Hemoglobin Testing Research Articles

Diagnostic Performance of Faecal Immunochemical Testing (FIT) in Patients with Lynch Syndrome Scheduled for Colonoscopic Surveillance

Background and Aims: Lynch syndrome (LS) carries a substantial lifetime risk of colorectal cancer which is currently mitigated by biennial colonoscopy surveillance. Paramount to the surveillance programme is the removal of adenomas before malignant transformation but there is an associated service burden and morbidity of repeated endoscopy. We investigated if faecal immunochemical testing (FIT) for faecal haemoglobin has the diagnostic performance to replace colonoscopy. Methods: In this retrospective cohort study, patients due to undergo planned surveillance for LS between November 2020 and April 2022 were sent two FIT kits prior to colonoscopy. Test diagnostic performance of colorectal cancer (CRC), advanced and non-advanced adenoma detection was calculated for single and double FIT strategies. A faecal-Hb of 10 µg Hb/g was considered positive. Results: In total, 78 patients, with 45 (57.7%) female, median age 52 years (IQR 41–63), completed at least one FIT and colonoscopy. The median time from FIT to colonoscopy was 47 days. A single FIT was positive in 7/30 cases of adenoma (2/3 advanced, 5/27 non-advanced). A total of 64 (82.1% of FIT1T returners) completed a second FIT. Using the greatest of the two FITs (FIT2TMAX) 8/26 (2/3 advanced, 4/23 non-advanced), patients with adenomas were identified. There were no cases of CRC. The sensitivity for adenoma detection was 23.3% and 23.1%, respectively. Conclusions: In patients with LS awaiting colonoscopy, FIT has a low sensitivity for detecting adenomas and advanced adenomas. This is not improved by the addition of a second FIT test.

The Relation of Diabetes Complications to a New Interpretation of Glycaemic Variability from Continuous Glucose Monitoring in People with Type 1 Diabetes.

Microvascular and macrovascular complications in type 1 diabetes (T1D) may be linked to endothelial stress due to glycaemic variability. Continuous glucose monitoring systems (CGMs) provide new opportunities to quantify this variability, utilising the amplitude of glucose change summated over time. The aim of this study was to examine whether this determination of glucose variability (GV) is associated with microvascular clinical sequelae. Continuous glucose monitoring values were downloaded for 89 type 1 diabetes mellitus (T1D) individuals for up to 18 months from 2021 to 2023. Data for patient demographics was also taken from the patient record which included Sex, Date of Birth, and Date of Diagnosis. The recorded laboratory glycated haemoglobin (HbA1c) test results were also recorded. The glucose management index (GMI) was calculated from average glucose readings for 18 months using the formula GMI (%) = (0.82-(Average glucose/100)). This was then adjusted to give GMI (mmol/mol) = 10.929 * (GMI (%) - 2.15). Average Glucose Fluctuation (AGF) was calculated by adding up the total absolute change value between all recorded results over 18 months and dividing by the number of results minus one. The % Above Critical Threshold (ACT) was calculated by summing the total number of occurrences for each result value. A cumulative 95% limit was then applied to identify the glucose value that only 5% of results exceeded in the overall population. Using this value, we estimated the percentage of total tests that were above the Critical Threshold (ACT). Results for the 89 individuals (44 men and 45 women) were analysed over 18months. The mean age of participants was 43 years and the mean duration of diabetes was 18years. A total of 3.22 million readings were analysed, giving an average of 10.3mmol/L blood glucose. Those with the largest change in glucose from reading to reading, summated over time, showed the greatest change in eGFR of 3.12ml/min/1.73 m2 (p = 0.007). People with a higher proportion of glucose readings > 18mmol/L showed a fall in eGFR of 2.8ml/min/1.73 m2 (p = 0.009) and experienced higher rates of sight-threatening retinopathy (44% of these individuals) (p = 0.01) as did 39% of individuals in the highest tertile of glucose levels (p = 0.008). Those individuals with T1D in the highest tertile of reading-to-reading glucose change showed the greatest change in eGFR. Those with a higher proportion of glucose readings > 18mmol/L also showed a fall in eGFR and experienced higher rates of sight-threatening retinopathy, as did people with higher mean glucose. Discussions with T1D individuals could reflect on how the percentage recorded glucose above a critical level and degree of change in glucose are important in avoiding future tissue complications.

Unveiling the Spectrum of Glucose Variability: A Novel Perspective on FreeStyle Libre Monitoring Data.

