Exploring the Perspectives of Patients Living With Lupus: Retrospective Social Listening Study.

BACKGROUND: Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory disease affecting various organs with a wide range of clinical manifestations. Cutaneous lupus erythematosus (CLE) can manifest as a feature of SLE or an independent skin ailment. Health-related quality of life (HRQoL) is frequently compromised in individuals living with lupus. Understanding patients' perspectives when living with a disease is crucial for effectively meeting their unmet needs. Social listening is a promising new method that can provide insights into the experiences of patients living with their disease (lupus) and leverage these insights to inform drug development strategies for addressing their unmet needs. OBJECTIVE: The objective of this study is to explore the experience of patients living with SLE and CLE, including their disease and treatment experiences, HRQoL, and unmet needs, as discussed in web-based social media platforms such as blogs and forums. METHODS: A retrospective exploratory social listening study was conducted across 13 publicly available English-language social media platforms from October 2019 to January 2022. Data were processed using natural language processing and knowledge graph tagging technology to clean, format, anonymize, and annotate them algorithmically before feeding them to Pharos, a Semalytix proprietary data visualization and analysis platform, for further analysis. Pharos was used to generate descriptive data statistics, providing insights into the magnitude of individual patient experience variables, their differences in the magnitude of variables, and the associations between algorithmically tagged variables. RESULTS: A total of 45,554 posts from 3834 individuals who were algorithmically identified as patients with lupus were included in this study. Among them, 1925 (authoring 5636 posts) and 106 (authoring 243 posts) patients were identified as having SLE and CLE, respectively. Patients frequently mentioned various symptoms in relation to SLE and CLE including pain, fatigue, and rashes; pain and fatigue were identified as the main drivers of HRQoL impairment. The most affected aspects of HRQoL included "mobility," "cognitive capabilities," "recreation and leisure," and "sleep and rest." Existing pharmacological interventions poorly managed the most burdensome symptoms of lupus. Conversely, nonpharmacological treatments, such as exercise and meditation, were frequently associated with HRQoL improvement. CONCLUSIONS: Patients with lupus reported a complex interplay of symptoms and HRQoL aspects that negatively influenced one another. This study demonstrates that social listening is an effective method to gather insights into patients' experiences, preferences, and unmet needs, which can be considered during the drug development process to develop effective therapies and improve disease management.

Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators.

Patients, life science industry and regulatory authorities are united in their goal to reduce the disease burden of patients by closing remaining unmet needs. Patients have, however, not always been systematically and consistently involved in the drug development process. Recognizing this gap, regulatory bodies worldwide have initiated patient-focused drug development (PFDD) initiatives to foster a more systematic involvement of patients in the drug development process and to ensure that outcomes measured in clinical trials are truly relevant to patients and represent significant improvements to their quality of life. As a source of real-world evidence (RWE), social media has been consistently shown to capture the first-hand, spontaneous and unfiltered disease and treatment experience of patients and is acknowledged as a valid method for generating patient experience data by the Food and Drug Administration (FDA). While social media listening (SML) methods are increasingly applied to many diseases and use cases, a significant piece of uncertainty remains on how evidence derived from social media can be used in the drug development process and how it can impact regulatory decision making, including legal and ethical aspects. In this policy paper, we review the perspectives of three key stakeholder groups on the role of SML in drug development, namely patients, life science companies and regulators. We also carry out a systematic review of current practices and use cases for SML and, in particular, highlight benefits and drawbacks for the use of SML as a way to identify unmet needs of patients. While we find that the stakeholders are strongly aligned regarding the potential of social media for PFDD, we identify key areas in which regulatory guidance is needed to reduce uncertainty regarding the impact of SML as a source of patient experience data that has impact on regulatory decision making.

[Salmonella in laying hens: what does voluntary monitoring tell us?]. / Trendbetrachtung von Salmonellen bei Legehennenherden--was sagen uns freiwillige Untersuchungen?

Based on voluntary examinations for Salmonella in laying hen flocks in Germany, it was investigated whether a statistically significant trend in Salmonella prevalence could be observed in the period 2003 to 2007. Furthermore, it was studied whether the implementation of Regulation (EC) No 1168/2006 led to an improvement of the collected data and a change in the Salmonella prevalence in 2008. To compensate for differences in data availability, submitted data were weighted by regional laying hen population size and compared with results from the non-weighted data. Between the years 2003 to 2007 a significant reduction of Salmonella prevalence could be observed. Weighting of data by population size improved trend recognition for routine sampling results. This may point towards a real reduction of Salmonella prevalence in German layer flocks in the years till 2007. The obligatory implementation of the control programme in 2008 led to a remarkable increase of examinations performed and an increased frequency of detection of Salmonella in flocks of laying hens. This tendency was statistically highly significant (p < 0,0042) for the overall dataset as well as for data from targeted sampling and other sampling. Again, after weighting data from routine sampling, a statistically significant (p < 0.05) increase of Salmonella prevalence could be shown. The two dominant serovars in human salmonellosis, namely S. Enteritidis and S. Typhimurium were most frequently observed in German laying hen flocks with S. Enteritidis being much more recurrent than S. Typhimurium. It is obvious from the available data that a good data quality is the prerequisite for a realistic evaluation of the Salmonella situation and that weighting may compensate for some of the bias inherent in the data reporting system.

Chemiluminescent immunoassay in comparison with the indirect ELISA as reference method for detecting Salmonella antibodies in swine meat juice.

The efficiency of chemiluminescent immunoassay (CLIA) in detecting Salmonella antibodies in the meat juice of slaughter swine was compared with the indirect ELISA (BgVV method). Based on the screening test results of 987 meat juice samples obtained from different laboratories in Germany, a good level of agreement between the two systems was obtained with a kappa value of 0.824 at 20% cut-off and 0.798 at 40% cut-off. At 20% and 40% cut-off levels, a sensitivity of 96.2% and 97.3%, respectively, and a specificity of 94.6% and 95.1%, respectively, were demonstrated between CLIA and ELISA. The detecting LPS antigen was tested for specificity and a cross-reaction with two E. coli and Yersinia strains was found when tested with ELISA. This reaction was not observed in CLIA, possibly because of the broader measurement spectrum of this test which allows a more distinctive definition of immunologic reactions. The same explanation can be given for the increased number of meat juice samples which were positively detected only in ELISA but not in CLIA. The positively classified samples in screening were further tested for reciprocal titers in both test systems, and a higher correlation between screening and titration results was obtained for CLIA. Towards the end of the study, a preliminary comparison of CLIA with two available commercial ELISA test kits was conducted and the same tendency was observed, namely, wider detection range of CLIA compared to the other tests. Based on the results of this study, CLIA can be used as a reference method in detecting Salmonella antibodies in the meat juice of slaughter pigs.