Clinical utility and cost modelling of the phi test to triage referrals into image-based diagnostic services for suspected prostate cancer: the PRIM (Phi to RefIne Mri) study.

BACKGROUND: The clinical pathway to detect and diagnose prostate cancer has been revolutionised by the use of multiparametric MRI (mpMRI pre-biopsy). mpMRI however remains a resource-intensive test and is highly operator dependent with variable effectiveness with regard to its negative predictive value. Here we tested the use of the phi assay in standard clinical practice to pre-select men at the highest risk of harbouring significant cancer and hence refine the use of mpMRI and biopsies. METHODS: A prospective five-centre study recruited men being investigated through an mpMRI-based prostate cancer diagnostic pathway. Test statistics for PSA, PSA density (PSAd) and phi were assessed for detecting significant cancers using 2 definitions: ≥ Grade Group (GG2) and ≥ Cambridge Prognostic Groups (CPG) 3. Cost modelling and decision curve analysis (DCA) was simultaneously performed. RESULTS: A total of 545 men were recruited and studied with a median age, PSA and phi of 66 years, 8.0 ng/ml and 44 respectively. Overall, ≥ GG2 and ≥ CPG3 cancer detection rates were 64% (349/545), 47% (256/545) and 32% (174/545) respectively. There was no difference across centres for patient demographics or cancer detection rates. The overall area under the curve (AUC) for predicting ≥ GG2 cancers was 0.70 for PSA and 0.82 for phi. AUCs for ≥ CPG3 cancers were 0.81 and 0.87 for PSA and phi respectively. AUC values for phi did not differ between centres suggesting reliability of the test in different diagnostic settings. Pre-referral phi cut-offs between 20 and 30 had NPVs of 0.85-0.90 for ≥ GG2 cancers and 0.94-1.0 for ≥ CPG3 cancers. A strategy of mpMRI in all and biopsy only positive lesions reduced unnecessary biopsies by 35% but missed 9% of ≥ GG2 and 5% of ≥ CPG3 cancers. Using PH ≥ 30 to rule out referrals missed 8% and 5% of ≥ GG2 and ≥ CPG3 cancers (and reduced unnecessary biopsies by 40%). This was achieved however with 25% fewer mpMRI. Pathways incorporating PSAd missed fewer cancers but necessitated more unnecessary biopsies. The phi strategy had the lowest mean costs with DCA demonstrating net clinical benefit over a range of thresholds. CONCLUSION: phi as a triaging test may be an effective way to reduce mpMRI and biopsies without compromising detection of significant prostate cancers.

Roots of the total testing process.

Laboratory professionals can contribute to improvement of diagnosis in the context of the total testing process (TTP), a multidisciplinary framework complementary to the diagnostic process. While the testing process has been extensively characterized in the literature, needed is accurate identification of the source of the term "total testing process". This article clarifies first appearance of the term in the literature and supplies a formal definition.

Structured case reviews for organizational learning about diagnostic vulnerabilities: initial experiences from two medical centers.

Background An organization's ability to identify and learn from opportunities for improvement (OFI) is key to increasing diagnostic safety. Many lack effective processes required to capitalize on these learning opportunities. We describe two parallel attempts at creating such a process and identifying generalizable lessons and learn from them. Methods Triggered case review programs were created independently at two organizations, Site 1 (Regions Hospital, HealthPartners, Saint Paul, MN, USA) and site 2 (University of California, San Diego). Both used a five-step process to create the review system and provide feedback: (1) identify trigger criteria; (2) establish a review panel; (3) develop a system to conduct reviews; (4) perform reviews; and (5) provide feedback. Results Site 1 identified 112 OFI in 184 case reviews (61%), with 66 (59%) provider OFI and 46 (41%) system OFI. Site 2 focused mainly on systems OFI identifying 105 OFI in 346 cases (30%). Opportunities at both sites were variable; common themes included test result management and communication across teams in peri-procedural care and with consultants. Of provider-initiated reviews, 67% of cases had an OFI at site 1 and 87% at site 2. Conclusions Lessons learned include the following: (1) peer review of cases provides opportunities to learn and calibrate diagnostic and management decisions at an organizational level; (2) sharing cases in review groups supports a culture of open discussion of OFIs; (3) reviews focused on diagnostic safety identify opportunities that may complement other organization-wide review opportunities.

