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Shaffer Hyllested posted an update 6 months, 4 weeks ago
Four overarching themes relating to RA patients’ preferences for treatment modification were identified (i) patient satisfaction, (ii) patients’ beliefs, (iii) information needs, and (iv) patient-clinician relationships.
Uptake of treatment changes in clinical practice can be improved by understanding how RA patients approach the decision to modify their treatment and how this relates to their satisfaction, beliefs, information needs, and relationships with clinicians. Future work is needed to systematically determine the significance of these factors in RA patients’ decision-making processes.
Uptake of treatment changes in clinical practice can be improved by understanding how RA patients approach the decision to modify their treatment and how this relates to their satisfaction, beliefs, information needs, and relationships with clinicians. Future work is needed to systematically determine the significance of these factors in RA patients’ decision-making processes.
Non-alcoholic steatohepatitis (NASH) is a progressive form of non-alcoholic fatty liver disease characterized by excessive liver fat accumulation, inflammation, cell injury, and fibrosis. It is viewed as largely asymptomatic in its earlier (non-cirrhotic) stages, and information on the patient-perceived impact of NASH is scarce.
This study aimed to develop a NASH-specific patient-reported outcome (PRO) measure (NASH-CHECK) for use as a trial endpoint, using methods compliant with regulatory expectations.
A NASH conceptual model was developed based on the literature and clinical/patient expert review. The model guided concept elicitation (CE) interviews in patients with non-cirrhotic NASH recruited via a US tertiary care center. NASH-CHECK content was generated via thematic analysis of CE data and review by clinical/patient experts. Cognitive debriefing (CD) interviews with US patients evaluated content validity.
The literature review confirmed that NASH impacts on functioning and health-related quality of life (HRQoL). Overall, 23 CE and 20 CD interviews were conducted. Key symptoms reported in CE interviews included pain in the upper-right abdomen (n=14), fatigue (n=18), poor sleep quality (n=12), impaired memory (n=13), and reduced focus (n=11); key HRQoL impacts included impaired physical functioning, reduced ability to conduct daily living tasks, reduced quality of relationships, low mood, anxiety, and self-consciousness. The 52-item first-draft NASH-CHECK was reduced to 31 items based on patient feedback on item relevance, acceptability, and comprehension.
The interviews revealed key symptoms and broad HRQoL impacts of NASH. As a disease-specific PRO measure assessing symptoms and HRQoL, the NASH-CHECK is relevant, comprehensive, and acceptable to patients and clinicians.
The interviews revealed key symptoms and broad HRQoL impacts of NASH. As a disease-specific PRO measure assessing symptoms and HRQoL, the NASH-CHECK is relevant, comprehensive, and acceptable to patients and clinicians.
Outcome prediction in patients with acute respiratory distress syndrome (ARDS) greatly improves when patients are reclassified based on predefined arterial oxygen partial pressure to fractional inspired oxygen ratios (PaO
/FiO
) and positive end-expiratory pressure (PEEP) cutoffs 24 h after the initial ARDS diagnosis. The aim of this study was to test whether outcome prediction improves when patients are reclassified based on predefined PaO
/FiO
and PEEP cutoffs 24 h after development of mild hypoxemia while not having ARDS.
Post hoc analysis of a large prospective, multicenter, observational study that ran in the ICUs of two academic hospitals in the Netherlands between January 2011 and December 2013. Patients were classified into four groups using predefined cutoffs for PaO
/FiO
(250 mmHg) and PEEP (5 cm H
O), both at onset of hypoxemia and after 24 h PaO
/FiO
≥ 250 mmHg and PEEP < 6 cm H
O (group I), PaO
/FiO
≥ 250 mmHg and PEEP ≥ 6 cm H
O (group II), PaO
/FiO
< 250 mmHg and Pls.gov identifier NCT01905033. Registered on July 11, 2013. Retrospectively registered.
ClinicalTrials.gov identifier NCT01905033. Registered on July 11, 2013. JNJ64264681 Retrospectively registered.There is growing interest in using observational data to assess the safety, effectiveness, and cost effectiveness of medical technologies, but operational, technical, and methodological challenges limit its more widespread use. Common data models and federated data networks offer a potential solution to many of these problems. The open-source Observational and Medical Outcomes Partnerships (OMOP) common data model standardises the structure, format, and terminologies of otherwise disparate datasets, enabling the execution of common analytical code across a federated data network in which only code and aggregate results are shared. While common data models are increasingly used in regulatory decision making, relatively little attention has been given to their use in health technology assessment (HTA). We show that the common data model has the potential to facilitate access to relevant data, enable multidatabase studies to enhance statistical power and transfer results across populations and settings to meet the needs of local HTA decision makers, and validate findings. The use of open-source and standardised analytics improves transparency and reduces coding errors, thereby increasing confidence in the results. Further engagement from the HTA community is required to inform the appropriate standards for mapping data to the common data model and to design tools that can support evidence generation and decision making.
Alkaline phosphatase (AP), a dephosphorylating enzyme, is involved in various physiological processes and has been shown to have anti-inflammatory effects.
To determine the correlation between pulmonary AP activity and markers of inflammation in invasively ventilated critically ill patients with or without acute respiratory distress syndrome (ARDS), and to investigate the effect of administration of recombinant AP on pulmonary inflammation in a well-established lung injury model in rats METHODS AP activity was determined and compared with levels of various inflammatory mediators in bronchoalveolar lavage fluid (BALF) samples obtained from critically ill patients within 2 days of start of invasive ventilation. The endpoints of this part of the study were the correlations between AP activity and markers of inflammation, i.e., interleukin (IL)-6 levels in BALF. In RccHan Wistar rats, lung injury was induced by intravenous administration of 10 mg/kg lipopolysaccharide, followed by ventilation with a high tidal volume for 4 h.
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