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: Adults with active NIIPPU received adalimumab in this prospective, observational study (06/2017-04/2020). Patients were evaluated at baseline (V0) and four follow-up visits over 12 months (V1-V4).
PRIMARY ENDPOINT: proportion of patients achieving quiescence (anterior chamber (AC) cells grade and vitreous haze (VH) grade≤0.5+ in both eyes, no new active chorioretinal lesions) at any follow-up visit. Secondary endpoints: proportion of patients achieving quiescence at each visit; proportion of patients maintaining response; and proportion of patients with flares. Workability, visual function, healthcare resource utilisation, and safety were evaluated.
RESULTS: Full analysis set included 149 patients. Quiescence at any follow-up visit was achieved by 129/141 (91%) patients. Quiescence at individual visits was achieved by 99/145 (68%), 110/142 (77%), 102/131 (78%), and 99/128 (77%) patients at V1-V4, respectively. Number of patients in corticosteroid-free quiescence increased from 51/147 (35%; V1) to 67/128 (52%; V4; p<0.05). Proportion of patients with maintained response increased from 89/141 (63%; V2) to 92/121 (76%; V4; p<0.05) and proportion of patients with flare decreased from 25/145 (17%; V1) to 13/128 (10%; V4; p=0.092). Workability and visual function improved throughout the study. Proportion of patients with medical visits for uveitis decreased from 132/149 (89%; V0) to 27/127 (21%; V4). No new safety signals were observed.
CONCLUSION: These results demonstrated adalimumab effectiveness in improving quality of life while reducing economic burden of active NIIPPU.
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: 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.
METHODS: A qualitative design, using semi-structured in-depth interviews with 10 young women with breast cancer who underwent mastectomy, was conducted between June to December 2022.
RESULTS: Thematic analysis was used to analyze the data, and five main themes were identified: (1) psychological and emotional well-being (altered self-esteem and femininity, impact on sexual life and relationships, psychological distress associated with mastectomy, mirror trauma and the need for psychological care); (2) body image and breast reconstruction (the dilemma over reconstruction decision, body image and clothing and lack of access to prosthetic information/services); (3) social and interpersonal factors (lack of marriage choices and society's view and stigma); (4) coping mechanisms with mastectomy effects (family support; faith in god almighty; comparing their situation to others and use of prosthetics) and (5) physical health and functioning (physical effects on mobility and function).
CONCLUSION: Mastectomy has significant physical, emotional, and social consequences on young women with breast cancer, particularly in crisis-affected Syria where access to breast reconstruction is limited. It is crucial for healthcare professionals to understand these impacts, to raise awareness, encourage early detection, and promote less aggressive treatments to improve women's quality of life.
AIM: To explore mental illness stigmatisation in Malaysian adults.
METHOD: A systematic literature review was conducted using thematic analysis to synthesise and categorise evidence. Five key themes emerged, providing insight into mental health stigmatisation.
FINDINGS: Cultural beliefs, limited knowledge of mental health and lack of education on mental health were factors influencing stigmatisation. Stigmatisation significantly affected the wellbeing and functioning of people with a mental illness. Interventions such as contact-based education effectively reduce stigmatising attitudes manifested by healthcare providers.
CONCLUSION: Establishing mental health literacy, encouraging patient contact, promoting mental health awareness and strengthening mental health policies could reduce mental illness stigmatisation and its impact in Malaysia. Future research is warranted to investigate the impact on physical wellbeing and anti-stigmatising strategies targeting the general public.
METHODS: A total of 2319 university students were recruited from mainland China and they completed the TAPAS. Rasch analysis was used to examine the TAPAS' rating scaling functioning, test unidimensionality, item hierarchy, ceiling and floor effects, and differential item functioning (DIF). Moreover, the concurrent validity of the TAPAS was examined using the Weight Self-Stigma Questionnaire (WSSQ), Weight Bias Internalization Scale (WBIS), and body mass index (BMI).
RESULTS: Unidimensionality was confirmed except for one item. Items corresponding to attitude toward physical activity were more easily adopted compared to items corresponding to actual behavioral aspects. No ceiling and floor effects were found. No DIF existed in the TAPAS items. The TAPAS was strongly correlated with both the WSSQ and WBIS, but not BMI.
CONCLUSION: The study showed that overall, the TAPAS has robust psychometric properties. However, future research needs to address the misfit item and explore the feasibility of applying the TAPAS to other populations including wider ethnic groups, age ranges, and life stages.
