METHODS: This retrospective study involved consecutive hospitalized patients with non-structural protein 1 (NS1) antigen positivity during an outbreak (Jan to April 2014). Multiplex RT-PCR was performed directly on NS1 positive serum samples to detect and determine the DENV serotypes. All PCR-positive serum samples were inoculated onto C6/36 cells. Multiplex PCR was repeated on the supernatant of the first blind passage of the serum-infected cells. Random samples of supernatant from the first passage of C6/36 infected cells were subjected to whole genome sequencing. Clinical and laboratory variables were compared between patients with and without DENV co-infections.
RESULTS: Of the 290 NS1 positive serum samples, 280 were PCR positive for DENV. Medical notes of 262 patients were available for analysis. All 4 DENV serotypes were identified. Of the 262 patients, forty patients (15.3 %) had DENV co-infections: DENV-1/DENV-2(85 %), DENV-1/DENV-3 (12.5 %) and DENV-2/DENV-3 (2.5 %). Another 222 patients (84.7 %) were infected with single DENV serotype (mono-infection), with DENV- 1 (76.6 %) and DENV- 2 (19.8 %) predominating. Secondary dengue infections occurred in 31.3 % patients. Whole genome sequences of random samples representing DENV-1 and DENV-2 showed heterogeneity amongst the DENVs. Multivariate analysis revealed that pleural effusion and the presence of warning signs were significantly higher in the co-infected group, both in the overall and subgroup analysis. Diarrhoea was negatively associated with co-infection. Additionally, DENV-2 co-infected patients had higher frequency of patients with severe thrombocytopenia (platelet count < 50,000/mm(3)), whereas DENV-2 mono-infections presented more commonly with myalgia. Elevated creatinine levels were more frequent amongst the co-infected patients in univariate analysis. Haemoconcentration and haemorrhagic manifestations were not higher amongst the co-infected patients. Serotypes associated with severe dengue were: DENV-1 (n = 9), DENV-2 (n = 1), DENV-3 (n = 1) in mono-infected patients and DENV-1/DENV-2 (n = 5) and DENV-1/DENV-3 (n = 1) amongst the co-infected patients.
CONCLUSION: DENV co-infections are not uncommon in a hyperendemic region and co-infected patients are skewed towards more severe clinical manifestations compared to mono-infected patients.
METHODS AND DESIGN: A randomised, single blind controlled trial will be conducted. Twenty-eight patients aged 18 years and above with a recent grade-2 hamstring injury will be invited to take part. Participants will be randomised to receive either autologous PRP injection with rehabilitation programme, or rehabilitation programme only. Participants will be followed up at day three of study and then weekly for 16 weeks. At each follow up visit, participants will be assessed on readiness to return-to-play using a set of criteria. The primary end-point is when participants have fulfilled the return-to-play criteria or end of 16 weeks.The main outcome measure of this study is the duration to return-to-play after injury.
CONCLUSION: This study protocol proposes a rigorous and potential significant evaluation of PRP use for grade-2 hamstring injury. If proven effective such findings could be of great benefit for patients with similar injuries.
TRIAL REGISTRATION: Current Controlled Trials ISCRTN66528592.
METHODS: The newly developed CKDPS instrument was tested on 300 patients with diabetes mellitus in a cross-sectional study. The number of domains, model-fit index, construct validity, and internal consistency of this instrument were determined using exploratory (EFA) and confirmatory factor analysis (CFA).
RESULTS: The EFA yielded nine domains: illness identity, timeline motivation, medical practice and co-operation for Social Psychology, and perceived benefit, perceived barriers, perceived susceptibility, perceived severity, and perceived cue to action for HBM. Four items with low factor loading were removed. CFA yielded the following fit indices for Social Psychology: the goodness of fit index (GFI) = 0.889, comparative fit index (CFI) = 0.934, root mean square error of approximation (RMSEA) = 0.053, normed chi-square (NC) = 1.831; and the following for HBM: GFI = 0.834, CFI = 0.957, RMSEA = 0.053, NC = 1.830. Values of Cronbach's α ranged between 0.760 and 0.909.
CONCLUSIONS: The CKDPS includes 61 questions across nine domains, divided under two categories of Social Psychology and HBM. It is also a valid and reliable tool for measuring diabetic patients' perception of CKD prevention that can be used in larger studies.
METHODS: Data for this study was extracted from the 2011 Bangladesh Demographic and Health Survey (BDHS-2011). In this survey, data was collected using a two-stage stratified cluster sampling approach. The chi-square test and a two-level logistic regression model were used for further analysis.