Since the introduction of insulin therapy, it has become apparent that type 1 diabetes (T1D) is accompanied by long-term microvascular and macrovascular complications. In the context of the many benefits of continuous glucose monitoring (CGM), there remain opportunities to study the large amount of data now available in order to maximise its potential in the endeavour to reduce the occurrence of diabetes tissue complications in the longer term. Continuous glucose monitoring values were downloaded for 89 type 1 diabetes mellitus (T1D) individuals for up to 18 months from 2021 to 2023. Data for patient demographics was also taken from the patient record which included Sex, Date of Birth, and Date of Diagnosis. The recorded laboratory glycated haemoglobin (HbA1c) test results were also recorded. The glucose management index (GMI) was calculated from average glucose readings for 18 months using the formula GMI (%) = (0.82-(Average glucose/100)). This was then adjusted to give GMI (mmol/mol) = 10.929 * (GMI (%) - 2.15). Average Glucose Fluctuation (AGF) was calculated by adding up the total absolute change value between all recorded results over 18 months and dividing by the number of results minus one. The % Above Critical Threshold (ACT) was calculated by summing the total number of occurrences for each result value. A cumulative 95% limit was then applied to identify the glucose value that only 5% of results exceeded in the overall population. Using this value, we estimated the percentage of total tests that were above the Critical Threshold (ACT). The mean age of the participants was 42.6years, and the mean duration of T1D was 18.4years. A total of 3.22 million readings were analysed, yielding an average blood glucose level of 10.3mmol/l and a GMI of 57.2mmol/mol. There was a strong correlation between GMI and measured HbA1c (r2 = 0.82). However, there were patients who had an above-critical threshold (ACT) of 4-10% at a GMI of 60mmol/mol or less. The percentage average value at the time of day (%AVTD) was applied to all blood glucose readings at each 15-min interval throughout the day, averaged over 18months. The %AVTD of GMI (overall average 57.2mmol/mol) increased after midday, dipped at 18:00, and peaked at 22:00. The %AVTD of AGF (overall average 0.60mmol/l) showed higher change rates after 09:00 declining at the end of the day. The %AVTD of ACT peaked at 22:00, with those having the highest %ACT showing an additional peak at 15:00. We have shown here that the percentage glucose results above 18mmol/l (top 5% of distribution) increased exponentially above 54mmol/mol HbA1c. The %AVTD is introduced as a useful measure. Our data indicate that over the 24-h period, improvement in metabolic control could be focussed on the afternoon and evening, when there are higher-than-average levels of GMI, a higher-than-average degree of glucose change, and higher-than-average risks of being above the critical threshold. In conclusion, a measure of glycaemic variation based on the amplitude of glucose change to a population mean could be used to provide valuable clinical insights into glucose change over a 24-h period.

Routine uptake of prenatal iron-folic acid supplementation and associated factors among pregnant women in peri-urban areas of Dodoma City, Tanzania: a cross-sectional study

BackgroundThe physiological requirements for iron and folic acid in pregnancy are a significant challenge to achieve through normal dietary intake, especially in low resource settings. The World Health Organization recommends daily oral iron and folic acid supplementation (IFAS) to prevent maternal anaemia and related adverse effects in community settings where the prevalence of anaemia during pregnancy is > 40%. The objective of this study was to assess the routine uptake of prenatal iron-folic acid supplementation and associated factors among pregnant women at peri-urban areas of Dodoma City, Tanzania.MethodsA cross-sectional study was conducted in peri-urban areas. Data was collected through face-to-face interviews and review of records from maternal clinic card (RCH 4 card). Routine uptake of iron-folic acid supplementation was defined as pregnant woman who reported taking iron-folic acid supplements at least once within the past seven days prior to data collection. Frequency and percentage were used to report respondents’ characteristics and uptake of prenatal iron-folic acid supplementation. Chi-square test and logistic regression were conducted to determine the relationship and association of routine uptake of iron-folic acid supplementation with respondents’ characteristics.ResultsThe total respondents were 452. Overall routine uptake of iron-folic acid supplementation was 35.6% (161). The majority of the respondents (66.5%) initiated iron-folic acid supplementation during the second trimester of pregnancy. Most of the respondents (86.3%) obtained IFA supplements at the health centers where they were receiving antenatal care. The prevalence of routine uptake of iron-folic acid supplementation was significantly higher among women in the third trimester of pregnancy (54.9%), those with more than a five-year interval since last pregnancy (40.6%), those with at least four antenatal care (ANC) visits (73.7%) and women who had undergone haemoglobin testing in the current pregnancy (63.0%). Factors associated with routine uptake of iron-folic acid supplementation were; frequency of ANC visits (AOR = 1.69) and haemoglobin testing (AOR = 3.02).ConclusionApproximately one third of the pregnant women took iron-folic acid supplementation at least once a week. The current frequency for intake of iron-folic acid supplementation can be described as intermittent. This practise is unacceptable for prevention of maternal anaemia and associated adverse pregnant outcomes. Frequency of ANC visits and haemoglobin testing during pregnancy were found to be associated with routine uptake of iron-folic acid supplements. Stakeholders are urged to consider novel systems for provision of prenatal IFAS in community settings with limited access to health-care professionals to ensure a timely and continuous supply of supplements.