OBJECTIVE: To establish consensus on a core set of clinician- and patient-reported outcome measures recommended for use in clinical practice and to establish the appropriate interval within which these measures should be applied.
EVIDENCE REVIEW: Clinician- and patient-reported HS measures and studies describing their psychometric properties were identified through literature reviews. Identified measures comprised an item reduction survey and subsequent electronic Delphi (e-Delphi) consensus rounds. In each consensus round, a summary of outcome measure components and scoring methods was provided to participants. Experts were provided with feasibility characteristics of clinician measures to aid selection. Consensus was achieved if at least 67% of respondents agreed with use of a measure in clinical practice.
FINDINGS: Among HS experts, response rates for item reduction, e-Delphi round 1, and e-Delphi round 2 surveys were 76.4% (42 of 55), 90.5% (38 of 42), and 92.9% (39 of 42), respectively; among patient research partners (PRPs), response rates were 70.8% (17 of 24), 100% (17 of 17), and 82.4% (14 of 17), respectively. The majority of experts across rounds were practicing dermatologists with 18 to 19 years of clinical experience. In the final e-Delphi round, most PRPs were female (12 [85.7%] vs 2 males [11.8%]) and aged 30 to 49 years. In the final e-Delphi round, HS experts and PRPs agreed with the use of the HS Investigator Global Assessment (28 [71.8%]) and HS Quality of Life score (13 [92.9%]), respectively. The most expert-preferred assessment interval in which to apply these measures was 3 months (27 [69.2%]).
CONCLUSIONS AND RELEVANCE: An international group of HS experts and PRPs achieved consensus on a core set of HS measures suitable for use in clinical practice. Consistent use of these measures may lead to more accurate assessments of HS disease activity and life outcomes, facilitating shared treatment decision-making in the practice setting.
METHODS: This study reports baseline data from a longitudinal study that was conducted at a hospital in Vietnam. KTRs aged ≥18 years and >3 months post-transplantation were recruited. Assessments included sociodemographic and blood biomarkers. Dietary intake was estimated from 24-hour recalls. A Short Form-36 Health Survey, comprising physical (PCS) and mental component summaries (MCS), was administered to assess QoL. Multivariate linear regression models were performed.
RESULTS: The study included 106 patients (79 men) with a mean age of 43.2 years (± 11.9). Mean duration after kidney transplantation was 28.5 months (± 14.9). Patients with MetS had 6.43 lower PCS score (P < .05) and 3.20 lower MCS score (P < .05) than their counterparts without MetS. Calcium intake (β = -0.01; 95% CI, -0.03 to 0.00) and inadequate protein (β = -14.8; 95% CI, -23 to -6.65) were negatively associated with PCS score. MCS score was negatively associated with calcium intake (β = -0.02; 95% CI, -0.04 to -0.01) and inadequate protein intake (β = -15.1; 95% CI, -24.3 to -5.86), and positively associated with fat intake (β = 0.43, 95% CI, 0.02-0.85).
CONCLUSIONS: MetS and poor dietary intake are independently associated with the QoL of KTRs. Nutritional intervention plans developed specifically for the recipients will improve dietary intake, reduce the incidence of MetS, and help enhance QoL.
METHODS AND ANALYSIS: This 12-week randomised double-blind, placebo-controlled, parallel-group study aims to evaluate the efficacy of the standardised water extract of EL known as Physta in increasing the quality of life of perimenopausal and postmenopausal women. The study involves 150 women aged 40-55 years who score more than 61 on the Menopause-Specific Quality of Life (MENQOL) assessment. These participants will be randomised into three groups, receiving Physta at either 50 mg or 100 mg or a placebo. The outcomes measures include mood state, quality of life, fatigue, sleep quality, sexual function and pain score assessed using Profile of Mood State, MENQOL, Chalder Fatigue Scale, Pittsburgh Sleep Quality Index, Female Sexual Function Index and the Brief Pain Inventory questionnaires, respectively. The secondary outcome of the study includes full blood analysis, urine analysis, female reproductive hormone profiling, inflammatory and oxidative stress biomarkers analysis.
ETHICS AND DISSEMINATION: The research protocol of the study was reviewed and approved by the Research Ethics Committee of Universiti Kebangsaan Malaysia (UKM/PPI/111/8/JEP-2021-898). The findings will be disseminated to participants, healthcare professionals and researchers via conference presentations and peer-reviewed publications.
