METHODS: A multi-center study of multi-ethnic Asian patients with IBS was conducted in two phases: (i) an initial cross-sectional gut microbiota composition study of IBS patients and healthy controls, followed by (ii) a single-arm 6-week dietary interventional study of the IBS patients alone, exploring clinical and gut microbiota changes.
RESULTS: A total of 34 adult IBS patients (IBS sub-types of IBS-D 44.1%, IBS-C 32.4%, and IBS-M 23.5%) and 15 healthy controls were recruited. A greater abundance of Parabacteroides species with lower levels of bacterial fermenters and short-chain fatty acids producers were found among IBS patients compared with healthy controls. Age and ethnicity were found to be associated with gut microbiota composition. Following a low FODMAP dietary intervention, symptom and quality of life improvement were observed in 24 (70.6%) IBS patients. Symptom improvement was associated with adherence to the low FODMAP diet (46.7% poor adherence vs 92.9% good adherence, P = 0.014), and gut microbiota patterns, particularly with a greater abundance of Bifidobacterium longum, Anaerotignum propionicum, and Blautia species post-intervention.
CONCLUSION: Gut microbiota variation in multi-ethnic IBS patients may be related to dietary intake and may be helpful to identify patients who are likely to respond to a low FODMAP diet.
SUMMARY: Cockroach allergy is an important risk factor for allergic rhinitis in the tropics, that disproportionately affects children and young adults and those living in poor socio-economic environments. Immunotherapy would provide long-lasting improvement in quality of life, with reduced medication intake. However, the present treatment regime is long and has a risk of adverse effects. In addition, cockroach does not seem to have an immuno-dominant allergen, that has been traditionally used to treat allergies from other sources. Future trends of cockroach immunotherapy involve precision diagnosis, to correctly identify the offending allergen. Next, precision immunotherapy with standardized allergens, which have been processed in a way that maintains an immunological response without allergic reactions. This approach can be coupled with modern adjuvants and delivery systems that promote a Th1/Treg environment, thereby modulating the immune response away from the allergenic response.
AIMS: The aim of this study is to determine whether a potent antioxidative and anti-inflammatory agent, Tocovid, a tocotrienol-rich capsule, could reduce the incidence of POAF and affect the mortality and morbidity as well as the duration of ICU, HDU and hospital stay.
METHODS: This study was planned as a prospective, randomised, controlled trial with parallel groups. The control group received placebo containing palm superolein while the treatment group received Tocovid capsules. We investigated the incidence of POAF, the length of hospital stay after surgery and the health-related quality of life.
RESULTS: Recruitment commenced in January 2019 but the preliminary results were unblinded as the study is still ongoing. Two-hundred and two patients have been recruited out of a target sample size of 250 as of January 2021. About 75% have completed the study and 6.4% were either lost during follow-up or withdrew; 4% of participants died. The mean age group was 61.44 ± 7.30 years with no statistical difference between the groups, with males having a preponderance for AF. The incidence of POAF was 24.36% and the mean time for developing POAF was 55.38 ± 29.9 h post-CABG. Obesity was not a predictive factor. No statistically significant difference was observed when comparing left atrial size, NYHA class, ejection fraction and the premorbid history. The mean cross-clamp time was 71 ± 34 min and the mean bypass time was 95 ± 46 min, with no difference between groups. There was a threefold increase in death among patients with POAF (p = 0.008) and an increase in the duration of ICU stay (p = 0.01), the total duration of hospital stay (p = 0.04) and reintubation (p = 0.045).
CONCLUSION: A relatively low incidence rate of POAF was noted although the study is still ongoing. It remains to be seen if our prophylactic intervention using Tocovid would effectively reduce the incidence of POAF. Clinical Registration Number: US National Library of Medicine. Clinical Trials - NCT03807037. Registered on 16th January 2019. Link: https://clinicaltrials.gov/ct2/show/NCT03807037.
METHODS: Health-related quality of life was captured using the EuroQol-5 Dimension-3 Level (EQ-5D-3L), with data collected at baseline and throughout the trial. Multilevel mixed-effects linear regression with random effects estimated health-related quality of life over time, capturing variation between hospital sites and individuals, and a fixed-effects linear model estimated the impact of cardiovascular and gastrointestinal events.
