SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13205-023-03479-1.
METHODS: A total of 29 international experts with clinical and/or research experience in GD completed three iterative rounds of a Delphi survey. Experts rated proposed criteria in progressive rounds until a pre-determined level of agreement was achieved.
RESULTS: For DSM-5 IGD criteria, there was an agreement both that a subset had high diagnostic validity, clinical utility and prognostic value and that some (e.g. tolerance, deception) had low diagnostic validity, clinical utility and prognostic value. Crucially, some DSM-5 criteria (e.g. escapism/mood regulation, tolerance) were regarded as incapable of distinguishing between problematic and non-problematic gaming. In contrast, ICD-11 diagnostic guidelines for GD (except for the criterion relating to diminished non-gaming interests) were judged as presenting high diagnostic validity, clinical utility and prognostic value.
CONCLUSIONS: This Delphi survey provides a foundation for identifying the most diagnostically valid and clinically useful criteria for GD. There was expert agreement that some DSM-5 criteria were not clinically relevant and may pathologize non-problematic patterns of gaming, whereas ICD-11 diagnostic guidelines are likely to diagnose GD adequately and avoid pathologizing.
METHODS: Patients with schizophrenia from Japan, South Korea, Malaysia, and Taiwan were randomly assigned to 6 weeks of double-blind treatment with 40 or 80 mg/d of lurasidone or placebo. The primary efficacy measure was change from baseline to week 6 on the Positive and Negative Syndrome Scale (PANSS) total score. Efficacy was evaluated using a mixed-model repeated-measures (MMRM) analysis in the modified intention-to-treat (mITT) population.
RESULTS: On the basis of the analysis for the mITT population, the estimated difference score for lurasidone 40 and 80 mg/d vs placebo was -4.8 (P = 0.050) and -4.2 (P = 0.080). For the full intention-to-treat (ITT) population, the difference score for lurasidone 40 and 80 mg/d vs placebo was -5.8 (P = 0.017) and -4.2 (P = 0.043). The most frequent adverse events in the lurasidone 40 and 80 mg/d and placebo groups, respectively, were akathisia (7.3%, 10.4%, 3.3%), somnolence (6.0%, 2.6%, 0.7%), and vomiting (6.0%, 5.8%, 2.0%). The proportion of patients experiencing clinically significant weight gain (≥7%) was 5.3% for lurasidone 40 mg/d, 1.3% for 80 mg/d, and 1.4% for placebo. End point changes in metabolic parameters and prolactin were comparable for both lurasidone groups and placebo.
CONCLUSIONS: In the ITT (but not the mITT) population, treatment with lurasidone was associated with significant improvement in the PANSS total score in patients with schizophrenia. Lurasidone was generally well tolerated with minimal impact on weight and metabolic parameters.
MATERIALS AND METHODS: A total of 197 participants were randomly assigned to either the 8-week Kuala Lumpur Qigong Trial or control groups in 2010-2011. Measurement taken at baseline and post- intervention included QoL, distress and fatigue. Analysis of covariance (ANCOVA) and Kruskal Wallis were used to examine for differences between groups in the measurements.
RESULTS: There were 95 consenting participants in this 8week trial. The adherence rates were 63% for Qigong and 65% for the placebo group. The Qigong group showed significant marginal improvement in Quality of life scores compared to placebo (mean difference=7.3 unit; p=0.036), compared to usual care (mean difference=6.7 unit; p=0.048) on Functional Assessment Cancer Therapy-Breast measure. There were no significant changes between the placebo and usual care groups in fatigue or distress at post intervention (8-week).
CONCLUSIONS: Cancer survivors who participated in the Qigong intervention showed slightly better QOL. Follow up studies are greatly needed to evaluate which subgroups may best benefit from Qigong. With a steep rise of cancer survivors, there is an urgent need to explore and engage more cultural means of physical activity to fight side effects of treatment and for cancer control in developing countries.
METHOD: The clinical trial was conducted at University Malaya Medical Centre between 2006 and 2008. The experimental group underwent a 4-week self management program, and the control group underwent usual care. Two years after the intervention, questionnaires were randomly posted out to the participants.
RESULTS: A total of 51 questionnaires returned. There were statistically differences between groups in psychological, self-care, mobility and participation aspects in PIPP (p<0.05). The experimental group reported having higher confidence to live with breast cancer compared to control group (p<0.05). There were significant between-group changes in anxiety scores at T2 (immediately after intervention) to T4 (two years later), and the differences in anxiety scores within groups between time point T2 and T4 were significantly different (p<0.05).
CONCLUSION: The SAMA program is potentially capable to serve as a model intervention for successful transition to survivorship following breast cancer treatment. The program needs to be further tested for efficacy in a larger trial involving more diverse populations of women completing breast cancer treatment.
METHODS: We used a grounded theory approach to analyze three focus groups conducted between May and August 2010 in Kuala Lumpur. We used random sampling to recruit the informants (n=21), all of whom had earlier participated in the 4 week self-management program held two years previously.
FINDINGS: The women reported positive experience and growth with the self management program. Self-efficacy appears as an important underlying theme for successful experiences. The lack of proactive plans to provide bereavement support to surviving women was a key negative experience.
CONCLUSION: The intervention successfully brought women together to work in close partnership with health professionals on ways to self manage the medical, emotional and role task as they live indefinitely with breast cancer, a new chronic illness. The beneficial effect from the 4 week intervention was expressed by women even at 2 years after the program. Having successfully developed a tightly knitted group, a major oversight was the lack of professional support on bereavement for grieving members when close friends passed away.
MATERIALS AND METHOD: The Qigong trial is a three-arm trial with a priori power size of 114 patients for 80% power. The University Malaya Medical Centre database showed a total of 1,933 patients from 2006-2010 and 751 patients met our inclusion criteria. These patients were approached via telephone interview. 131 out of 197 patients attended the trial and the final response rate was 48% (n=95/197).
RESULTS: Multiple barriers were identified, and were regrouped as patient- related, clinician-related and/or institutional related. A major consistent barrier was logistic difficulty related to transportation and car parking at the Medical Centre. conclusions: All clinical trials must pay considerable attention to the recruitment process and it should even be piloted to identify potential barriers and facilitators to reduce attrition rate in trials.
METHODS: The N. oleracea fractions were obtained using solid phase extraction (SPE). A metabolomics approach that coupled the use of proton nuclear magnetic resonance (1H NMR) with multivariate data analysis (MVDA) was applied to distinguish the metabolite variations among the N. oleracea fractions, as well as to assess the correlation between metabolite variation and the studied bioactivities (DPPH free radical scavenging and α-glucosidase inhibitory activities). The bioactive fractions were then subjected to ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS) analysis to profile and identify the potential bioactive constituents.
RESULTS: The principal component analysis (PCA) discriminated EF and MF from the other fractions with the higher distributions of phenolics. Partial least squares (PLS) analysis revealed a strong correlation between the phenolics and the studied bioactivities in the EF and the MF. The UHPLC-MS/MS profiling of EF and MF had tentatively identified the phenolics present. Together with some non-phenolic metabolites, a total of 37 metabolites were tentatively assigned.
CONCLUSIONS: The findings of this work supported that N. oleracea is a rich source of phenolics that can be potential antioxidants and α-glucosidase inhibitors for the management of diabetes. To our knowledge, this study is the first report on the metabolite-bioactivity correlation and UHPLC-MS/MS analysis of N. oleracea fractions.