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To identify predictors of treatment changes and to evaluate the effectiveness and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) initiating tofacitinib in a real-world setting.
The non-interventional study ESCALATE-RA included 1518 patients with RA from Germany. RA treatment, including all changes in therapy, was documented for 24 months starting from the initial intake of tofacitinib.
All patients started with tofacitinib therapy, either as monotherapy or in combination with methotrexate (MTX).
The impact of several factors of interest on the number and timing of treatment changes was assessed as primary outcome using Cox proportional hazards models. Further outcomes were tofacitinib drug survival and the use of follow-up disease-modifying antirheumatic drugs after first treatment change. We also assessed the effectiveness, concomitant glucocorticoid (GC) use, PROs (such as functional ability, patient satisfaction, pain and quality of life) and safety. Analyses were based on observed data.
‘Lack of efficacy’ (HR 3.30) and ‘intolerance’ (HR 4.43) leading to termination of tofacitinib were key factors favouring therapy changes. Higher patient satisfaction was significantly associated with a reduced likelihood of treatment changes (HR 0.82). Increasing GC doses were associated with a higher probability of step-up/switch changes (HR 1.21). The estimated tofacitinib drug survival was 48% at the end of study. Proportions of patients achieving low disease activity (both Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) 62%) and remission (SDAI 25%, CDAI 28%) increased from baseline under tofacitinib and were comparable between monotherapy and combination therapy with MTX. Mean concomitant GC dose decreased (2 mg/day). PROs indicated reduced pain and fatigue, while functional ability and quality of life improved. 63.9% of the patients experienced a treatment-emergent adverse event (AE), 8.8% a treatment-emergent AE of special interest and deaths occurred in 0.5%.
Key factors for therapy changes in patients with RA treated with tofacitinib were lack of efficacy and intolerance. Higher patient satisfaction was associated with a reduced probability of treatment changes, while increased GC doses led to a higher likelihood of step-ups/switches. Patients demonstrated a marked reduction in disease activity for up to 24 months, along with improvements in functional ability, pain and quality of life. Observed AEs were consistent with the known safety profile of tofacitinib.
To explore challenges parents of children with cancer encounter while providing complex medical care at home.
Design: Cross-sectional convergent mixed-methods study. Instruments: Questionnaire and open interviews that mirrored and complemented each other.
Parents (n = 32), with no prior medical training, were expected to remain constantly vigilant as they monitored and managed rapidly changing situations. Regardless of time from diagnosis, they detected a mean of 3.3 ± 1.4 (0–6) symptoms, reported administering up to 22 daily medications, including cytotoxics, narcotics and injections, and dealt with many related challenges. Parents described needing responsive communication channels, especially when dealing with bleeding and infection emergency situations during off-hours.
Findings highlight the constantly shifting demands when managing a child with cancer at home. Educational programmes that address parental needs throughout treatment, tailored to protocol changes and individual circumstances, should be expanded and further developed.
Parents need continual education regarding home management throughout their children's illness and treatment.
This study addresses challenges parents of children with cancer encounter while providing complex medical care at home. The findings demonstrated that parents, responsible for administering numerous medications via various routes and managing symptoms and side effects, did not feel confident performing these tasks regardless of time from diagnosis. Nurses should adapt ongoing parental education regarding complex medical tasks, symptoms, side effects, emergency detection and management for children with cancer at home. The study adhered to the Mixed Methods Appraisal Tool (MMAT) and STROBE reporting method.
Parents of children with cancer participated in the design and questionnaire validation.
Open femoral vessel access is commonly performed in vascular surgery, but surgical site complications (SSCs) occur frequently. The aim of this study is to evaluate the incidence and identify potential risk factors by applying a new standardised definition and grading of various types of groin wound complications. This retrospective analysis includes 201 consecutive patients with 219 vertical groin incisions to expose the femoral vessels for different vascular interventions. A prophylactic drain was placed intraoperatively in almost all incisions (91%). Groin SSCs were defined and graded into four categories according to a modified Clavien-Dindo classification. Potential risk factors were evaluated using univariable analysis. For multivariable analysis, a multiple logistic regression was performed. Cutoff values were determined through ROC analysis. According to the proposed definition, regular postoperative course grade 0 (no SSC) occurred in 163 patients (74.4%), grade 1 (minor SSC) in 10 (4.6%), grade 2 (moderate SSC) in 14 (6.4%), and grade 3/4 (major or life-threatening SSC) in 32 (14.6%) incisions. The incidence of clinically relevant SSCs (grade 2–4) was 21%. Drainage volume was an independent parameter that predicted relevant SSCs with a threshold value of 70 mL/24 h on postoperative day 4 (sensitivity 100%; specificity 67%; AUC = 0.835; p = 0.0004). Groin wound complications following vascular procedures are common. Lymphatic leakage appears to be the most significant, potentially preventable condition associated with relevant SSCs. Prophylactic or early therapeutic interventions should focus on reducing lymphatic morbidity.
FreshRSS 