Analytical evaluation of eight qualitative FIT for haemoglobin products, for professional use in the UK.

Qualitative faecal immunochemical tests for haemoglobin (FIT), for triaging for colorectal cancer investigations, are available for professional use. The aim was to evaluate these lateral flow tests. No previous analytical evaluations have been published. Analytical sensitivity (AS) was assessed using samples spanning manufacturers' quoted AS, concurrently with the quantitative OC-SENSOR PLEDIA, using Hb-spiked samples in manufacturers' buffer (n≥5;≤9-99 ng Hb/mL buffer), Hb-spiked faeces (n=6;<2-34 µg Hb/g faeces) and natural faeces (n=17;<2-82 μg/g); concentrations for 50 %/100 % Hb-detected were compared with quoted AS. Compatibility with two external quality assessment schemes (EQAS) (n=9; 3-96 μg/g) and prozone compared with manufacturers limits (n=9; 2,500-10,000,000 ng/mL) were tested. Ease-of-use by five healthcare personnel was assessed. Seven products showed lower AS (ng/mL) than manufacturers quoted using Hb-spiked aqueous samples compared with OC-SENSOR, one was equivocal; six manufacturers quoted AS in µg/g, five showed lower AS using Hb-spiked faeces. Results were similar but less consistent for natural faeces. Result lines for low concentrations can be faint and open to interpretation. Results were consistent with manufacturers quoted prozone limits. Results were consistent for seven products for two EQAS. The ease-of-use was 68.5-85.6 %; products with lower scores could be improved with better instructions and sample bottles. AS was lower for seven products (aqueous samples) and five products (aqueous/faecal samples) and prozone consistent with manufacturers expected concentrations, compared with OC-SENSOR. EQAS results were mostly consistent with expected results; products can be used by healthcare professionals, though some manufacturer improvements could be made.

An Adjustable Positivity Threshold for Non-invasive Screening Tests for Colorectal Neoplasms Can Improve Screening Program Effectiveness and Feasibility.

In two-step population screening for colorectal cancer (CRC), a simple non-invasive test, commonly a fecal immunochemical test for hemoglobin (FIT), is first undertaken to predict, based on the fecal hemoglobin concentration (f-Hb), who is more likely to have colorectal neoplasia and needs colonoscopy. To evaluate the importance of being able to adjust the f-Hb threshold that triggers follow-up colonoscopy (the "positivity threshold"), we evaluated the predictive value of f-Hb for colorectal neoplasia and its implications for the configuration of new non-invasive tests. A literature review was conducted on the use of quantitative FIT to select the positivity threshold, followed by using f-Hb from a large population to model how adjusting the positivity threshold enabled achievement of the desired program outcomes in a feasible manner. The literature review and the modeling found that while the f-Hb positivity threshold is predictive for colorectal neoplasia across a wide range of f-Hb, there is a complex relationship between program outcomes and f-Hb. The threshold determines not just clinical accuracy (including true- and false-positive results for CRC and/or advanced precursor lesions), but also the colonoscopy workload. A lower f-Hb threshold is associated with a higher sensitivity for neoplasia but a lower specificity and a heavier load of follow-up colonoscopies. Consequently, the threshold determines a program's impact on population CRC mortality and incidence, but also its feasibility and cost-effectiveness within a health-care system. We are entering a new era of non-invasive screening tests, where multiple biomarkers found in biological samples such as blood as well as feces, are being developed and evaluated. These typically specify a non-transparent algorithm, developed with machine learning, to provide a predictive dichotomous positive/negative result with a fixed associated clinical accuracy and colonoscopy workload. This will restrict use of new tests in jurisdictions where the accuracy and workload implications do not match the desired screening program outcomes. However, similar to flexible FIT positivity thresholds, it would be ideal if new tests also provide capacity for screening program providers to select the positivity threshold that delivers their desired screening outcomes in a feasible manner. How marketing, distribution and reimbursement of non-invasive tests are approved, funded and implemented varies widely across jurisdictions and must be taken into account.

