From evidence to care delivery: Opportunities and risks in health and science policy. A position paper of the Association of the Scientific Medical Societies in Germany (AWMF).

Objective: After over 25 years of developing clinical practice guidelines, the Association of the Scientific Medical Societies in Germany (AWMF) held a symposium to discuss the following topics in order to improve the way evidence is implemented in the delivery of care: expansion of the data pool for guideline development, the regulatory policy framework for this expansion, the transfer of clinical practice guideline statements to medical practice, the associated opportunities and risks resulting from the European legislation.

Methods: The AWMF held its Berlin Forum on 27 April 2022 where experts from scientific medical societies and national institutions in the healthcare sector reported their experiences and perceptions on the topics mentioned. Three writing groups compiled the key statements from these contributions to and discussions made at the Berlin Forum into a position paper.

Report from the HarmoSter study: different LC-MS/MS androstenedione, DHEAS and testosterone methods compare well; however, unifying calibration is a double-edged sword.

Objectives: Current liquid chromatography-tandem mass spectrometry (LC-MS/MS) applications for circulating androgen measurements are technically diverse. Previously, variable results have been reported for testosterone. Data are scarce for androstenedione and absent for dehydroepiandrosterone sulfate (DHEAS).

Pharmacokinetics and Efficacy of the Benzothiazinone BTZ-043 against Tuberculous Mycobacteria inside Granulomas in the Guinea Pig Model.

Tuberculosis (TB), caused by Mycobacterium tuberculosis, is the world's leading cause of mortality from a single bacterial pathogen. With increasing frequency, emergence of drug-resistant mycobacteria leads to failures of standard TB treatment regimens. Therefore, new anti-TB drugs are urgently required.

Report from the HarmoSter study: inter-laboratory comparison of LC-MS/MS measurements of corticosterone, 11-deoxycortisol and cortisone.

Objectives: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) panels that include glucocorticoid-related steroids are increasingly used to characterize and diagnose adrenal cortical diseases. Limited information is currently available about reproducibility of these measurements among laboratories. The aim of the study was to compare LC-MS/MS measurements of corticosterone, 11-deoxycortisol and cortisone at eight European centers and assess the performance after unification of calibration.

Step towards elimination of Wuchereria bancrofti in Southwest Tanzania 10 years after mass drug administration with Albendazole and Ivermectin.

Background: Lymphatic filariasis is a mosquito transmitted parasitic infection in tropical regions. Annual mass treatment with ivermectin and albendazole is used for transmission control of Wuchereria bancrofti, the infective agent of lymphatic filariasis in many African countries, including Tanzania.

Methodology: In a general population study in Southwest Tanzania, individuals were tested for circulating filarial antigen, an indicator of W.

Report from the HarmoSter study: impact of calibration on comparability of LC-MS/MS measurement of circulating cortisol, 17OH-progesterone and aldosterone.

Objectives: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is recommended for measuring circulating steroids. However, assays display technical heterogeneity. So far, reproducibility of corticosteroid LC-MS/MS measurements has received scant attention.

Clinical Management and Outcome of Grade III Pneumonitis after Chemoradioimmunotherapy for Inoperable Stage III Non-Small Cell Lung Cancer-A Prospective Longitudinal Assessment.

Background: Maintenance treatment with immune-checkpoint inhibition (ICI) has been shown to significantly improve patient prognosis after chemoradiotherapy (CRT) for inoperable stage III NSCLC. This survival advantage may be achieved at the expense of an increased probability for symptomatic pneumonitis as CRT as well as ICI treatment is associated with the risk of treatment-related pulmonary toxicity.

Methods: We screened a prospective chemoradioimmunotherapy (CRT-IO) cohort consisting of 38 patients and identified patients with therapy-related grade 3 pneumonitis.

Treatment Sequencing for Anaplastic Lymphoma Kinase-Rearranged Non-Small-Cell Lung Cancer.

Non-small-cell lung cancer (NSCLC) accounts for about 85% of all lung cancer cases and is the leading cause of cancer-related deaths. Most NSCLC patients are diagnosed with advanced disease and require systemic treatment. Despite emerging advances in chemotherapy and immunotherapy, the prognosis of stage IV patients remains poor.

Averaging of results derived from different, simultaneously acquired mass transitions in ID-LC-MS/MS - Potential impact on measurement imprecision.

Background: LC-MS/MS allows for many measurands monitoring different mass transitions simultaneously. So far, such alternative mass transitions are usually assessed as "quantifier and qualifier ions" in order to rule out interferences in individual samples. However, quantification can also be based on assessment of alternative mass transitions for both the measurand and its internal standard, with two distinct results for one injection of an individual sample.

From therapeutic drug monitoring to total drug monitoring and drug-omics.