RESULTS: Data from 2231 children aged 6-59 months were included for analysis. The prevalence of child anemia was noted to be 52.10%. Among these anemic children, 48.40% where from urban environment and 53.90% were from rural areas. The prevalence of mild, moderate and severe anemia among children was 57.10, 41.40 and 1.50% respectively. The two-level logistic regression model revealed that the following factors were associated with childhood anemia: children of anemic mothers (p
METHODS: A comparative cross-sectional study was conducted in two tertiary referral hospitals in 2014. Postpartum women with severe morbidity and without severe morbidity who fulfilled the inclusion and exclusion criteria were eligible as cases and controls, respectively. The study population included all postpartum women regardless of their age. Pregnancy at less than 22 weeks of gestation, more than 42 days after the termination of pregnancy and non-Malaysian citizens were excluded. Consecutive sampling was applied for the selection of cases and for each case identified, one unmatched control from the same hospital was selected using computer-based simple random sampling. Simple and multiple logistic regressions were performed using Stata Intercooled version 11.0.
RESULTS: A total of 23,422 pregnant women were admitted to these hospitals in 2014 and 395 women with severe maternal morbidity were identified, of which 353 were eligible as cases. An age of 35 or more years old [Adj. OR (95 % CI): 2.6 (1.67, 4.07)], women with past pregnancy complications [Adj. OR (95 % CI): 1.7 (1.00, 2.79)], underwent caesarean section deliveries [Adj. OR (95 % CI): 6.8 (4.68, 10.01)], preterm delivery [Adj. OR (95 % CI): 3.4 (1.87, 6.32)] and referral to tertiary centres [Adj. OR (95 % CI): 2.7 (1.87, 3.97)] were significant associated factors for severe maternal morbidity.
CONCLUSIONS: Our study suggests the enhanced screening and monitoring of women of advanced maternal age, women with past pregnancy complications, those who underwent caesarean section deliveries, those who delivered preterm and the mothers referred to tertiary centres as they are at increased risk of severe maternal morbidity. Identifying these factors may contribute to specific and targeted strategies aimed at tackling the issues related to maternal morbidity.
METHODS: A cross-sectional population survey using an online questionnaire commenced on 14 February 2020. The study participants were residents of Taiwan ages 20 to 70 years. The 6-item state version of the State-Trait Anxiety Inventory (STAI-6) was used to assess anxiety symptoms. The questions about preventive measures asked participants about their personal protection, cough etiquette, contact precautions, voluntary quarantine, and prompt reporting. Multivariable logistic regression was used to determine the factors influencing an increase in the preventive measures scores.
RESULTS: Of a total of 3555 completed responses, a total of 52.1% (95% confidence interval [CI] 50.4-53.7) of the respondents reported moderate to severe levels of anxiety symptoms in the past week, whereas 48.8% (95%CI 47.2-50.5) reported moderate to severe anxiety symptoms at the beginning of the outbreak. With a higher score indicating greater anxiety, the median scores for anxiety symptoms in the past week and at the beginning of the outbreak were 46.7 (IQR [interquartile range] 36.7-53.3) and 43.3 (IQR 36.7-53.3), respectively. The median scores for the preventive measures taken in the past week and at the beginning of the outbreak were 26.0 (IQR 21.0-30.0) and 24.0 (IQR 19.0-28.0), respectively, out of a maximum score of 36. In the multivariable analysis, an increased anxiety symptom score from the beginning of the outbreak to the past week (adjusted OR = 7.38, 95%CI 6.28-8.66) was a strongly significant determinant of an increased preventive measures score in the past week compared with the score at the beginning of the outbreak.
CONCLUSIONS: Anxiety and preventive measures scores were high and increased with the epidemic rate. Higher anxiety was associated with an increased use of preventive measures against COVID-19.
METHODS: All enterovirus cases in Taiwan over almost ten years from three main databases, including national notifiable diseases surveillance, sentinel physician surveillance and laboratory surveillance programs from July 1, 1999 to December 31, 2008 were analyzed. The Pearson's correlation coefficient was applied for measuring the consistency of the trends in the cases between different surveillance systems. Cross correlation analysis in a time series model was applied for examining the capability to predict severe enterovirus infections. Poisson temporal, spatial and space-time scan statistics were used for identifying the most likely clusters of severe enterovirus outbreaks. The directional distribution method with two standard deviations of ellipse was applied to measure the size and the movement of the epidemic.