B-335 Analytical Performance of the Novel EQA Material for Fecal Immunochemical Test for Hemoglobin

Abstract Background EQA (external quality assurance) program for FIT (fecal immunochemical test for hemoglobin) is performed in many countries, and its demand increases as FIT is widely used in organized colorectal cancer screening programs. The materials used in FIT EQA vary from buffer-based liquid control, and lyophilized stool, to material that mimics stool, artificial stool. We could not find ideal EQA material with hemoglobin uniformly contained, good stability of hemoglobin, and ease in use such as ready-to-use form. The merit to use material that simulates actual sample, stool, is not only to be compliant with ISO15189 but also to suit various methods and sampling devices in FIT. The development of artificial stool material has been awaited by laboratories using FIT to evaluate errors and precisions in specimen collection.We assessed the analytical performance of the new artificial stool developed in HECTEF (Health Care Technology Foundation) to evaluate this artificial stool material was suitable as an EQA material. We examined the following three points: 1) Sample collection, 2) Uniformity, and 3) Stability of hemoglobin. Methods 1) Sample collection: The material was collected with the sampling probes of OC-Auto Sampling Bottle 3 (Eiken Chemical) and the collection amount was calculated by comparing the weight before and after sampling the artificial stool. 2) Uniformity: The uniformity of hemoglobin was evaluated during production before and after bottling based on “Uniformity of dosage units” section of The Japanese Pharmacopoeia 18th edition, 2021. The material was sampled from 10 different points and hemoglobin concentrations were measured using OC-Sensor DIANA. The uniformity of hemoglobin between the vials was evaluated by calculating the CV from the average of hemoglobin concentrations from samples of three points from three vials. 3) Stability of hemoglobin: The materials stored under different temperature conditions were compared with the material stored frozen at -20 °C. Storage conditions were at refrigeration for 20 months, at 30 °C for 1 month, and freeze-thawing for five times. Evaporation from the material was evaluated by weighing the samples before and after storage at 30 °C for 1 month. Results 1) Sample collection: The material was collected with sampling probes and the collection amounts were 106% (compared to theoretical amount).2) Uniformity: Uniformity of hemoglobin during production was within the specification of “Uniformity of dosage units” section of the pharmacopoeias, acceptance value&amp;lt;15.0. Uniformity of hemoglobin among three vials was within ±10% CV.3) Stability of hemoglobin: Stabilities of the material were all within ±10% from the control material (frozen) after storage at all temperature conditions. Evaporation from the material in a vial was below 1% at 30 °C storage for 1 month. Conclusions This artificial stool is suitable for EQA material because it is confirmed that it shows favorable analytical results in sample collection, uniformity, and stability of hemoglobin. The evaluation of this material in the EQA program to show its suitability was performed by Labquality. The result is reported in a poster at ADLM 2024.

COMPARISON OF DIABETES DISEASE CLASSIFICATION MODELS USING LOGISTIC REGRESSION AND RANDOM FOREST ALGORITHMS

Diabetes is a lifelong chronic disease that disrupts blood sugar regulation. Diabetes is a life-threatening condition that, if left untreated, can lead to death and other health problems. Several medical tests, including the glycated hemoglobin (A1C) test, blood sugar test, oral glucose tolerance test, and fasting blood sugar test, can be used to detect diabetes. According to statistics, high glucose levels are one of the problems associated with diabetes. This study aims to categorize patients into diabetic and non-diabetic groups using specific diagnostic metrics included in the dataset. 1500 patient records with 9 attributes and 2 classes were used by the researchers. The study used machine learning techniques, including Logistic Regression and Random Forest, along with Confusion Matrix and Receiver Operating Characteristics (ROC) assessment. The Random Forest method produced results of 97% accuracy, 97% precision, 100% recall, and 98% f1-score, indicating that the accuracy level seems good but can still be improved. Based on the accuracy findings, Random Forest is the most effective strategy of Logistic Regression.

Reticulocyte haemoglobin content in the differential diagnosis of iron deficiency anaemia and thalassemia traits in pregnancy

Background: Iron deficiency anaemia (IDA) and thalassemia traits are the common conditions of microcytic hypochromic anaemia in pregnant women. However, the laboratory tests to differentiate them are expensive. The reticulocyte haemoglobin (Ret-Hb) test is relatively cheap. This study aimed to assess whether Ret-Hb can differentiate IDA from thalassemia traits in pregnant patients. Method: This cross-sectional study was conducted in the Bangabandhu Sheikh Mujib Medical University (BSMMU) from March 2023 to February 2024. We recruited pregnant women aged 18 to 40 through antenatal visits in the Obstetrics and Gynecology Department. Microcytic hypochromic anaemia was diagnosed by complete blood counts, IDA by iron profile and thalassemia traits by haemoglobin electrophoresis. Ret-Hb was measured using the flow cytometric method. Ninety pregnant women—30 each with IDA, thalassemia traits and healthy individuals—were enrolled. Result: The mean age was 27 years. The IDA patients had significantly (P&lt;0.001) lower levels of Ret-Hb (mean 18.1, standard deviation 3.2 pg) compared to thalassemia traits (20.8, 2.2 pg) and healthy pregnant women (29.2, 1.9 pg). Using a Ret-Hb cut-off point of 19 pg, the test had 86.7% sensitivity and 53.3% specificity to differentiate thalassemia traits from IDA. Conclusion: Ret-Hb could be considered a diagnostic test to differentiate thalassemia traits from IDA in clinical settings before expensive confirmatory tests are performed.

