Technical evaluation and usability of a quantitative G6PD POC test in cord blood: a mixed-methods study in a low-resource setting

Objectives
New point-of-care (POC) quantitative G6PD testing devices developed to provide safe radical cure for Plasmodium vivax malaria may be used to diagnose G6PD deficiency in newborns at risk of severe neonatal hyperbilirubinaemia, improving clinical care, and preventing related morbidity and mortality.

Methods
We conducted a mixed-methods study analysing technical performance and usability of the ‘STANDARD G6PD’ Biosensor when used by trained midwives on cord blood samples at two rural clinics on the Thailand–Myanmar border.

Results
In 307 cord blood samples, the Biosensor had a sensitivity of 1.000 (95% CI: 0.859 to 1.000) and a specificity of 0.993 (95% CI: 0.971 to 0.999) as compared with gold-standard spectrophotometry to diagnose G6PD-deficient newborns using a receiver operating characteristic (ROC) analysis-derived threshold of ≤4.8 IU/gHb. The Biosensor had a sensitivity of 0.727 (95% CI: 0.498 to 0.893) and specificity of 0.933 (95% CI: 0.876 to 0.969) for 30%–70% activity range in girls using ROC analysis-derived range of 4.9–9.9 IU/gHb. These thresholds allowed identification of all G6PD-deficient neonates and 80% of female neonates with intermediate phenotypes.
Need of phototherapy treatment for neonatal hyperbilirubinaemia was higher in neonates with deficient and intermediate phenotypes as diagnosed by either reference spectrophotometry or Biosensor.
Focus group discussions found high levels of learnability, willingness, satisfaction and suitability for the Biosensor in this setting. The staff valued the capacity of the Biosensor to identify newborns with G6PD deficiency early (‘We can know that early, we can counsel the parents about the chances of their children getting jaundice’) and at the POC, including in more rural settings (‘Because we can know the right result of the G6PD deficiency in a short time, especially for the clinic which does not have a lab’).

Conclusions
The Biosensor is a suitable tool in this resource-constrained setting to identify newborns with abnormal G6PD phenotypes at increased risk of neonatal hyperbilirubinaemia.

Leggi
Dicembre 2022

Point-of-care biomarkers for prediction of kidney function trajectory among sugarcane cutters: a comparative test accuracy study

Objectives
Heat-stressed Mesoamerican workers, such as sugarcane cutters, suffer from high rates of chronic kidney disease of non-traditional origin (CKDnt). We aimed to identify easily available early markers of rapid kidney function decline in a population at high risk of CKDnt.

Design
The accuracy of different biomarkers measured during harvest for prediction of cross-harvest kidney function decline were assessed in an exploratory study group, and the performance of the most promising biomarker was then assessed in an independent confirmation group.

Setting
Male sugarcane cutters in El Salvador and Nicaragua.

Participants
39 male Salvadoran sugarcane cutters sampled fortnightly at ≤9 occasions before and after work shift during harvest. 371 male Nicaraguan sugarcane cutters were sampled as part of routine monitoring during two harvests. Cutters worked at high physical intensity at wet-bulb globe temperatures mostly above 29°C for 6–8 hours per day 6 days a week during the 5–6 months harvest season.

Primary outcomes
Change in estimated glomerular filtration rate (CKD Epidemiology Collaboration) across the harvest season (eGFRcross-harvest).

Results
Dipstick leukocyturia after work shift in the El Salvadoran group was the most promising marker, explaining >25% of eGFRcross-harvest variance at 8/9 occasions during harvest. Leukocyturia was associated with experiencing fever, little or dark urine, cramps, headache, dizziness and abdominal pain in the preceding 2-week period. Decreasing blood haemoglobin (Hb) and eGFR during harvest were also predictive of eGFRcross-harvest. In the Nicaraguan confirmation dataset, those having ≥++ leukocyturia at any sampling during harvest had a 13 mL/min/1.73 m2 (95% CI 10 to 16 mL/min/1.73 m2) worse eGFRcross-harvest than those without recorded leukocyturia.

Conclusion
Leukocyturia and Hb, both measurable with point-of-care methods, may be early indicators for kidney injury and risk for eGFR decline among heat-stressed male workers, thereby facilitating individual-level prevention and research aiming to understand the causes of CKDnt.

Leggi
Novembre 2022

Test reliability and comparability of paper and Chinese electronic version of the western Ontario and McMaster University osteoarthritis index: protocol for a randomised controlled clinical trial

Introduction
The Western Ontario and McMaster University osteoarthritis index (WOMAC) is the most commonly used indicator of disease-specific outcome in knee osteoarthritis for its convenience and reliability. It has two formats the paper-based WOMAC (p-WOMAC) and the electronic WOMAC (e-WOMAC). In China, the p-WOMAC has been widely used though e-WOMAC is yet untested. This study aims to test whether e-WOMAC is consistent with the p-WOMAC before and after the intervention.

Methods and analysis
A total of 70 patients from Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine will be randomly assigned in two groups, named, group A and group B. This study is divided into three stages. In the first stage, patients in group A will be evaluated first by p-WOMAC and then by e-WOMAC. Patients in group B will be evaluated by e-WOMAC and then by p-WOMAC. In the second stage of the study, drug interventions will be implemented. 200 mg celecoxib will be administered orally once a day starting from the second day of enrolment for a period of 21 days. In the third stage, postintervention evaluation will be conducted after administration. Patients in group A will be evaluated first by e-WOMAC and then by p-WOMAC. Patients in group B will be evaluated first by p-WOMAC and then by e-WOMAC. In order to avoid the possible bias because of patients’ potential memory, e-WOMAC and p-WOMAC will be taken for each patient at 15 min apart. The primary outcome of the study is the mean score difference in WOMAC, and the secondary outcomes are the score differences in WOMAC subscales: pain, stiffness and physical function.

Ethics and dissemination
The protocol has been approved by the Independent Review Board of SGH (approval number: 2020-814-21-01). The results of the trial will be submitted for publication in a peer-reviewed journal.

Trial registration number
ChiCTR2100050914.

Leggi
Novembre 2022