"Global Health": Time to Refocus while We still Have Time.

Two decades of growing resource availability from agencies and foundations in wealthy countries has transformed approaches to health in poorly resourced nations. This progress looks increasingly unstable as climate change, social unrest, and, now, disruptive pandemics present threats not only to health but also to the mechanisms that manage it, and to funding itself. The growth in "global health" schools, technology development laboratories, nongovernmental organizations and multilateral institutions in donor countries has delivered not only successes but also disappointment, and reflect a paradigm that is in many ways contrary to the principles of population-based ownership that they espouse. Although the COVID-19 crisis has underlined the importance of health access and health service capacity, we may have a limited window of opportunity in which to rethink the current model and improve both efficiency and effectiveness. With a dose of humility, we may all benefit from studying our own rhetoric on human-centered design and applying these principles across global health to ensure that our approach is effective, efficient, and defensible.

The Research on the Outpatient Cost Adjustment Framework of the Urban Workers in a Southern China City During 2013 to 2015.

Based on a large amount of data, the study aimed to analyze all expenses of outpatients in a southern China city from 2013 to 2015. It draws a conclusion that the total cost of outpatient has increased in the past 3 years, and various cost indexes either increased or decreased in different ways. Drug costs and treatment fees are the main influencing factors for the change in total outpatient cost. The structural change from 2013 to 2015 was 70.15%. Drug costs, laboratory fees, and inspection fees are the main indexes that account for the increasing total outpatient costs. This study puts emphasis on the cost of human resources, which eliminates the phenomenon of "Yi Yao Yang Yi" (support medical cost with medicine) and "Yi Xie Yang Yi" (support medical cost with medical device). This study also focuses on the balance of outpatient cost, as well as the compensation function of medical insurance, which encourages multiple participation and coordinated adjustment.

Lab-based and diagnosis-based chronic kidney disease recognition and staging concordance.

BACKGROUND: Chronic kidney disease (CKD) is often under-recognized and poorly documented via diagnoses, but the extent of under-recognition is not well understood among Medicare beneficiaries. The current study used claims-based diagnosis and lab data to examine patient factors associated with clinically recognized CKD and CKD stage concordance between claims- and lab-based sources in a cohort of Medicare beneficiaries. METHODS: In a cohort of fee-for-service (FFS) beneficiaries with CKD based on 2011 labs, we examined the proportion with clinically recognized CKD via diagnoses and factors associated with clinical recognition in logistic regression. In the subset of beneficiaries with CKD stage identified from both labs and diagnoses, we examined concordance in CKD stage from both sources, and factors independently associated with CKD stage concordance in logistic regression. RESULTS: Among the subset of 206,036 beneficiaries with lab-based CKD, only 11.8% (n = 24,286) had clinically recognized CKD via diagnoses. Clinical recognition was more likely for beneficiaries who had higher CKD stages, were non-elderly, were Hispanic or non-Hispanic Black, lived in core metropolitan areas, had multiple chronic conditions or outpatient visits in 2010, or saw a nephrologist. In the subset of 18,749 beneficiaries with CKD stage identified from both labs and diagnoses, 70.0% had concordant CKD stage, which was more likely if beneficiaries were older adults, male, lived in micropolitan areas instead of non-core areas, or saw a nephrologist. CONCLUSIONS: There is significant under-diagnosis of CKD in Medicare FFS beneficiaries, which can be addressed with the availability of lab results.

Continual improvement of the pre-analytical process in a public health laboratory with quality indicators-based risk management.