Clinical Risk Assessment and Comparison of Bias between Laboratory Methods for Estimation of HbA1c for Glycated Hemoglobin in Hyperglycemic Patients.

Hemoglobin A1c (HbA1c), also known as glycated hemoglobin, is a blood test used to evaluate and track a patient's blood sugar levels over the previous 2-3 months. We have compared the analytical performance of the D10 hemoglobin (HPLC) testing system to that of the immunoturbidimetric technique, which is a light-scattering immunoassay. To assess the clinical risk assessment between two methods (Compare the two Immunoturbidometric methods (AU680) vs. HPLC method (D10)) in hyperglycemic patients and assess the acceptability of the respective methods in the Clinical biochemistry laboratory. The charge of the globins in Hb was used as the basis for the HPLC method used to measure HbA1c. HPLC detects and quantifies even the tiniest Hb fractions and the full spectrum of Hb variants. HbA1c was measured using the immunoturbidimetric (AU 680 Beckmann coulter analyzer) and high-performance liquid chromatography (HPLC) techniques. Experiments also made use of immunoturbidimetric techniques (using an AU 680 Beckmann coulter analyzer equipment). There is no statistically significant difference in HbA1c readings between male and female patients, as measured by either the Immunoturbidimetric or HPLC techniques. The immunoturbidimetric and high-performance liquid chromatography techniques for estimating HbA1c yielded identical results. From the results of this study, we may deduce that both techniques are valid for estimating HbA1c. As a result, it may be suggested that both approaches can be used to estimate HbA1c in diabetic individuals.

A novel index combining fecal immunochemical test, DNA test, and age improves detection of advanced colorectal adenoma.

Although the fecal immunochemical test for hemoglobin (FIT) is a widely used screening test for colorectal cancer, it is not sensitive enough to detect advanced colorectal adenoma. To address this issue, we performed this study to investigate whether combining the FIT and fecal DNA testing of methylated somatostatin (SST) could improve diagnostic performance for advanced colorectal adenoma. We collected feces from 79 healthy subjects with negative results on colonoscopy, 43 patients with non-advanced colorectal adenoma, 117 patients with advanced colorectal adenoma, and 126 patients with colorectal cancer. After fecal DNA was incubated with methylation-sensitive restriction enzymes, SST methylation levels were measured by droplet digital PCR. Using logistic multivariate analysis, we established a prediction formula for detecting colorectal neoplasia and named it the FAMS (FIT, age, methylated SST) index. The diagnostic performance of a single use of FIT for advanced colorectal adenoma showed a sensitivity of 29.1% (34/117) and specificity of 89.3% (109/122). In contrast, the FAMS index showed a sensitivity of 56.4% (66/117) at a similar specificity point of 91.0% (111/122). Furthermore, even at the higher specificity point of 94.3% (115/122), the sensitivity was still higher than that of FIT, reaching 42.7% (50/117). As the FAMS index showed better diagnostic performance for advanced colorectal adenoma than a single use of FIT, the FAMS index could be a promising tool for detecting advanced colorectal adenoma.

Systematic review: Mortality associated with raised faecal immunochemical test and positive faecal occult blood results.

Faecal haemoglobin (f-Hb) testing is used in colorectal cancer (CRC) screening and increasingly to guide the investigation in patients with symptoms suggestive of CRC. Studies have demonstrated increased mortality with raised f-Hb. To assess the association of raised f-Hb with all-cause, non-CRC (any cause excluding CRC) and cause-specific mortality. We searched Medline and Embase on 9 February 2024 to identify papers reporting mortality after faecal immunochemical (FIT) or guaiac faecal occult blood tests (gFOBT). The primary outcome was all-cause mortality following a positive compared to a negative test. The search identified 3155 papers. Ten met the inclusion criteria: three reported gFOBT and seven reported FIT results, as screening tests. These reported a total of 14,687,625 f-Hb results. Elevated f-Hb was associated with an increased risk of all-cause, non-CRC and cause-specific mortality including death from cardiovascular, digestive and respiratory diseases. Crude risk ratios for all-cause mortality with a positive versus negative test were derived from six papers (three reporting gFOBT, three FIT). An increased risk was demonstrated in five, with RRs ranging from 1.11 (95% CI: 1.06-1.16) to 2.95 (95% CI: 2.85-3.05). For non-CRC mortality risk, RRs ranged from 1.09 (95% CI: 1.04-1.15) to 2.79 (95% CI: 2.70-2.89). We did not perform meta-analysis due to a limited number of papers reporting suitable results for each type of f-Hb test. All-cause, non-CRC and cause-specific mortality appear higher in those with raised f-Hb. Population-based studies are warranted to elicit whether this association occurs in symptomatic patients.

