Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies.

Introduction: This study evaluated the safety and tolerability of fezolinetant in women with vasomotor symptoms (VMS) due to menopause in a pooled analysis of data from three 52-week phase 3 studies (SKYLIGHT 1, 2, and 4).

Methods: SKYLIGHT 1 and 2 were double-blind, placebo-controlled studies where women (≥ 40 to ≤ 65 years), with moderate to severe VMS (minimum average ≥ 7 hot flashes/day) were randomized to once-daily placebo, fezolinetant 30 mg or 45 mg. After 12 weeks, those on placebo were re-randomized to fezolinetant 30 mg or 45 mg, while those on fezolinetant continued on their assigned dose for 40 weeks.

Translation, cultural adaptation, and assessment of the linguistic and content validity of the PG-SGA to the Spanish linguistic setting by cancer patients and healthcare professionals.

Purpose: Malnutrition is frequent in hospitalized patients and is related to functional decline and poorer clinical outcomes. The Patient-Generated Subjective Global Assessment (PG-SGA) is a globally implemented malnutrition tool. We aimed to perform a linguistic and content validation of the translation and cultural adaptation of the PG-SGA for the Spanish language setting.

Swedish translation and cultural adaptation of the scored Patient-Generated Subjective Global Assessment (PG-SGA©)-A validated tool for screening and assessing malnutrition in clinical practice and research.

Introduction: The scored Patient-Generated Subjective Global Assessment (PG-SGA©) is a validated tool for the screening, assessment and monitoring of malnutrition, and triaging of interventions. It contains a patient-generated component and a healthcare professional (HCP)-generated component.

Aim: To translate the PG-SGA into Swedish, assess the linguistic and content validity of the Swedish version, and ensure conceptional, semantic and operational equivalence to the original English PG-SGA.

Phase I/II study to assess the clinical pharmacology and safety of single ascending and multiple subcutaneous doses of PF-06881894 in women with non-distantly metastatic breast cancer.

Purpose: To evaluate the pharmacodynamics (PD), pharmacokinetics (PK), and safety of single and multiple doses of PF-06881894 (pegfilgrastim-apgf; Nyvepria), a biosimilar to reference pegfilgrastim (Neulasta), in women with non-distantly metastatic breast cancer.

Methods: In Phase I (Cycle 0) of this Phase I/II study, the PD response (absolute neutrophil count [ANC]; CD34 + count), PK profile, and safety of a single 3- or 6-mg subcutaneous dose of PF-06881894 were assessed in chemotherapy-naïve patients before definitive breast surgery. In Phase II (Cycles 1-4), the PD response (duration of severe neutropenia [DSN, Cycle 1], ANC [Cycles 1 and 4]) and PK profile (Cycles 1 and 4) of single and multiple 6-mg doses of PF-06881894 concomitant with chemotherapy and after definitive breast surgery were assessed.

A Japanese translation, cultural adaptation, and linguistic and content validity confirmation of the Scored Patient-Generated Subjective Global Assessment.

Purpose: The Scored Patient-Generated Subjective Global Assessment (PG-SGA) is a globally recognized and used nutritional screening, assessment, monitoring, and triaging tool. The aim of this study was to translate and culturally adapt the original English PG-SGA for the Japanese speaking populations and to assess its linguistic validity (i.e.

Greek translation and cultural adaptation of the scored patient-generated subjective global assessment: A nutritional assessment tool suitable for cancer patients.

Background And Aims: Patients with cancer frequently present with disease-related malnutrition and functional decline. The scored Patient-Generated Subjective Global Assessment (PG-SGA©) is a malnutrition screening and assessment tool commonly used in patients with cancer. The aim of the current study was to translate and culturally adapt the original English PG-SGA for the Greek setting, including assessment of comprehensibility, difficulty and content validity in patients and healthcare professionals.

Linguistic and content validation of the translated and culturally adapted PG-SGA, as perceived by Norwegian cancer patients and healthcare professionals.

Background & Aims: The Scored Patient-Generated Subjective Global Assessment (PG-SGA©) is a validated nutritional screening, assessment, monitoring, and triage tool. When translated to other languages, the questions and answering items need to be conceptually, semantically, and operationally equivalent to the original tool. In this study, we aimed to assess linguistic and content validity of the PG-SGA translated and culturally adapted for the Norwegian setting, as perceived by Norwegian cancer patients and healthcare professionals (HCPs).

Prevalence of Malnutrition or Risk in Residents in Long Term Care: Comparison of Four Tools.

The ideal tool for determination of malnutrition risk or malnutrition in long term care (LTC) is elusive. This study compares prevalence, association with resident risk factors and sensitivity (SE) and specificity (SP) of malnutrition or risk categorization in 638 residents from 32 LTC homes in Canada using four tools: the Mini-Nutritional Assessment Short Form (MNA-SF); Patient-Generated Subjective Global Assessment (PG-SGA) Global Category Rating and the Pt-Global webtool; and the interRAI Long Term Care Facility undernutrition trigger. Prevalence was most common with MNA-SF (53.

