OBJECTIVE: To describe the demographic characteristics, treatment duration, and survival of patients with GIST in LMICs treated with imatinib and sunitinib through The Max Foundation programs.
DESIGN, SETTING, AND PARTICIPANTS: This retrospective database cohort analysis included patients in 2 access programs administered by The Max Foundation: the Glivec International Patient Assistance Program (GIPAP), from January 1, 2001, to December 31, 2016, and the Max Access Solutions (MAS) program, January 1, 2017, to October 12, 2020. Sixty-six countries in which The Max Foundation facilitates access to imatinib and sunitinib were included. Participants consisted of patients with approved indications for imatinib, including adjuvant therapy in high-risk GIST by pathologic evaluation of resected tumor or biopsy-proven unresectable or metastatic GIST. All patients were reported to have tumors positive for CD117(c-kit) by treating physicians. A total of 9866 patients received treatment for metastatic and/or unresectable disease; 2100 received adjuvant imatinib; 49 received imatinib from another source and were only included in the sunitinib analysis; and 53 received both imatinib and sunitinib through The Max Foundation programs. Data were analyzed from October 13, 2020, to January 30, 2024.
MAIN OUTCOMES AND MEASURES: Demographic and clinical information was reported by treating physicians. Kaplan-Meier analysis was used to estimate time to treatment discontinuation (TTD) and overall survival (OS). An imputation-based informed censoring model estimated events for patients lost to follow-up after treatment with adjuvant imatinib. Patients who were lost to follow-up with metastatic or unresectable disease were presumed deceased.
RESULTS: A total of 12 015 unique patients were included in the analysis (6890 male [57.6%]; median age, 54 [range, 0-100] years). Of these, 2100 patients were treated with imatinib in the adjuvant setting (median age, 54 [range 8-88] years) and 9866 were treated with imatinib for metastatic or unresectable disease (median age, 55 [range, 0-100] years). Male patients comprised 5867 of 9866 patients (59.5%) with metastatic or unresectable disease and 1023 of 2100 patients (48.7%) receiving adjuvant therapy. The median OS with imatinib for unresectable or metastatic disease was 5.8 (95% CI, 5.6-6.1) years, and the median TTD was 4.2 (95% CI, 4.1-4.4) years. The median OS with sunitinib for patients with metastatic or unresectable GIST was 2.0 (95% CI, 1.5-2.5) years; the median TTD was 1.5 (95% CI, 1.0-2.1) years. The 10-year OS rate in the adjuvant setting was 73.8% (95% CI, 67.2%-81.1%).
CONCLUSIONS AND RELEVANCE: In this cohort study of patients with GIST who were predominantly from LMICs and received orally administered therapy through the GIPAP or MAS programs, outcomes were similar to those observed in high-resource countries. These findings underscore the feasibility and relevance of administering oral anticancer therapy to a molecularly defined population in LMICs, addressing a critical gap in cancer care.
OBJECTIVE: This study aims to explore the main drivers influencing the completeness of Malaysian AE reports in VigiBase over a 15-year period using vigiGrade. A secondary objective was to understand the strategic measures taken by the Malaysian authorities leading to enhanced report completeness across different time frames.
METHODS: We analyzed 132,738 Malaysian reports (2005-2019) recorded in VigiBase up to February 2021 split into historical International Drug Information System (INTDIS; n=63,943, 48.17% in 2005-2016) and newer E2B (n=68,795, 51.83% in 2015-2019) format subsets. For machine learning analyses, we performed a 2-stage feature selection followed by a random forest classifier to identify the top features predicting well-documented reports. We subsequently applied tree Shapley additive explanations to examine the magnitude, prevalence, and direction of feature effects. In addition, we conducted time-series analyses to evaluate chronological trends and potential influences of key interventions on reporting quality.
RESULTS: Among the analyzed reports, 42.84% (56,877/132,738) were well documented, with an increase of 65.37% (53,929/82,497) since 2015. Over two-thirds (46,186/68,795, 67.14%) of the Malaysian E2B reports were well documented compared to INTDIS reports at 16.72% (10,691/63,943). For INTDIS reports, higher pharmacovigilance center staffing was the primary feature positively associated with being well documented. In recent E2B reports, the top positive features included reaction abated upon drug dechallenge, reaction onset or drug use duration of <1 week, dosing interval of <1 day, reports from public specialist hospitals, reports by pharmacists, and reaction duration between 1 and 6 days. In contrast, reports from product registration holders and other health care professionals and reactions involving product substitution issues negatively affected the quality of E2B reports. Multifaceted strategies and interventions comprising policy changes, continuity of education, and human resource development laid the groundwork for AE reporting in Malaysia, whereas advancements in technological infrastructure, pharmacovigilance databases, and reporting tools concurred with increases in both the quantity and quality of AE reports.
