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.

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.

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.

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.

Valuing the professional work of diagnostic radiologic services.

The challenges to the technical component (TC) of radiology services as a result of the Deficit Reduction Act of 2005 have been widely publicized, but a number of regulatory changes will affect the professional component (PC) of our physician work. The third 5-year review is complete, and although there were no major reductions in work relative value units (RVUs) for radiology, proposed budget-neutrality adjustments to physician work RVUs will potentially reduce payments for both the PC and global payments. Additionally, if there is no congressional intervention, reductions in the conversion factor will further decrease Medicare payments. In the article, the history of the radiology relative value scale and the methodology of American Medical Association/Specialty Society Relative Value Scale Update Committee's valuation of physician work are reviewed. The results of the third 5-year review are presented. Future challenges to radiology physician work valuation are discussed, including outsourcing, the Medicare Payment Advisory Commission's search for overvalued services, and the bundling of physician services. Whereas the TC is compensation for performing a diagnostic test, ultimately, it is our physician work that defines our specialty, and challenges to our physician work will be vigorously defended by the ACR without compromise.

Physician survey of a laboratory medicine interpretive service and evaluation of the influence of interpretations on laboratory test ordering.

CONTEXT: Complex coagulation test panels ordered by clinicians are typically reported to clinicians without a patient-specific interpretive paragraph. OBJECTIVES: To survey clinicians regarding pathologist-generated interpretations of complex laboratory testing panels and to assess the ability of the interpretations to educate test orderers. DESIGN: Surveys were conducted of physicians ordering complex coagulation laboratory testing that included narrative interpretation. Evaluation of order requisitions was performed to assess the interpretation's influence on ordering practices. SETTING: Physicians ordering coagulation testing at a large academic medical center hospital in Boston, Mass, and physicians from outside hospitals using the academic medical center as a reference laboratory for coagulation testing. OUTCOME MEASURES: Physician surveys and evaluation of laboratory requisition slips. RESULTS: In nearly 80% of responses, the ordering clinicians perceived that the interpretive comments saved them time and improved the diagnostic process. Moreover, the interpretations were perceived by ordering clinicians to help prevent a misdiagnosis or otherwise impact the differential diagnosis in approximately 70% of responses. In addition, interpretations appeared to be able to train the ordering clinicians as to the standard ordering practices. CONCLUSIONS: The results demonstrate physician satisfaction with an innovative information delivery approach that provides laboratory diagnostic interpretation and test-ordering education to clinicians in the context of their daily workflow.