Refining Timely Diagnosis of Early Syphilis by Using Treponema pallidum PCR or IgM Immunoblotting Next to Conventional Serology for Syphilis.

Treponema pallidum subsp. pallidum is a fastidious spirochete and the etiologic agent of syphilis, a sexually transmitted infection (STI). Syphilis diagnoses and disease staging are based on clinical findings and serologic testing. Moreover, according to most international guidelines, PCR analysis of swab samples from genital ulcers is included in the screening algorithm where possible. It has been suggested that PCR might be omitted from the screening algorithm due to low added value. As an alternative to PCR, IgM serology might be used. In this study, we wanted to establish the added value of PCR and IgM serology for diagnosing primary syphilis. Added value was defined as finding more cases of syphilis, preventing overtreatment, or limiting the extent of partner notification to more recent partners. We found that both PCR and IgM immunoblotting could aid the timely diagnosis of early syphilis in ~24% to 27% of patients. PCR has the greatest sensitivity and can be applied to cases with an ulcer with suspected reinfection or primary infection. In the absence of lesions, the IgM immunoblot could be used. However, the IgM immunoblot has better performance in cases with suspected primary infection than in reinfections. The target population, testing algorithm, time pressures, and costs should determine whether either test provides sufficient value to be implemented in clinical practice.

Choosing which in-hospital laboratory tests to target for intervention: a scoping review.

INTRODUCTION: Some laboratory testing practices may be of low value, leading to wasted resources and potential patient harm. Our scoping review investigated factors and processes that developers report using to inform decisions about what tests to target for practice improvement. METHODS: We searched Medline on May 30th, 2019 and June 28th, 2021 and included guidelines, recommendation statements, or empirical studies related to test ordering practices. Studies were included if they were conducted in a tertiary care setting, reported making a choice about a specific test requiring intervention, and reported at least one factor informing that choice. We extracted descriptive details, tests chosen, processes used to make the choice, and factors guiding test choice. RESULTS: From 114 eligible studies, we identified 30 factors related to test choice including clinical value, cost, prevalence of test, quality of test, and actionability of test results. We identified nine different processes used to inform decisions regarding where to spend intervention resources. CONCLUSIONS: Intervention developers face difficult choices when deciding where to put scarce resources intended to improve test utilization. Factors and processes identified here can be used to inform a framework to help intervention developers make choices relevant to improving testing practices.

The impact of removing financial incentives and/or audit and feedback on chlamydia testing in general practice: A cluster randomised controlled trial (ACCEPt-able).