RESULTS: Patients were followed for a median of 5 years (interquartile range 3.4-6.0). The average baseline EQ-5D score of 0.930 (SD 0.104) remained relatively unchanged over the trial period with no evidence of statistically significant differences in EQ-5D score between randomized treatment groups. The largest decrement in the year of an event was estimated for stroke (-0.107, P life beyond the year in which the event occurred (-0.031, P = .006, and -0.067, P life in ACE trial participants with CHD and IGT. Events such as MI, stroke, heart failure, and angina reduce health-related quality of life around the time they occurred, but only MI and stroke impacted on longer-term health-related quality of life.
METHODS: A cross-sectional study on 284 epilepsy patients was performed in a local tertiary centre. The demographic and clinical epilepsy data were collected. The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) questionnaires were utilised to determine the quality of life and daytime hypersomnolence of epilepsy patients, respectively.
RESULTS: Poor sleep quality was reported in 78 (27.5%) patients while daytime hypersomnolence was present in 17 (6%) patients. The predictors of poor sleep quality include structural causes (OR = 2.749; 95% CI: 1.436, 5.264, p = 0.002), generalised seizures (OR = 1.959, 95% CI: 1.04, 3.689, p = 0.037), and antiseizure medications such as Carbamazepine (OR = 2.34; 95% CI: 1.095, 5.001, p = 0.028) and Topiramate (OR 2.487; 95% CI: 1.028, 6.014, p = 0.043). Females are 3.797 times more likely score higher in ESS assessment (OR 3.797; 95% CI: 1.064, 13.555 p = 0.04).
DISCUSSION: Sleep disturbances frequently coexist with epilepsy. Patients should be actively evaluated using the PSQI and ESS questionnaires. It is imperative to identify the key factors that lead to reduced sleep quality and heightened daytime sleepiness in patients with epilepsy, as this is essential to properly manage their condition.
METHODS: In this prospective, multinational, longitudinal cohort study, we used data from patients with SLE in the Asia Pacific Lupus Collaboration cohort collected between May 1, 2013, and Dec 31, 2020. Eligible patients were adults (aged ≥18 years) who met either the 1997 American College of Rheumatology modified classification criteria for SLE or the 2012 Systemic Lupus International Collaborating Clinics classification criteria. The primary outcome was all-cause mortality, and LLDAS, remission, and variations of remission with lower glucocorticoid thresholds were the primary exposure variables. Survival analyses were used to examine longitudinal associations between these endpoints and risk of mortality. This study is registered with ClinicalTrials.gov, NCT03138941.
FINDINGS: Among a total of 4106 patients in the cohort, 3811 (92·8%) patients were included in the final analysis (median follow-up 2·8 years [IQR 1·0-5·3]; 3509 [92·1%] women and 302 [7·9%] men), of whom 80 died during the observation period (crude mortality rate 6·4 deaths per 1000 person-years). LLDAS was attained at least once in 43 (53·8%) of 80 participants who died and in 3035 (81·3%) of 3731 participants who were alive at the end of the study (p<0·0001); 22 (27·5%) participants who died versus 1966 (52·7%) who were alive at the end of the study attained LLDAS for at least 50% of observed time (p<0·0001). Remission was attained by 32 (40·0%) of 80 who died and in 2403 (64·4%) of 3731 participants who were alive at the end of the study (p<0·0001); 14 (17·5%) participants who died versus 1389 (37·2%) who were alive at the end of the study attained remission for at least 50% of observed time (p<0·0001). LLDAS for at least 50% of observed time (adjusted hazard ratio 0·51 [95% CI 0·31-0·85]; p=0·010) and remission for at least 50% of observed time (0·52 [0·29-0·93]; p=0·027) were associated with reduced risk of mortality. Modifying the remission glucocorticoid threshold (<5·0 mg/day prednisolone) was more protective against mortality than current remission definitions (0·31 [0·12-0·77]; p=0·012), and glucocorticoid-free remission was the most protective (0·13 [0·02-0·96]; p=0·046).
INTERPRETATION: LLDAS significantly reduced the risk of mortality in patients with SLE. Remission did not further reduce the risk of mortality compared with LLDAS, unless lower glucocorticoid thresholds were used.
FUNDING: The Asia-Pacific Lupus Collaboration received funding from Janssen, Bristol Myers Squibb, Eli Lilly, and UCB for this study.
