A patient focused relationship for specialists in laboratory medicine.

Technological change is driving individualized healthcare delivery including laboratory medicine. Ensuring patients gain from their empowerment it is essential that they access data that enables them to utilize reliable information. The potential difficulties of comprehension, information retention and imperfect modes of communication can significantly impair utilization of information by patients. Support for understanding and decision-making needs to be clinically competent and integrated within the healthcare team. Specialists in laboratory medicine are well placed to undertake such a role, the issues around this are explored and proposals for better direct engagement with patients made.

Quality evaluation of smartphone applications for laboratory medicine.

Background Many of the mobile applications (apps) used for delivering health interventions involve laboratory medicine data. This survey was conducted to search the online market for health apps that manage laboratory medicine data. The aim was to review them and perform a quality evaluation. Methods Apps search criteria were "Lab results blood work", "Lab results", and "Health apps". After the stepwise exclusion process, 52 selected apps were downloaded and analyzed. For review and content analysis of the apps, a multidimensional tool for classifying and rating the quality of mobile health apps - Mobile App Rating Scale (MARS), was used. Results Selected apps were classified into five categories according to their intended use by patients or physicians, and the type of data engaged. Spearman's correlation analysis found significant correlations between MARS individual scoring items, as with the subjective quality and number of technical aspects. Kruskal-Wallis analysis showed a significant difference in the number of technical aspects employed, MARS engagement and informational quality score items, total score, and subjective quality. The lowest values for all of these items were in the category of apps designed for patients, and the post hoc test showed that the difference was statistically significant between this and the values in all other categories. Conclusions Apps designed for patients, are of the poorest quality, considering the total quality of the content and information they provide, estimated using the MARS tool. This estimation needs to be validated for laboratory medicine apps, and eventually modified after consideration of specific quality benchmarks.

Role of laboratory medicine in collaborative healthcare.

Healthcare delivery and responsibility is changing. Patient-centered care is gaining international acceptance with the patient taking greater responsibility for his/her health and sharing decision making for the diagnosis and management of illness. Laboratory medicine must embrace this change and work in a tripartite collaboration with patients and with the clinicians who use clinical laboratory services. Improved communication is the key to participation, including the provision of educational information and support. Knowledge management should be targeted to each stakeholder group. As part of collaborative healthcare clinical laboratory service provision needs to be more flexible and available, with implications for managers who oversee the structure and governance of the service. Increased use of managed point of care testing will be essential. The curriculum content of laboratory medicine training programs will require trainees to undertake practice-based learning that facilitates interaction with patients, clinicians and managers. Continuing professional development for specialists in laboratory medicine should also embrace new sources of information and opportunities for collaborative healthcare.

A survey of patients' views from eight European countries of interpretive support from Specialists in Laboratory Medicine.

BACKGROUND: There is increasing interest in direct patient engagement including receiving their laboratory medicine results. We previously established an appetite for Specialists in Laboratory Medicine to support patients in understanding results. The aim of this study was to establish whether patients agreed with such an approach, determined through surveying views in eight European countries. METHODS: A standardized five-question survey was administered across eight European countries to a total of 1084 individuals attending medical outpatient clinics, with 100 patients each in Poland, Serbia, Netherlands, Turkey and Czech Republic, 101 in Estonia, 116 in Denmark and 367 in Norway. The responses across countries were compared using the chi-square test (p<0.05). RESULTS: Patients wanting their results ranged from 50% to 94% (mean 65%) of those responding positively, a mean of 72% wanted additional information with their results; direct receipt was preferred over referral to a website. Specialists in Laboratory Medicine providing such information were acceptable to a mean of 62% of those respondents wishing their results; in countries where payment was possible, there was little interest in making additional payment for such a service. CONCLUSIONS: A clear proportion of patients are interested in receiving their laboratory medicine results, the majority with explanatory notes; a role for Specialists in Laboratory Medicine is acceptable and raises the potential for direct engagement by such specialists with patients offering a new paradigm for the provision of laboratory medicine activities.

European views on patients directly obtaining their laboratory test results.