BACKGROUND: Financial incentives and audit/feedback are widely used in primary care to influence clinician behaviour and increase quality of care. While observational data suggest a decline in quality when these interventions are stopped, their removal has not been evaluated in a randomised controlled trial (RCT), to our knowledge. This trial aimed to determine whether chlamydia testing in general practice is sustained when financial incentives and/or audit/feedback are removed. METHODS AND FINDINGS: We undertook a 2 × 2 factorial cluster RCT in 60 general practices in 4 Australian states targeting 49,525 patients aged 16-29 years for annual chlamydia testing. Clinics were recruited between July 2014 and September 2015 and were followed for up to 2 years or until 31 December 2016. Clinics were eligible if they were in the intervention group of a previous cluster RCT where general practitioners (GPs) received financial incentives (AU$5-AU$8) for each chlamydia test and quarterly audit/feedback reports of their chlamydia testing rates. Clinics were randomised into 1 of 4 groups: incentives removed but audit/feedback retained (group A), audit/feedback removed but incentives retained (group B), both removed (group C), or both retained (group D). The primary outcome was the annual chlamydia testing rate among 16- to 29-year-old patients, where the numerator was the number who had at least 1 chlamydia test within 12 months and the denominator was the number who had at least 1 consultation during the same 12 months. We undertook a factorial analysis in which we investigated the effects of removal versus retention of incentives (groups A + C versus groups B + D) and the effects of removal versus retention of audit/feedback (group B + C versus groups A + D) separately. Of 60 clinics, 59 were randomised and 55 (91.7%) provided data (group A: 15 clinics, 11,196 patients; group B: 14, 11,944; group C: 13, 11,566; group D: 13, 14,819). Annual testing decreased from 20.2% to 11.7% (difference -8.8%; 95% CI -10.5% to -7.0%) in clinics with incentives removed and decreased from 20.6% to 14.3% (difference -7.1%; 95% CI -9.6% to -4.7%) where incentives were retained. The adjusted absolute difference in treatment effect was -0.9% (95% CI -3.5% to 1.7%; p = 0.2267). Annual testing decreased from 21.0% to 11.6% (difference -9.5%; 95% CI -11.7% to -7.4%) in clinics where audit/feedback was removed and decreased from 19.9% to 14.5% (difference -6.4%; 95% CI -8.6% to -4.2%) where audit/feedback was retained. The adjusted absolute difference in treatment effect was -2.6% (95% CI -5.4% to -0.1%; p = 0.0336). Study limitations included an unexpected reduction in testing across all groups impacting statistical power, loss of 4 clinics after randomisation, and inclusion of rural clinics only. CONCLUSIONS: Audit/feedback is more effective than financial incentives of AU$5-AU$8 per chlamydia test at sustaining GP chlamydia testing practices over time in Australian general practice. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614000595617.

Price, quality, and market dynamics of malaria rapid diagnostic tests: analysis of Global Fund 2009-2018 data.

BACKGROUND: Rapid diagnostic tests (RDTs) for malaria are a vital part of global malaria control. Over the past decade, RDT prices have declined, and quality has improved. However, the relationship between price and product quality and their larger implications on the market have yet to be characterized. This analysis used purchase data from the Global Fund together with product quality data from the World Health Organization (WHO) and Foundation for Innovative New Diagnostics (FIND) Malaria RDT Product Testing Programme to understand three unanswered questions: (1) Has the market share by quality of RDTs in the Global Fund's procurement orders changed over time? (2) What is the relationship between unit price and RDT quality? (3) Has the market for RDTs financed by the Global Fund become more concentrated over time? METHODS: Data from 10,075 procurement transactions in the Global Fund's database, which includes year, product, volume, and price, was merged with product quality data from all eight rounds of the WHO-FIND programme, which evaluated 227 unique RDT products. To describe trends in market share by quality level of RDT, descriptive statistics were used to analyse trends in market share from 2009 to 2018. A generalized linear regression model was then applied to characterize the relationship between price and panel detection score (PDS), adjusting for order volume, year purchased, product type, and manufacturer. Third, a Herfindahl-Hirschman Index (HHI) score was calculated to characterize the degree of market concentration. RESULTS: Lower-quality RDTs have lost market share between 2009 and 2018, as have the highest-quality RDTs. No statistically significant relationship between price per test and PDS was found when adjusting for order volume, product type, and year of purchase. The HHI was 3,570, indicating a highly concentrated market. CONCLUSIONS: Advancements in RDT affordability, quality, and access over the past decade risk stagnation if health of the RDT market as a whole is neglected. These results suggest that from 2009 to 2018, this market was highly concentrated and that quality was not a distinguishing feature between RDTs. This information adds to previous reports noting concerns about the long-term sustainability of this market. Further research is needed to understand the causes and implications of these trends.

Performance-based risk-sharing arrangements for devices and diagnostics in the United States: a systematic review.