TRIAL REGISTRATION NUMBER: ACTRN12622001341718.
MATERIALS AND METHODS: Full-text articles of case report, case control, cohort and cross-sectional studies that were published from 1st January 2012 until 30th June 2022, were searched using PubMed, CINAHL and Scopus. Periodontal related diseases were excluded in this review due to its wellknown associated disease with P. gingivalis. A comparison studies of detection methods were also excluded in this review.
RESULTS: Out of 612 articles that were screened, only 106 met the eligibility criteria to be selected for further review. Risk of bias was performed using FEAT principles and reviewers' discussion. A total of 21 final articles that were reviewed showed significant correlation with P. gingivalis and were classified into several clinical domains. Twelve out of 13 detection methods showed high sensitivity and specificity with short duration analysis.
CONCLUSION: Due to asymptomatic periodontal disease and the high prevalence of P. gingivalis-associated clinical diseases, this review suggests the need for oral public health awareness and early screening for the bacterium detection especially among elderly groups to maintain their quality of life.
MATERIALS AND METHODS: The present study is a retrospective cohort study using hospital medical records (patient files) from October 2019 to November 2021 (for 2 years). This study was performed in Malaysian women (n=53) suffering from advanced stages of POP, in which Gellhorn pessaries of diameter (44-76mm) were inserted by trained personnel. Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Floor Impact Questionnaire-7 (PFIQ-7) were used to measure patients' symptoms and quality of life before and after Gellhorn pessary fitting. Patients were reassessed every three months for two years and their satisfaction scores were recorded.
RESULTS: We observed a significant difference in pre-test (pre-fitting) and post-test (three months post-fitting) scores on all three subscales and the PFIQ-7 total score. Twentyeight (52.83%) patients continued the use of Gellhorn pessary for at least 24 months, whereas 25 (47.20%) patients discontinued during this period. A retrospective analysis of the patients who discontinued Gellhorn pessary showed that 13 (24.52%) patients gave up the use of pessary for definitive surgery. It is noteworthy to mention here that only one out of the 13 patients who were awaiting surgery, chose surgery and the remaining 12 changed their mind after being fitted with the Gellhorn pessary. Seven (13.20%) patients declined reinsertion due to discomfort and voiding difficulties and refused further intervention, whereas three (5.66%) patients requested a ring pessary. Two (3.77%) patients, requested the removal of pessary due to vesicovaginal fistula and rectovaginal fistula (caused by an impacted pessary). The rate of continued use was 79.24% (42 patients) after 1st year and 52.83% (28 patients) at the end of two years.
CONCLUSION: In the current study, the Gellhorn pessary was used to treat stage 3 and 4 POP with significant symptom reduction post-fitting. More than half of the patients continued to use the pessary after 24 months of fitting. Therefore, the Gellhorn pessary can be used as a treatment strategy for stage 3 and 4 POP with reasonable acceptance in the Malaysian population.
METHODS: A cross-sectional study was conducted to establish a psychometric instrument validation. A total of 389 participants aged 55 years and above were included. The study was conducted in Sarawak, Malaysia, from November 2021 to January 2022 in two phases, translation of the PMT Scale, cross-cultural adaptation, face validation and pre-testing of the PMT Scale. The participants were selected using multistage random sampling in a primary healthcare clinic. Data entry and statistical analysis were performed using IBM SPSS version 26 for exploratory factor analysis and SmartPLS version 3.3.7 for confirmatory factor analysis using partial least square structural equation modelling.
RESULTS: The Kaiser-Meyer-Olkin value was 0.760, Bartlett's sphericity test was significant and the total variance explained was 61%. It identified 31 items within eight dimensions of the Protection Motivation Theory scale. The Higher Order Constructs' measurement model indicates that the convergent and discriminant validity were established (Cronbach's alpha and composite reliability: ≥ 0.740; average variance extracted: 0.619 to 0.935 and Henseler's Heterotrait-Monotrait criterion for all constructs' discriminant validity:
METHODS: This multicentre, randomised, placebo-controlled, phase 2b trial was done at 60 hospitals and clinics in 20 countries. Eligible study participants were aged between 12 and 75 years with a documented history of GPP as per the European Rare and Severe Psoriasis Expert Network criteria, with a history of at least two past GPP flares, and a GPP Physician Global Assessment (GPPGA) score of 0 or 1 at screening and random assignment. Patients were randomly assigned (1:1:1:1) to receive subcutaneous placebo, subcutaneous low-dose spesolimab (300 mg loading dose followed by 150 mg every 12 weeks), subcutaneous medium-dose spesolimab (600 mg loading dose followed by 300 mg every 12 weeks), or subcutaneous high-dose spesolimab (600 mg loading dose followed by 300 mg every 4 weeks) over 48 weeks. The primary objective was to demonstrate a non-flat dose-response curve on the primary endpoint, time to first GPP flare.
