METHODS: A total of 1065 patients aged ≥18 years with T2DM initiating insulin therapy in normal clinical course were enrolled from Hong Kong, Malaysia, Philippines, Taiwan and Thailand. Participants' data was recorded by the treating physicians. Patient-reported outcomes (PROs) were assessed using questionnaires completed by participants.
RESULTS: The mean age of patients was 57.2 years with mean glycosylated hemoglobin (HbA1c) of 10.0%. About 66% of patients had an HbA1c ≥9.0% at insulin initiation despite 74% of them being on two or more oral antidiabetic agents at the time of insulin initiation. Basal insulin was initiated in 72% and premixed insulin in 27% of patients. Changes in insulin therapy was observed in 63% of patients and, by the end of study, 28% achieved HbA1c levels of <7.5%. The proportion of patients completely satisfied with their insulin treatment increased over the study course and the quality of life (QoL) score increased from baseline to the study end.
CONCLUSION: As high HbA1C levels indicate a delayed start of insulin therapy, timely initiation and early intensification of insulin therapy is necessary in the region to achieve adequate glycemic control in time and prevent diabetes complications. Data from PROs suggests that the insulin treatment improves QoL in most patients.
MATERIAL AND METHODS: A validated database was used to generate data related to countries with declared lockdown. Simple regression analysis was conducted to assess the rate of change in infection and death rates. Subsequently, a k-means and hierarchical cluster analysis was done to identify the countries that performed similarly. Sweden and South Korea were included as counties without lockdown in a second-phase cluster analysis.
RESULTS: There was a significant 61% and 43% reduction in infection rates 1-week post lockdown in the overall and India cohorts, respectively, supporting its effectiveness. Countries with higher baseline infections and deaths (Spain, Germany, Italy, UK, and France-cluster 1) fared poorly compared to those who declared lockdown early on (Belgium, Austria, New Zealand, India, Hungary, Poland and Malaysia-cluster 2). Sweden and South Korea, countries without lock-down, fared as good as the countries in cluster 2.
CONCLUSION: Lockdown has proven to be an effective strategy is slowing down the SARS-CoV-2 disease progression (infection rate and death) exponentially. The success story of non-lock-down countries (Sweden and South Korea) need to be explored in detail, to identify the variables responsible for the positive results.
AIM: The aim of this study was to classify the primary outcomes used in Cochrane Systematic Reviews (CSRs) into the ICF domains of functioning; to describe the differences in primary outcomes in reviews related to rehabilitation intervention and non-rehabilitation intervention; and to describe the trend of outcome selections according year of publication.
DESIGN: Methodological paper.
POPULATION: Adult stroke population.
METHODS: We analyzed the primary outcomes used in the CSRs published by the Cochrane Stroke Review Group up to December 2017. The primary outcomes were extracted and classified into the ICF domains of functioning (body functions, body structures and activity and participation).
RESULTS: One hundred and seventy-four papers with 216 primary outcomes were included in this analysis. Less than half (102/216, 47.2%) of the outcomes could be classified into the ICF domains of functioning. For the outcomes that could be classified into the ICF domains, the majority (72/102, 70.5%) were in the activity and participation domain, followed by body functions (26/102, 25.5%) and body structures (4/102, 4.0%). Of the outcomes that could not be classified into the ICF domains (N.=114), death (81/114, 71.1%) and recurrent stroke (21/114,18.4%) formed the majority of the outcome. There were 75 CSRs on rehabilitation related interventions; the majority of the outcomes (75/97, 77.3%) used in rehabilitation related CSRs could be classified into the ICF framework with more than half (49/75, 65.3%) in the activity and participation domain.
CONCLUSIONS: The majority of the primary outcomes selected by the Cochrane Stroke Review Group in their CSRs could not be classified into the ICF domains of functioning. Death and recurrence of vascular events remains the major outcome of interest. In rehabilitation related interventions, activity and participation domain is the functioning domain most commonly used.
CLINICAL REHABILITATION IMPACT: The systematic use of patients-centered ICF-based outcomes in CSRs could help the application of evidence in clinical decision making.
METHODS: In this umbrella review, we searched four databases (Pubmed, Embase, the Cochrane Database of Systematic Reviews, and Epistemonikos) from database inception to April 2022. The methodological quality of each meta-analysis was assessed using the Assessment of Multiple Systematic Reviews, version 2 (AMSTAR-2). The strength of evidence of the associations between race and ethnicity with outcomes was ranked according to established criteria as convincing, highly suggestive, suggestive, weak, or non-significant. The study protocol was registered with PROSPERO, CRD42022336805.
