multivariate logistic regression. The primary outcome of this study is to better enhance our understanding of the potential threat of MERS-CoV spreading through MG beyond the Middle East.
ETHICS AND DISSEMINATION: This study has obtained ethical approval from the Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia. Results from the study will be submitted for publication in peer-reviewed journals and presented in conferences and scientific meetings.
TRIAL REGISTRATION NUMBER: NMRR-15-1640-25391.
METHODS AND ANALYSIS: This is a community-based nationwide cross-sectional study in Malaysia. The data collection period is from July 2023 until September 2023, with a planned sample size of 1296 participants. We use a two-stage proportionate stratified random sampling method to ensure national representativeness. The definition of MetS follows the Harmonised Joint Interim Statement in 2009. A diagnosis of MAFLD is made if a participant has fatty liver, defined as having a Fatty Liver Index ≥60 and has type 2 diabetes, a body mass index ≥23 kg/m2, or ≥2 metabolic risk abnormalities. Complex sample analysis will be conducted, and the disease prevalence will be reported with 95% CIs, unweighted counts and estimated populations.
ETHICS AND DISSEMINATION: The protocol has been approved by the Medical Research and Ethics Committee of the Ministry of Health Malaysia (NMRR ID-22-02845-GUT). The findings will be disseminated through a formal report, policy brief, scientific publications, conference presentations, social media, print media and stakeholder engagement activities.
DESIGN: Qualitative study utilising semi-structured in-depth interviews. The interviews were conducted in English language.
SETTING: Different healthcare facilities across the UAE. These facilities were accessed for data collection over a period of 3 months from January 2023 to March 2023.
PARTICIPANTS: 14 purposively selected healthcare practitioners.
INTERVENTION: No specific intervention was implemented; this study primarily aimed at gaining insights through interviews.
PRIMARY AND SECONDARY OUTCOMES: To understand the implications of language barriers on service quality, patient safety, and healthcare providers' well-being.
RESULTS: Three main themes emerged from our analysis of participants' narratives: Feeling left alone, Trying to come closer to their patients and Feeling guilty, scared and dissatisfied.
CONCLUSIONS: Based on the perspectives and experiences of participating healthcare professionals, language barriers have notably influenced the delivery of healthcare services, patient safety and the well-being of both patients and practitioners in the UAE. There is a pressing need, as highlighted by these professionals, for the inclusion of professional interpreters and the provision of training to healthcare providers to enhance effective collaboration with these interpreters.
METHODS AND ANALYSIS: A 2×2 cross-over randomised mechanistic dietary trial will allocate 16 participants with NAFLD to a 2-week either HGI or LGI diet followed by a 4-week wash-out period and then the LGI or HGI diet, alternative to that followed in the first 2 weeks. Baseline and postintervention (four visits) outcome measures will be collected to assess liver fat content (using MRI/S and controlled attenuation parameter-FibroScan), gut microbiota composition (using 16S RNA analysis) and blood biomarkers including glycaemic, insulinaemic, liver, lipid and haematological profiles, gut hormones levels and short-chain fatty acids.
ETHICS AND DISSEMINATION: Study protocol has been approved by the ethics committees of The University of Nottingham and East Midlands Nottingham-2 Research Ethics Committee (REC reference 19/EM/0291). Data from this trial will be used as part of a Philosophy Doctorate thesis. Publications will be in peer-reviewed journals.
TRIAL REGISTRATION NUMBER: NCT04415632.
DESIGN: Cross-sectional study.
SETTING: This study is part of a larger national study on the perception of the Malaysian public healthcare professionals on FMSs.
PARTICIPANTS: PHCPs from three categories of health facilities, namely hospitals, health clinics and health offices.
MAIN OUTCOME MEASURES: Qualitative analysis of written comments of respondents' expectation of FMSs.
RESULTS: The participants' response rate was 58% (780/1345) with an almost equal proportion from each public healthcare facility. We identified 21 subthemes for the 623 expectation comments. The six emerging themes are (1) need for more FMSs, (2) clinical roles and functions of FMSs, (3) administrative roles of FMSs, (4) contribution to community and public health, (5) attributes improvement and (6) research and audits. FMSs were expected to give attention to clinical duty. Delivering this responsibility with competence included having the latest medical knowledge in their own and others' medical disciplines, practising evidence-based medicine in prehospital and posthospital care, better supervision of staff and doctors under their care, fostering effective teamwork, communicating more often with hospital specialists and making appropriate referral. Expectations ranged from definite and strong for more FMSs at the health clinics to low expectation for FMSs' involvement in research; to mal-expectation on FMSs' involvement in community and public health programmes.
CONCLUSIONS: There were some remarkable differences in expectations on FMSs from the three different PHCPs. These ranged from being clinically competent and administratively available for patients and staff at the health clinics, to mal-expectations on FMSs to engage in public health affairs. Relevant parties, including FMSs themselves, could take appropriate self-improvement initiatives to enhance public practice of family medicine and patient care.
TRIAL REGISTRATION NUMBER NMRR ID: 08-12-1167.
DESIGN: Data were extracted from the Malaysian Thalassaemia Registry, a web-based system accessible to enrolled users through www.mytalasemia.net.my.
SETTING: The Malaysian Thalassaemia Registry data was recorded from reports obtained from 110 participating government and university hospitals in Malaysia.
PARTICIPANTS: The patients were those attending the 110 participating hospitals for thalassaemia treatment.
