Country-Specific Roadmaps for Scaling Up Integrated Care in Belgium, Slovenia, and Cambodia - Lessons Learned from the SCUBY Project.

Introduction: The SCUBY project aimed to provide knowledge on the scaling-up of an Integrated Care Package (ICP) for type 2 diabetes and hypertension across three distinct health systems (Cambodia, Slovenia, and Belgium). Here, we analyse the different elements of the country-specific scale-up roadmaps to identify similarities and differences, and share lessons learned.

Methods: Thematic analysis was used to derive crucial roadmap elements from key SCUBY documents (n = 20), including policy briefs, interim reports, research outputs, and consortium meeting notes.

Efficacy and Safety of Venetoclax Plus Azacitidine for Patients With Treatment-Naive High-Risk Myelodysplastic Syndromes.

Patients with higher-risk myelodysplastic syndromes (HR MDS) have a median survival of ~1.5 years with azacitidine, and hematopoietic stem cell transplantation is their only curative option. Therefore, improved therapies are needed.

A framework for chronic care quality: results of a scoping review and Delphi survey.

Frameworks conceptualising the quality of care abound and vary; some concentrate on specific aspects such as safety, effectiveness, others all-encompassing. However, to our knowledge, tailoring to systematically arrive at a comprehensive care for chronic conditions quality (CCCQ) framework has never been done. We conducted a scoping review and Delphi survey to produce a CCCQ framework, comprehensively delineating aims, determinants and measurable attributes.

Cost of "Ideal Minimum Integrated Care" for Type 2 Diabetes and Hypertension Patients in Cambodia Context: Provider Perspective.

Introduction: As in other countries worldwide, Diabetes mellitus type 2 (T2D) and hypertension (HTN) prevalence is increasing in Cambodia. The country is examining models to scale-up integrated T2D and HTN care. However, costs of integrated care in this setting are not yet well-understood.

Process Evaluations for the Scale-Up of Complex Interventions - a Scoping Review.

Introduction: Complex health interventions (CHIs) are common in (public) health and social care practice and policy. A process evaluation (PE) is an essential part of designing and testing CHIs and questions what is implemented, the mechanisms of change, and how context affects implementation. The scale-up of CHIs is challenging and heterogeneous, making the accompanying PE unique to the nature of the inquiry.

Automated Lugano Metabolic Response Assessment in F-Fluorodeoxyglucose-Avid Non-Hodgkin Lymphoma With Deep Learning on F-Fluorodeoxyglucose-Positron Emission Tomography.

Purpose: Artificial intelligence can reduce the time used by physicians on radiological assessments. For F-fluorodeoxyglucose-avid lymphomas, obtaining complete metabolic response (CMR) by end of treatment is prognostic.

Methods: Here, we present a deep learning-based algorithm for fully automated treatment response assessments according to the Lugano 2014 classification.

Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia.

Venetoclax-azacitidine is approved for treatment of patients with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive chemotherapy based on the interim overall survival (OS) analysis of the VIALE-A study (NCT02993523). Here, long-term follow-up is presented to address survival benefit and long-term outcomes with venetoclax-azacitidine. Patients with newly diagnosed AML who were ineligible for intensive chemotherapy were randomized 2:1 to receive venetoclax-azacitidine or placebo-azacitidine.

The barriers and facilitators of implementing a national laboratory-based AMR surveillance system in Cambodia: key informants' perspectives and assessments of microbiology laboratories.

Background: Collecting data on antimicrobial resistance (AMR) is an essential approach for defining the scope of the AMR problem, developing evidence-based interventions and detecting new and emerging resistances. Our study aimed to identify key factors influencing the implementation of a laboratory-based AMR surveillance system in Cambodia. This will add additional insights to the development of a sustainable and effective national AMR surveillance system in Cambodia and other low- and middle-income countries.

Descriptive assessment of COVID-19 responses and lessons learnt in Cambodia, January 2020 to June 2022.

As a member state of the International Health Regulations 2005, Cambodia is continuously strengthening its capacity to respond to health emergencies and prevent the international spread of diseases. Despite this, Cambodia's capacity to prevent, detect and rapidly respond to public health threats remained limited at the onset of the pandemic, as was the case in most countries. This paper describes epidemiological phases, response phases, strategy and lessons learnt in Cambodia between 27 January 2020 and 30 June 2022.

Integrated summary of immunogenicity of polatuzumab vedotin in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Polatuzumab vedotin, marketed under the trade name POLIVY, is a CD79b-targeted antibody-drug conjugate that preferentially delivers a potent anti-mitotic agent (monomethyl auristatin E) to B cells, resulting in anti-cancer activity against B-cell malignancies. In 2019, polatuzumab vedotin in combination with rituximab and bendamustine was approved by the United States Food and Drug Administration for the treatment of adult patients with diffuse large B-cell lymphoma who have received at least two prior therapies. Recent Health Authority guidance recommendations for submitting an Integrated Summary of Immunogenicity were followed including a comprehensive immunogenicity risk assessment, bioanalytical strategy, and immunogenicity data to support the registration of polatuzumab vedotin.