RESULTS: Of 880 records screened, we selected seven meta-analyses for evidence synthesis, with 42 associations examined. Overall, 10 of 42 associations were statistically significant (p ≤ 0.05). Two associations were highly suggestive, two were suggestive, and two were weak, whereas the remaining 32 associations were non-significant. The risk of COVID-19 infection was higher in Black individuals compared to White individuals (risk ratio, 2.08, 95% Confidence Interval (CI), 1.60-2.71), which was supported by highly suggestive evidence; with the conservative estimates from the sensitivity analyses, this association remained suggestive. Among those infected with COVID-19, Hispanic individuals had a higher risk of COVID-19 hospitalization than non-Hispanic White individuals (odds ratio, 2.08, 95% CI, 1.60-2.70) with highly suggestive evidence which remained after sensitivity analyses.
CONCLUSION: Individuals of Black and Hispanic groups had a higher risk of COVID-19 infection and hospitalization compared to their White counterparts. These associations of race and ethnicity and COVID-19 outcomes existed more obviously in the pre-hospitalization stage. More consideration should be given in this stage for addressing health inequity.
OBJECTIVE: With the growing body of evidence supporting the use of eHealth interventions, the intention is to conduct a meta-analysis on various health outcomes of eHealth interventions among ischaemic heart disease (IHD) patients.
METHODS: Based on PRISMA guidelines, eligible studies were searched through databases of Web of Science, Scopus, PubMed, EBSCOHost, and SAGE (PROSPERO registration CRD42021290091). Inclusion criteria were English language and randomised controlled trials published between 2011 to 2021 exploring health outcomes that empower IHD patients with eHealth interventions. RevMan 5.4 was utilised for meta-analysis, sensitivity analysis, and risk of bias (RoB) assessment while GRADE software for generating findings of physical health outcomes. Non-physical health outcomes were analysed using SWiM (synthesis without meta-analysis) method.
RESULTS: This review included 10 studies, whereby, six studies with 895 participants' data were pooled for physical health outcomes. Overall, the RoB varied significantly across domains, with the majority was low risks, a substantial proportion of high risks and a sizeable proportion of unclear. With GRADE evidence of moderate to high quality, eHealth interventions improved low density lipoprotien (LDL) levels in IHD patients when compared to usual care after 12 months of interventions (SMD -0.26, 95% CI [-0.45, -0.06], I2 = 0%, p = 0.01). Significance appraisal in each domain of the non-physical health outcomes found significant findings for medication adherence, physical activity and dietary behaviour, while half of the non-significant findings were found for other behavioural outcomes, psychological and quality of life.
CONCLUSIONS: Electronic Health interventions are found effective at lowering LDL cholesterol in long-term but benefits remain inconclusive for other physical and non-physical health outcomes for IHD patients. Integrating sustainable patient empowerment strategies with the advancement of eHealth interventions by utilising appropriate frameworks is recommended for future research.
AIM: This is a planned interim analysis of pathfinder™3, an international, open-label, Phase 3 trial evaluating the efficacy and safety (including immunogenicity) of N8-GP administered before, during and after major surgery in severe haemophilia A patients aged ≥12 years.
METHODS: Sixteen patients who underwent 18 major surgical procedures (including synovectomy, joint replacement and ankle arthrodesis) were included here. Postoperative assessments were conducted daily for days 1-6, and once for days 7-14. Primary endpoint was N8-GP haemostatic efficacy, assessed after completion of surgery using a four-point scale ('excellent', 'good', 'moderate', 'none').
RESULTS: Haemostasis was successful (rated 'excellent' or 'good') on completion of surgery in 17 (94.4%) procedures and rated as 'moderate' (5.6%) for one surgery in a patient with multiple comorbidities who needed an intraoperative N8-GP dose (20.7 IU kg-1 ). In the postoperative period, three bleeds occurred (one during days 1-6; two during days 7-14); all were successfully treated with N8-GP. Mean N8-GP consumption on day of surgery was 80.0 IU kg-1 ; patients received a mean of 1.7 doses (median: 2, range: 1-3). No safety concerns were identified.