BACKGROUND: Performance-based risksharing arrangements (PBRSAs) have continued to emerge and evolve over the last 2 decades. To date, most of the attention and available literature have focused on pharmaceuticals. OBJECTIVE: To assess the current status and trends regarding the use of PBRSAs for diagnostics and devices in the United States. METHODS: We reviewed publicly available PBRSAs for diagnostics and devices using the University of Washington Performance Based Risk Sharing Database. We augmented the review using PubMed, Google, and payer and industry websites. Key words and phrases such as outcomes-based, value-based, coverage with evidence development, performance-based, and risk-sharing were used in combination with device or diagnostic. To characterize arrangements in terms of product and market attributes, we extracted data for each product, including arrangement descriptions, arrangement type, year, therapeutic area, product manufacturer, payer, and product type. Arrangements were analyzed using descriptive statistics. RESULTS: Fifty-two arrangements were identified between the years 2001 and 2019, with 30 (57.7%) for devices and 22 (42.3%) for diagnostic tests. Among these, 23 (44.2%) were coverage with evidence development (CED), only in research; 17 (32.7%) were performance-linked reimbursement (PLR); and 12 (23.1%) were CED, only with research. The majority of arrangements for devices were developed in cardiology (12, 40%), endocrinology (4, 13.3%), and radiology (3, 10%). Most of arrangements for identified diagnostic tests were in oncology (17, 77.3%). Over time, there has been a trend towards increasing adoption of PLR and CED, only with research, especially since 2014. CONCLUSIONS: This is the first study to comprehensively review PBRSA arrangements for diagnostics and devices in the United States. Our findings demonstrated that there is substantial PBRSA activity for devices and diagnostics, and the pace of PBRSA adoption appears to be increasing in terms of frequency and variety. These arrangements have implications for managed care into the future as the health care system shifts towards value-based care and value-based pricing to contain cost for payers and ensure value in the patient populations. DISCLOSURES: No funding supported this study. The authors have nothing to disclose.

Rethinking the routine: Preoperative laboratory testing among American Society of Anesthesiologists class 1 and 2 patients before low-risk ambulatory surgery in the 2017 National Surgical Quality Improvement Program cohort.

BACKGROUND: Routine preoperative laboratory testing is not recommended for American Society of Anesthesiologists classification 1 or 2 patients before low-risk ambulatory surgery. METHODS: The 2017 National Surgical Quality Improvement Program data set was retrospectively queried for American Society of Anesthesiologists class 1 and 2 patients who underwent low-risk, elective outpatient anorectal, breast, endocrine, gynecologic, hernia, otolaryngology, oral-maxillofacial, orthopedic, plastic/reconstructive, urologic, and vascular operations. Preoperative laboratory testing was defined as any chemistry, hematology, coagulation, or liver function studies obtained ≤30 days preoperatively. Demographics, comorbidities, and outcomes were compared between those with and without testing. The numbers needed to test to prevent serious morbidity or any complication were calculated. Laboratory testing costs were estimated using Centers for Medicare and Medicaid Services data. RESULTS: Of 111,589 patients studied, 57,590 (51.6%) received preoperative laboratory testing; 26,709 (46.4%) had at least 1 abnormal result. Factors associated with receiving preoperative laboratory testing included increasing age, female sex, non-White race/ethnicity, American Society of Anesthesiologists class 2, diabetes, dyspnea, hypertension, obesity, and steroid use. Mortality did not differ between patients with and without testing. The complication rate was 2.5% among tested patients and 1.7% among patients without tests (P < .01). The numbers needed to test was 599 for serious morbidity and 133 for any complication. An estimated $373 million annually is spent on preoperative laboratory testing in this population. CONCLUSION: Despite American Society of Anesthesiologists guidelines, a majority of American Society of Anesthesiologists class 1 and 2 patients undergo preoperative laboratory testing before elective low-risk outpatient surgery. The differences in the rates of complications between patients with and without testing is low. Preoperative testing should be used more judiciously in this population, which may lead to cost savings.

Provider views on rapid diagnostic tests and antibiotic prescribing for respiratory tract infections: A mixed methods study.