BACKGROUND: Medicine is a highly professionalized endeavour, by tradition centred on the authority of physicians. Better education and the advent of the information age cater for increased demands on society in general and on health care in particular to enable people to make informed decisions regarding themselves. Participation in medical decisions requires informed knowledge which is hard to obtain without substantial and time consuming professional help. METHODS: We performed a survey amongst the member organizations of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) in order to investigate the recognition and preparedness of providing help to patients in interpreting their laboratory results. RESULTS: Out of 40 EFLM Member Societies, 27 sent their responses to the survey. In most cases the first line delivery of laboratory results to physicians is by computer link (63%). Patients receive their laboratory results on demand from their physician in 60% of cases. However, 34% of laboratory specialists showed a negative attitude for delivering laboratory results to patients. Yet, in 48% of countries 1-5 patients per day ask a laboratory specialist about the significance of laboratory results outside the reference range. When patients are informed about the purpose of laboratory testing, they seek information primarily from their physician, followed by the internet and the Specialist in Laboratory Medicine. CONCLUSIONS: Changing practices increasingly enabling patient access to their records are on the increase facilitated by recent innovations in information technologies. Successful transfer of some of the responsibilities of physicians, demands a mutual triangular dialogue between the patient, their physician and laboratory medicine.

Rapidly building global health security capacity--Uganda demonstration project, 2013.

Increasingly, the need to strengthen global capacity to prevent, detect, and respond to public health threats around the globe is being recognized. CDC, in partnership with the World Health Organization (WHO), has committed to building capacity by assisting member states with strengthening their national capacity for integrated disease surveillance and response as required by International Health Regulations (IHR). CDC and other U.S. agencies have reinforced their pledge through creation of global health security (GHS) demonstration projects. One such project was conducted during March-September 2013, when the Uganda Ministry of Health (MoH) and CDC implemented upgrades in three areas: 1) strengthening the public health laboratory system by increasing the capacity of diagnostic and specimen referral networks, 2) enhancing the existing communications and information systems for outbreak response, and 3) developing a public health emergency operations center (EOC) (Figure 1). The GHS demonstration project outcomes included development of an outbreak response module that allowed reporting of suspected cases of illness caused by priority pathogens via short messaging service (SMS; i.e., text messaging) to the Uganda District Health Information System (DHIS-2) and expansion of the biologic specimen transport and laboratory reporting system supported by the President's Emergency Plan for AIDS Relief (PEPFAR). Other enhancements included strengthening laboratory management, establishing and equipping the EOC, and evaluating these enhancements during an outbreak exercise. In 6 months, the project demonstrated that targeted enhancements resulted in substantial improvements to the ability of Uganda's public health system to detect and respond to health threats.

An enzymatic assay for the detection of glycolic acid in serum as a marker of ethylene glycol poisoning.

BACKGROUND: Ingestion of ethylene glycol is a relatively rare event but one with potentially lethal consequences. Early diagnosis and appropriate treatment are essential. However, diagnosis of poisoning can only be confirmed definitively by the measurement of ethylene glycol and/or its metabolites, usually performed by gas chromatographic methods. These methods are complex, requiring specialized equipment and expertise, and are often not available on an emergency basis. METHODS: A quick, simple, and inexpensive enzymatic assay has been developed to detect glycolic acid, the major metabolite of ethylene glycol and the main cause of the resulting metabolic acidosis. In this assay, glycolic acid is converted to glyoxylic acid by glycolate oxidase, with the production of hydrogen peroxide, which is converted to a quinoneimine dye for spectrophotometric detection. RESULTS: The assay has a functional sensitivity of 26 mg/L and coefficients of variation less than 13% (interassay) and less than 10% (intra-assay). No significant interference was observed for a range of compounds, and a comparison with a gas chromatography-mass spectrometry method gave clinical sensitivity of 86% and clinical specificity of 92%. Stability of enzyme solutions was increased by the use of an alternative buffer, in which greater than 90% of the original activity was retained after storage at -20°C. CONCLUSIONS: As ethylene glycol poisoning is a medical emergency, there is a need for a screening test to minimize delays in diagnosis. The assay we describe is a simple and effective way to detect ethylene glycol poisoning, enabling earlier initiation of appropriate therapy and improving patient outcomes.