Early Real-World First-Line Treatment With Venetoclax Plus HMAs Versus HMA Monotherapy Among Patients With AML in a Predominately US Community Setting.

Background: Venetoclax in combination with hypomethylating agents (HMAs) is standard-of-care in patients with newly diagnosed acute myeloid leukemia (AML) who are ≥ 75 years old or unfit for intensive chemotherapy. We examined early real-world treatment experience among patients with AML receiving venetoclax+HMAs or HMA monotherapy.

Patients And Methods: This retrospective cohort study used an electronic health record-derived, deidentified, United States nationwide database comprised of patient-level structured and unstructured data, curated via technology-enabled abstraction.

Establishing a global regulatory floor for children's decisions about participation in clinical research.

Background: Enrolling children in clinical trials typically requires parental or guardian permission and, when appropriate, child assent. Aligning requirements across jurisdictions would facilitate multisite pediatric trials. Guidance from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is the best candidate for a global standard but would benefit from additional specification.

Process evaluation of the scale-up of integrated diabetes and hypertension care in Belgium, Cambodia and Slovenia (the SCUBY Project): a study protocol.

Introduction: Integrated care interventions for type 2 diabetes (T2D) and hypertension (HT) are effective, yet challenges exist with regard to their implementation and scale-up. The 'SCale-Up diaBetes and hYpertension care' (SCUBY) Project aims to facilitate the scale-up of integrated care for T2D and HT through the co-creation and implementation of contextualised scale-up roadmaps in Belgium, Cambodia and Slovenia. We hereby describe the plan for the process and scale-up evaluation of the SCUBY Project.

Cobimetinib Alone and Plus Venetoclax With/Without Atezolizumab in Patients With Relapsed/Refractory Multiple Myeloma.

Introduction: Mitogen-activated protein kinase pathway mutations are present in >50% of patients with relapsed/refractory (R/R) multiple myeloma (MM). MEK inhibitors show limited single-agent activity in R/R MM; combination with B-cell lymphoma-2 (BCL-2) and programmed death-ligand 1 inhibition may improve efficacy. This phase Ib/II trial (NCT03312530) evaluated safety and efficacy of cobimetinib (cobi) alone and in combination with venetoclax (ven) with/without atezolizumab (atezo) in patients with R/R MM.

Extracorporeal photopheresis for the treatment of chronic graft versus host disease.

Objectives: Chronic graft versus host disease (chronic GVHD) still remains the leading cause of late morbidity and mortality for allogeneic hematopoietic stem cell transplant (allo-HSCT) recipients. In this retrospective study, 53 consecutive allo-HSCT patients with chronic GVHD refractory to corticosteroids were treated with extracorporeal photopheresis (ECP).

Methods: This study was performed as a retrospective single-center study.

Polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory DLBCL: survival update and new extension cohort data.

Polatuzumab vedotin plus bendamustine and rituximab (pola + BR) received regulatory approvals for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) based on primary results from the randomized arms of the GO29365 study. After the randomized phase, 106 additional patients received pola + BR in a single-arm extension cohort. We report updated results from the randomized arms and results of the extension cohort.

Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

Purpose: The CD79b-targeted antibody-drug conjugate polatuzumab vedotin (pola), alone and with chemoimmunotherapy, has clinical efficacy and a tolerable safety profile in B-cell non-Hodgkin lymphoma (B-NHL). We assessed (a) whether exposure from global studies of pola is comparable to Asian patients, and (b) if the recommended pola dose is appropriate in Asian patients based on exposure.

Methods: The pharmacokinetics (PK) of pola in Asian and global populations was characterized for three analytes (antibody-conjugated monomethyl auristatin E (MMAE) [acMMAE], total antibody, and unconjugated MMAE) in five phase 1b/2 single-agent and combination studies in B-NHL patients (JO29138 [JAPICCTI-142580], DCS4968g [NCT01290549], GO27834 [NCT01691898], GO29044 [NCT01992653], and GO29365 [NCT02257567]).

Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma.

Purpose: Patients with transplantation-ineligible relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) fare poorly, with limited treatment options. The antibody-drug conjugate polatuzumab vedotin targets CD79b, a B-cell receptor component.

Methods: Safety and efficacy of polatuzumab vedotin with bendamustine and obinutuzumab (pola-BG) was evaluated in a single-arm cohort.

The effect of text message support on diabetes self-management in developing countries - A randomised trial.

Objective: mHealth interventions have the potential to facilitate self-management. This TEXT4DSM study implemented a mobile phone intervention in existing diabetes programmes in three low- and middle-income countries (Democratic Republic of Congo, Cambodia, and the Philippines).

Research Design And Methods: Sub-studies with a similar randomised controlled trial design were conducted in three different countries.

NCCN Guidelines Insights: Survivorship, Version 1.2016.

The NCCN Guidelines for Survivorship provide screening, evaluation, and treatment recommendations for common consequences of cancer and cancer treatment. They are intended to aid health care professionals who work with survivors of adult-onset cancer in the posttreatment period, including those in general oncology, specialty cancer survivor clinics, and primary care practices. Guidance is also provided to help promote physical activity, weight management, and proper immunizations in survivors.