BACKGROUND: Respiratory tract infections (RTIs) are often inappropriately treated with antibiotics. Rapid diagnostic tests (RDTs) have been developed with the aim of improving antibiotic prescribing but uptake remains low. The aim of this study was to examine provider knowledge, attitudes and behaviors regarding RDT use and their relationship to antibiotic prescribing decisions across multiple clinical departments in an urban safety-net hospital. METHODS: We conducted a mixed methods sequential explanatory study. Providers with prescribing authority (attending physicians, nurse practitioners and physician assistants) who had at least 20 RTI encounters from January 1, 2016 to December 31, 2018. Eighty-five providers completed surveys and 16 participated in interviews. We conducted electronic surveys via RedCap from April to July 2019, followed by semi-structured individual interviews from October to December 2019, to ascertain knowledge, attitudes and behaviors related to RDT use and antibiotic prescribing. RESULTS: Survey findings indicated that providers felt knowledgeable about antibiotic prescribing guidelines. They reported high familiarity with the rapid streptococcus and rapid influenza tests. Familiarity with comprehensive respiratory panel PCR (RPP-respiratory panel PCR) and procalcitonin differed by clinical department. Qualitative interviews identified four main themes: providers trust their clinical judgment more than rapid test results; patient-provider relationships play an important role in prescribing decisions; there is patient demand for antibiotics and providers employ different strategies to address the demand and providers do not believe RDTs are implemented with sufficient education or evidence for clinical practice. CONCLUSION: Prescribers are knowledgeable about prescribing guidelines but often rely on clinical judgement to make final decisions. The utility of RDTs is specific to the type of RDT and the clinical department. Given the low familiarity and clinical utility of RPP and procalcitonin, providers may require additional education and these tests may need to be implemented differently based on clinical department.

Mobile Hysteroscopy With the Use of a Smartphone as a Cost-Effective, Diagnostic Technique.

BACKGROUND: Smartphone technology can be adapted to promote cable-free, wireless, and cost-effective diagnostic mobile office hysteroscopy. INSTRUMENT: We developed a new cable-free setup by coupling a rigid 30°, 2-mm-diameter hysteroscope to a smartphone using a commercially available adapter and using a portable and rechargeable light-emitting diode cold light source. The new setup cost is considerably lower compared with that of a typical endoscopic tower. EXPERIENCE: We performed both standard hysteroscopy and hysteroscopy using the new portable setup in 40 patients for a variety of benign gynecologic indications. The operating time was compared between the two methods, as was the pain perceived by the patients. Videos from the two setups were blindly reviewed and scored by experts regarding image resolution, brightness, color, and overall image quality. The new technique was acceptable for diagnosis in 97.5% of the videos. CONCLUSION: We report a promising initial experience using a smartphone to provide a convenient, cable-free, low-cost, office hysteroscopy system.

Development of an alternative saliva test for diagnosis of SARS-CoV-2 using TRIzol: Adapting to countries with lower incomes looking for a large-scale detection program.

The use of saliva for the diagnosis of SARS-CoV-2 has shown to be a good alternative to nasopharyngeal swabs (NPS), since it permits self-collection, avoids the exposure of healthy persons to infected patients, reduces waiting times, eliminates the need of personal protective equipment and is non-invasive. Yet current saliva testing is still expensive due to the need of specialized tubes containing buffers to stabilize the RNA of SARS-CoV-2 and inactivate the virus. These tubes are expensive and not always accessible in sufficient quantities. We now developed an alternative saliva testing method, using TRIzol for extraction, viral inactivation, and storage of SARS-CoV-2 RNA, combined with RT-qPCR, which was comparable in its performance to NPS. Paired saliva samples and NPS were taken from 15 asymptomatic healthcare workers and one patient with SARS-CoV-2. Further 13 patients with SARS-CoV-2 were only saliva-tested. All the tests were performed according to CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. Saliva (4 mL) was taken in sterile 50 mL tubes, 1.5 mL TRIzol were added and mixed. Our results show that 5 µL of saliva RNA extracted with TRIzol allow for an adequate detection of the virus in patients positive for SARS-CoV-2 and was equally sensitive to NPS in TRIzol. We conclude that saliva testing using TRIzol is a recommendable method for diagnosis of SARS-CoV-2 since it has several advantages over currently used saliva tests: it can be done with normal sterile tubes, does not need cold-chain handling, is stable at room temperature, is non-invasive and less costly, making it more accessible for low-income countries. Cheaper saliva testing using TRIzol is especially relevant for low-income countries to optimize diagnosis and help define quarantine durations for families, healthcare workers, schools, and other public workplaces, thus decreasing infections and mortality caused by SARS-CoV-2.