Glucose meters - fit for clinical purpose.

Glucose meters have improved considerably since they were first introduced in 1960, but many questions are being asked about their accuracy and reliability in certain clinical situations. These questions have arisen because of the widespread use of these meters into clinical areas they have not been designed for such as critical care. The lack of understanding by some health professionals on factors that affect glucose results, such as sample type, glucose test strip methodologic limitations, calibration to recognized reference methods, and interferences, leads to misleading results that may affect patient care. Much debate continues on the quality specifications for glucose meters. Because there is an extensive use of these meters in different clinical scenarios, the setting of quality specifications will remain a challenge for regulatory and professional organizations. In this article, we have attempted to collect and provide relevant information addressing the limitations above. Pivotal to obtaining the best quality of results is education, particularly for diabetic patients monitoring their glucose. The International Federation of Clinical Chemistry and Laboratory Medicine through its Point-of-Care Testing Task Force and its Working Group on Glucose Point-of-Care Testing is actively working toward improving the quality of glucose results by improving education and working with the industry to improve strip performance and work toward the better standardization of strips.

What is the role of cerebrospinal fluid ferritin in the diagnosis of subarachnoid haemorrhage in computed tomography-negative patients?

BACKGROUND: Spectrophotometry of cerebrospinal fluid (CSF) for bilirubin is the recommended method for investigation in suspected cases of subarachnoid haemorrhage (SAH), when a computed tomography (CT) of the head is negative for blood. There is a potential need for a simpler alternative. Measurement of CSF ferritin might fulfil this need. METHOD: We have measured ferritin in the CSF from 252 patients with suspected SAH who were negative on a CT of the head for blood, recruited on a consecutive intention to recruit basis from four centres. CSF spectrophotometry was performed on all samples. A positive outcome was taken as an aneurysm found on angiography that was treated or a discharge diagnosis of non-aneurysmal SAH. RESULTS: A final diagnosis of aneurysmal SAH was made in six patients, an arteriovenous malformation in one and non-aneurysmal SAH in nine. Receiver operating characteristic (ROC) analysis showed that at 6.4 microg/L, sensitivity, specificity, positive and negative predictive values were 1.0, 0.48, 0.12 and 1.0, respectively. At 12 microg/L, these values were 0.81, 0.91, 0.38 and 0.98, respectively. CONCLUSIONS: At an appropriate negative predictive value (1.0) for a rule-out test, ferritin has too low a specificity to function as a stand-alone test and we cannot recommend it as an initial screen to be followed by spectrophotometry.

Executive summary. The National Academy of Clinical Biochemistry Laboratory Medicine Practice Guideline: evidence-based practice for point-of-care testing.

BACKGROUND: Point-of-care testing (POCT) is clinical laboratory testing conducted close to the site of patient care. POCT has the potential to provide faster test results and therapeutic intervention with improved patient outcomes. However, when over-utilized or used inappropriately POCT results can be misleading and increase healthcare costs. METHODS: The National Academy of Clinical Biochemistry developed evidence-based Laboratory Medicine Practice Guidelines for POCT. RESULTS: These Laboratory Medicine Practice Guidelines systematically review the scientific literature relating POCT to clinical outcomes and offer recommendations to improve the clinical utility of POCT. CONCLUSIONS: These guidelines will be useful to clinicians considering the addition of POCT, to those that question current practices in POCT, and to clinicians seeking evidence-based support for POCT in clinical management. These guidelines represent the most comprehensive systematic review of the POCT literature to date and will help define future research that is needed to add to our current POCT knowledge base.

Hyperoxaluria, hypocitraturia, hypomagnesiuria, and lack of intestinal colonization by Oxalobacter formigenes in a cervical spinal cord injury patient with suprapubic cystostomy, short bowel, and nephrolithiasis.

