"The first ones now, will later be last":understanding the importance of historical context when reading ESMO-MCBS scores

SCOPUS: ed.jinfo:eu-repo/semantics/publishe

The treatment of achalasia patients with esophageal varices: an international study

Background: Treatment options for achalasia include endoscopic and surgical techniques that carry the risk of esophageal bleeding and perforation. The rare coexistence of esophageal varices has only been anecdotally described and treatment is presumed to carry additional risk. Methods: Experience from physicians/surgeons treating this rare combination of disorders was sought through the International Manometry Working Group. Results: Fourteen patients with achalasia and varices from seven international centers were collected (mean age 61 9 years). Five patients were treated with botulinum toxin injections (BTI), four had dilation, three received peroral endoscopic myotomy (POEM), one had POEM then dilation, and one patient underwent BTI followed by Heller’s myotomy. Variceal eradication preceded achalasia treatment in three patients. All patients experienced a significant symptomatic improvement (median Eckardt score 7 vs 1; p < 0.0001) at 6 months follow-up, with treatment outcomes resembling those of 20 non- cirrhotic achalasia patients who underwent similar therapy. No patients had recorded complications of bleeding or perforation. Conclusion: This study shows an excellent short-term symptomatic response in patients with esophageal achalasia and varices and demonstrates that the therapeutic outcomes and complications, other than transient encephalopathy in both patients who had a portosystemic shunt, did not differ to disease-matched patients without varices

Analysis of Yield Attributing Characters of Different Genotypes of Wheat in Rupandehi, Nepal

Field experiment was conducted at National Wheat Research Program, Bhairahawa, Rupandehi with the objective to identify high yielding superior wheat genotypes for Rupandehi district of Nepalduring 2014. Experiment was laid out in one factorial Randomized completely block design with ten wheat genotypes including both released and promising; Annapurna 1, Annapurna 3, Pasang Lahmu, Bijaya, BL 3623, Bhirkuti, NL 297, BL 4316, BL 3978 and BL 4347with three replications. The results showed that the grain yield of BL 3978 was found higher (4.03 t ha-1) than other genotypes followed by BL 4347 (3.93t ha-1). BL 3978 have also higher number of effective tillers m-2 and test weight. Among release varieties, NL 297 show higher yield (4 t ha-1) followed by Bhirkuti (3.43 t ha-1)and Bijaya (3.37 t ha-1). From this experiment it can be concluded that BL 3978 was found promising among all genotypes however should be tested at on-farms before promoted for general cultivation in Rupandehi district of Nepal

Value chain analysis of non-timber forest products in Baglung district, Nepal

This study was carried out in five Village Development Committees of Baglung district, Nepal. The main objective was to assess the constraints and opportunities to run the non-timber forest products based enterprises, and to design business solutions to make their value chains more efficient and competitive with the best utilization of the available resources. Primary data were collected through group discussions, key informants interview, informal meetings and direct observations, using open-ended questionnaires and checklists. Similarly, secondary data were gathered from reports and records of community forest user groups, District Forest Office and other organizations. The data were analyzed using qualitative and quantitative tools. The identified major constraints concerning the selected value chains are: absence of detailed resource inventory; inadequate knowledge and skills with local people about modern technology and product quality parameters, local resource management policy and sustainable resource harvesting; insufficient finance with local processors; lack of sufficient information about market; and poor infrastructure development. In addition, the study also identified a number of opportunities such as the resource potential and monetary benefits to the local people; financial access through community forest user groups&apos; fund and financial institutions; growing market demand for quality products; involvement of service providers in forest resource management; and supportive policy for employment generation from locally available natural resources. This paper has suggested some business solutions for the effective value chain of selected products

Assessing population diversity in phase III trials of cancer drugs supporting Food and Drug Administration approval in solid tumors