Background Quality indicators (QIs) and risk management are important tools for a quality management system designed to reduce errors in a laboratory. This study aimed to show the effectiveness of QI-based risk management for the continual improvement of pre-analytical processes in the Kayseri Public Health Laboratory (KPHL) which serves family physicians and collects samples from peripheral sampling units. Methods QIs of pre-analytical process were used for risk assessment with the failure modes and effects analysis (FMEA) method. Percentages and risk priority numbers (RPNs) of QIs were quantified. QI percentages were compared to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) performance specifications and RPNs were compared to risk level scale, and corrective actions planned if needed. The effectiveness of risk treatment actions was re-evaluated with the new percentages and with RPNs of predefined QIs. Results RPNs related to four QIs required corrective action according to the risk evaluation scale. After risk treatment, the continual improvement was achieved for performance and risk level of "transcription errors", for risk levels of "misidentified samples" and "not properly stored samples" and for the performance of "hemolyzed samples". "Not properly stored samples" had the highest risk score because of sample storage and centrifugation problems of peripheral sampling units which are not under the responsibility of the KPHL. Conclusions Public health laboratories may have different risk priorities for pre-analytical process. Risk management based on predefined QIs can decrease the risk levels and increase QI performance as evidence-based examples for continual improvement of the pre-analytical process.

Assessing the cost-effectiveness of a routine versus an extensive laboratory work-up in the diagnosis of anaemia in Dutch general practice.

Background Establishing the underlying cause of anaemia in general practice is a diagnostic challenge. Currently, general practitioners individually determine which laboratory tests to request (routine work-up) in order to diagnose the underlying cause. However, an extensive work-up (consisting of 14 tests) increases the proportion of patients correctly diagnosed. This study investigates the cost-effectiveness of this extensive work-up. Methods A decision-analytic model was developed, incorporating all societal costs from the moment a patient presents to a general practitioner with symptoms suggestive of anaemia (aged ≥ 50 years), until the patient was (correctly) diagnosed and treated in primary care, or referred to (and diagnosed in) secondary care. Model inputs were derived from an online survey among general practitioners, expert estimates and published data. The primary outcome measure was expressed as incremental cost per additional patient diagnosed with the correct underlying cause of anaemia in either work-up. Results The probability of general practitioners diagnosing the correct underlying cause increased from 49.6% (95% CI: 44.8% to 54.5%) in the routine work-up to 56.0% (95% CI: 51.2% to 60.8%) in the extensive work-up (i.e. +6.4% [95% CI: -0.6% to 13.1%]). Costs are expected to increase slightly from €842/patient (95% CI: €704 to €994) to €845/patient (95% CI: €711 to €994), i.e. +€3/patient (95% CI: €-35 to €40) in the extensive work-up, indicating incremental costs of €43 per additional patient correctly diagnosed. Conclusions The extensive laboratory work-up is more effective for diagnosing the underlying cause of anaemia by general practitioners, at a minimal increase in costs. As accompanying benefits in terms of quality of life and reduced productivity losses could not be captured in this analysis, the extensive work-up is likely cost-effective.

An epidemiology-based model as a tool to monitor the outbreak of inappropriateness in tumor marker requests: a national scale study.

BACKGROUND: Evaluation of appropriateness of laboratory tests on the basis of individual requests remains a serious problem as the clinical question is usually not reported with the test order. This study explored the comparison of the rate of tumor marker orders with cancer prevalence as a putative indicator of inappropriateness. METHODS: Tumor marker orders (2011 and 2012) were obtained from the Ministry of Health and cancer prevalence from the Italian Association of Cancer Registries. The rate of tumor marker orders was matched with demographic data and tumor prevalence and examined by using the confidence interval approach. Region-to-region and year-to-year variations were also examined. Focus was placed on CEA, CA125, CA19.9 and CA15.3. RESULTS: Tumor markers ordered in Italy were 13,207,289 in 2012 (221.3/1000 individuals). Given an estimated prevalence of 2,243,953 cancer cases, 7.04 tumor markers appear to be requested for each prevalent case of epithelial cancer per year. The rate of requests of CEA, CA125, CA19.9 and CA15.3 (in aggregate 5,834,167 requests in 2012, 44.2% of total) from the first and the last ranked region (96 and 244/1000 individuals) are significantly different (p<0.01). Region-to-region differences do not correspond to any known variation of prevalence in the different regions. CONCLUSIONS: The developed approach provides a proxy indicator of inappropriateness showing that tumor markers are overused in Italy and their ordering pattern is not related to tumor prevalence. The model is suitable to be validated in other laboratory tests used in diseases whose prevalence is known.

