Michael Schlichting
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View article: The protein deacetylase SIRT2 exerts metabolic control over adaptive β cell proliferation
The protein deacetylase SIRT2 exerts metabolic control over adaptive β cell proliferation Open
Selective and controlled expansion of endogenous β cells has been pursued as a potential therapy for diabetes. Ideally, such therapies would preserve feedback control of β cell proliferation to avoid excessive β cell expansion. Here, we id…
View article: Cost-effectiveness of cetuximab-containing regimens for squamous cell carcinoma of the head and neck in Italy
Cost-effectiveness of cetuximab-containing regimens for squamous cell carcinoma of the head and neck in Italy Open
CCRs are likely to represent a comparable or more effective treatment option compared to pembrolizumab ± chemotherapy. Model results consistently demonstrated that CCRs are a cost-effective treatment strategy. CCRs remain a relevant treatm…
View article: Avelumab First-line Maintenance for Advanced Urothelial Carcinoma: Long-term Analyses of Patient-reported Outcomes and Quality-adjusted Time Without Symptoms or Toxicity from the JAVELIN Bladder 100 Trial
Avelumab First-line Maintenance for Advanced Urothelial Carcinoma: Long-term Analyses of Patient-reported Outcomes and Quality-adjusted Time Without Symptoms or Toxicity from the JAVELIN Bladder 100 Trial Open
View article: Handling missing values in patient-reported outcome data in the presence of intercurrent events
Handling missing values in patient-reported outcome data in the presence of intercurrent events Open
Introduction As patient-reported outcomes (PROs) are increasingly used in the evaluation of medical treatments, it is important that PROs are carefully analyzed and interpreted. This may be challenging due to substantial missing values. Th…
View article: The role of the estimand framework in the analysis of patient-reported outcomes in single-arm trials: a case study in oncology
The role of the estimand framework in the analysis of patient-reported outcomes in single-arm trials: a case study in oncology Open
View article: Metabolic control of adaptive β-cell proliferation by the protein deacetylase SIRT2
Metabolic control of adaptive β-cell proliferation by the protein deacetylase SIRT2 Open
Selective and controlled expansion of endogenous β-cells has been pursued as a potential therapy for diabetes. Ideally, such therapies would preserve feedback control of β-cell proliferation to avoid excessive β-cell expansion and an incre…
View article: Methodological Work and Use of Patient-Reported Outcomes Data in Randomised Controlled Trials (Rcts) in Cancer: Literature Reviews on Current Practices and Guidelines
Methodological Work and Use of Patient-Reported Outcomes Data in Randomised Controlled Trials (Rcts) in Cancer: Literature Reviews on Current Practices and Guidelines Open
View article: Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures
Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures Open
View article: Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice
Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice Open
View article: Development of a Conceptual Model of the Patient Experience in Small Cell Lung Cancer: A Qualitative Interview Study
Development of a Conceptual Model of the Patient Experience in Small Cell Lung Cancer: A Qualitative Interview Study Open
View article: Investigating the trends in patient-reported outcomes pre-treatment and implications to efficacy analyses: A post-hoc analysis of a cancer clinical trial
Investigating the trends in patient-reported outcomes pre-treatment and implications to efficacy analyses: A post-hoc analysis of a cancer clinical trial Open
View article: Engineered vasculature induces functional maturation of pluripotent stem cell-derived islet organoids
Engineered vasculature induces functional maturation of pluripotent stem cell-derived islet organoids Open
Blood vessels play a critical role in pancreatic islet health and function, yet current culture methods to generate islet organoids from human pluripotent stem cells (SC-islets) lack a vascular component. Here, we engineered 3D vascularize…
View article: Interpreting Within-Patient Changes on the EORTC QLQ-C30 and EORTC QLQ-LC13
Interpreting Within-Patient Changes on the EORTC QLQ-C30 and EORTC QLQ-LC13 Open
This study confirms the appropriateness of the 10-point EORTC score threshold generally used by the field for interpreting within-patient changes, but the thresholds proposed from this study enhance interpretability by corresponding to onl…
View article: Patient-reported outcomes in the context of the benefit assessment in Germany
Patient-reported outcomes in the context of the benefit assessment in Germany Open
Since the 2011 Act on the Reform of the Market for Medicinal Products, benefit dossiers are submitted by pharmaceutical companies to facilitate the Health Technology Assessment (HTA) appraisals in Germany. The Institute for Quality and Eff…
View article: Patient-reported outcomes in the context of the benefit assessment in\n Germany
Patient-reported outcomes in the context of the benefit assessment in\n Germany Open
Since the 2011 Act on the Reform of the Market for Medicinal Products,\nbenefit dossiers are submitted by pharmaceutical companies to facilitate the\nHealth Technology Assessment (HTA) appraisals in Germany. The Institute for\nQuality and …
View article: How Assessment-Schedule Matching Limits Bias When Comparing Progression-Free Survival in Single-Arm Studies: An Application in Second-Line Urothelial Carcinoma Treatments
How Assessment-Schedule Matching Limits Bias When Comparing Progression-Free Survival in Single-Arm Studies: An Application in Second-Line Urothelial Carcinoma Treatments Open
Small variations in assessment schedules can introduce bias in unanchored indirect treatment comparisons of interval-censored time-to-event outcomes. In this study, adjusted PFS was comparable across second-line urothelial carcinoma treatm…
View article: Single-cell chromatin accessibility identifies pancreatic islet cell type– and state-specific regulatory programs of diabetes risk
Single-cell chromatin accessibility identifies pancreatic islet cell type– and state-specific regulatory programs of diabetes risk Open
View article: What is the Impact of the Analysis Method Used for Health State Utility Values on QALYs in Oncology? A Simulation Study Comparing Progression-Based and Time-to-Death Approaches
What is the Impact of the Analysis Method Used for Health State Utility Values on QALYs in Oncology? A Simulation Study Comparing Progression-Based and Time-to-Death Approaches Open
View article: Health-related quality of life trajectory of treatment-naive patients with Merkel cell carcinoma receiving avelumab
Health-related quality of life trajectory of treatment-naive patients with Merkel cell carcinoma receiving avelumab Open
Aim: To evaluate changes in health-related quality of life (HRQoL) in a Phase II trial (NCT02155647) of treatment-naive patients with metastatic Merkel cell carcinoma treated with avelumab (15-month follow-up). Materials & method…
View article: Vorsicht beim Import schamanischer Heilmethoden!
