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Inconsistent approaches of the G-BA regarding acceptance of primary study endpoints as being relevant to patients - an analysis of three disease areas: oncological, metabolic, and infectious diseases.

BackgroundPrevious evaluations of oncological medicines in the German early benefit assessment (EBA) procedure have demonstrated inconsistent acceptance of endpoints by regulatory authorities and the Federal Joint Committee (G-BA). Accepted standard endpoints for regulatory purposes are frequently not considered as patient-relevant in the German EBA system. In this study the acceptance of clinically acknowledged primary endpoints (PEPs) from regulatory trials in EBAs conducted by the G-BA was evaluated across three therapeutic areas.MethodsMedicines for oncological, metabolic and infectious di

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… test, ADO Working Group on Dermatological Oncology, AGO Working Group on Gynaecologic Oncology, AIO Working Group on Internal Oncology, ASIM Working Group on Congenital Metabolic Disorders in Internal Medicine, BDU Professional Association of German Urologists, bng Federal Association of Registered Gastroenterologists … test, ADO Working Group on Dermatological Oncology, AGO Working Group on Gynaecologic Oncology, AIO Working Group on Internal Oncology, ASIM Working Group on Congenital Metabolic Disorders in Internal Medicine, BDU Professional Association of German Urologists, bng Federal Association of Registered Gastroenterologists …

Adverse Events of Oncologic Immunotherapy and Their Management.

Over the past two decades, immunotherapy has emerged as a promising treatment option for patients with cancer. However, newer versions of immunotherapy, such as checkpoint inhibitors, may be associated with unusual adverse effects (AEs) that can range in severity from mild to life-threatening. Unlike common AEs of conventional chemotherapy, which have a predictable nadir or cyclic pattern after administration, AEs of these newer immunotherapies are variable, depending on the type of immunotherapy, route of administration, and mechanism of action. The onset and resolution of these AEs may be pr

The Impact of Inflammatory Bowel Disease in Canada 2018: IBD in Seniors.

UNLABELLED: Approximately one in every 160 seniors live with IBD. Due to the fact that IBD has no known cure, and thus patients diagnosed at … ure research is necessary to improve the identification of senior patients with IBD in databases.2. Gastroenterologists will need to contend with an older IBD population with greater comorbidities. Research focusing on defining the burden of comorbidities in senior IBD patients is needed for healthcare resource utilization planning.3. The use of anti-TNF in senior pa …

Barriers to Colonoscopy Quality Measurement in Rural Wisconsin.

BACKGROUND: Patients in rural areas have limited colonoscopy access, which is critical for colorectal cancer prevention. General surgeons pe … rural hospitals were surgeons (66.3%), followed by family/internal medicine physicians (20.0%) and gastroenterologists (13.8%). The average hospital volume/week was 19.9 colonoscopies (SD = 13.4). Hospitals reported operating at ~75% capacity. Withdrawal time was the most tracked measure (44.0%), followed by adenoma detection (36.0%) and cecal intubation (28.0%) rat …

Light Chain (AL) Amyloidosis: The Journey to Diagnosis.

BackgroundLight chain (AL) amyloidosis is a rare, complex disease associated with significant morbidity and mortality. Delays in diagnosis are common and may have detrimental consequences on patients' prognosis. Too little is known regarding the patient journey to diagnosis.ObjectiveThe objective of this study was to describe the patient-reported journey to a correct diagnosis for AL amyloidosis.MethodsUsing a mixed-methods approach, data were collected from clinician (n = 4) and patient (n = 10) interviews and a survey of community-based patients with AL amyloidosis (n = 341). Data were used

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… As described in Table 4 , the types of specialty consultations depended on the patients’ organ involvement and included primary care physicians, cardiologists, hematologists, nephrologists, gastroenterologists, pulmonologists, and others. … Table 4 Types of specialists consulted prior to diagnosis among patient interviewees, by organ involvement Patient a Organ involvement Physician specialists consulted Cardiologist Gastroenterologist Hematologist Nephrologist Oncologist Primary care physician Pulmonology Other 001 K ✓ ✓ ✓ ✓ 002 K ✓ ✓ …

Diabetic autonomic neuropathy.

Diabetic autonomic neuropathy (DAN) is a serious and common complication of diabetes. Despite its relationship to an increased risk of cardiovascular mortality and its association with multiple symptoms and impairments, the significance of DAN has not been fully appreciated. The reported prevalence of DAN varies widely depending on the cohort studied and the methods of assessment. In randomly selected cohorts of asymptomatic individuals with diabetes, approximately 20% had abnormal cardiovascular autonomic function. DAN frequently coexists with other peripheral neuropathies and other diabetic

Brazilian consensus recommendations on the diagnosis and treatment of light chain amyloidosis.