Free Market Availability of Rapid Diagnostics Will Empower Communities To Control Malaria in India.

Globally, malaria incidence has declined but further reductions in malaria are not evident in many countries. In addition to the public health approaches for tackling malaria, involvement of the private sector is vital because the private sector plays a central role in healthcare delivery to the masses. In India, malaria management is primarily provided through government programs, nonetheless, significant numbers of fever patients continue to seek healthcare in the private sector. The private sector in India is comprised of formal healthcare (qualified and approved), informal healthcare (unqualified, untrained), including traditional healers. Commercial channels for the procurement of quality-assured malaria diagnostics like rapid diagnostic tests via pharmacies or other approved outlets would empower Indian populations to self-detect malaria without delay. Easier access would minimize the diagnostic time gap, reduce costs to the patient, prevent inappropriate malaria treatment, and foster timely treatment of both malaria and non-malaria infections. Commercially available rapid diagnostic tests in the hands of the people could be an important tool in our fight against malaria.

Folate Deficiency in an Urban Safety Net Population.

PURPOSE: Since mandatory fortification of grain products with folic acid in the United States in 1998, folate deficiency has become rare. Some have suggested that serum folate levels should be tested rarely in countries with mandatory folic acid fortification, given low rates of deficiency, high cost per deficiency diagnosis, and low rates of supplementation for those diagnosed as deficient. Given persistent racial, ethnic, and socioeconomic disparities in folate deficiency, these suggestions may not apply to all populations. We examine the rate at which serum testing detected folate deficiency in an urban safety net hospital and the characteristics of folate-deficient patients. METHODS: We reviewed the charts of all inpatients and emergency department patients with low serum folate results at a safety net hospital in Boston in 2018. We collected data concerning demographics, social determinants of health, clinical factors, and whether folate supplementation was prescribed. Finally, we performed a cost analysis. RESULTS: Of 1368 patients tested, 76 (5.5%) met criteria for folate deficiency. Overall, 86.8% of these patients were anemic, and 17.1% had macrocytic anemia; 42% were diagnosed with malnutrition. Common social determinants in folate-deficient patients included birth outside of the United States, homelessness, and alcohol use disorder. Of folate-deficient patients, 88% were newly prescribed folic acid supplementation at discharge. The estimated charge per deficient test was $1278. CONCLUSION: Compared with a nearby institution, serum folate testing at our safety net hospital detected deficiency at a higher rate, incurred a lower charge per deficient test, and was more likely to impact management.

Strengthening health systems to improve the value of tuberculosis diagnostics in South Africa: A cost and cost-effectiveness analysis.

