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1.
Ann Am Thorac Soc ; 19(10): 1722-1729, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-35363591

RESUMEN

Rationale: Tunneled, indwelling pleural catheters (IPCs) have been demonstrated to be an effective method of managing malignant pleural effusions. However, they allow pleurodesis and can therefore be removed in only a subset of patients. A novel, silver nitrate-coated IPC was developed with the intention of creating a rapid, effective chemical pleurodesis to allow more frequent and earlier catheter removal. This study represents the pivotal clinical trial evaluating that catheter versus the standard IPC. Objectives: To compare the efficacy of a novel silver nitrate-eluting indwelling pleural catheter (SNCIPC) with that of a standard, uncoated catheter. Methods: The SWIFT [A Pivotal Multi-Center, Randomized, Controlled, Single-Blinded Study Comparing the Silver Nitrate-Coated Indwelling Pleural Catheter (SNCIPC) to the Uncoated PleurX® Pleural Catheter for the Management of Symptomatic, Recurrent, Malignant Pleural Effusions] trial was a multicenter, parallel-group, randomized, controlled, patient-blind trial. Central randomization occurred according to a computer-generated schedule, stratified by site. Recruitment was from 17 secondary or tertiary care hospitals in the United States and 3 in the United Kingdom and included adult patients with malignant pleural effusion needing drainage, without evidence of lung entrapment or significant loculation. The intervention group underwent insertion of an SNCIPC with maximal fluid drainage, followed by a tapering drainage schedule. The control group received a standard, uncoated catheter. Follow-up was conducted until 90 days. The primary outcome measure was pleurodesis efficacy, measured by fluid drainage, at 30 days. Results: A total of 119 patients were randomized. Five withdrew before receiving treatment, leaving 114 (77 SNCIPC, 37 standard IPC) for analysis. The mean age was 66 years (standard deviation, 11). More patients in the SNCIPC group were inpatients (39% vs. 14%; P = 0.009). For the primary outcome, pleurodesis rates were 12 (32%) of 37 in the control group and 17 (22%) of 77 in the SNCIPC group (rate difference, -0.10; 95% confidence interval, -0.30 to 0.09). Median time to pleurodesis was 11 days (interquartile range, 9 to 23) in the control group and 4 days (interquartile range, 2 to 15) in the SNCIPC group. No significant difference in treatment-related adverse event rates was noted between groups. Conclusions: The SNCIPC did not improve pleurodesis efficacy compared with a standard IPC. This study does not support the wider use of the SNCIPC device. Clinical trial registered with www.clinicaltrials.gov (NCT02649894).


Asunto(s)
Derrame Pleural Maligno , Adulto , Anciano , Catéteres de Permanencia/efectos adversos , Drenaje/métodos , Humanos , Derrame Pleural Maligno/etiología , Pleurodesia/métodos , Nitrato de Plata , Talco/uso terapéutico
2.
Patient Educ Couns ; 104(8): 2126-2132, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-33422369

RESUMEN

OBJECTIVE: Consultation skills are essential to clinical practice and, when effective, can facilitate diagnoses and improve patient satisfaction. Various models exist to facilitate consultation teaching. These can be prescriptive, a challenge to apply in clinical settings and are often designed for primary care. In redesigning our entire curriculum, we sought to create a new visual, digital, resource for consultation teaching, aligned with statements from the UK Council for Clinical Communication (UKCCC), and suitable for the evolving expectations of patients, clinicians and the UK NHS, in 21st century medicine. METHODS: We conducted a literature review encompassing teaching methods, NHS Priorities, patients' priorities, lifestyle interventions and practitioner resilience. COGConnect was designed iteratively through consultation with a graphic designer, health psychologists, a range of clinicians, and a consultation expert, and has evolved through extensive use in our new "effective consulting" course in primary and secondary care. RESULTS: COGConnect is deliberately visual, iterative, bi-directional and multi-phasic. The central image of COGConnect is two persons in connection; the floating cogs suggesting an encounter of different agents who must adapt their cog-connection in terms of speed, direction and dimension. Around this image we place five core values. The consultation phases are represented by ten colourful cogs, with important additions including 'formulating', 'activating' and 'integrating'. CONCLUSION: COGConnect builds on the strengths of existing frameworks and provides a strong visual resource suitable for digital learning. It offers greater emphasis on explicit clinical reasoning, activation of patient self-care and learning from the interaction. Having become the de facto resource for consultation skills training across primary and secondary care in our institution, the next phase is to develop the COGConnect.info website and a programme of formal evaluation.


Asunto(s)
Competencia Clínica , Curriculum , Comunicación , Humanos , Derivación y Consulta , Enseñanza
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