Although urolithiasis is common in spinal cord injury patients, it is presumed that the predisposing factors for urinary stones in spinal cord injury patients are immobilization-induced hypercalciuria in the initial period after spinal injury and, in later stages, urine infection by urease-producing micro-organisms, e.g., Proteus sp., which cause struvite stones. We describe a patient who sustained C-7 complete tetraplegia in a road traffic accident in 1970, when he was 16 years old. Left ureterolithotomy was performed in 1971 followed by left nephrectomy in 1972. Probably due to adhesions, this patient developed volvulus of the intestine in 1974. As he had complete tetraplegia, he did not feel pain in the abdomen and there was a delay in the diagnosis of volvulus, which led to ischemia of a large segment of the small bowel. All but 1 ft of jejunum and 1 ft of ileum were resected leaving the large bowel intact. In 1998, suprapubic cystostomy was performed. In 2004, this patient developed calculus in the solitary right kidney. Complete stone clearance was achieved by extracorporeal shock wave lithotripsy. Stone analysis: calcium oxalate 60% and calcium phosphate 40%. Metabolic evaluation revealed hyperoxaluria, hypocitraturia, and hypomagnesiuria. Since this patient had hyperoxaluria, the stool was tested for Oxalobacter formigenes, a specific oxalate-degrading, anerobic bacterium inhabiting the gastrointestinal tracts of humans; absence of this bacterium appears to be a risk factor for development of hyperoxaluria and, subsequently, calcium oxalate kidney stone disease. DNA from the stool was extracted using the QIAamp DNA stool Mini Kit (Qiagen, Chatsworth, CA). The genomic DNA was amplified by polymerase chain reaction using specific primers for oxc gene (developed by Sidhu and associates). The stool sample tested negative for O. formigenes. The patient was prescribed potassium citrate mixture; he was advised to avoid oxalate-rich food, maintain recommended levels of calcium in his diet, and take live bio-yogurt. Two months later, 24-h urinary oxalate decreased from 0.618 to 0.411 mmol/day; 24-h urine citrate increased from 0.58 to 1.10 mmol/day. Six months later, an oxalate absorption test was performed. The patient swallowed a capsule, soluble in gastric juice, containing 50 mg (0.37 mmol) sodium [13C2]oxalate corresponding to 33.8 mg of [13C2]oxalic acid. The amount of labeled oxalate, excreted in urine, was measured by a gas chromatographic-mass spectrometric assay. Oxalate absorption, expressed as the percentage of the labeled dose recovered in the 24-h urine after dosing, was 8.3% (reference range: 2.3-17.5%). In addition to other conventional measures, oral administration of O. formigenes or lactic acid bacteria mixture to promote bacterial degradation of oxalate in the gut, and thus combat hyperoxaluria, may play a role in prevention of calcium oxalate kidney stones.

Critical illness with hyponatraemia and impaired cell membrane integrity--the "sick cell syndrome" revisited.

OBJECTIVE: To determine whether impaired cell membrane permeability exists in critically ill patients with "sick cell" type hyponatraemia. DESIGN AND METHODS: A 36 year old male patient was identified in an intensive care unit (ICU) with liver disease and multi-organ failure. His initial serum sodium (Na) was 101 mmol/L and osmolar gap + 35 mmol/L. A flow cytometric system was used to assess lymphocyte membrane integrity using fluorescein diacetate (FDA) and propidium iodide (PI). Following this, similar studies were carried out in 17 hyponatraemic (Na < 130 mmol/L) and 19 normonatraemic (Na > 136 mmol/L) ICU patients. RESULTS: Flow cytometry in the index patient showed two clear populations of cells-one was normal (with identical characteristics to a healthy control) and the other had dysfunctional cell membrane integrity. The extended patient series, however, revealed only 2 other patients with similar flow cytometric patterns-one hyponatraemic and one normonatraemic. CONCLUSIONS: Cell membrane studies in the index patient demonstrated supportive evidence for the "sick cell syndrome" in critically ill patients. The extended series revealed that 3/37 (8%) had this abnormality, which was however not consistently associated with hyponatraemia.

Definitive angiographic detection of subarachnoid haemorrhage compared with laboratory assessment of intracranial bleed in CT-negative patients.