INTRODUCTION: Systemic immunoglobulin light chain amyloidosis is characterized by the extracellular deposition of misfolded light chains, leading to progressive dysfunction of multiple organs. Diagnosis remains a significant clinical challenge and is frequently delayed due to the presence of nonspecific symptoms, coupled with limited access to specialized diagnostic tools and expertise. Currently, no established national recommendations for the diagnosis and management of this condition exist in Brazil. METHODS: These expert recommendations were developed following a structured advisory meeti

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… Cardiologist Nephrologist Neurologist Dermatologist Gastroenterologist Gastrointestinal surgeon Hepatologist Interventional radiologist Quaternary hospital 5) Which of the following tests for detecting the monoclonal components are available in your clinical practice for investigating AL amyloidosis? … HCPs involved in diagnosis include, but are not limited to, primary care providers, medical internists, cardiologists, nephrologists, neurologists, gastroenterologists and hematologists [ 34 ]. …

Paraparesis and Disseminated Osteolytic Lesions Revealing Cholangiocarcinoma: A Case Report.

Bone metastases in cholangiocarcinoma are uncommon. We report the case of a patient with disseminated osteolytic lesions who was admitted to the Neurology Department for progressive paraparesis. On the computed tomography examination, specific features for cholangiocarcinoma were described, confirmed later by the histopathological aspect of the bone lesions.

Endocrine paraneoplastic syndromes in lung cancer: A call for clinical vigilance (Review).

Endocrine paraneoplastic syndromes (PNS) are uncommon but clinically impactful manifestations associated with malignancies, particularly lung cancer, most notably small-cell lung cancer. These syndromes arise from ectopic hormone production by malignant cells, causing systemic effects that are independent of direct tumor invasion or metastasis. Their presentation often precedes or signals recurrence of the primary cancer, underscoring the importance of early recognition and targeted intervention. Common endocrine PNS in lung cancer include syndrome of inappropriate antidiuretic hormone secreti

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… Managing Zollinger-Ellison syndrome in the context of lung cancer is particularly complex and requires a multidisciplinary approach involving oncologists, gastroenterologists and surgeons. … SIF-AIGO-FIMMG Group; Italian Society of Pharmacology, the Italian Association of Hospital Gastroenterologists, the Italian Federation of General Practitioners. 54. Jin XF, Spampatti MP, Spitzweg C, Auernhammer CJ. …

Bile Acid Malabsorption as a Consequence of Cancer Treatment: Prevalence and Management in the National Leading Centre.

The aim was to establish prevalence of bile acid malabsorption (BAM) and management in patients who underwent treatment for malignancy. Retrospective evaluation of data in patients seen within six months (August 2019-January 2020) was carried out. Demographic, nuclear medicine (Selenium Homocholic Acid Taurine (SeHCAT) scan result), clinical (previous malignancy, type of intervention (medication, diet), response to intervention) and laboratory (vitamin D, vitamin B12 serum levels) data were searched. In total, 265 consecutive patients were reviewed. Out of those, 87/265 (33%) patients (57 fema

Major approaches in early diagnostics of common variable immunodeficiency in adults in Moscow.

Common variable immunodeficiency (CVID) is a primary immunological disease characterized predominantly by hypogammaglobulinemia. The main clinical manifestations are severe recurrent infections that often lead to structural damage of affected organs. The early start of adequate intravenous immunoglobulin therapy has significantly improved the prognosis of this serious disorder. Patients with CVID are also predisposed to autoimmune and lymphoproliferative complications. This article deals with the features of this primary immunodeficiency in adults. Clinical manifestations, immunological featur

Is There a Role for Bismuth in Diarrhea Management?

Diarrhea, an illness of both the developed and developing world, involves the burdensome characteristics of frequent bowel movements, loose stools, and abdominal discomfort. Diarrhea is a long-standing challenge in palliative care and can have a myriad of causes, making symptomatic treatment pertinent when illness evaluation is ongoing, when there is no definitive treatment approach, or when effective treatment cannot be attained. Symptomatic therapy is a common approach in palliative care settings. Bismuth is a suitable agent for symptomatic therapy and can be effectively employed for managem

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… side effect of antibiotic therapy. 4 Diarrhea is also known to be a main symptom of microscopic colitis (MC), 5 – 7 which is a chronic inflammatory disease of the colon with a prevalence of 21–24.7 cases per 100,000 person years in the population. 8 This disease is becoming a more prevalent focus for gastroenterologists … with bismuth, compared to untreated control. 30 Bismuth has also been observed to adhere to the toxins synthesized by E. coli . 28 Microscopic Colitis As mentioned above, MC is an inflammatory condition of the bowel, which has had an increasing incidence 31 , 32 and a growing rate of detection by gastroenterologists …

AGA Clinical Practice Update on the Diagnosis and Management of Atrophic Gastritis: Expert Review.

