METHODS AND RESULTS: We prospectively studied 3886 Asian patients (60 ± 13 years, 21% women) with HF (ejection fraction ≤40%) from 11 regions in the Asian Sudden Cardiac Death in Heart Failure study. Anaemia was defined as haemoglobin <13 g/dL (men) and <12 g/dL (women). Ethnic groups included Chinese (33.0%), Indian (26.2%), Malay (15.1%), Japanese/Korean (20.2%), and others (5.6%). Overall, anaemia was present in 41%, with a wide range across ethnicities (33-54%). Indian ethnicity, older age, diabetes, and chronic kidney disease were independently associated with higher odds of anaemia (all P
METHODS: Seven (7) ASPECT members were approached to provide a harmonised anonymised dataset from their local registry. Patient characteristics were summarised and associations between the characteristics and in-hospital outcomes for STEMI patients were analysed.
RESULTS: Six (6) participating sites (86%) provided governance approvals for the collation of individual anonymised patient data from 2015 to 2017. Five (5) sites (83%) provided >90% of agreed data elements and 68% of the collated elements had <10% missingness. From the registry (n=12,620), 84% were male. The mean age was 59.2±12.3 years. The Malaysian cohort had a high prevalence of previous myocardial infarction (34%), almost twice that of any other sites (p<0.001). Adverse in-hospital outcomes were the lowest in Hong Kong whilst in-hospital mortality varied from 2.7% in Vietnam to 7.9% in Singapore.
CONCLUSIONS: Governance approvals for the collation of individual patient anonymised data was achieved with a high level of data alignment. Secure data transfer process and repository were established. Patient characteristics and presentation varied significantly across the Asia-Pacific region with this likely to be a major predictor of variations in the clinical outcomes observed across the region.
DESIGN: Retrospective observational analysis.
SETTING: 56 acute stroke hospitals in eight countries.
PARTICIPANTS: 1074 trial physiotherapists, nurses, and other clinicians.
OUTCOME MEASURES: Number of babies born during trial recruitment per trial participant recruited.
RESULTS: With 198 site recruitment years and 2104 patients recruited during AVERT, 120 babies were born to trial staff. Births led to an estimated 10% loss in time to achieve recruitment. Parental leave was linked to six trial site closures. The number of participants needed to recruit per baby born was 17.5 (95% confidence interval 14.7 to 21.0); additional trial costs associated with each birth were estimated at 5736 Australian dollars on average.
CONCLUSION: The staff absences registered in AVERT owing to parental leave led to delayed trial recruitment and increased costs, and should be considered by trial investigators when planning research and estimating budgets. However, the celebration of new life became a highlight of the annual AVERT collaborators' meetings and helped maintain a cohesive collaborative group.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry no 12606000185561.
DISCLAIMER: Participation in a rehabilitation trial does not guarantee successful reproductive activity.
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).
METHODOLOGY: Data were collected form 5310 patients in 249 private clinics. The patients evaluated their satisfaction on the quality of service on the basis of nine criteria that comprised 31 subcriteria. We used multicriteria satisfaction analysis (MUSA) to analyze the data.
FINDINGS AND CONCLUSION: The data analysis results showed low level of satisfaction on the health care quality services offered by the private clinics in Yemen. The majority of the criteria and subcriteria showed low level of satisfaction, high demand, and high mandate for improvement.
OBJECTIVES: This paper aims to identify requirements in developing a breast examination awareness mobile app based on the component of the Health Belief Model (HBM) for integration in health promotion strategy.
METHODS: A qualitative approach using semi-structured in-depth interview was utilized in this study. A purposive sampling method was conducted among public women attending hospital services, software and content experts in a tertiary teaching hospital in the East coast of Peninsular Malaysia. These interviews were recorded, transcribed and organized using NVIVO 11. The main themes were identified through thematic analysis of the interview transcripts. Results: A total of 37 participants recruited in this study. The themes that emerged from the analysis are vulnerability, forecasting, reactive, influence, outcome and obstacles. The sub-themes findings supported the HBM's component in terms of the requirement for are an infographic risk factor, video (symptoms, self-examination), info (metastasis, survival, screening, triple assessment, treatment, myth and facts, benefit of early treatment, support groups), features (screening reminder, sharing button, prompt) and mobile app's design.
CONCLUSION: The research findings could provide a guide for future app development from public women, content and software experts. The information will be used to develop a breast examination awareness mobile app integrated with health theories.
METHODS: The original 20-item QIRC was forward-backward translated into Malay in preparation for the Pilot Malay QIRC. The pilot version was pre-tested on 105 spectacle/contact lens-corrected myopes, and the results were reviewed and cross-culturally adapted to produce the Final Malay QIRC. The final version was self-administered to a new sample of 304 participants. A Rasch analysis was conducted to evaluate the items and response categories of the Pilot and the Final Malay QIRC. Test-retest reliability was also analysed on the Final Malay QIRC.
RESULTS: Based on the pre-test findings, Rasch analysis revealed a multidimensional scale (functional scale [Items 1 to 13] and emotional scale [Items 14 to 20], which were separated in subsequent analysis), unordered response categories for the functional scale (Category 3 was collapsed into Category 2), one misfit item (Item 3 was removed) and six items required modification (Items 4, 6 to 9, and 12 were reworded and cross-culturally adapted). In the Final Malay QIRC, both the functional and emotional scales had ordered response categories, good person reliability (functional, 0.80; emotional, 0.81) and separation index (functional, 2.01; emotional, 2.06), well-targeted items (targeting precision: functional, 0.28 logits; emotional, 0.08 logits), and satisfactory fit statistics (infit and outfit mean square were less than 1.50 for all items). A noticeable differential item functioning (DIF) between genders was found in Item 18 (DIF contrast, 0.40 logits; p = 0.04). Test-retest reliability analysis demonstrated a high intraclass correlation coefficient (0.94) and Cronbach's alpha (0.97) with a coefficient of repeatability of ±8.14 units.
CONCLUSIONS: The Malay-translated version of the QIRC has good psychometric characteristics for assessing the quality of life of refractive correction wearers in Malaysia. This translated and cross-culturally adapted Malay QIRC is a valid and reliable instrument that can be used in routine clinical practice.