Self-Completion of the Patient-Generated Subjective Global Assessment Short Form Is Feasible and Is Associated With Increased Awareness on Malnutrition Risk in Patients With Head and Neck Cancer.

Background: We aimed to assess feasibility of self-completion of the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF) by head and neck cancer patients, and to assess self-reported increased awareness regarding malnutrition risk after self-completion.

Methods: Participants were randomized to complete the PG-SGA SF by paper or app. Feasibility was assessed by time needed to complete the PG-SGA SF, perceived difficulty, and help needed during completion.

PF-06881893 (Nivestym™), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers.

Background: Three comparative clinical studies assessed the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and safety of PF-06881893 (filgrastim-aafi; Nivestym™), a filgrastim biosimilar, versus US-licensed reference product (filgrastim; US-Neupogen) in healthy volunteers (HVs).

Methods: Two separate open-label, crossover-design PK/PD studies were conducted: a single-dose study (n = 24) and a multiple-dose study (n = 60). In each study, HVs were randomized to Nivestym followed by US-Neupogen, or vice versa.

Tri-country translation, cultural adaptation, and validity confirmation of the Scored Patient-Generated Subjective Global Assessment.

Purpose: The Scored Patient-Generated Subjective Global Assessment (PG-SGA) is the only malnutrition (risk) assessment tool that combines patient-generated measures with professional-generated (medical) factors. We aimed to apply international standards to produce a high quality, validated, translation and cultural adaptation of the original PG-SGA for the Austrian, German, and Swiss setting.

Methods: Analogue to methodology used for the Dutch, Portuguese, and Thai versions of PG-SGA, the ten steps of the International Society for Pharmacoeconomics and Outcomes Research's principles of good practice for translation and cultural adaptation were followed.

Assessing nutritional status in cancer: role of the Patient-Generated Subjective Global Assessment.

Purpose Of Review: The Scored Patient-Generated Subjective Global Assessment (PG-SGA) is used internationally as the reference method for proactive risk assessment (screening), assessment, monitoring and triaging for interventions in patients with cancer. This review aims to explain the rationale behind and data supporting the PG-SGA, and to provide an overview of recent developments in the utilization of the PG-SGA and the PG-SGA Short Form.

Recent Findings: The PG-SGA was designed in the context of a paradigm known as 'anabolic competence'.

Translation and Cultural Adaptation of the Scored Patient-Generated Subjective Global Assessment: An Interdisciplinary Nutritional Instrument Appropriate for Dutch Cancer Patients.

Background: Assessment of malnutrition is important in cancer patients. The Scored Patient-Generated Subjective Global Assessment (PG-SGA), an instrument that enables interdisciplinary assessment of malnutrition and its risk factors, was not available in Dutch.

Objective: Translation and cultural adaption of the original English PG-SGA to the Dutch setting.

Content validity across methods of malnutrition assessment in patients with cancer is limited.

Objective: To identify malnutrition assessment methods in cancer patients and assess their content validity based on internationally accepted definitions for malnutrition.

Study Design And Setting: Systematic review of studies in cancer patients that operationalized malnutrition as a variable, published since 1998. Eleven key concepts, within the three domains reflected by the malnutrition definitions acknowledged by European Society for Clinical Nutrition and Metabolism (ESPEN) and the American Society for Parenteral and Enteral Nutrition (ASPEN): A: nutrient balance; B: changes in body shape, body area and body composition; and C: function, were used to classify content validity of methods to assess malnutrition.

Infusion-related reactions with pegloticase, a recombinant uricase for the treatment of chronic gout refractory to conventional therapy.

Background: In clinical trials of pegloticase, a PEGylated uricase developed for treatment of gout refractory to conventional therapy, infusion-related reactions (IRs) were the second most frequent adverse event reported.

Objective: The objective of this study was to provide a detailed account of IRs with pegloticase therapy.

Methods: Data from 2 replicate, 6-month randomized trials and an open-label extension study were pooled.

Effect of pegloticase on renal function in patients with chronic kidney disease: a post hoc subgroup analysis of 2 randomized, placebo-controlled, phase 3 clinical trials.

Background: Pegloticase is approved in the US for treatment of refractory chronic gout. Since chronic kidney disease (CKD) is common in these patients, we conducted a post-hoc analysis of 2 replicate phase 3 trials and the subsequent open-label extension study to determine the effects of pegloticase on renal function in patients with CKD stages 3 and 4, as well as the effects of renal dysfunction on pegloticase efficacy and safety.

Findings: Patients with renal insufficiency were randomized to pegloticase 8 mg every 2 weeks (n = 42), pegloticase 8 mg every 4 weeks (n = 41), or placebo (n = 20) for 6 months as defined by the study protocols.