CONCLUSION: The data showed that N8-GP was effective and well tolerated for the prevention and treatment of bleeds during major surgery; such FVIII products with extended half-lives may modify current treatment schedules, enabling fewer infusions and earlier patient discharge.
METHOD: A single-blind randomized controlled trial was carried out among 162 oncology patients undergoing chemotherapy from July 2013 to February 2014 in a government hospital with oncology facilities in Malaysia. Participants were randomized to either the intervention group or the control group. Chemotherapy counseling using the module on 'Managing Patients on Chemotherapy' by Pharmacists was delivered to the intervention group. The outcome measures were assessed at baseline, first follow-up and second follow-up and third follow-up post-intervention. Chi-square, independent samples t-test and two-way repeated measures ANOVA were conducted in the course of the data analyses.
RESULTS: In assessing the impact of the chemotherapy counseling module, the study revealed that the module along with repetitive counseling showed significant improvement of quality of life in the intervention group as compared to the control group with a large effect size in physical health (p = 0.001, partial Ƞ2 = 0.66), psychological (p = 0.001, partial Ƞ2 = 0.65), social relationships (p = 0.001, partial Ƞ2 = 0.30), and environment (p = 0.001, partial Ƞ2 = 0.67) and decrease in the anxiety (p = 0.000; partial Ƞ2 = 0.23), depression (p = 0.000; partial Ƞ2 = 0.40).
CONCLUSION: The module on 'Managing Patients on Chemotherapy' along with repetitive counseling by pharmacists has been shown to be effective in improving quality of life and decreasing anxiety and depression among oncology patients undergoing chemotherapy.
TRIAL REGISTRATION NUMBER: National Medical Research Register (NMRR) of Malaysia and given a registration number NMRR-12-1057-12,363 on 21 December 2012.
METHODS: We recruited 112 patients who were newly diagnosed with ACS and treated at the referral hospital, Sarawak General Hospital, Malaysia. In the intervention group (modified CRP), all medication was reviewed by the clinical pharmacists, focusing on drug indication; understanding of secondary prevention therapy and adherence to treatment strategy. We compared the "pre-post" quality of life (QoL) of three groups (intervention, conventional and control) at baseline, 6 months and 12 months post-discharge with Malaysian norms. QoL data was obtained using a validated version of Short-Form 36 Questionnaire (SF-36). Analysis of variance (ANOVA) with repeated measure tests was used to compare the mean differences of scores over time.
RESULTS: A pre-post quasi-experimental non-equivalent group comparison design was applied to 112 patients who were followed up for one year. At baseline, the physical and mental health summaries reported poor outcomes in all three groups. However, these improved gradually but significantly over time. After the 6-month follow-up, the physical component summary reported in the modified CRP (MCRP) participants was higher, with a mean difference of 8.02 (p = 0.015) but worse in the mental component summary, with a mean difference of -4.13. At the 12-month follow-up, the MCRP participants performed better in their physical component (PCS) than those in the CCRP and control groups, with a mean difference of 11.46 (p = 0.008), 10.96 (p = 0.002) and 6.41 (p = 0.006) respectively. Comparing the changes over time for minimal important differences (MICD), the MCRP group showed better social functioning than the CCRP and control groups with mean differences of 20.53 (p = 0.03), 14.47 and 8.8, respectively. In role emotional subscales all three groups showed significant improvement in MCID with mean differences of 30.96 (p = 0.048), 31.58 (p = 0.022) and 37.04 (p care intervention significantly improved HRQoL. The study also highlights the importance of early rehabilitation in the hospital setting. The MCRP group consistently showed better QoL, was more highly motivated and benefitted most from the CRP.
TRIAL REGISTRATION: Medical Research and Ethics Committee (MREC) Ministry of Health Malaysia, November 2007, NMRR-08-246-1401.
METHODS: The English version of Catquest-9SF questionnaire was translated and back translated into Malay and Chinese languages. The Malay and Chinese translated versions were self-administered by 236 and 202 pre-operative patients drawn from a cataract surgery waiting list, respectively. The translated Catquest-9SF data and its four response options were assessed for fit to the Rasch model.