BACKGROUND: Between 2.5% and 5% of cases of subarachnoid haemorrhage (SAH) give negative results for computed tomography (CT) scanning. Recent UK guidelines make recommendations as to standardization of laboratory methodology for the detection of SAH in individuals with a negative CT scan. We have compared this approach with our routine assessment using first-order derivative spectrophotometry, a recently reported iterative computer prediction model and measurement of cerebrospinal fluid (CSF) ferritin concentration. All methods were judged against cerebral angiography as the definitive means of determining patient outcome. METHODS: Scanning spectrophotometry of CSF is necessary for both the UK guidelines and our in-house method. Absorbance measurements at 360, 405, 414 and 455 nm are required for the computer model. CSF ferritin concentration was measured using a serum method on a DPC Immulite 2000. This gave a value of <12 microg/L for normal CSF. Ethical approval and informed patient consent to additional investigation were obtained. RESULTS: The sensitivity and specificity for the UK guidelines method, derivative spectrophotometry (in-house), iterative computer model and CSF ferritin were, respectively: 0.8, 1.0; 0.9, 1.0; 0.9, 0.5; 1.0, 0.78. CONCLUSION: First-order derivative spectrophotometry had best concordance with angiography. Combination of this with CSF ferritin measurement may improve sensitivity, although the zero-order method recommended in the UK guidelines for the detection of an intracranial bleed is more amenable and has comparable performance.

Problems in early diagnosis of bladder cancer in a spinal cord injury patient: report of a case of simultaneous production of granulocyte colony stimulating factor and parathyroid hormone-related protein by squamous cell carcinoma of urinary bladder.

BACKGROUND: Typical symptoms and signs of a clinical condition may be absent in spinal cord injury (SCI) patients. CASE PRESENTATION: A male with paraplegia was passing urine through penile sheath for 35 years, when he developed urinary infections. There was no history of haematuria. Intravenous urography showed bilateral hydronephrosis. The significance of abnormal outline of bladder was not appreciated. As there was large residual urine, he was advised intermittent catheterisation. Serum urea: 3.5 mmol/L; creatinine: 77 umol/L. A year later, serum urea: 36.8 mmol/l; creatinine: 632 umol/l; white cell count: 22.2; neutrophils: 18.88. Ultrasound: bilateral hydronephrosis. Bilateral nephrostomy was performed. Subsequently, blood tests showed: Urea: 14.2 mmol/l; Creatinine: 251 umol/l; Adjusted Calcium: 3.28 mmol/l; Parathyroid hormone: < 0.7 pmol/l (1.1 - 6.9); Parathyroid hormone-related protein (PTHrP): 2.3 pmol/l (0.7 - 1.8). Ultrasound scan of urinary bladder showed mixed echogenicity, which was diagnosed as debris. CT of pelvis was interpreted as vesical abscess. Urine cytology: Transitional cells showing mild atypia. Bladder biopsy: Inflamed mucosa lined by normal urothelial cells. A repeat ultrasound scan demonstrated a tumour arising from right lateral wall; biopsy revealed squamous cell carcinoma. In view of persistently high white cell count and high calcium level, immunohistochemistry for G-CSF and PTHrP was performed. Dense staining of tumour cells for G-CSF and faintly positive staining for C-terminal PTHrP were observed. This patient expired about five months later. CONCLUSION: This case demonstrates how delay in diagnosis of bladder cancer could occur in a SCI patient due to absence of characteristic symptoms and signs.

Position paper of the EPMA and EFLM: a global vision of the consolidated promotion of an integrative medical approach to advance health care.

The authors consider acute problems in the quality and management of medical services challenging health care systems worldwide. This actuality has motivated the representatives of the European Association for Predictive, Preventive and Personalised Medicine and European Federation of Clinical Chemistry and Laboratory Medicine to consider the efforts in promoting an integrative approach based on multidisciplinary expertise to advance health care. The current paper provides a global overview of the problems related to medical services: pandemic scenario in the progression of common chronic diseases, delayed interventional approaches of reactive medicine, poor economy of health care systems, lack of specialised educational programmes, problematic ethical aspects of treatments as well as inadequate communication among professional groups and policymakers. Further, in the form of individual paragraphs, the article presents a consolidated position of the represented European organisations. This position is focused on the patients' needs, expert recommendations for the relevant medical fields and plausible solutions which have a potential to advance health care services if the long-term strategies were to be effectively implemented as proposed here.