FINDINGS: From June 8, 2020, to Nov 23, 2022, 157 patients were screened, of whom 123 were randomly assigned. 92 were assigned to receive spesolimab (30 high dose, 31 medium dose, and 31 low dose) and 31 to placebo. All patients were either Asian (79 [64%] of 123) or White (44 [36%]). Patient groups were similar in sex distribution (76 [62%] female and 47 [38%] male), age (mean 40·4 years, SD 15·8), and GPP Physician Global Assessment score. A non-flat dose-response relationship was established on the primary endpoint. By week 48, 35 patients had GPP flares; seven (23%) of 31 patients in the low-dose spesolimab group, nine (29%) of 31 patients in the medium-dose spesolimab group, three (10%) of 30 patients in the high-dose spesolimab group, and 16 (52%) of 31 patients in the placebo group. High-dose spesolimab was significantly superior versus placebo on the primary outcome of time to GPP flare (hazard ratio [HR]=0·16, 95% CI 0·05-0·54; p=0·0005) endpoint. HRs were 0·35 (95% CI 0·14-0·86, nominal p=0·0057) in the low-dose spesolimab group and 0·47 (0·21-1·06, p=0·027) in the medium-dose spesolimab group. We established a non-flat dose-response relationship for spesolimab compared with placebo, with statistically significant p values for each predefined model (linear p=0·0022, emax1 p=0·0024, emax2 p=0·0023, and exponential p=0·0034). Infection rates were similar across treatment arms; there were no deaths and no hypersensitivity reactions leading to discontinuation.
INTERPRETATION: High-dose spesolimab was superior to placebo in GPP flare prevention, significantly reducing the risk of a GPP flare and flare occurrence over 48 weeks. Given the chronic nature of GPP, a treatment for flare prevention is a significant shift in the clinical approach, and could ultimately lead to improvements in patient morbidity and quality of life.
FUNDING: Boehringer Ingelheim.
METHODS: An international cross-sectional study was conducted in 30 countries across six World Health Organization regions from July 2020 to August 2021, with 16 512 adults self-reporting changes in 18 lifestyle factors and 13 interim health outcomes since the pandemic.
RESULTS: Three networks were computed and tested. The central variables decided by the expected influence centrality were consumption of fruits and vegetables (centrality = 0.98) jointly with less sugary drinks (centrality = 0.93) in the lifestyles network; and quality of life (centrality = 1.00) co-dominant (centrality = 1.00) with less emotional distress in the interim health outcomes network. The overall amount of exercise had the highest bridge expected influence centrality in the bridge network (centrality = 0.51). No significant differences were found in the network global strength or the centrality of the aforementioned key variables within each network between males and females or health workers and non-health workers (all P-values >0.05 after Holm-Bonferroni correction).
CONCLUSIONS: Consumption of fruits and vegetables, sugary drinks, quality of life, emotional distress, and the overall amount of exercise are key intervention components for improving overall lifestyle, overall health and overall health via lifestyle in the general population, respectively. Although modifications are needed for all aspects of lifestyle and interim health outcomes, a larger allocation of resources and more intensive interventions were recommended for these key variables to produce the most cost-effective improvements in lifestyles and health, regardless of gender or occupation.
AIM: The study evaluates the effectiveness and safety of a topical moisturizer containing tocotrienol-rich composition over 12 weeks on patients aged between 1 month and 12 years with mild to moderate AD.
METHODS: We conducted a 12 weeks, prospective, open-label clinical study on the effect of tocotrienol as an adjunct to conventional treatment. This study was approved by the Ethics Committee for Research Involving Human Subject. JKEUPM-2019-274 (NMMR-19-1588-49234).
RESULTS: Thirty AD patients with a mean age of 2.77 ± 3.05 were enrolled in the study. At week-12, significant reduction of investigator global assessment (63.4%), Patient-Oriented Scoring Atopic Dermatitis Index (PO-SCORAD) (65%), and SCORAD (52.3%) was noted (p Life Index and Children's Dermatology Life Quality Index were found to improve significantly compared to baseline (p