Prevalence and severity of anaemia among the Temiar sub-ethnic indigenous Orang Asli communities in Kelantan, Peninsular Malaysia.

Anaemia remains a primary concern of public health in developing countries. Indigenous populations are a significant and frequently underreported group at risk for anaemia. This study aimed to assess the prevalence of anaemia and identify its determinants in the Temiar sub-ethnic indigenous Orang Asli (OA) community in Peninsular Malaysia. A community-based cross-sectional study was conducted among 640 indigenous Temiar OA participants from a remote settlement in Gua Musang, Kelantan, Malaysia. Data was collected using face-to-face interviews with a standardised pretested questionnaire and through blood samples collected for haemoglobin (Hb) testing. Anaemia status was determined using the Hb level cut-off established by the World Health Organization (WHO). Descriptive analysis was used to determine the prevalence of anaemia, while multiple logistic regression was used to determine factors associated with anaemia. The overall anaemia prevalence was 44.7% (286/640), and the prevalence rates of mild, moderate and severe anaemia were 42.7, 50.7 and 6.6%, respectively. Anaemia-specific prevalence varied significantly by age group (p < 0.001) and was highest in the ≤5 group for both moderate anaemia (43.4%) and severe (42.1%), followed by the 6-17 age group for mild anaemia (39.3%). The prevalence of anaemia was also highest among students (53.9%), with a significant difference observed between the three anaemia severity classifications (p = 0.002). In the multivariate logistic regression, only age groups of 6-17 (adjusted odds ratio [aOR] 0.38, p < 0.001), 18-40 (aOR 0.18, p < 0.001) and > 40 (aOR 0.25, p < 0.001) were significantly associated with the lower odds of anaemia in the population. This study has highlighted the high prevalence of anaemia among indigenous OA in Peninsular Malaysia and revealed that younger children were positively associated with childhood anaemia. Effective interventions and special attention to this indigenous population need to be implemented to reduce the risk of anaemia.

A comprehensive investigation of biochemical status in patients with telogen effluvium: Analysis of Hb, ferritin, vitamin B12, vitamin D, thyroid function tests, zinc, copper, biotin, and selenium levels.

The etiology of telogen effluvium (TE) includes situations that may cause physiological stress, surgical trauma, inflammatory, infectious, iatrogenic causes, medications and nutritional deficiencies. TE has been associated with iron deficiency, vitamin B12 deficiency and thyroid diseases. In recent years, the use of over-the-counter food supplements containing vitamins and minerals such as biotin, vitamin D, zinc (Zn), copper (Cu) and selenium (Se) has been increasing in TE patients. The aim of this study is to investigate whether there are differences in nutritional status, vitamin and mineral levels by comparing individuals with TE and a control group. This case-control study included 90 female patients diagnosed with chronic telogen effluvium (CTE), and 90 female controls volunteered to participate in the study who consulted for reasons other than TE. Both groups aged 18 and over and applied to dermatology polyclinic between 01.09.2022 and 01.09.2023. A detailed anamnesis was taken from all patients, a hair pull test was performed, and TE was diagnosed after a dermoscopic examination was performed on all areas of the scalp. Then, serum vitamin D, Zn, Cu, Se levels and biotin levels in serum and urine were measured. Hemoglobin (Hb), ferritin, vitamin B12 and thyroid function tests were retrospectively scanned from the hospital database. It was determined that Zn levels were significantly lower in CTE patients than in controls. Se levels were found to be significantly higher in patients than in controls. There was no difference in Hb, ferritin, vitamin B12, thyroid function tests, vitamin D, Cu levels, serum and urine biotin levels between the two groups. Zn, Cu/Zn and Se levels were found to have statistically significant diagnostic performance in predicting the diagnosis of CTE. Cu/Zn ratio and Se value were found to be significant predictors of CTE. This study shows us that nutritional deficiencies are not as common as thought in patients diagnosed with TE. Other causes that may cause TE should be investigated by a detailed anamnesis and a good physical examination. After all, tests for suspected conditions should be performed and individualized treatment options should be created for each patient.