BACKGROUND: In South Africa, replacing smear microscopy with Xpert-MTB/RIF (Xpert) for tuberculosis diagnosis did not reduce mortality and was cost-neutral. The unchanged mortality has been attributed to suboptimal Xpert implementation. We developed a mathematical model to explore how complementary investments may improve cost-effectiveness of the tuberculosis diagnostic algorithm. METHODS: Complementary investments in the tuberculosis diagnostic pathway were compared to the status quo. Investment scenarios following an initial Xpert test included actions to reduce pre-treatment loss-to-follow-up; supporting same-day clinical diagnosis of tuberculosis after a negative result; and improving access to further tuberculosis diagnostic tests following a negative result. We estimated costs, deaths and disability-adjusted-life-years (DALYs) averted from provider and societal perspectives. Sensitivity analyses explored the mediating influence of behavioural, disease- and organisational characteristics on investment effectiveness. FINDINGS: Among a cohort of symptomatic patients tested for tuberculosis, with an estimated active tuberculosis prevalence of 13%, reducing pre-treatment loss-to-follow-up from ~20% to ~0% led to a 4% (uncertainty interval [UI] 3; 4%) reduction in mortality compared to the Xpert scenario. Improving access to further tuberculosis diagnostic tests from ~4% to 90% among those with an initial negative Xpert result reduced overall mortality by 28% (UI 27; 28) at $39.70/ DALY averted. Effectiveness of investment scenarios to improve access to further diagnostic tests was dependent on a high return rate for follow-up visits. INTERPRETATION: Investing in direct and indirect costs to support the TB diagnostic pathway is potentially highly cost-effective.

Targeted ordering of investigations reduces costs of treatment for surgical inpatients.

BACKGROUND: Laboratory testing forms an important part of diagnostic investigation in modern medicine; however, the overuse of 'routine blood tests' can result in significant potential harm and financial cost to the patient and the healthcare system. In 2018, a new protocol targeting the ordering of investigations was implemented within the General Surgical Teams of Wollongong Hospital in New South Wales, an Australian tertiary referral hospital, to reduce the number of 'routine blood tests' as a quality improvement initiative. OBJECTIVE: To identify whether there was a reduction in the number of 'routine blood tests' and associated costs following implementation of the new protocol. METHODS: The protocol involved regular review of the laboratory investigations being ordered for the following day with a senior team member. The medical records of all patients admitted under the general surgery service at Wollongong Hospital were retrospectively reviewed over two 10-week periods in 2017 and 2018 (control and study, respectively). The casemix was categorized into Minor, Intermediate, Major or Unscored, depending on case complexity coding. RESULTS: A total of 838 patients were identified during the control period (2017) and 805 patients were identified during the study period (2018). Ten thousand and thirty tests were included in the control period, compared to 8610 over the study period, resulting in a 16% (or greater) reduction in 'routine blood tests' per patient, per day of admission and a 6% reduction in costs in the study group (P < 0.001). CONCLUSION: Targeted ordering of investigations with personalized education and feedback to junior staff during review of clinical status of each patient as a part of normal workflow can reduce inappropriate ordering of 'routine blood tests' and associated costs to the patient and the healthcare system.

Variability and Costs of Low-Value Preoperative Testing for Cataract Surgery Within the Veterans Health Administration.

Importance: The Choosing Wisely guidelines indicate that preoperative testing is often unnecessary and wasteful for patients undergoing cataract operations. However, little is known about the impact of these widely disseminated guidelines within the US Veterans Health Administration (VHA) system. Objective: To examine the extent, variability, associated factors, and costs of low-value tests (LVTs) prior to cataract operations in the VHA. Design, Setting, and Participants: This cohort study examined records of all patients receiving cataract operations within the VHA in fiscal year 2017 (October 1, 2016, to September 31, 2017). Records from 135 facilities nationwide supporting both ambulatory and inpatient surgery were included. Exposures: A laboratory test occurring within 30 days prior to cataract surgery and within 30 days after clinic evaluation. Main Outcomes and Measures: Overall national and facility-level rates and associated costs of receiving any of 8 common LVTs in the 30 days prior to cataract surgery. The patient characteristics, procedure type, and facility-level factors associated with receiving at least 1 test, the number of tests received, and receipt of a bundle of 4 tests (complete blood count, basic metabolic profile, chest radiograph, and electrocardiogram). Results: A total of 69 070 cataract procedures were identified among 50 106 patients (66 282 [96.0%] men; mean [SD] age, 71.7 [8.1] years; 53 837 [77.9%] White, 10 292 [14.9%] Black). Most of the patient population had either overweight (23 292 [33.7%] patients) or obesity (27 799 [40.2%] patients). Approximately 49% of surgical procedures (33 424 procedures) were preceded by 1 or more LVT with an overall LVT cost of $2 597 623. Among patients receiving LVTs, electrocardiography (7434 patients [29.9%]) was the most common, with some patients also receiving more costly tests, including chest radiographs (489 patients [8.2%]) and pulmonary function tests (127 patients [3.4%]). For receipt of any LVT, the intraclass correlation coefficient was 0.61 (P < .001) at the facility level and 0.06 (P < .001) at the surgeon level, indicating the substantial contribution of the facility to amount of tests given. Conclusions and Relevance: Despite existing guidelines, use of LVTs prior to cataract surgery is both common and costly within a large, national integrated health care system. Our results suggest that publishing evidence-based guidelines alone-such as the Choosing Wisely campaign-may not sufficiently influence individual physician behavior, and that system-level efforts to directly deimplement LVTs may therefore necessary to effect sustained change.