INTERVENTION: Data were collected from the Malaysian Thalassaemia Registry from 2007 until the fourth quarter of 2018.
PRIMARY OUTCOME MEASURE: 7984 out of 8681 patients with thalassaemia registered in the Malaysian Thalassaemia Registry were reported alive.
RESULTS: Majority of the patients were reported in the state of Sabah (22.72%); the largest age group affected was 5.0-24.9 years old (64.45%); the largest ethnic group involved was Malay (63.95%); and the major diagnosis was haemoglobin E/β-thalassaemia (34.37%). From the 7984 patients, 56.73% were on regular blood transfusions and 61.72% were on chelation therapy. A small fraction (14.23%) has undergone splenectomy, while the percentage of patients with severe iron overload (serum ferritin ≥5000 µg/L) reduced over time. However, cardiac complications are still the main cause of death in patients with thalassaemia.
CONCLUSION: Data gathered into the registry can be used to understand the progression of the disorder, to monitor iron overload management and to improve the outcomes of treatment, to enhance preventive strategies, reduce healthcare burden and improve the quality of life. Sustainability of the Malaysian Thalassaemia Registry is important for surveillance of thalassaemia management in the country and help the national health authorities to develop more effective policies.
METHODS AND ANALYSIS: The systematic review, will be conducted by extensively searching different databases such as PubMed, Web of Science, Scopus, Wiley and ProQuest to identify randomised controlled trials (with no time frame) which relate to the administration of probiotics to patients with colorectal cancer. The search strategy will include words like colorectal cancer, probiotics, Bifidobacterium, clinical trials etc. A systematic search of databases was performed between 17 and 20 January 2020. Two reviewers will independently review the studies and also search the reference lists of the eligible studies to obtain more references. Data will be extracted from the eligible studies using standardised data extraction form. After assessing the risk of bias, qualitative analysis will be used to synthesise the systematic review.
ETHICS AND DISSEMINATION: This is a protocol for a systematic review; therefore, it doesn't require any ethics approval. We intend to disseminate the protocol in a peer reviewed journal.
METHODS: A prepost study design was conducted in 2017. The 8-hour Smoking Cessation Organising, Planning and Execution (SCOPE) training comprised lectures, practical sessions and role-play sessions to 218 healthcare providers. A validated evaluation tool, Providers' Smoking Cessation Training Evaluation, was administered to assess the impact of training on knowledge, attitude and self-efficacy on smoking cessation intervention.
RESULTS: After SCOPE training, the knowledge score increased significantly from 7.96±2.34 to 10.35±1.57 (p<0.001). Attitude and self-efficacy in smoking cessation intervention also increased significantly from 34.32±4.12 to 37.04±3.92 (p<0.001) and 40.31±8.61 to 54.67±7.45 (p<0.001) respectively. Pretraining and post-training scores improved significantly for all professions, and each measure, particularly self-efficacy.
CONCLUSION: This study demonstrates that SCOPE training could improve healthcare providers' knowledge, attitude and self-efficacy on smoking cessation intervention. Future training is recommended to equip healthcare providers with current knowledge, positive attitude and high self-efficacy to integrate what they have learned into practice successfully.
METHODS AND ANALYSIS: The scoping review will be conducted based on the methodology developed by Arksey and O'Malley's scoping review methodology, and Levac et al 's methodological enhancement. An experienced information specialist (HM) searched the following databases MEDLINE, EMBASE, the Cochrane Library, Cumulative Index to Nursing and Allied Health Literature. The search terms were both keywords in the title and/or abstract and subject headings (eg, MeSH, EMTREE) as appropriate. Search results were downloaded, imported and stored into a 'Refworks' folder specifically created for reference management. The preliminary search was conducted between 7 December 2017 and 14 December 2017. Quantitative methods using content analysis will be used to categorise study findings on factors associated with trust between patients, clients and healthcare providers. The collection of studies will be also examined for heterogeneity. Qualitative analysis on peer reviewed articles of qualitative interviews and focus group discussion will be conducted; it allows clear identification of themes arising from the data, facilitating prioritisation, higher order abstraction and theory development. A consultation exercise with stakeholders may be incorporated as a knowledge translation component of the scoping study methodology.
ETHICS AND DISSEMINATION: Ethical approval will be obtained for the research project from the Institutional Review Board. The International Medical University will use the findings of this scoping review research to improve the understanding of trust in healthcare, in its endeavour to improve health services delivery in its healthcare clinics and hospitals, and in its teaching and learning curriculum. The findings will also help faculty make evidence based decisions to focus resources and research as well as help to advance the science in this area. Dissemination of the results of the scoping review will be made through peer-reviewed publications, research reports and presentations at conferences and seminars.
METHOD AND ANALYSIS: We will conduct a systematic review of randomised controlled trials that investigate the effect and safety of GO for the treatment of patients with AML. We will search for any eligible articles from selected electronic databases. We will follow the Preferred Reporting Items for Systematic reviews and Meta-Analysis for study selection and reporting. We will use The Cochrane Handbook for Systematic Reviews of Interventions and Meta-Analysis as guidance to select eligible studies. All data will be extracted using a standardised data extraction form.
ETHICS AND DISSEMINATION: There was no patient involved in this study, therefore no ethical consideration is needed. The findings of this study will be disseminated in a peer-reviewed journal and any relevant conference presentation.
PROSPERO REGISTRATION NUMBER: CRD42019123286.