Ferritin Cutoffs and Diagnosis of Iron Deficiency in Primary Care

Ferritin is often measured by general practitioners, but the association of different cutoffs with the rates of iron deficiency diagnoses, particularly nonanemic iron deficiency, is unknown. To investigate the association of the ferritin cutoff choice with the incidence of nonanemic and anemic iron deficiency diagnoses in primary care. In this retrospective cohort study, patients 18 years or older with at least 1 consultation with a general practitioner participating in the Family Medicine Research Using Electronic Medical Records (FIRE) project, an electronic medical records database of Swiss primary care, from January 1, 2021, to November 30, 2023, were evaluated. Sex, age, clinical patient characteristics, and professional general practitioner characteristics. Incidence of iron deficiency diagnoses (nonanemic and anemic) at ferritin cutoffs of 15, 30, and 45 ng/mL and ferritin testing itself. Time-dependent Cox proportional hazards regression was used to examine associations of patient and general practitioner characteristics with ferritin testing as adjusted hazard ratios (AHRs). The study included 255 351 patients (median [IQR] age, 52 [36-66] years; 52.1% female). Per 1000 patient-years and at ferritin cutoffs of 15, 30, and 45 ng/mL, iron deficiency diagnoses had incidences of 10.9 (95% CI, 10.6-11.2), 29.9 (95% CI, 29.4-30.4), and 48.3 (95% CI, 47.7-48.9) cases, respectively; nonanemic iron deficiency diagnoses had incidences of 4.1 (95% CI, 3.9-4.2), 14.6 (95% CI, 14.3-15.0), and 25.8 (95% CI, 25.3-26.2) cases, respectively; and anemic iron deficiency diagnoses had incidences of 3.5 (95% CI, 3.3-3.7), 6.0 (95% CI, 5.8-6.2), and 7.5 (95% CI, 7.3-7.7) cases, respectively. Ferritin testing showed notable associations with fatigue (AHR, 2.03; 95% CI, 1.95-2.12), anemia (AHR, 1.75; 95% CI, 1.70-1.79), and iron therapy (AHR, 1.50; 95% CI, 1.46-1.54). Ferritin testing was associated with female sex in all age groups, including postmenopausal. Of the patients who received ferritin testing, 72.1% received concomitant hemoglobin testing, and 49.6% received concomitant C-reactive protein testing. In this retrospective cohort study of primary care patients, ferritin cutoffs of 30 and 45 ng/mL were associated with a substantially higher incidence of iron deficiency compared with 15 ng/mL. These results provide a basis for health system-level evaluation and benchmarking of ferritin testing in high-resource settings and call for a harmonization of diagnostic criteria for iron deficiency in primary care.

Comparing the effectiveness and cost-effectiveness of alternative type 2 diabetes monitoring intervals in resource limited settings.

Type 2 diabetes (T2D) represents a growing disease burden in South Africa. While glycated haemoglobin (HbA1c) testing is the gold standard for long-term blood glucose management, recommendations for HbA1c monitoring frequency are based on expert opinion. This study investigates the effectiveness and cost-effectiveness of alternative HbA1c monitoring intervals in the management of T2D. A Markov model with three health states (HbA1c <7%, HbA1c ≥ 7%, Dead) was used to estimate lifetime costs and quality-adjusted life years (QALYs) of alternative HbA1c monitoring intervals among patients with T2D, using a provider's perspective and a 3% discount rate. HbA1c monitoring strategies (three-monthly, four-monthly, six-monthly and annual tests) were evaluated with respect to the incremental cost-effectiveness ratio (ICER) assessing each comparator against a less costly, undominated alternative. The scope of costs included the direct medical costs of managing diabetes. Transition probabilities were obtained from routinely collected public sector HbA1c data, while health service utilization and health-related-quality-of-life (HRQoL) data were obtained from a local cluster randomized controlled trial. Other parameters were obtained from published studies. Robustness of findings was evaluated using one-way and probabilistic sensitivity analyses. A South African indicative cost-effectiveness threshold of USD2665 was adopted. Annual and lifetime costs of managing diabetes increased with HbA1c monitoring, while increased monitoring provides higher QALYs and life years. For the overall cohort, the ICER for six-monthly vs annual monitoring was cost-effective (USD23 22.37 per QALY gained), whereas the ICER of moving from six-monthly to three-monthly monitoring was not cost effective (USD6437.79 per QALY gained). The ICER for four-monthly vs six-monthly monitoring was extended dominated. The sensitivity analysis showed that the ICERs were most sensitive to health service utilization rates. While the factors influencing glycaemic control are multifactorial, six-monthly monitoring is potentially cost-effective while more frequent monitoring could further improve patient HrQoL.

The value of routine hemoglobin level evaluation following elective cesarean section: Is it worthwhile?

The aim of this study was to assess the usefulness of routine hemoglobin testing following elective and urgent cesarean section (CS) in patients without primary postpartum hemorrhage (PPH). This retrospective cohort study included women who underwent vaginal delivery (VD), elective CS, and urgent CS at Carmel Medical Center from 2015 to 2020. Data were extracted from the obstetric database, excluding deliveries with PPH. Demographic and obstetric variables were recorded. Primary outcomes were the need for packed red blood cell transfusion. A total of 19 446 women were included, with five (0.3%) requiring a blood transfusion in the elective CS group, 27 (0.17%) in the VD group, and eight (0.4%) in the urgent CS group. Urgent CS was associated with a higher risk of blood transfusion, but there was no significant difference between elective CS and VD. Elective CS showed the lowest rates of post-delivery hemoglobin below 7 g/dL 1 (0.1%) compared to VD 16 (0.6%) and urgent CS 13 (0.7%). Routine postoperative hemoglobin testing following elective CS in asymptomatic patients without PPH appears unnecessary. This study supports reconsidering routine hemoglobin testing following elective CS, aligning with the goal of optimizing resource utilization while maintaining patient quality.

