Standardising the biochemical confirmation of adult male hypogonadism: A joint position statement by the Society for Endocrinology and Association of Clinical Biochemistry and Laboratory Medicine.

BACKGROUND: Inter-assay variation between different immunoassays and different mass spectrometry methods hampers the biochemical confirmation of male hypogonadism. Furthermore, some laboratories utilise assay manufacturer reference ranges that do not necessarily mirror assay performance characteristics, with the lower limit of normality ranging from 4.9 nmol/L to 11 nmol/L. The quality of the normative data underlying commercial immunoassay reference ranges is uncertain. DESIGN: A working group reviewed published evidence and agreed upon standardised reporting guidance to augment total testosterone reports. RESULTS: Evidence-based guidance on appropriate blood sampling, clinical action limits, and other major factors likely to affect the interpretation of results are provided. CONCLUSIONS: This article aims to improve the quality of the interpretation of testosterone results by non-specialist clinicians. It also discusses approaches for assay harmonisation which have been successful in some but not all healthcare systems.

Direct costs of managing in-ward dengue patients in Sri Lanka: A prospective study.

INTRODUCTION: The cost in managing hospitalised dengue patients varies across countries depending on access to healthcare, management guidelines, and state sponsored subsidies. For health budget planning, locally relevant, accurate costing data from prospective studies, is essential. OBJECTIVE: To characterise the direct costs of managing hospitalised patients with suspected dengue infection in Sri Lanka. METHODS: Colombo Dengue Study is a prospective single centre cohort study in Sri Lanka recruiting suspected hospitalised dengue fever patients in the first three days of fever and following them up until discharge. The diagnosis of dengue is retrospectively confirmed and the cohort therefore has a group of non-dengue fever patients with a phenotypically similar illness, managed as dengue while in hospital. The direct costs of hospital admission (base and investigation costs, excluding medication) were calculated for all recruited patients and compared between dengue and non-dengue categories as well as across subgroups (demographic, clinical or temporal) within each of these categories. We also explored if excluding dengue upfront, would lead to an overall cost saving in several hypothetical scenarios. RESULTS: From October 2017 to February 2020, 431 adult dengue patients and 256 non-dengue fever patients were recruited. The hospitalisation costs were USD 18.02 (SD: 4.42) and USD 17.55 (SD: 4.09) per patient per day for dengue and non-dengue patients respectively (p>0.05). Laboratory investigations (haematological, biochemical and imaging) accounted for more than 50% of the total cost. The costs were largely homogenous in all subgroups within or across dengue and non-dengue categories. Excluding dengue upfront by subsidised viral genomic testing may yield overall cost savings for non-dengue patients. CONCLUSION: As non-dengue patients incur a similar cost per day as the dengue patients, confirming dengue diagnosis using subsidised tests for patients presenting in the first three days of fever may be cost-efficient.

Dengue and post-infection fatigue: findings from a prospective cohort-the Colombo Dengue Study.

BACKGROUND: Previous studies on post-infection fatigue in dengue are few but suggest that up to 25% of dengue patients may suffer from fatigue. This study aimed to evaluate the prevalence and associations of post-infection fatigue in dengue patients compared with non-dengue fever patients. METHODS: Post-infection fatigue and its demographic and clinical associations were assessed in adult dengue and non-dengue fever patients 2 months after the acute infection in a prospective cohort study in Sri Lanka. Fatigue at 2 months (primary endpoint) was assessed with the fatigue questionnaire as a dichotomous outcome based on a pre-recommended cut-off (score ≥4) and as the total score from the questionnaire (higher score indicates more fatigue). RESULTS: Of 260 patients, 158 had dengue and, of these, 51 (32%) had fatigue at 2 months. Risk was higher in dengue patients (vs non-dengue; relative risk [RR] 4.93 [95% confidence interval {CI} 2.3 to 10.4]) and more so in female dengue patients (vs male dengue patients; RR 2.45 [95% CI 1.24 to 4.86]). Severe dengue patients had a higher mean fatigue score (p=0.024). CONCLUSIONS: Post-infection fatigue is an underappreciated burden of this widely prevalent infection. Our findings are useful to triage patients at risk of fatigue for follow-up.

Prevention and management of COVID-19 among patients with diabetes: an appraisal of the literature.

The coronavirus disease 2019 (COVID-19) pandemic has emerged as one of the greatest challenges faced by humankind in the recent past. People with diabetes and related comorbidities are at increased risk of its complications and of COVID-19-related death. Older age, multi-morbidity, hyperglycaemia, cardiac injury and severe inflammatory response are predictors of poor outcome. The complex interplay between COVID-19, diabetes and the effects of related therapies is being explored. Most patients experience a mild illness with COVID-19, while people with diabetes are at increased risk of severe disease. Optimising glycaemic control and adopting measures to prevent disease spread are critical aspects. The management of mild disease is supportive, while very many immunomodulatory and antiviral therapies are being investigated for the treatment of severe disease. Several of these agents have specific considerations for use in people with diabetes. Since mass population lockdowns are considered a key step in controlling disease spread, it follows that, in addition to the direct vulnerability to severe COVID-19, people with diabetes can be affected by limited access to healthcare, insulin, other medications and blood glucose monitoring equipment. Measures to prevent disease spread at the individual and community level are the key to mitigating the rapidly escalating pandemic, while agents for chemoprophylaxis and vaccines are being explored. People with diabetes should be recognised as a vulnerable group for complicated disease and are at risk during times of disturbed social systems. Strategies are needed to safeguard the health of patients with diabetes during the pandemic. This review summarises the current knowledge and perceived challenges for prevention and management of COVID-19 in people with diabetes.

Effects of modifying the World Health Organization standard operating procedures for malaria microscopy to improve surveillance in resource poor settings.

BACKGROUND: Individuals with fever are screened for malaria in specially-established malaria diagnostic laboratories set up in rural hospitals in the Northern and Eastern Provinces of Sri Lanka. Large numbers of blood smears negative for malaria parasites are being screened daily. Good quality smears are essential to maintain a high diagnostic competency among the technical staff. The modifications made to the World Health Organization (WHO) standard operating procedures to improve the quality of smears have been studied. METHODS: A blinded, controlled, interventional study was conducted in 22 intervention and 21 control malaria diagnostic laboratories. Changes were made to the WHO standard operating procedure protocols to prepare, stain and examine blood smears for malaria parasite detection which were implemented in intervention laboratories. These included wipe-cleaning slides, preparing both thick and thin smears on the same slide, reversing the order of collecting blood for thick and thin smears, dry fixing thick smear for 20-25 minutes under table lamp, polishing the edge of spreader slide with sand paper and fixing the thin smear with methanol if not stained within four hours. Parameters with respect to quality of the smear as per WHO criteria were studied using randomly selected slides, and time taken for the report to be issued was recorded in both groups before and after the intervention. RESULTS: There were no significant differences observed in the parameters studied at baseline between the two groups or pre and post intervention in the control group. In the intervention group streak formation in thin smears was reduced from 29.4% to 5.0%. The average fixing time of thick smears was reduced from 2.4 hours to 20 minutes. Inappropriate thickness of thick smears reduced from 18.3% to 1.5%. Overall quality of thick smears and thin smears increased from 76.1% to 98.0% and 81.7% to 87.0%, respectively. The quality of slides bearing both thick and thin smears increased from 60.0% to 87.0%. CONCLUSIONS: New protocols with amendments to the WHO standard technical procedures ensure that good quality blood smears are prepared rapidly to diagnose malaria and the time required to issue the reports was reduced.