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'. Uniquely, the PG-SGA evaluates the patient's status as a dynamic rather than static process. The PG-SGA has received new attention, particularly as a screening instrument for nutritional risk or deficit, identifying treatable impediments and guiding patients and professionals in triaging for interdisciplinary interventions. The international use of the PG-SGA indicates a critical need for high-quality and linguistically validated translations of the PG-SGA. Summary: As a 4-in-1 instrument, the PG-SGA can streamline clinic work flow and improve the quality of interaction between the clinician and the patient. The availability of multiple high-quality language versions of the PG-SGA enables the inclusion of the PG-SGA in international multicenter studies, facilitating meta-analysis and benchmarking across countries

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. Renal function was assessed by estimated glomerular filtration rate (eGFR). All patients completing the randomized trials could participate in an open-label extension study for a further 2.5 years. Uric acid response, the primary end point in the trials, was plasma uric acid \u3c 6.0 mg/dl for 80% of months 3 and 6.Mean eGFR in both pegloticase dosing cohorts remained constant over the randomized treatment phase and long-term open-label extension study. The number of patients achieving uric acid response was similar across CKD stages (32% stage 1, 23% stage 2, 35% stage 3, and 39% stage 4, respectively, P = 0.3). There was no difference in the pegloticase safety profile based on CKD stage. CONCLUSIONS: Pegloticase treatment does not impact eGFR in CKD patients and response to pegloticase is independent of CKD stage. TRIAL REGISTRATION: Clinical trial identifier: NCT00325195

Feasibility of the patient-generated subjective global assessment in long-stay nursing home residents

Lecture based on abstract at APNEP congress 2016, Porto

Agreement between scored patient-generated subjective global assessment (PG-SGA) and the mini nutritional assessment (MNA) in long-stay nursing home residents:an exploratory study

Lecture based on abstract at APNEP congress 2016, Porto

Patient-generated subjective global assessment:innovation from paper to digital app

Purpose: The Patient-Generated Subjective Global Assessment (PG-SGA), including the PG-SGA Short Form (SF, aka ‘abridged’), was originally developed in the mid 1990’s as a scored, patient self-report, paperbased instrument and has been widely validated. The PG-SGA (SF) has been used for screening, assessment and monitoring, triageing for multimodal intervention and for evaluation of clinical and health economic outcomes. There have been ad hoc translations, often with permission of the originator (FDO) but broad international use requires consistent, medically accurate, and certified translations. Although the PG-SGA (or SF) is known to be quick and easy, current advances in technology could further improve and facilitate quick and easy use of global patient screening and assessment, standardized scoring algorithms, limiting inter-observer variability, and global collaboration and communication. We aimed to develop a user friendly, cross-culturally validated, multilingual digital app and resources to support the clinical and research applications of the PG-SGA (SF) and Pt-Global app in the context of a global centralized database and research consortium. Methods: After completion of a Dutch PG-SGA cross-cultural adaptation project, a digital app based on the English and Dutch PG-SGA was developed. Steps included: 1) development and testing of standardized scoring and decision-making algorithms based on the validated PG-SGA scoring system; 2) compatibility with iOS, Android and WindowsPhone platforms; 3) development and pilot testing of prototype by an international test panel (n=35; professionals testing the app on patients as part of routine care process, researchers, and lay persons) from Australia, Belgium, Canada, Norway, Sweden, The Netherlands and USA, evaluating the app on lay-out, user friendliness, relevance and time of completion; 4) improvement based on input; 5) launch of app and supportive website at www.pt-global.org on 12 Jun 2014, including complimentary introductory use; 5) international education activities; 6) digital presence through Twitter, Facebook, LinkedIn and YouTube; 7) launch of web-based version on 15 September 2014. Results: 15 professionals (Pros; 11 dietitians, 1 doctor, 1 physiotherapist) and 2 lay persons participated in the pilot testing. Included settings were: 9 hospitals, 4 cancer centers, 2 nursing homes, 3 research. 8/15 had experience with the PG-SGA, 7/15 PG-SGA were naïve. 5 Pros tested on 1-5 patients, and 9 on 6-10 patients. 88% rated layout (very) good with feedback: calm, professional, clear, intuitive, easy; 88% rated good for user friendliness. 75% rated flow/user interface (very) good. In 88% Patient screens were completed by Pros. Reported time to complete Patient screens was: 65% in 0-5 minutes, 29% in 5-10 min; 6% (n=1) >10 minutes. Interestingly, patients started completing the app spontaneously. Some issues with concerns about touch screen were expressed. 87% completed the professional section in