DESCRIPTION: The purpose of this Clinical Practice Update Expert Review is to provide clinicians with guidance on the diagnosis and manageme … nvariably implies the diagnosis of atrophic gastritis. There should be a coordinated effort between gastroenterologists and pathologists to improve the consistency of documenting the extent and severity of atrophic gastritis, particularly if marked atrophy is present. BEST PRACTICE ADVICE 3: Providers should recognize typical endoscopic features of atrophic gastritis …

AGA Clinical Practice Update on Management of Ampullary Neoplasms: Expert Review.

DESCRIPTION: Although ampullary neoplasia is a rare entity and represents 0.6%-0.8% of gastrointestinal cancers, the incidence among young a … te resection, or suspected malignancy should be discussed by a multidisciplinary team that includes gastroenterologists, surgeons, and oncologists.

Probiotics for treatment of chronic constipation in children.

BACKGROUND: Functional constipation is defined as chronic constipation with no identifiable underlying cause. It is a significant cause of morbidity in children, accounting for up to 25% of visits to paediatric gastroenterologists. Probiotic preparations may sufficiently alter the gut microbiome and promote normal gut physiology in a way that helps relieve functional constipation. Several studies have sought to address this hypothesis, as well as the role of probiotics in other functional gut disorders. Therefore, it is important to have a focused review to assess the evidence to date. OBJECT…

[Dysphagia or dysphagias during neuroleptic medication?].

INTRODUCTION: Dysphagia is a common symptom in the general population, and even more among psychiatric patients, but rarely seen as a sign o … the different mechanisms underlying dysphagia in psychiatric patients, and good communication with gastroenterologists to establish a precise diagnosis of the disorder, and adapt the therapy.

Оценка лечения множественных склерозов и его воздействия на здоровье мозга: опыт Объединенного центра Арабских Эмиратов.

Множественный склероз является хроническим, сложным неврологическим заболеванием, которое часто вызывает как видимые, так и невидимые симптомы, которые существенно влияют на повседневное функционирование. Комплексный подход к многоплановому склерозовому уходу имеет важное значение для благополучия пациентов, особенно в уникальном социокультурном контексте Объединенных Арабских Эмиратов, где такие факторы, как страхование и наличие специалистов, могут создавать дополнительные проблемы. МЕТОДОЛОГИЯ: В одном из специализированных центров Объединенных Арабских Эмиратов было проведено ретроспективн

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… There is access to MS specialized physical therapists and other specialties like urologists, gastroenterologists, internal medicine, and cardiologists. During this study, there was limited access to in-house psychologists or trained psychiatrists. …

AGA Clinical Practice Update on Noncolorectal Cancer Screening and Vaccinations in Patients With Inflammatory Bowel Disease: Expert Review.

DESCRIPTION: The aim of this American Gastroenterological Association (AGA) Clinical Practice Update (CPU) is to provide Best Practice Advice statements for gastroenterologists and other healthcare providers who provide care to patients with inflammatory bowel disease (IBD). The focus is on IBD-specific screenings (excluding colorectal cancer screening, which is discussed separately) and vaccinations. We provide guidance to ensure that patients are up to date with the disease-specific cancer screenings and vaccinations, as well as advice for mental health and general well-being. METHODS: This…

American Gastroenterological Association Clinical Practice Update: Management of Pancreatic Necrosis.

DESCRIPTION: The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update is to review the availabl … ial morbidity and mortality and optimal management requires a multidisciplinary approach, including gastroenterologists, surgeons, interventional radiologists, and specialists in critical care medicine, infectious disease, and nutrition. In situations where clinical expertise may be limited, consideration should be given to transferring patients with significant panc …

A Rare Case of Aggressive Systemic Mastocytosis With Skeletal Osteosclerotic Lesions on Presentation: A Diagnostic Conundrum.

Systemic mastocytosis (SM) is a heterogeneous group of disorders caused by mast cell proliferation. SM often presents with non-specific symptoms making it a diagnostic challenge. Moreover, presentation with bone involvement is highly uncommon. Here, we report a rare case of SM in a 68-year-old female who initially presented with gastrointestinal symptoms and was later found to have sclerotic bone lesions on imaging. This case highlights an unusual presentation of SM, informing clinicians of the importance of keeping this disease process on the differential list of diagnostic conundrums.