Our study aimed to assess inequities in the clinical trial participation for the selected patient groups. We searched the Food and Drug Administration (FDA) database and extracted phase-III clinical trial data from MEDLINE for each approved drug by the FDA between January 1, 2006, and June 30, 2020. We analyzed the inclusion/exclusion criteria, participation according to gender, ethnic group, performance score, the positivity of HBV and HCV, and HIV, having comorbidities and brain metastasis. We compared the findings with that of the general population by retrieving data from the Surveillance, Epidemiology and End Results (SEER) database. We identified 142 phase III pivotal oncology trials that enrolled 105 397 patients. The proportion of female patients in trials was lower than their relative prevalence in the general population from SEER region (36% vs 49.6%, P < .001). The rates of black patients included were lower than their relative prevalence from SEER region (2.1% vs 9.8%, P < .001). 1.3% and 0.8% of patients had HBV and HCV infections, respectively. The patients' numbers with organ dysfunction were not established due to insufficient data from clinical trials. 1.6% of all patients had controlled brain metastasis. Black patients, women and patients with brain metastasis or with HBV and HCV were underrepresented. Our study underscores the importance of expanding the inclusion/exclusion criteria of pivotal oncology trials to be more representative of patients seen in clinical practice

Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring

BACKGROUND: The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a validated, widely used tool developed to score the clinical benefit from cancer medicines reported in clinical trials. ESMO-MCBS scores assume valid research methodologies and quality trial implementation. Studies incorporating flawed design, implementation, or data analysis may generate outcomes that exaggerate true benefit and are not generalisable. Failure to either indicate or penalise studies with bias undermines the intention and diminishes the integrity of ESMO-MCBS scores. This review aimed to evaluate the adequacy of the ESMO-MCBS to address bias generated by flawed design, implementation, or data analysis and identify shortcomings in need of amendment. METHODS: As part of a refinement of the ESMO-MCBS, we reviewed trial design, implementation, and data analysis issues that could bias the results. For each issue of concern, we reviewed the ESMO-MCBS v1.1 approach against standards derived from Helsinki guidelines for ethical human research and guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, the Food and Drugs Administration, the European Medicines Agency, and European Network for Health Technology Assessment. RESULTS: Six design, two implementation, and two data analysis and interpretation issues were evaluated and in three, the ESMO-MCBS provided adequate protections. Seven shortcomings in the ability of the ESMO-MCBS to identify and address bias were identified. These related to (i) evaluation of the control arm, (ii) crossover issues, (iii) criteria for non-inferiority, (iv) substandard post-progression treatment, (v) post hoc subgroup findings based on biomarkers, (vi) informative censoring, and (vii) publication bias against quality-of-life data. CONCLUSION: Interpretation of the ESMO-MCBS scores requires critical appraisal of trials to understand caveats in trial design, implementation, and data analysis that may have biased results and conclusions. These will be addressed in future iterations of the ESMO-MCBS.SCOPUS: re.jinfo:eu-repo/semantics/publishe

Challenges in diabetes mellitus type 2 management in Nepal: a literature review

BACKGROUND AND OBJECTIVES: Diabetes has become an increasingly prevalent and severe public health problem in Nepal. The Nepalese health system is struggling to deliver comprehensive, quality treatment and services for diabetes at all levels of health care. This study aims to review evidence on the prevalence, cost and treatment of diabetes mellitus type 2 and its complications in Nepal and to critically assess the challenges to be addressed to contain the epidemic and its negative economic impact. DESIGN: A comprehensive review of available evidence and data sources on prevalence, risk factors, cost, complications, treatment, and management of diabetes mellitus type 2 in Nepal was conducted through an online database search for articles published in English between January 2000 and November 2015. Additionally, we performed a manual search of articles and reference lists of published articles for additional references. RESULTS: Diabetes mellitus type 2 is emerging as a major health care problem in Nepal, with rising prevalence and its complications especially in urban populations. Several challenges in diabetes management were identified, including high cost of treatment, limited health care facilities, and lack of disease awareness among patients. No specific guideline was identified for the prevention and treatment of diabetes in Nepal. CONCLUSIONS: We conclude that a comprehensive national effort is needed to stem the tide of the growing burden of diabetes mellitus type 2 and its complications in Nepal. The government should develop a comprehensive plan to tackle diabetes and other non-communicable diseases supported by appropriate health infrastructure and funding

Prevalence of type 2 diabetes in Nepal: a systematic review and meta-analysis from 2000 to 2014

