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Palmoplantar pustulosis (PPP) is a rare, debilitating inflammatory skin disease involving painful pustules on the palms and soles. Janus kinase (JAK) inhibitors target pathways relevant to PPP disease biology but also confer a risk of major adverse cardiovascular events and malignancy in certain ‘at risk’ individuals; this includes those with PPP given prevalent smoking and cardiovascular risk factors in the PPP population. The feasibility of JAK inhibitor therapy for PPP requires assessment prior to a randomised controlled trial evaluation of drug efficacy and safety for this indication.
The ‘Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility’ trial is an open-label, single-centre, single-arm, mixed-methods feasibility trial of JAK inhibition in PPP (REC reference: 24/NE/0147; ISRCTN61751241). Participants (n=20) will receive 8 weeks of treatment with the JAK inhibitor upadacitinib (‘Rinvoq’, 30 mg, once daily). Qualitative semistructured interviews (up to n=40) will be undertaken with trial participants, trial decliners and healthcare professionals. The primary outcome will be a composite assessment of feasibility across three domains: recruitment, adherence and acceptability, using a mixed-methods analysis approach. Secondary objectives include the identification of trial recruitment optimisation strategies, using the ‘Quintet Recruitment Intervention’, and the generation of an indication of effect size on disease severity (measured using the Palmoplantar Pustulosis Psoriasis Area and Severity Index) to inform future sample size calculations. Historic placebo control data from the Anakinra for Pustular Psoriasis: Response in a Controlled Trial (National Institute of Health and Social Care reference: 13/50/17; Research Ethics Commitee reference: 16/LO/0436) will be used as the effect size comparator. Study recruitment will be undertaken over a 24-month period, commencing in November 2024.
This study has been approved by the Newcastle North Tyneside 2 Research Ethics Committee, 24/NE/0132. Our findings will inform the feasibility of a future adequately powered RCT evaluating the efficacy of JAK inhibitor therapy in PPP.
To demonstrate how interoperable nursing care data can be used by nurses to create a more holistic understanding of the healthcare needs of multiple traumas patients with Impaired Physical Mobility. By proposing and validating linkages for the nursing diagnosis of Impaired Physical Mobility in multiple trauma patients by mapping to the Nursing Outcomes Classification (NOC) and Nursing Interventions Classification (NIC) equivalent terms using free-text nursing documentation.
A descriptive cross-sectional design, combining quantitative analysis of interoperable data sets and the Kappa's coefficient score with qualitative insights from cross-mapping methodology and nursing professionals' consensus.
Cross-mapping methodology was conducted in a Brazilian Level 1 Trauma Center using de-identified records of adult patients with a confirmed medical diagnosis of multiple traumas and Impaired Physical Mobility (a nursing diagnosis). The hospital nursing free-text records were mapped to NANDA-I, NIC, NOC and NNN linkages were identified. The data records were retrieved for admissions from September to October 2020 and involved medical and nursing records. Three expert nurses evaluated the cross-mapping and linkage results using a 4-point Likert-type scale and Kappa's coefficient.
The de-identified records of 44 patients were evaluated and then were mapped to three NOCs related to nurses care planning: (0001) Endurance; (0204) Immobility Consequences: Physiological, and (0208) Mobility and 13 interventions and 32 interrelated activities: (6486) Environmental Management: Safety; (0840) Positioning; (3200) Aspiration Precautions; (1400) Pain Management; (0940) Traction/Immobilization Care; (3540) Pressure Ulcer Prevention; (3584) Skincare: Topical Treatment; (1100) Nutrition Management; (3660) Wound Care; (1804) Self-Care Assistance: Toileting; (1801) Self-Care Assistance: Bathing/Hygiene; (4130) Fluid Monitoring; and (4200) Intravenous Therapy. The final version of the constructed NNN Linkages identified 37 NOCs and 41 NICs.
These valid NNN linkages for patients with multiple traumas can serve as a valuable resource that enables nurses, who face multiple time constraints, to make informed decisions efficiently. This approach of using evidence-based linkages like the one developed in this research holds high potential for improving patient's safety and outcomes.
In this study, there was no direct involvement of patients, service users, caregivers or public members in the design, conduct, analysis and interpretation of data or preparation of the manuscript. The study focused solely on analysing existing de-identified medical and nursing records to propose and validate linkages for nursing diagnoses.
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