METHODS: The study encompassed a comprehensive three-stage approach to the development and validation of the PROM. Initially, during the preliminary design stage, the necessity for a new PROM was recognized, an expert panel was formed, and semi-structured qualitative interviews were carried out with GSM patients. In the second stage, the study used the five-step pre-validation methodology established by Prior et al. to generate and refine the PROM items. The third and final stage encompassed the determination of scale and item content validity indexes to ensure validity. Additionally, the reliability of each construct was evaluated using Cronbach's α.
RESULTS: The resulting PROM was named GSM-SVTAQ (GSM-symptoms and vaginal treatments acceptability questionnaire). It demonstrated excellent validity in assessing symptoms burden, health-related and sexual quality of life, and vaginal treatment acceptability, with high content validity indices and strong internal consistency. The scale content validity indices and Cronbach's α coefficients for the three domains were (0.926, 0.939), (0.875, 0.947), and (0.824, 0.855), respectively.
CONCLUSION: The GSM-SVTAQ stands as the first GSM-specific, valid, and reliable PROM capable of comprehensively measuring the three components of GSM and the acceptability of vaginal treatments. Its implementation has the potential to significantly enhance patient care and outcomes in GSM management.
METHODS: In this prospective cohort study, the QoL of 208 patients who underwent mastectomy and the BCS treatment were assessed, using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire. The questionnaire was administered at the baseline, 6 and 12 months following diagnosis. One-way ANCOVA was used for statistical analysis.
RESULTS: A total of 208 female survivors of Stage 0-II breast cancer were included, among them 47.1% underwent BCS and 52.9% underwent mastectomy. Older (63.3%), Chinese women (63.6%), and patients with primary education (71.7%) were more likely to undergo mastectomy. At baseline, no significant differences were observed for QoL in both treatment groups. At 6 months, patients who underwent BCS had better social functioning scales( P = 0.006) and worse symptom scales for dyspnoea (P = 0.031), compared to mastectomy patients. One year after diagnosis, the role functioning score of the mastectomy group was significantly higher than the BCS group, specifically among patients who had undergone chemotherapy (P = 0.034).
CONCLUSION: Patients who underwent BCS had better social functioning and worse dyspnoea symptoms compared to patients undergoing mastectomy at six months. During one year, there were only significant improvements in the role functioning among the mastectomy groups compared to the BCS groups. After further stratification, only mastectomy patients who received chemotherapy exhibited improved role functioning compared to patients those who did not undergo chemotherapy. Providing social and physical support postoperatively and monitoring patients for cancer worry, or other symptoms in the long-term survivorship period would be important to ensure optimal QoL.
MATERIALS AND METHODS: This is a prospective observational study to develop, validate and evaluate the ARSIA questionnaire based on ARIA guidelines. The sample will be obtained from the list of patients under follow-up in the ORL clinic HSAH and HUSM with ages of 18 to 60 years, patients clinically diagnosed with allergic rhinitis, and with positive skin prick test.
RESULTS: A total of 150 patients with a positive skin prick test participated in this study. In the 'nasal symptom' and 'impact on daily activities' domains, calculated Cronbach's alpha shows a value of 0.878 and 0.811 respectively. The inter-item correlation was calculated to analyse internal consistency reliability. Items B3 and B4 were dropped from the questionnaire as both showed a low correlation with other items. New Cronbach's alpha for the daily activities domain was 0.830, which showed better internal consistency reliability. All of the items were analysed for sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Clinician diagnosis from the proforma was used as a comparison to the participant's responses. In the analysis, a cut-off points of 12 was used to classify the patient's nasal symptoms into intermittent or persistent, with a sensitivity of 75%, specificity of 86%, PPV of 95%, and NPV of 51%. Whereas, a cut-off point of 15 was used to classify the rhinitis impact on daily activities into mild or moderate/severe, with a sensitivity of 58%, specificity of 100%, PPV of 100%, and NPV of 42%. The only item in the 'control' domain has been dropped out following a consensus of experts and judgement as it has not been used in the clinician diagnosis and thus, is unable to test for sensitivity, specificity, PPV, and NPV.
CONCLUSION: This newly developed, validated, and evaluated questionnaire is a good tool for the evaluation of allergic rhinitis symptoms and their impact on daily activities. It is important to understand that AR symptoms could have a significant impact on daily activities. Although further study and testing are needed, it provides an initial means for evaluating the patient condition and control level, as well as patients' perception of their rhinitis control.