CONCLUSIONS: Through interpretable machine learning and time-series analyses, this study identified key features that positively or negatively influence the completeness of Malaysian AE reports and unveiled how Malaysia has developed its pharmacovigilance capacity via multifaceted strategies and interventions. These findings will guide future work in enhancing pharmacovigilance and public health.
AIM: The study aimed to identify the effectiveness of the buddy program training module to enhance the daily living function, social participation and emotional status of older adults in residential aged care homes.
METHODS: A quasi-experimental study was conducted with 30 pairs of buddies and older adults for both the experimental group and control group in two randomly selected residential aged care homes. The buddies in the experimental group received the buddy program training module related to activities of daily living (basic and instrumental) while the buddy-older adults pairs in the control group continued to perform their usual daily life activities in residential aged care homes. Baselines were performed before intervention and at eight weeks post-intervention.
RESULTS: Over the eight weeks, for the older adults in the experimental group, there was a significant main effect of time after the intervention on BADL (p = 0.010). There were no significant interaction effects for the experiment group and control group on IADL and social participation. Also, there were no significant interaction effects for all domains in emotional status: depression, anxiety and stress. For buddies, there was a significant interaction effect for depression (p = 0.045) in the control group.
CONCLUSIONS: The buddy program training module can be used as a guideline for older adults with more significant disabilities in residential aged care homes in managing activities of daily living. Future studies could be implemented to explore the intergenerational buddy program among older adults and young children in the community.
CASE PRESENTATION: A 34-year-old male presented with C4 complete tetraplegia. Following surgical decompression and initial inpatient rehabilitation, he started consuming MLC901 two capsules three times daily at month 4 post injury for 6 months. He regained considerable neurological recovery following the supplementation. Apart from the improvement in the neurological level of injury, the patient exhibited motor recovery beyond the initial zone of partial preservation up to 24 months post injury.
DISCUSSION: Our findings align with a recent animal study demonstrating MLC901's potential to downregulate Vascular Endothelial Growth Factor (VEGF), a molecule known to increase vascular permeability and exacerbate tissue edema and infarction. In another animal study involving stroke-affected mice, MLC901 demonstrates the ability to promote neurological recovery by regulating the expression of proteins mediating angiogenesis, such as hypoxic inducible factor 1α, erythropoietin, angiopoietins 1 and 2, as well as VEGF. The anecdotal findings from this case report offer preliminary insights into NeuroAiD's potential in facilitating recovery during post-acute and chronic phases of severe SCI, necessitating further exploration.
OBJECTIVES: We undertook a scoping systematic review to map the literature regarding post-publication integrity issues in RCTs.
SEARCH STRATEGY AND SELECTION CRITERIA: Following prospective registration (https://osf.io/pgxd8) we initially searched PubMed and Scopus but subsequently extended it to include the Cochrane Library, and Google Scholar databases without language, article type or publication time restriction until November 2022. Reviewers independently selected published articles covering any aspect of post-publication research integrity concerns in RCTs.
DATA COLLECTION AND ANALYSIS: The study findings grouped within domains relating to issues concerning post-publication integrity were extracted in duplicate, verified by a third reviewer, and then tabulated.
MAIN RESULTS: The initial search captured 3159 citations, of which 89 studies were included in the review. Cross-sectional studies constituted the majority of included studies (n = 34, 38.2%), followed by systematic reviews (n = 10, 11.2%), methodology reviews/studies (n = 9, 10.1%) and other types of descriptive studies (n = 8, 9.0%). A total of 21 articles (23.6%) covered the domain on general issues, 25 (28.1%) in the journal's instructions and policies domain, eight (9.0%) in the editorial and peer review domain, one (1.1%) in the correspondence and complaints (post-publication peer review) domain, 12 (13.5%) in the investigation for concerns domain, six (6.7%) in the post-investigation decisions and sanctions domain, none in the critical appraisal guidance domain, five (5.6%) in the integrity assessment in systematic reviews domain, and 26 (29.2%) in the recommendations for future research domain. A total of 12 of the selected articles (13.5%) covered two (n = 9) or three (n = 3) different domains.
CONCLUSIONS: Various research integrity domains and issues covering post-publication aspects of RCT integrity were captured and gaps were identified, mostly related with the necessary implications for all stakeholders to improve research transparency. There is an urgent need for a multistakeholder consensus towards creating specific statements for addressing post-publication integrity concerns in RCTs.
MATERIALS AND METHODS: The study involved the analysis of 28 sets of 3-dimensional (3D) point cloud data, focused on the labial surface of the anterior teeth. These datasets were superimposed within each group in both genuine and imposter pairs. Group A incorporated data from the right to the left central incisor, group B from the right to the left lateral incisor, and group C from the right to the left canine. A comprehensive analysis was conducted, including the evaluation of root mean square error (RMSE) values and the distances resulting from the superimposition of dental arch segments. All analyses were conducted using CloudCompare version 2.12.4 (Telecom ParisTech and R&D, Kyiv, Ukraine).