Background: Understanding the prevalence of type 2 diabetes in Nepal can help in planning for health services and recognising risk factors. This review aims to systematically identify and collate studies describing the prevalence of type 2 diabetes, to summarise the findings, and to explore selected factors that may influence prevalence estimates. Design: This systematic review was conducted in adherence to the MOOSE Guidelines for Meta-Analysis and Systematic Reviews of Observational Studies. Medical Literature Analysis and Retrieval System (MEDLINE) database from 1 January 2000 to 31 December 2014 was searched for the prevalence of type 2 diabetes among Nepalese populations with a combination of search terms. We exploded the search terms to include all possible synonyms and spellings obtained in the search strategy. Additionally, we performed a manual search for other articles and references of published articles. Results: We found 65 articles; ten studies fulfilled the inclusion criteria and were included in the analyses. These ten studies comprised a total of 30,218 subjects. The sample size ranged from 489 to 14,009. All the studies used participants older than age 15, of whom 41.5% were male and 58.5% female. All the studies were cross-sectional and two were hospital-based. Prevalence of type 2 diabetes ranged from a minimum of 1.4% to a maximum of 19.0% and pooled prevalence of type 2 diabetes was 8.4% (95% CI: 6.2 10.5%). Prevalence of type 2 diabetes in urban and rural populations was 8.1% (95% CI: 7.3 8.9%) and 1.0% (95% CI: 0.7 1.3%), respectively. Conclusions: This is, to our knowledge, the first study to systematically evaluate the literature of prevalence of type 2 diabetes in Nepal. Results showed that type 2 diabetes is currently a high-burden disease in Nepal, suggesting a possible area to deliberately expand preventive interventions as well as efforts to control the disease

Earth Observation to Address Inequities in Post-Flood Recovery

Floods impact communities worldwide, resulting in loss of life, damaged infrastructure and natural assets, and threatened livelihoods. Climate change and urban development in flood-prone areas will continue to worsen flood-related losses, increasing the urgency for effective tools to monitor recovery. Many Earth Observation (EO) applications exist for flood-hazard monitoring and provide insights on location, timing, and extent in near real-time and historically to estimate flood risk. Less attention has been paid to flood recovery, even though differing recovery rates and outcomes can have immediate and enduring distributional effects within communities. EO data are uniquely positioned to monitor post-flood recovery and inform policy on hazard mitigation and adaptation but remain underutilized. We encourage the EO and flood research community to refocus on developing flood recovery applications to address growing risk. Translation of EO insights on flood recovery among flood-affected communities and decision-makers is necessary to address underlying social vulnerabilities that exacerbate inequitable recovery outcomes and advocate for redressing injustices where disparate recovery is observed. We identify an unequivocal need for EO to move beyond mapping flood hazard and exposure toward post-flood recovery monitoring to inform recovery across geographic contexts. This commentary proposes a framework for remote sensing scientists to engage community-based partners to integrate EO with non-EO data to advance flood recovery monitoring, characterize inequitable recovery, redistribute resources to mitigate inequities, and support risk reduction of future floods

School-based physical activity intervention for older adolescents: rationale and study protocol for the Burn 2 Learn cluster randomised controlled trial

Introduction This trial aims to investigate the impact of a school-based physical activity programme, involving high-intensity interval training (HIIT), on the physical, mental and cognitive health of senior school students. Methods and analysis The Burn 2 Learn (B2L) intervention will be evaluated using a two-arm parallel group cluster randomised controlled trial with allocation occurring at the school level (to treatment or wait-list control). Schools will be recruited in two cohorts from New South Wales, Australia. The trial will aim to recruit ∼720 senior school students (aged 16-18 years) from 20 secondary schools (ie, 10 schools per cohort). A range of implementation strategies will be provided to teachers (eg, training, equipment and support) to facilitate the delivery of HIIT sessions during scheduled classes. In phase I and II (3 months each), teachers will facilitate the delivery of at least two HIIT sessions/week during lesson-time. In phase III (6 months), students will be encouraged to complete sessions outside of lesson-time (teachers may continue to facilitate the delivery of B2L sessions during lesson-time). Study outcomes will be assessed at baseline, 6 months (primary end point) and 12 months. Cardiorespiratory fitness (shuttle run test) is the primary outcome. Secondary outcomes include: vigorous physical activity, muscular fitness, cognition and mental health. A subsample of students will (i) provide hair samples to determine their accumulated exposure to stressful events and (ii) undergo multimodal MRI to examine brain structure and function. A process evaluation will be conducted (ie, recruitment, retention, attendance and programme satisfaction)