RESULTS: The secular trend showed that the number of severe EV cases peaked in 2008, and the number of mild EV cases was significantly correlated with that of severe ones occurring in the same week [r = 0.553, p
METHODS: A total of 1840 subjects (1117 cases/723 controls) completed an investigator-administered questionnaire as part of a cross-sectional study, which include socio-demographics, familial history, lifestyle factors, dietary habits, and acne history. Acne cases were further evaluated for their severity (n = 1051) and scarring (n = 1052) grades by a trained personnel.
RESULTS: Majority of the acne cases (up to 69%) had mild acne or Grade 1/2 scarring, while 21.6% had moderate/severe acne and 5.5% had Grade 3/4 scarring. Males had significantly higher risk of presenting with higher grades of acne scarring. Those who had acne, regardless of severity and scarring grades, had strong positive familial history (either in parents and/or sibling). Frequent consumption (most or all days) of foods that are commonly consumed during breakfast (butter, probiotic drinks, cereals and milk) decreased the risk for acne presentation and higher acne scarring, while periodic consumption (once/twice per week) of nuts and burgers/fast food decreased the risk for higher acne severity. Alcohol drinking was significantly associated with increased risk for acne presentation, while paternal, parental and household smoking were associated with reduced risk of more severe acne.
CONCLUSIONS: In conclusion, positive familial history is a strong predisposing factor in influencing acne presentation, severity and scarring. Frequent consumption of foods that are commonly consumed during breakfast is protective against acne presentation.
METHODS: A multicenter prospective follow-up study. All eligible confirmed hypertensive HD patients who were consecutively enrolled for treatment at the study sites were included in the current study. HADS questionnaire was used to assess the depression level among study participants. Patients with physical and/or cognitive limitations that prevent them from being able to answer questions were excluded.
RESULTS: Two hundred twenty patients were judged eligible and completed questionnaire at the baseline visit. Subsequently, 216 and 213 patients completed questionnaire on second and final follow up respectively. The prevalence of depression among patients at baseline, 2nd visit and final visit was 71.3, 78.2 and 84.9% respectively. The results of regression analysis showed that treatment given to patients at non-governmental organizations (NGO's) running HD centers (OR = 0.347, p-value = 0.039) had statistically significant association with prevalence of depression at final visit.
CONCLUSIONS: Depression was prevalent in the current study participants. Negative association observed between depression and hemodialysis therapy at NGO's running centers signifies patients' satisfaction and better depression management practices at these centers.
METHODS: Asian women received dienogest (2 mg/daily) and were followed for 24 months. The effectiveness of dienogest to improve HRQoL and endometriosis-associated pelvic pain (EAPP) was assessed by patient-reported outcomes. HRQoL, especially the "pain" domain as primary endpoint, was evaluated with the Endometriosis Health Profile-30 (EHP-30) questionnaire. The numeric rating scale served to determine changes in the severity of EAPP. Within the presented interim analysis (data cut-off: 2017-11-27), the mean changes in EHP-30 and EAPP scores from baseline to 6 months upon availability of the data were evaluated. Treatment-emergent adverse events (TEAEs) and bleeding profiles were documented.
RESULTS: Dienogest therapy decreased EHP-30 scores in all assessed domains (score 0-100, lower scores indicate better HRQoL). Primarily, the "pain" domain was improved in 78.4% of patients. EAPP was reduced (score 0-10, lower scores reflect less pain), highlighted by a mean reduction of the pain score by - 4.5 points. Patients with a higher EAPP score at baseline had an increased response to dienogest (- 6.2 points mean change) compared to patients with low baseline EAPP severity (- 1.4 points mean change). Both surgically and clinically diagnosed patients described comparable pain reduction, as well as women with or without prior treatment. Drug-related TEAEs were documented for 31.5% of patients, with amenorrhoea (5.9%) and metrorrhagia (5.1%) being the most common events. The bleeding pattern was changed upon dienogest, characterized by decreased normal bleeding (84.2 to 28.8%) and increased amenorrhea (3.2 to 42.9%) at 6 months.
CONCLUSION: The data indicate an amelioration of HRQoL and EAPP upon dienogest therapy. No new safety signals were observed. Therefore, its use as first-line therapy for long-term management of debilitating and chronic endometriosis-associated pain represents an interesting option that remains to be further investigated.