Validation of a Major and Clinically Relevant Nonmajor Bleeding Phenotyping Algorithm on Electronic Health Records.

Bleeding is an important health outcome of interest in epidemiological studies. We aimed to develop and validate rule-based algorithms to identify (1) major bleeding and (2) all clinically relevant bleeding (CRB) (composite of major and all clinically relevant nonmajor bleeding) within real-world electronic healthcare data. We took a random sample (n = 1630) of inpatient admissions to Singapore public healthcare institutions in 2019 and 2020, stratifying by hospital and year. We included patients of all age groups, sex, and ethnicities. Presence of major bleeding and CRB were ascertained by two annotators through chart review. A total of 630 and 1000 records were used for algorithm development and validation, respectively. We formulated two algorithms: sensitivity- and positive predictive value (PPV)-optimized algorithms. A combination of hemoglobin test patterns and diagnosis codes were used in the final algorithms. During validation, diagnosis codes alone yielded low sensitivities for major bleeding (0.16) and CRB (0.24), although specificities and PPV were high (>0.97). For major bleeding, the sensitivity-optimized algorithm had much higher sensitivity and negative predictive values (NPVs) (sensitivity = 0.94, NPV = 1.00), however false positive rates were also relatively high (specificity = 0.90, PPV = 0.34). PPV-optimized algorithm had improved specificity and PPV (specificity = 0.96, PPV = 0.52), with little reduction in sensitivity and NPV (sensitivity = 0.88, NPV = 0.99). For CRB events, our algorithms had lower sensitivities (0.50-0.56). The use of diagnosis codes alone misses many genuine major bleeding events. We have developed major bleeding algorithms with high sensitivities, which can ascertain events within populations of interest.

Are Routine Postoperative Hemoglobin Tests Justified in All Patients Who Undergo Total Hip Arthroplasty Due to a Displaced Femoral Neck Fracture?

Background: Total hip arthroplasty (THA) is a standard treatment for a displaced femoral neck fracture in the elderly. In contemporary healthcare, there is a global shift towards fast-track treatment modalities, prioritizing early hospital discharge for patients. Consequently, routine postoperative blood tests may become redundant, offering significant time and cost savings. We aim to evaluate postoperative hemoglobin levels in trauma-related THA cases and identify patient profiles for whom these tests hold significance. Methods: A retrospective review of 176 THA procedures performed between 2018 and 2022, focusing on individuals undergoing THA for displaced femoral neck fractures. Multivariable logistic regression analysis was employed to identify factors associated with postoperative hemoglobin levels below 8.5 g/dL. Results: Of the 176 patients included, 109 (61.9%) were women and the mean age was 69.09 ± 8.13 (range 27 to 90) years. The majority of the patients underwent surgery within 48 hours of admission. The mean preoperative hemoglobin (Hb) level was 13.1 ± 1.4 g/dL, while the mean postoperative Hb level was 10.5 ± 1.2 g/dL. Only six patients (3.41%) exhibited postoperative Hb levels of ≤8.5 g/dL. No significant associations were found between postoperative Hb levels ≤ 8.5 and any demographic, surgical, or medical characteristics. Conclusions: Our findings suggest that routine postoperative blood count testing may not be necessary for most patients undergoing THA for displaced femoral neck fractures, particularly those without complications or significant comorbidities.

The 2024 American Diabetes Association guidelines on Standards of Medical Care in Diabetes: key takeaways for laboratory

The escalating prevalence of diabetes poses a significant health concern. Uncontrolled diabetes leads to a multitude of complications. A comprehensive management plan and continual adaptation of guidelines is needed. The American Diabetes Association (ADA) is a guiding force in this domain, providing diabetes care recommendations for clinicians, laboratorians, researchers, and policymakers since 1989. The latest ADA guidelines present both challenges and opportunities for laboratories. The increased emphasis on glycated hemoglobin (HbA1c) testing for early diagnosis and personalized monitoring is expected to increase testing volumes, potentially leading to a rise in point-of-care testing. Ensuring standardized testing procedures becomes paramount to maintaining consistent and reliable results across laboratories. Moreover, laboratories may need to expand their test menus to accommodate the growing demand for personalized medicine approaches and collaborate closely with healthcare providers to support informed decision-making. This commentary provides a focused analysis of the 2024 ADA guidelines for the laboratory assessment of diabetes.