Pharmacists in pharmacovigilance: can increased diagnostic opportunity in community settings translate to better vigilance?

The pharmacy profession has undergone substantial change over the last two to three decades. Whilst medicine supply still remains a central function, pharmacist's roles and responsibilities have become more clinic and patient focused. In the community (primary care), pharmacists have become important providers of healthcare as Western healthcare policy advocates patient self-care. This has resulted in pharmacists taking on greater responsibility in managing minor illness and the delivery of public health interventions. These roles require pharmacists to more fully use their clinical skills, and often involve diagnosis and therapeutic management. Community pharmacists are now, more than ever before, in a position to identify, record and report medication safety incidents. However, current research suggests that diagnostic ability of community pharmacists is questionable and they infrequently report to local or national schemes. The aim of this paper is to highlight current practice and suggest ways in which community pharmacy can more fully contribute to patient safety.

El futuro del Laboratorio en la investigación de la Lepra / No disponible

No disponible

Marcadores biológicos de infección neonatal / Biological markers of neonatal infection

No disponible

El Laboratorio, pieza clave en el proceso clínico asistencial / No disponible

No disponible

Imagen molecular / Molecular imaging

En este trabajo se describen brevemente los principales sistemas de imagen molecular en el laboratorio de investigación precínica y que a menudo se desarrollan en el marco d los hospiales con importante actividad intestigadora (AU)

This work briefly describes the main molecular imaging systems in pre-clinical research laboratories, and which are often developed in hospitals with an important research activity (AU)

Evaluación de tecnología sanitaria en el diagnóstico por la imagen / Health tecnology evaluation inimaging diagnosis

La evaluación de tecnologías sanitarias (ETS) puede contribuir a la mejora del proceso de decisión a diferentes niveles de la atenicón sanitaria con la información que genera acerca de los beneficios, riesgos y costes de la tecnología médica ™. En este artículo se define el concepto de ETS, se describe el proceso de evaluación de la TM y en paricular, de las pruebas diagnósticas, así como los retos a los que se debe hacer frente la evaluación (AU)

Health technology evaluation can contribute to improving the decision process at different leves of heath care with the information it generates about the benefits, risks and costs of medical technology. This article defines the concept f health technology evaluation, describes the evaluation process of medical technology and, in particular, of diagnosis tests, as well as the challenges which the evaluations hate to face (AU)

Objetivos y gestión de la investigación en un departamento de diagnóstico por la imagen / Research objectives and management in an imaging diagnosis department

El diagnóstico por la imagen es uno delos principales avances de la edicina moderan. El objetivo de este artículo es revisar los objetivos y gestión de la investigación en un servicio de Diagn´sotico por la Imagen basándose en responder las preguntas clásicas: qué porqué, cómo, dónde y cuándo. A investigaicón en diagn´sotico por la imagen actúa enel estudio de la fiabilidad diagnóstica de nuevos equipos, desarrollo de aplicaciones informáticas en la imagen médica, valoración comparativa de la eficacia de nuevos contrastes, estudio coste-eficacia de las nuevas técnicas diagnósticas, estudio de los mecanismo básicos de una enfermedad con propuesta de biomarcadores de imagen, estudio de la eficacia de nuevos fármacos con dichos biomarcadores de imagen y en el desarrollo de nuevos instrumentosde radilogía intervencionista. Sería deseable el desarrollo de políticas incentivadoras de la investigación en diagn´sotico así como el estableciminto de una planificación detallda que posibilite una investigación en diagnóstico por la imagen eficaz y sostenida (AU)

The objective of this article is to review the research objectives an management in an Imaging Diagnosis service by responding to the classic questions: what, why, how, where and when (AU)