A method for analyzing the typical structure of direct costs in the cost of a laboratory test.

The basis for calculating the cost price of any product, including laboratory tests, is based on an estimate of direct costs of the production. At present, there are no systematic ideas about the structure of such costs, and approaches to their analysis have not been defined, in the management practice of medical laboratories. The purpose of this work was developing and testing a method for analyzing the structure of direct costs and their allocation bases when calculating the cost of a laboratory test. We analyzed data on the volume of laboratory tests performed in the clinical diagnostic laboratory of the National Medical Research Center of Cardiology, prices for purchased reagents and consumables, depreciation and maintenance costs of equipment, staff salaries. As a result, we proposed a typical component structure of direct costs, established the allocation bases of fixed costs, and determined the ratio of some variable cost components to onе product unit cost. On the basis of these concepts, an algorithm for calculating the total direct laboratory (technological) cost per test has been developed, which makes it possible to simulate the cost structure under conditions of arbitrarily specified variables. During the testing of the algorithm, the values of direct costs and the technological cost per test were calculated for billable (ordered) laboratory tests. Comparison of the economic efficiency of various methods, as well as modeling of changes in the cost depending on the volume of testing and the turn-around time (TAT) has been performed. It can be concluded that the approach to creating the tables of the technological cost per test based on dividing direct costs into variable and fixed costs and structuring them by components and allocation bases is an effective tool for medical laboratory management.

Thrombophilia Testing After Ischemic Stroke: Why, When, and What?

Thrombophilia testing is frequently performed after an ischemic stroke, particularly when cryptogenic. However, there is minimal evidence supporting a significant association between most conditions assessed through thrombophilia testing and ischemic stroke, and the rationale for thrombophilia testing in many clinical situations remains uncertain. In this topical review, we review and contextualize the existing data on the risks, predictors, and outcomes of thrombophilic conditions in patients with ischemic stroke. We report that inherited thrombophilias have an uncertain relationship with ischemic stroke. Conversely, antiphospholipid syndrome, an acquired immune-mediated thrombophilia, seems to be a strong risk factor for arterial thromboembolic events, including ischemic stroke, and especially among young patients. Our findings suggest that certain circumstances may warrant targeted thrombophilia testing, such as stroke in the young, cryptogenic stroke, and high estrogen states. Future prospective studies should investigate the utility and cost effectiveness of thrombophilia testing in various stroke settings, including among patients with patent foramen ovale; as well as the optimal secondary stroke prevention regimen in patients with confirmed thrombophilia, particularly if no other potential stroke mechanism is identified.

Optimizing infant HIV diagnosis with additional screening at immunization clinics in three sub-Saharan African settings: a cost-effectiveness analysis.