1997-01-23 Faculty Senate Meeting Minutes

Faculty Senate Meeting Minutes for January 23, 1997

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. Infusions of pegloticase (8 mg) were administered biweekly or monthly; all patients received prophylaxis (antihistamine, acetaminophen, and corticosteroid) and were tested for urate levels prior to each infusion. An IR was defined by protocol as any otherwise unexplained adverse event or cluster of temporally related events occurring during or within 2 hours of infusion. RESULTS: Infusion-related reactions occurred in 94 (45%) of 208 patients receiving pegloticase; 10 patients reported IRs at first infusion and 84 during subsequent infusions. Chest discomfort (15%), flushing (12%), and dyspnea (11%) were the most common symptoms. Most IRs were rated mild or moderate; 7% were rated severe. All IRs resolved with slowing, interrupting, or stopping the infusion. No patient required blood pressure or ventilatory support. Infusion-related reactions were associated with loss of pegloticase urate-lowering efficacy: 91% of all IRs occurred in patients with preinfusion serum uric acid concentrations (sUA) greater than 6 mg/dL. For patients sustaining preinfusion sUA of less than 6 mg/dL, IRs occurred in fewer than 1 per 100 infusions. CONCLUSIONS: Phase 3 trial data combined with post hoc analyses demonstrated that knowledge of sUA preceding each pegloticase infusion and cessation of therapy when urate-lowering efficacy is lost provide a means to optimize the safety of pegloticase in clinical practice

Translation and cultural adaptation of the scored Patient-Generated Subjective Global Assessment (PG-SGA©)

Background and aim: The Patient-Generated Subjective Global Assessment (PG-SGA(C)) is a globally used malnutrition screening, assessment, triage and monitoring tool. The aim of this study was to perform a linguistic and content validation of the translated and culturally adapted version of the PG-SGA for the Danish setting. Method: The study was conducted according to the International Society of Pharmaeconomics and Outcomes Research (ISPOR) Principles of Good Practice for the Translational and Cultural Adaptation Process for Patient-Reported Outcomes Measures. Cancer patients (n = 121) and healthcare professionals (HCPs, n = 80) participated in the cognitive debriefing. A questionnaire was used in the cognitive debriefing in which comprehensibility, difficulty, and content validity (relevance) were quantified by a 4-point scale. Item and scale indices were calculated using the average item ratings divided by the number of respondents for content validity (Item-CVI, Scale-CVI), comprehensibility (Item-CI, Scale-CI) and difficulty (Item-DI, Scale-DI). As pre-defined, item indices = 0.90 were defined as excellent and 0.80-0.89 as acceptable. Results: The patient component of the PG-SGA was rated as excellent content validity (Scale-CVI = 0.95) by HCPs and easy to comprehend (Scale-CI = 0.97) and use (Scale-DI = 0.92) by patients. The professional component of the PG-SGA was rated as acceptable content validity (Scale-CVI = 0.80), but below acceptable for comprehension (Scale-CI = 0.71) and difficulty (Scale-DI = 0.69). The physical exam was rated the least comprehensible Item-CI = 0.51-0.70) and most difficult (Item-DI = 0.33-0.063). Conclusion: The PG-SGA was successfully translated and culturally adapted to the Danish setting. Patients found it easy to understand and to complete. Except for the physical exam, HCPs rated the PG-SGA as relevant, comprehensive, and easy to use. Training of HCPs is recommended before implementing the tool into clinical practise. (C) 2021 The Author(s). Published by Elsevier Ltd on behalf of European Society for Clinical Nutrition and Metabolism