RESULTS: The distances between genuine pairs in groups A, B, and C displayed an average range of 0.153 to 0.184 mm. In contrast, distances for imposter pairs ranged from 0.338 to 0.522 mm. RMSE values for genuine pairs showed an average range of 0.166 to 0.177, whereas those for imposter pairs ranged from 0.424 to 0.638. A statistically significant difference was observed between the distances of genuine and imposter pairs (P<0.05).
CONCLUSION: The exceptional performance observed for the labial surfaces of anterior teeth underscores their potential as a dependable criterion for accurate 3D dental identification. This was achieved by assessing a minimum of 4 teeth.
METHODOLOGY: This was a cross-sectional study, conducted among patients aged ≥ 18 years with cardiovascular risk factors attending a university primary care clinic. Patients were given the app to use for at least three months. Those who fulfilled the eligibility criteria were recruited. Data gathered were on sociodemographic, clinical characteristics, self-management support by doctors, utilisation of the app at home and social support in using the app. The previously translated and validated Malay version of the mHealth App Usability Questionnaire was used to measure usability. The mean usability score was calculated and linear regressions analysis was conducted to determine the factors associated with the usability of the app.
RESULTS: A total of 247 patients with at least one cardiovascular risk factor(s) were recruited. The mean age was 60.2 (±8.2). The majority were Malays (86.2%) and half of them were males (52.2%). The total mean (±SD) usability score was 5.26 (±0.67) indicating a high usability of the app. Usability of the app declined with increasing age in the simple linear regressions analysis. The multiple linear regressions yielded that being Malay (b = 0.31, 95% CI 0.08,0.54), using the app at home to understand their medications (b = 0.33, 95% CI 0.12,0.53) and having social support from family members and friends (b = 0.28, 95% CI 0.07,0.49) were significantly associated with higher usability of the app.
CONCLUSION: The usability of the EMPOWER-SUSTAIN Self-Management Mobile App© was high among patients with cardiovascular risk factors in our primary care clinic. This finding supports the widespread use of this app among our patients. Involvement of family members and friends should be encouraged to improve the usability of the app.
METHODS: We systematically searched three main electronic databases in May 2023 for all English-language qualitative and quantitative publications that suggested or described at least one QI related to pediatric asthma care in the ED. Two reviewers independently selected the included studies and extracted data on study characteristics, all relevant QIs reported, and the rates of compliance with these indicators when available. The identified QIs were classified according to Donabedian healthcare quality framework and the Institute of Medicine (IOM) framework. When feasible, we aggregated the compliance rates for the QIs reported in observational studies using random effects models. The quality assessment of the included studies was performed using various Joanna Briggs Institute (JBI) tools.
RESULTS: We identified twenty studies, including six expert panels, 13 observational studies, and one trial. Together, these studies presented 129 QIs for use in EDs managing pediatric asthma. Among these QIs, 66 were pinpointed by expert panel studies, whereas 63 were derived from observational studies. Within the Donabedian framework, most indicators (86.8%) concentrated on the process of care. In contrast, within the Institute of Medicine (IOM) domain, the predominant focus was on indicators related to effectiveness and safety. Observational studies reported varying compliance rates for the 36 QIs identified in the expert studies. The included studies showed a wide range of bias risks, suggesting potential methodological variances.
CONCLUSIONS: A significant number of QIs in pediatric asthma care have been proposed or documented in literature. Although most of these indicators prioritize the process of care, there is a conspicuous absence of outcome and structure indicators. This meta-analysis uncovered significant disparities in compliance to the identified QIs, highlighting the urgent necessity for targeted interventions to enhance pediatric asthma care in ED.
OBJECTIVE: This study aims to find the sleep quality status and its association with the socioeconomic, employment and lifestyle factors of working adults during the MCO period.
METHODS: A cross-sectional study was conducted among 500 eligible working adults. Data were collected using a structured questionnaire consisting of the Pittsburg Sleep Quality Index.
RESULTS: The proportion of poor sleep quality is found to be 59.4%. Analysis shows that the use of electronic devices before sleep (OR = 2.33, 95% CI = 1.02-5.35, p-value = 0.046), increased amount of workload (OR = 0.45, p-value = 0.005), decreased in amount of workload (OR = 0.48, p-value = 0.003) and distracted while working (OR = 0.57, p-value = 0.014) are the factors significantly associated with and are predictors of poor sleep quality.
CONCLUSION: During crisis, there is a need for public health interventions for the working population to adopt a healthy lifestyle. Employers are recommended to support employees' well-being and to provide a healthy workplace during challenging times. Policy recommendations are also made to implement flexible working arrangements, workload management, workplace mental health support and legal protections on reasonable working hours, rest breaks and time off during crises.