Vorsicht beim Import schamanischer Heilmethoden! Open
Summary „Das zunehmende Unbehagen in unserer Gesellschaft gegenüber Konzepten und Behandlungsmethoden des wissenschaftlich-medizinischen Establishments führt unter Patienten zu einer seit Jahren steigenden Nachfrage nach alternativen Heilv…
View article: Update on the psychometric properties and minimal important difference (MID) thresholds of the FACT-M questionnaire for use in treatment-naïve and previously treated patients with metastatic Merkel cell carcinoma
Update on the psychometric properties and minimal important difference (MID) thresholds of the FACT-M questionnaire for use in treatment-naïve and previously treated patients with metastatic Merkel cell carcinoma Open
Objectives For valid and reliable assessment of patients’ Health-Related Quality of Life (HRQoL), it is crucial to use psychometrically robust instruments. In the context of rare diseases such as Merkel cell carcinoma (MCC), validated dise…
View article: Evaluation of survival extrapolation in immuno-oncology using multiple pre-planned data cuts: learnings to aid in model selection
Evaluation of survival extrapolation in immuno-oncology using multiple pre-planned data cuts: learnings to aid in model selection Open
Background Due to limited duration of follow up in clinical trials of cancer treatments, estimates of lifetime survival benefits are typically derived using statistical extrapolation methods. To justify the method used, a range of approach…
View article: Programmed Death-Ligand 1 Immunohistochemistry Assay Comparison Studies in NSCLC: Characterization of the 73-10 Assay
Programmed Death-Ligand 1 Immunohistochemistry Assay Comparison Studies in NSCLC: Characterization of the 73-10 Assay Open
The 73-10 assay demonstrated high sensitivity for PD-L1 staining, and staining was comparable between the greater than or equal to 80% cutoff of the 73-10 assay and greater than or equal to 50% cutoff of the 22C3 assay.
View article: Single cell chromatin accessibility reveals pancreatic islet cell type- and state-specific regulatory programs of diabetes risk
Single cell chromatin accessibility reveals pancreatic islet cell type- and state-specific regulatory programs of diabetes risk Open
Genetic risk variants for complex, multifactorial diseases are enriched in cis -regulatory elements. Single cell epigenomic technologies create new opportunities to dissect cell type-specific mechanisms of risk variants, yet this approach …
View article: Correction to: Psychometric properties of the FACT-M questionnaire in patients with Merkel cell carcinoma
Correction to: Psychometric properties of the FACT-M questionnaire in patients with Merkel cell carcinoma Open
View article: Early objective response to avelumab treatment is associated with improved overall survival in patients with metastatic Merkel cell carcinoma
Early objective response to avelumab treatment is associated with improved overall survival in patients with metastatic Merkel cell carcinoma Open
Patients with OR by 7 or 13 weeks had significantly longer OS than patients without, confirming that early OR is an endpoint of major importance.
View article: Nonprogression with Avelumab Treatment Associated with Gains in Quality of Life in Metastatic Merkel Cell Carcinoma
Nonprogression with Avelumab Treatment Associated with Gains in Quality of Life in Metastatic Merkel Cell Carcinoma Open
In patients with metastatic Merkel cell carcinoma, nonprogression during treatment with avelumab correlated with gains in HRQoL.
View article: Psychometric properties of the FACT-M questionnaire in patients with Merkel cell carcinoma
Psychometric properties of the FACT-M questionnaire in patients with Merkel cell carcinoma Open
This study is a post-hoc analysis conducted on data collected in Part A of the JAVELIN Merkel 200 trial. This trial was registered on 2 June 2014 with ClinicalTrials.gov as NCT02155647 .