RESULTS: The Catquest-9SF performed well in the Malay and Chinese translated versions fulfilling all criteria for valid measurement, as demonstrated by Rasch analysis. Both versions of questionnaire had ordered response thresholds, with a good person separation (Malay 2.84; and Chinese 2.59) and patient separation reliability (Malay 0.89; Chinese 0.87). Targeting was 0.30 and -0.11 logits in Malay and Chinese versions respectively, indicating that the item difficulty was well suited to the visual abilities of the patients. All items fit a single overall construct (Malay infit range 0.85-1.26, outfit range 0.73-1.13; Chinese infit range 0.80-1.51, outfit range 0.71-1.36), unidimensional by principal components analysis, and was free of Differential Item Functioning (DIF).
CONCLUSIONS: These results support the good overall functioning of the Catquest-9SF in patients with cataract. The translated questionnaire to Malay and Chinese-language versions are reliable and valid in measuring visual disability outcomes in the Malaysian cataract population.
METHODS: In this cross sectional study, the Malay version of SAQLI was administered to 82 OSA patients seen at the OSA Clinic, Hospital Universiti Sains Malaysia prior to their treatment. Additionally, the patients were asked to complete the Malay version of Medical Outcomes Study Short Form (SF-36). Twenty-three patients completed the Malay version of SAQLI again after 1-2 weeks to assess its reliability.
RESULTS: Initial factor analysis of the 40-item Malay version of SAQLI resulted in four factors with eigenvalues >1. All items had factor loadings >0.5 but one of the factors was unstable with only two items. However, both items were maintained due to their high communalities and the analysis was repeated with a forced three factor solution. Variance accounted by the three factors was 78.17% with 9-18 items per factor. All items had primary loadings over 0.5 although the loadings were inconsistent with the proposed construct. The Cronbach's alpha values were very high for all domains, >0.90. The instrument was able to discriminate between patients with mild or moderate and severe OSA. The Malay version of SAQLI correlated positively with the SF-36. The intraclass correlation coefficients for all domains were >0.90.
CONCLUSIONS: In light of these preliminary observations, we concluded that the Malay version of SAQLI has a high degree of internal consistency and concurrent validity albeit demonstrating a slightly different construct than the original version. The responsiveness of the questionnaire to changes in health-related quality of life following OSA treatment is yet to be determined.
METHODS: Forty-eight hospital departments were recruited via open call and stratified by country. Departments were assigned to the operational program (intervention) or usual routine (control group). Data for analyses included 36 of these departments and their 5285 patients (median 147 per department; range 29-201), 2529 staff members (70; 10-393), 1750 medical records (50; 50-50), and standards compliance assessments. Follow-up was measured after 1 year. The outcomes were health status, service delivery, and standards compliance.
RESULTS: No health differences between groups were found, but the intervention group had higher identification of lifestyle risk (81% versus 60%, p health effects, the bias, and the limitations should be considered in implementation efforts and further studies.
TRIAL REGISTRATION: ClinicalTrials.gov : NCT01563575. Registered 27 March 2012. https://clinicaltrials.gov/ct2/show/NCT01563575.
Design: This study was a retrospective cohort study. The national hospital admissions database was reviewed and children who had died who had life-limiting illnesses were identified.
Setting: This study was conducted at Ministry of Health hospitals, Malaysia.
Patients: Children aged 18 years and below who had died between January 1, 2012 and December 31, 2014.
Main Outcome Measures: Life-limiting diagnoses based on Hain et al.'s directory of LLI or the ACT/RCPCH categories of life-limiting disease trajectories.
Results: There were 8907 deaths and 3958 (44.4%) were that of children with LLI. The majority, 2531 (63.9%) of children with LLI were neonates, and the most common diagnosis was extreme prematurity <28 weeks with 676 children (26.7%). For the nonneonatal age group, the median age at admission was 42 months (1-216 months). A majority, 456 (32.0%) had diagnoses from the ICD-10 chapter "Neoplasms" followed by 360 (25.3%) who had a diagnoses from "Congenital malformations, deformations, and chromosomal abnormalities" and 139 (9.7%) with diagnoses from "Disease of the nervous system." While a majority of the terminal admissions were to the general ward, there were children from the nonneonatal age group, 202 (14.2%) who died in nonpediatric wards.
Conclusion: Understanding the characteristics of children with LLI who die in hospitals could contribute toward a more efficient pediatric palliative care (PPC) service development. PPC service should include perinatal and neonatal palliative care. Palliative care education needs to extend to nonpediatric healthcare providers who also have to manage children with LLI.