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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.

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.

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.

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.

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.

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.

We developed a teleradiology system linking a general hospital on Sado Island to tertiary care hospitals in Niigata City. The island is 40 km from Niigata City on the mainland and has only one diagnostic radiologist (for 72,000 islanders). Fibre optic cables between Sado Island and Niigata City were used for transmission. The introduction of the teleradiology system facilitated diagnostic and therapeutic consultation with specialists in Niigata City. The performance of the system was evaluated (on a scale of 0-6, with higher scores indicating better performance) by five diagnostic radiologists, who rated 32 features of the system twice, once in April 2002 and once in September 2003. The performance ratings improved from 1.38 to 2.86. While many of the initial problems with the software had been resolved, many still remained.

Telepathology can be performed in an active or a passive manner. There are two main types: interdisciplinary telepathology and expert teleconsultations. Interdisciplinary telepathology involves a pathologist and another specialist (e.g. a radiologist or endoscopist). It is mainly used in an active manner (i.e. online and in realtime) and has three purposes: to ensure correct tissue sampling, to provide additional diagnostic information to the pathologist, or to facilitate collaborative therapeutic or diagnostic decision making between the clinician and pathologist. Expert teleconsultations, typically between two pathologists, are mainly undertaken in passive mode (i.e. offline and using store-and-forward techniques). The Internet often serves as a platform for both types of telepathology application. Experience with interdisciplinary telepathology is rare at present and is usually limited to partners at a local institution. The efficiency and accuracy of expert teleconsultations in telepathology have been demonstrated in numerous studies. In future, the application of expert teleconsultation in pathology will expand, with the Internet as the communications medium. Interdisciplinary telepathology is a promising technique to improve diagnostic quality.

The first part of this review discussed the facilities that are needed to provide a competent diagnostic virology service at the turn of the century. Just as important is to consider who will run it. Hitherto, there have been specialist virologists in most countries. Their roles have evolved with time, developing and running a variety of diagnostic tests, often to answer local needs and their own curiosity, and frequently linked to their research projects. Recently, the advent of an increasingly long list of commercial tests has raised the real possibility of introducing standardized centrally validated testing methods, and using them to bring laboratories up to a similarly uniform level. Unfortunately, they have also had the effect of seeming to make specialist virologists unnecessary, except in a few central reference laboratories. As a consequence, and because of increasing pressure on health service resources, vacated senior virology posts have remained unfilled and this now threatens the career structure of those who want to become, and continue as, virologists. This review explores these issues and offers a possible solution.

Care of patients with dysphagia includes screening, diagnosis, treatment and management. This article examines the increasing evidence that to be most effective each of these aspects of patient care must be tailored to the patient's medical diagnosis, specific swallowing disorders and stage of recovery or degeneration. The need to define the optimal window of intervention for each patient type is also discussed. Future research needs are emphasized.

Background and Study Aims: Provision of a reasonable colonoscopy service requires approximately 160 procedures per 100000 population per year. The aim of the present study was to document current levels of colonoscopy service, the use of guidelines in surveillance practice and the capacity for expansion in endoscopy units throughout the United Kingdom., Material and Methods: A postal questionnaire was sent to 294 endoscopy units., Results: Replies were received from 164 units (60 %). Of the units, 49 % have reached the calculated target figure. In units not meeting the target, 22% have only one colonoscopist, and 31% have one colonoscopy session a week. Overall, 50 % of units are working at full capacity. Out of all units, 70 % are unable to expand their service further, because of lack of nursing support in 81%, non-availability of endoscopist in 72 % and lack of physical space in 51%. Guidelines for surveillance colonoscopy were a problem: 51% of units reported that guidelines were available for surveillance of ulcerative colitis, 28 % for Crohn's disease, 59 % for polyp follow-up, and 44 % for follow-up of resected colorectal cancer. The majority of units (>70%) had no protocols for their surveillance practice. Nonetheless, 92% of units performed surveillance colonoscopy for ulcerative colitis, 34% for Crohn's disease, and 76% for resected colorectal cancer., Conclusions: The colonoscopy service has expanded, but there are constraints on further growth. There is a pressing need for national guidelines on surveillance colonoscopy.

Pleural needle biopsy (PNB) maintained its value in spite of introduction of videothoracoscopy. Diagnostic possibilities of PNB using Abrams needle were evaluated during 1989-1998 in 114 patients aged 17-82 years. In histological examinations of the biopsy specimens were diagnosed: neoplasms--in 47 (41%) patients, tuberculosis--in 10 (9%) and chronic nonspecific pleuritis--in remaining 57 patients. Data from further course of the disease confirmed diagnosis of neoplasms and tuberculosis. Complication of PNB was encountered only in 1 patient (pneumothorax). Among 47 patients with malignant infiltration of the pleura in the biopsy specimen only in 20 (42%) neoplastic cells were demonstrated in cytologic examination of the pleural fluid. PNB remains still useful in the diagnosis of causes of pleural diseases. Specificity of this method can be enhanced by more precise localization of the pleural lesions using imaging technics (USG, CT, MRI). PNB should be more widely performed in the diagnosis of pleural diseases of unknown etiology particularly when videothoracoscopy is not feasible.

The author proposes a programme for improving the functionally diagnostic service of antituberculosis institutions, which envisages studies of major spirographic parameters, the forced expiratory flow-volume curve, blood gases and acid-alkali balance in all antituberculosis institutions, global plethysmography, examinations of the diffuse capacity of the lung and spiroergometry in the regional, republican dispensaries and research institutes of tuberculosis and phthisiopulmonology. Studies of lung function are considered to be a mandatory part of clinical examination of patients with tuberculosis in the diagnosis of lung disease, during treatment and after its completion.

Traditionally, information technology in health care has helped practitioners to collect, store, and present information and also to add a degree of automation to simple tasks (instrument interfaces supporting result entry, for example). Thus commercially available information systems do little to support the need to model, execute, monitor, coordinate, and revise the various complex clinical processes required to support health-care delivery. Workflow computing, which is already implemented and improving the efficiency of operations in several nonmedical industries, can address the need to manage complex clinical processes. Workflow computing not only provides a means to define and manage the events, roles, and information integral to health-care delivery but also supports the explicit implementation of policy or rules appropriate to the process. This article explains how workflow computing may be applied to health-care and the inherent advantages of the technology, and it defines workflow system requirements for use in health-care delivery with special reference to diagnostic pathology.

Chromatography is widely employed in industry for the purification of biotherapeutics and diagnostics. Regulatory requirements dictate that the chromatographic process be reproducible and provide the necessary product purity. Current trends in designing and implementing purification strategies take into consideration the requirements for both chromatography media and equipment. Future trends will require that cost containment is considered. New chromatography materials, new methods for equipment design analysis, and new technologies to ensure regulatory compliance will provide the biotechnology industry with tools to provide tomorrow's products.

In Part 1 of this series we discussed how it is that our new understandings of biology at the molecular level are revealing to us unexpected complexities in those processes labeled as diseases. Here in Part 2 we examine some remarkable ultra-sensitive tools with which it is becoming feasible to clarify these complexities with degrees of certainty heretofore regarded as impossible.