In view of the role of pharmacotherapy in medicine, on the one hand, and the powerful technical possibilities that are now available on the other hand, therapeutic drug monitoring is a surprisingly neglected area of laboratory medicine. In this viewpoint article, an "omics approach" to pharmacovigilance and drug monitoring is proposed and discussed. A realistic goal for laboratory medicine in the 21st century should indeed be to enable clinicians to check whether the right drug is present in the right patient with an appropriate blood concentration for each compound.

Isotope dilution-LC-MS/MS method for quantification of the urinary cotinine-to-creatinine ratio.

Background: Appropriate monitoring of tobacco smoking is extremely important in several areas of medicine, e.g. management of chronic obstructive pulmonary disease (COPD), epidemiological surveys, and allocation of heart or lung transplants.

The design and development of a multicentric protocol to investigate the impact of adjunctive doxycycline on the management of peripheral lymphoedema caused by lymphatic filariasis and podoconiosis.

Background: As new lymphatic filariasis infections are eliminated through mass chemotherapy, previously affected individuals are left with the sequellae, especially chronic progressive lymphoedema. Currently this is managed by careful attention to limb hygiene to prevent infection. Studies over the past 15 years have suggested that the incorporation of doxycycline treatment may arrest or even reverse progression of lymphoedema.

A suggested standard for validation of LC-MS/MS based analytical series in diagnostic laboratories.

•Policies applied to confirm LC-MS/MS-based results differ between laboratories.•We suggest a systematic approach for validation of individual diagnostic series.•An individual series validation plan can be established with a checklist.

Changes of brain DTI in healthy human subjects after 520 days isolation and confinement on a simulated mission to Mars.

Introduction: Long-term confinement is known to be a stressful experience with multiple psycho-physiological effects. In the MARS500 project, a real-time simulation of a space-flight to Mars conducted in a hermetically isolated habitat, effects of long-term confinement could be investigated in a unique manner. The aim of this study was to evaluate effects of long-term-confinement on brain cytoarchitecture.

The views of patients, healthcare professionals and hospital officials on barriers to and facilitators of quality pain management in Ethiopian hospitals: A qualitative study.

Background: Postoperative pain remains a challenge in the developed world, but the consequences of inadequately treated postoperative pain are particularly severe in low- and middle-income countries. Since 2011, reports have drawn attention to the poor quality of postoperative pain management in Ethiopia; however, our multicenter qualitative study was the first to attempt to understand the factors that are barriers to and facilitators of quality pain managment in the country. To this aim, the study explored the perspectives of patients, healthcare professionals, and hospital officials.

The Diagnosis and Treatment of Primary CNS Lymphoma.

Background: Primary central nervous system lymphoma is a diffuse large B-celllymphoma with exclusive manifestation in the central nervous system (CNS), leptomeninges, and eyes. Its incidence is 0.5 per 100 000 persons per year.

Surgical treatment options following chemotherapy plus cetuximab or bevacizumab in metastatic colorectal cancer-central evaluation of FIRE-3.

Background: The FIRE-3 trial investigated combination chemotherapy plus either cetuximab or bevacizumab in patients with untreated metastatic colorectal cancer (mCRC) not scheduled for upfront surgery. We aimed to determine the number of patients who present with potentially resectable disease during systemic first-line therapy and to compare the findings with study reports concerning resections and outcome.

Patients And Methods: This evaluation of 448 patients was performed as central review blinded for treatment, other reviewers' evaluations and conducted interventions.

The impact of phosphate-balanced crystalloid infusion on acid-base homeostasis (PALANCE study): study protocol for a randomized controlled trial.

Background: This study aims to investigate the effects of a modified, balanced crystalloid including phosphate in a perioperative setting in order to maintain a stable electrolyte and acid-base homeostasis in the patient.

Methods/design: This is a single-centre, open-label, randomized controlled trial involving two parallel groups of female patients comparing a perioperative infusion regime with sodium glycerophosphate and Jonosteril® (treatment group) or Jonosteril® (comparator) alone. The primary endpoint is to maintain a stable concentration of weak acids [A] according to the Stewart approach of acid-base balance.

The Perception of Physician Empathy by Patients with Inflammatory Bowel Disease.

Background And Aims: This study focused on the difference between perceived and desired physician empathy (pPE and dPE) in the eye of patients with inflammatory bowel disease (IBD). It was investigated if a discrepancy (ΔPE) correlates with trust and satisfaction of patients. At the same time the aim was to gain detailed information about the subjective burden of disease and the resources of IBD patients, in order to better understand them.

Low expression of galectin-3 is associated with poor survival in node-positive breast cancers and mesenchymal phenotype in breast cancer stem cells.

Background: Galectin-3 (Gal3) plays diverse roles in cancer initiation, progression, and drug resistance depending on tumor type characteristics that are also associated with cancer stem cells (CSCs). Recurrence of breast carcinomas may be attributed to the presence of breast CSCs (BCSCs). BCSCs exist in mesenchymal-like or epithelial-like states and the transition between these states endows BCSCs with the capacity for tumor progression.