TRIAL REGISTRATION: Name of registry: Clinical Trials Clinicaltrials.gov registration number: NCT02425462 Registration date: 2015-04-24. Registration timing: prospective.
METHODS AND ANALYSIS: ACT KNOW, the first randomised controlled trial ever performed in knowlesi malaria, is a two-arm open-label trial with enrolments over a 2-year period at three district sites in Sabah, powered to show a difference in proportion of patients negative for malaria by microscopy at 24 h between treatment arms (clinicaltrials.gov #NCT01708876). Enrolments started in December 2012, with completion expected by September 2014. A total sample size of 228 is required to give 90% power (α 0.05) to determine the primary end point using intention-to-treat analysis. Secondary end points include parasite clearance time, rates of recurrent infection/treatment failure to day 42, gametocyte carriage throughout follow-up and rates of anaemia at day 28, as determined by survival analysis.
ETHICS AND DISSEMINATION: This study has been approved by relevant institutional ethics committees in Malaysia and Australia. Results will be disseminated to inform knowlesi malaria treatment policy in this region through peer-reviewed publications and academic presentations.
TRIAL REGISTRATION NUMBER: NCT01708876.
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 AND SETTING: We performed a retrospective review of medical records among emergency departments (EDs) of eight PATOS centres, from September 2014 - August 2015.
PARTICIPANTS: We included children <16 years old who presented within 24 hours of head injury and were admitted for observation or required a computed tomography (CT) of the brain from the ED. We excluded children with known coagulopathies, neurological co-morbidities or prior neurosurgery. We reviewed the mechanism, intent, location and object involved in each injury, and the patients' physical findings on presentation.
OUTCOMES: Primary outcomes were death, endotracheal intubation or neurosurgical intervention. Secondary outcomes included hospital and ED length of stay.
RESULTS: 1438 children were analysed. 953 children (66.3%) were male and the median age was 5.0 years (IQR 1.0-10.0). Falls predominated especially among children younger than 2 years (82.9%), while road traffic injuries were more likely to occur among children 2 years and above compared with younger children (25.8% vs 11.1%). Centres from upper and lower middle-income countries were more likely to receive head injured children from road traffic collisions compared with those from high-income countries (51.4% and 40.9%, vs 10.9%, p<0.0001) and attended to a greater proportion of children with severe outcomes (58.2% and 28.4%, vs 3.6%, p<0.0001). After adjusting for age, gender, intent of injury and gross national income, traffic injuries (adjusted OR 2.183, 95% CI 1.448 to 3.293) were associated with severe outcomes, as compared with falls.
CONCLUSIONS: Among children with head injuries, traffic injuries are independently associated with death, endotracheal intubation and neurosurgery. This collaboration among Asian centres holds potential for future prospective childhood injury surveillance.
SETTING: Tertiary level teaching institution in Malaysia.
PARTICIPANTS: The validation process involved 211 adult patients (English language n=101, Malay language n=110) with chronic liver disease. Characteristics of the study subjects were as follows: mean (SD) age was 56 (12.8) years, 58.3% were male and 41.7% female. The inclusion criteria were patients 18 years or older with chronic hepatitis and/or liver cirrhosis of any aetiology. The exclusion criteria were as follows: presence of hepatic encephalopathy, ongoing treatment with interferon and presence of other chronic conditions that have an impact on health-related quality of life (HRQOL).
METHODS: A cross-sectional study was conducted. Cultural adaptation of the English version of the CLDQ was performed, and a Malay version was developed following standard forward-backward translation by independent native speakers. Psychometric properties of both versions were determined by assessing their internal consistency, test-retest reliability and discriminant and convergent validity.
RESULTS: Cronbach's alpha for internal consistency across the various domains of the CLDQ was 0.95 for the English version and 0.92 for the Malay version. Test-retest analysis showed excellent reliability with an intraclass correlation coefficient of 0.89 for the English version and 0.93 for the Malay version. The average scores of both the English and Malay versions of the CLDQ demonstrated adequate discriminant validity by differentiating between non-cirrhosis (English 6.3, Malay 6.1), compensated cirrhosis (English 5.6, Malay 6.0) and decompensated cirrhosis (English 5.1, Malay 4.9) (p<0.001). Convergent validity showed that correlation was fair between the English (ρ=0.59) and Malay (p=0.47) CLDQ versions with the EQ-5D, a generic HRQOL instrument.
CONCLUSION: The English and Malay versions of the CLDQ are reliable and valid disease-specific instruments for assessing HRQOL in Malaysian patients with chronic liver disease.