INTRODUCTION: Uptake of early infant HIV diagnosis (EID) varies widely across sub-Saharan African settings. We evaluated the potential clinical impact and cost-effectiveness of universal maternal HIV screening at infant immunization visits, with referral to EID and maternal antiretroviral therapy (ART) initiation. METHODS: Using the CEPAC-Pediatric model, we compared two strategies for infants born in 2017 in Côte d'Ivoire (CI), South Africa (SA), and Zimbabwe: (1) existing EID programmes offering six-week nucleic acid testing (NAT) for infants with known HIV exposure (EID), and (2) EID plus universal maternal HIV screening at six-week infant immunization visits, leading to referral for infant NAT and maternal ART initiation (screen-and-test). Model inputs included published Ivoirian/South African/Zimbabwean data: maternal HIV prevalence (4.8/30.8/16.1%), current uptake of EID (40/95/65%) and six-week immunization attendance (99/74/94%). Referral rates for infant NAT and maternal ART initiation after screen-and-test were 80%. Costs included NAT ($24/infant), maternal screening ($10/mother-infant pair), ART ($5 to 31/month) and HIV care ($15 to 190/month). Model outcomes included mother-to-child transmission of HIV (MTCT) among HIV-exposed infants, and life expectancy (LE) and mean lifetime per-person costs for children with HIV (CWH) and all children born in 2017. We calculated incremental cost-effectiveness ratios (ICERs) using discounted (3%/year) lifetime costs and LE for all children. We considered two cost-effectiveness thresholds in each country: (1) the per-capita GDP ($1720/6380/2150) per year-of-life saved (YLS), and (2) the CEPAC-generated ICER of offering 2 versus 1 lifetime ART regimens (e.g. offering second-line ART; $520/500/580/YLS). RESULTS: With EID, projected six-week MTCT was 9.3% (CI), 4.2% (SA) and 5.2% (Zimbabwe). Screen-and-test decreased total MTCT by 0.2% to 0.5%, improved LE by 2.0 to 3.5 years for CWH and 0.03 to 0.07 years for all children, and increased discounted costs by $17 to 22/child (all children). The ICER of screen-and-test compared to EID was $1340/YLS (CI), $650/YLS (SA) and $670/YLS (Zimbabwe), below the per-capita GDP but above the ICER of 2 versus 1 lifetime ART regimens in all countries. CONCLUSIONS: Universal maternal HIV screening at immunization visits with referral to EID and maternal ART initiation may reduce MTCT, improve paediatric LE, and be of comparable value to current HIV-related interventions in high maternal HIV prevalence settings like SA and Zimbabwe.

Tradition Versus Value: Is There Utility in Protocolized Postoperative Laboratory Testing After Elective Colorectal Surgery?

OBJECTIVE: Determine if routine ordering of postoperative day 1 (POD 1) serum laboratory tests after elective colorectal surgery are clinically warranted and valuable given the associated costs of these lab tests. SUMMARY OF BACKGROUND DATA: Routine postoperative serum laboratory tests are a part of many colorectal surgery order sets. Whether these protocolized lab tests represent cost-effective care is unknown. METHODS: Patients undergoing elective colorectal surgery between January 1, 2015 and December 31, 2017 at our institution were identified. The protocolized POD 1 lab tests obtained as part of the postoperative order set were reviewed to determine the rate of abnormal values and any intervention in response. Costs associated with protocolized laboratory testing were calculated using dollar amounts representing 2017 outpatient Medicare reimbursement. RESULTS: A total of 2252 patients were identified with 8205 total lab test values. Of these, only 4% were abnormal (3% of hemoglobin values, 6% of creatinine values, 3% of potassium of values, and 3% of glucose values), and only 1% were actively intervened upon. The total aggregate cost of the protocolized POD 1 laboratory tests in these years was $64,000 based on Medicare outpatient reimbursement dollars. CONCLUSIONS: Routine POD 1 lab tests after elective colorectal surgery are rarely abnormal, and they even less frequently require active intervention beyond rechecking. This results in increased resource utilization and cost of care without appreciable impact on clinical care, and is not cost-effective. Protocolized POD 1 laboratory testing should be replaced with clinically-based criteria to trigger serum laboratory investigations.