METHODS AND ANALYSIS: A total of 294 eligible participants will be recruited and allocated into 3 groups comprising of mHealth intervention alone, mHealth intervention integrated with personal medical nutrition therapy and a control group. Pretested structured questionnaires are used to obtain the respondents' personal information, anthropometry data, prenatal knowledge, physical activity, psychosocial well-being, dietary intake, quality of life, sleep quality and GWG. There will be at least three time points of data collection, with all participants recruited during their first or second trimester will be followed up prospectively (after 3 months or/and after 6 months) until delivery. Generalised linear mixed models will be used to compare the mean changes of outcome measures over the entire study period between the three groups.
ETHICS AND DISSEMINATION: Ethical approvals were obtained from the ethics committee of human subjects research of Universiti Putra Malaysia (JKEUPM-2022-072) and medical research & ethics committee, Ministry of Health Malaysia: NMRR ID-22-00622-EPU(IIR). The results will be disseminated through journals and conferences targeting stakeholders involved in nutrition research.
TRIAL REGISTRATION NUMBER: Clinicaltrial.gov ID: NCT05377151.
Methods: A randomized control trial study was run among 2120 cancer patients in public hospitals in Peninsular Malaysia, from Apr 2016-Jan 2018. The treatment group received counselling regarding chemotherapy by using developed module. The data were collected at three time-points: baseline, 1st, 2nd and 3rd follow-ups after counseling by Validated Malay version of the WHOQOL-BREF of questionnaire. Data analyses were done using χ2 and two-way repeated measure ANOVA.
Results: The treatment group improved significantly as compared to control group in physical health, psychological health, social relationship, environment and overall QOL (P<0.00).
Conclusion: The "Managing Patients on Chemotherapy" book along with repetitive counselling by pharmacists is a useful intervention for improving QOL of cancer patients undergoing treatment.
METHODS: This is an exploratory mixed-methods study. In phase 1 (qualitative phase), three groups of participants (i.e., clinicians, employers, and workers) will be invited to participate to focus group discussions (FGDs) until thematic saturation. The aim of the FGDs is to explore the understanding, experience, and potential risk factors of Long Covid-19 among manufacturing workers. Findings from the FGDs will be analysed thematically. Themes generated from the FGDs will be used to generate items in a new questionnaire. The newly developed questionnaire will be validated using a fuzzy Delphi study, which will also be conducted among clinicians, employers, and workers. Phase 2 is a cross-sectional study that will be conducted among manufacturing workers across all states in Malaysia to identify the prevalence and risk factors of Long COVID-19, as well as the prevalence and risk factors of adverse work outcomes among workers with Long COVID-19. A multistage cluster sampling will be used to collect data from 4500 manufacturing workers in Malaysia. Logistic regression will be performed to determine the association between risk factors with both Long COVID-19 and adverse work outcomes.
CONCLUSION: Once the prevalence and risk factors of Long COVID and its associated adverse work outcome are identified, timely support and effective interventions could be provided to manufacturing workers to maintain their health and productivity.
ETHICAL CONSIDERATIONS: Ethical approval has been granted by the Research Ethics Committee of the National University of Malaysia (JEP-2023-607) and the Medical Research and Ethics Committee (MREC) Malaysia (NMRR ID-23-03310-H3E).
Methods: This cross-sectional study was carried out on 400 pregnant women who were selected using stratified random sampling technique from eight private maternity centers located in Indore city. A questionnaire collected information on socio-demographic characteristics, oral hygiene practices, previous dental visit and past medical history. OHRQOL was assessed using Oral Health Impact Profile-14 questionnaire. Lifestyle factors were assessed using the Health practice Index.
Results: The lifestyle factors were the strongest predictor for poor OHRQOL. The pregnant women (OR = 3.22, P-value < 0.0001*) with poor lifestyle had significantly poor OHRQOL. Logistic regression analysis showed that poor socio-economic status (OR = 2.63, P-value = 0.025*), brushing frequency of less than or equal to once daily (OR = 2.02, P-value = 0.025*), and suffering from systemic diseases (OR = 2.11, P-value = 0.017*) were other important predictors for poor OHRQOL in pregnant women.
Conclusions: Our findings showed that lifestyle factors significantly impact OHRQOL in pregnant women. Thus, it is recommended that effective policies should be drafted to improve lifestyle factors and OHRQOL in pregnant women.