BackgroundDespite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials.MethodsA conceptual model for SLE was developed from structured review of published articles from 2007 to August 2013 identified from literature databases (MEDLINE, EMBASE, PsycINFO, EconLit) plus other sources (PROLabels, FDA/EMA websites, Clinicaltrials.gov). PROs targeting key symptoms/impacts were identified from the literature. They were reviewed in the context of available guidance and assessed for face and content validity and psychometric properties to determine appropriateness for use in SLE trials.ResultsThe conceptual model identified fatigue, pain, cognition, daily activities, emotional well-being, physical/social functioning and work productivity as key SLE concepts. Of the 68 articles reviewed, 38 reported PRO data. From these and the other sources, 15 PROs were selected for review, including SLE-specific health-related quality of life (HRQoL) measures (n = 5), work productivity (n = 1), and generic measures of fatigue (n = 3), pain (n = 2), depression (n = 2) and HRQoL (n = 2). The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue), Brief Pain Inventory (BPI-SF) and LupusQoL demonstrated the strongest face validity, conceptual coverage and psychometric properties measuring key concepts in the conceptual model. All PROs reviewed, except for three Lupus-specific measures, lacked qualitative SLE patient involvement during development. The Hospital Anxiety and Depression Scale (HADS), Short Form [36 item] Health Survey version 2 (SF-36v2), EuroQoL 5-dimensions (EQ-5D-3L and EQ-5D-5L) and Work Productivity and Activity Impairment Questionnaire: Lupus (WPAI:Lupus) showed suitability for SLE economic models.ConclusionsBased on the identification of key symptoms and impacts of SLE using a scientifically sound conceptual model, we conclude that SLE is a condition associated with high unmet need and considerable burden to patients. This review highlights the availability and need for disease-specific and generic patient-reported measures of relevant domains of disease signs and symptoms, HRQoL and work productivity, providing useful insight for SLE clinical trial design.

The findings suggest that the Post Stroke Checklist is a feasible and useful measure for identifying long term stroke care needs in a clinical practice setting. Pilot testing indicated that the Post Stroke Checklist is able to identify a wide range of unmet needs, and patient and clinician feedback indicated a high level of satisfaction with the Post Stroke Checklist assessment. The items were generally well understood and considered relevant to stroke survivors, indicating the Post Stroke Checklist is a feasible, useful, and relevant measure of poststroke care.

Background: Weight management is complex even in times of stability. Supporting individuals to develop strategies to maintain a healthier weight is beneficial. This paper reports data from an ongoing mixed-methods study describing the impact the COVID-19 lockdown situation had on people engaged in weight management. Information on health-related behaviours and well-being was captured from surveys completed by Slimming World (SW) members 0-4 weeks after joining providing pre-joining and baseline (T0&T1) data, and after 3 (T2) and 6 months (T3-during COVID-19). Representative samples from the general population, not attending a weight management service, completed the same questionnaires.Results: 1884 SW members completed the baseline survey and 222 completed all three surveys up to May 2020, achieving a weight loss of 7.7±7.5% during this time. SW members were able to maintain most of the positive health-related behaviour changes they had made since joining, including increased fruit and vegetable consumption (p<0.001), having fewer sugary drinks (P<0.001), cooking from scratch more (p<0.001) and increasing activity levels (p<0.001). During the COVID-19 situation members were still reporting improvements in all behaviours compared to before joining and had healthier scores than the general population on all but alcohol intake, although still within guidelines. Qualitative data indicated that the COVID-19 situation created various challenges to managing weight for both groups with fresh foods harder to access, comfort eating, drinking more alcohol, eating more sugary foods and snacking through boredom. However, some people also reported having more free time enabling better planning, more time to cook from scratch and increased physical activity.Conclusions: The findings highlight the value of supporting individuals to develop sustainable behaviour changes and a level of resilience to draw upon and manage their weight even in challenging times.

ObjectivesMany hospitals cannot afford an hCG assay on a central lab analyzer and turn to point of care testing (POCT) solutions. The Radiometer AQT90 FLEX is a small benchtop immunoareement between the AQT90 and comparator methods for samples with hCG ssay analyzer for use in the laboratory or at the patient bedside. This study evaluated the analytical performance of the AQT90's βhCG assay.MethodsPrecision was assessed using whole blood patient samples and two levels of quality control. Linearity was assessed by dilution of a high hCG plasma sample. Carryover and hook effect were assessed using high and low hCG samples. Method comparisons were done against Abbott i-STAT Total βhCG, Beckman Coulter Total βhCG (5th IS), and Roche hCG+β. Sample concentrations ranged from<2 IU/L to 4,973 IU/L.ResultsRepeatability and within-laboratory precision passed most manufacturer's claims and allowable error criteria. Linearity was validated from<2 IU/L to 4,741 IU/L. Hook effect was not observed up to 2,446,448 IU/L. Carryover was<4.0 ppm. A linear relationship was observed with i-STAT, Beckman and Roche methods. At>20 IU/L, biases were apparent against all three comparator assays (i-STAT: +20%, Roche: +30%, Beckman: +5 to 15%). At ≤20 IU/L, the acceptability of agreement varied according to TAE specifications. Concordance between AQT90 and comparator assays using 5 IU/L as the medical decision level ranged from 69% to 81%.ConclusionsOverall, the AQT90 hCG assay performed well and would be suitable for smaller suburban or rural hospitals. Some limitations have been noted and should be kept in mind during clinical testing.

Background Weight management is complex for people even in times of stability. Supporting individuals to develop strategies to maintain a healthier weight when there are additional life challenges may prevent relapse. This mixed-methods study describes the impact the COVID-19 restrictions had on adults engaged in weight management before and during the pandemic in order to determine helpful strategies. Methods Longitudinal data was captured from online surveys completed by Slimming World (SW) members 0–4 weeks after joining, October/November 2019, providing pre-joining and baseline (T0&T1), 3- (T2) and 6- month (T3-during COVID-19) data. Representatives from the general population, not attending a weight management service, completed the same questionnaires providing cross-sectional control data. All weights are self-reported. For this study, questions assessing the impact of the COVID-19 challenges on health-related behaviours and well-being are included comparing responses at T0/T1, T2 & T3. Longitudinal data were analysed using repeated measures ANOVA and cross-sectional data, one-way independent ANOVAs to compare means. Comparisons between SW members and controls were determined using z-proportion tests. Qualitative data generated was thematically analysed using a six-step approach to produce the key emerging themes. Results 222 SW members completed all three surveys, achieving a weight loss of 7.7 ± 7.5%. They maintained positive health-related behaviour changes made since joining, including increased fruit and vegetables (p < 0.001), fewer sugary drinks (p < 0.001), cooking from scratch (p < 0.001) and increased activity levels (p < 0.001). Despite COVID-19 restrictions, they were still reporting improvements in all behaviours and had healthier scores than the controls on all but alcohol intake, although still within guidelines. Qualitative data indicated that the situation created various challenges to managing weight with fresh foods harder to access, comfort eating, drinking more alcohol, eating more sugary foods and snacking through boredom. However, some reported having more free time enabling better planning, more time to cook from scratch and increased physical activity. Conclusions The findings highlight the value of peer, group and online support and guidance for individuals to develop sustainable behaviour changes and a level of resilience. These strategies can then be drawn upon enabling maintenance of lifestyle changes and management of weight even in challenging times.