Request of laboratory liver tests in primary care in Spain: potential savings if appropriateness indicator targets were achieved.

AIMS: Liver laboratory tests are used to screen for liver disease, suggest the underlying cause, estimate the severity, assess prognosis, and monitor the efficacy of therapy. The aim of this study was to compare the liver laboratory tests requesting patterns by GPs in Spain, according to geographic and hospital characteristics, to investigate the degree of requesting appropriateness. MATERIALS AND METHODS: One hundred and forty-one clinical laboratories were invited to participate from diverse regions across Spain. They filed out the number of laboratory liver tests requested by GPs for the year 2012. Two types of appropriateness indicators were calculated: every test request per 1000 inhabitants or ratios of related tests requests. The indicator results obtained were compared between the different hospitals, according to their setting, location, and management. The savings generated, if each area would have achieved indicator targets, were calculated. RESULTS: We recruited 76 laboratories covering a population of 17,679,195 inhabitants. GPs requested 20,916,780 laboratory liver tests in the year 2012. No differences were obtained according to their setting. Lactate dehydrogenase and direct bilirubin per 1000 inhabitants were significantly higher in institutions with private management. Largest differences were observed between communities. Nine, 31, 0, and 13 laboratories, respectively, achieved the aspartate aminotransferase, lactate dehydrogenase, γ-glutamyl transpeptidase, and total bilirubin-related alanine aminotransferase indicator targets. Reaching ratios would have resulted in savings of €1,028,468. CONCLUSION: There was a high variability in the request of liver tests. This emphasizes the need to implement interventions to improve appropriate use of liver tests.

Results of the National External Quality Assessment for Toxoplasmosis Serological Testing in China.

BACKGROUND: Toxoplasmosis is typically diagnosed by serologic testing. External quality assessment (EQA) of clinical laboratories could ensure the accuracy and reliability of serological tests. We assessed the quality of toxoplasma serological assays in Chinese clinical laboratories by an EQA performed between 2004 and 2013 by the National Center for Clinical Laboratories. METHODOLOGY AND FINDINGS: EQA panels were prepared and shipped at room temperature to participating laboratories that employed toxoplasma IgG and IgM serological detection. By 2013, 5,384 EQA test reports for toxoplasma-specific IgM and 2,666 reports for toxoplasma-specific IgG were collected. Enzyme-linked immunosorbent (ELISA) and chemical immunofluorescent assays were the most commonly used detection methods. The overall coincidence rates of negative samples were better than those of positive samples. The overall EQA score for toxoplasma-specific IgM detection ranged between 84.3% and 99.6%. The ratio of laboratories that achieved correct IgG detection ranged from 61.1% to 99.3%. However, the inter- and intra-assay variabilities were found to be considerable. The most common problem was failure to detect low titers of antibody. CONCLUSION: The EQA scheme showed an improvement in toxoplasma serological testing in China. However, further optimization of assay sensitivity to detect challenging samples remains a future challenge.

The changing face of hemostasis testing in modern laboratories: consolidation, automation, and beyond.

The reality of laboratory diagnostics as a whole, and hemostasis testing in particular, is evolving under new paradigms of efficiency. The driving forces of health care and laboratory diagnostics in the third millennium are mainly represented by macro- and microeconomics. In a world with limited resources, shattered by an unprecedented economic crisis, laboratory diagnostics is undergoing a substantial reorganization, with emergence of new models under the imperative of terms, such as bedside testing, consolidation, and networking. The paradigms under which these changes are being developed include a variety of environment, preanalytical, technological, professional, and health-care aspects. The maintenance of continued quality is indeed the major challenge to be faced in the foreseeable future. In fact, some challenges prepotently emerge during a consolidation process, which basically involve delayed testing, centrifugation, transportation, and stability of the specimens, as well as the potential mismatch of sample matrix. This article is aimed to provide an overview of the current economic scenario of laboratory diagnostics and discuss the changing face of hemostasis testing in modern laboratories, providing a synthetic overview about potential drawbacks of actualized solutions.