Psychometric properties of End Stage Renal Disease-Adherence Questionnaire-Sinhalese version among patients receiving haemodialysis.

The chronic kidney disease is a leading public health concern, particularly in low-to middle-income countries, while the number of patients receiving haemodialysis is rapidly increasing. Adherence to a complex treatment regimen is vital for those patients on maintenance haemodialysis though the precise evaluation is reported inadequately. This study aimed to evaluate the psychometric properties of Sinhalese version of End Stage Renal Disease-Adherence Questionnaire (SINESRD-AQ) to assess treatment adherence behaviour among patients receiving haemodialysis in a Sri Lankan hospital. The cultural adaptation of ESRD-AQ involved forward and back translation, expert committee consolidation and pretesting among patients (n = 10). Face and content validity of the questionnaire was evaluated using a modified Delphi technique. Construct validity of the subscales of SINESRD-AQ was evaluated using confirmatory factor analysis (CFA). A descriptive cross-sectional study among a consecutive sample of 150 patients receiving haemodialysis in a selected Teaching hospital, Sri Lanka was involved in performing CFA. Reliability was confirmed with test-retest reliability. Excellent face and content validity were reported with Item level content validity index (0.83-1.0), Average Item level content validity index for whole scale (0.93), Item level content validity ratio (0.67-1.0) and modified kappa statistic coefficient (0.81-1.0). CFA of two subscales demonstrated better indices closure to the model fit with five- item two factor model for direct adherence behaviour subscale and eight-item two factor model for attitude/perception subscale. The intra class correlation coefficient of 0.837 (p<0.001) and 0.752 (p<0.001) indicated acceptable test-retest reliability of direct adherence behaviour and attitude/perception subscale respectively. The study confirmed SINESRD-AQ as a valid and reliable measure which enables periodic assessment of treatment adherence behaviour of the patients receiving haemodialysis in a Sri Lankan hospital.

Approach to Study the Efficacy and Safety of New Complementary and Alternative Medicine Formulations: Lesson during COVID-19 from Sri Lanka.

COVID-19 affected Sri Lanka from early 2020, a time of considerable ignorance accompanied by wide media coverage of a devastating epidemic in Italy and Europe. Many were attracted to complementary and alternative medicine (CAM) or traditional medicine (TM) in this desperate situation. Several preparations were claimed to be effective against COVID-19 globally. Dammika Bandara Syrup© was one such preparation promoted for preventing and treating SARS-CoV-2 infection. It was based on bees' honey, pericarp and mace of Myristica fragrans (nutmeg), the seed of Foeniculum vulgare and fresh rhizome of Zingiber officinale, all believed to have anti-viral properties. Following an unpublished clinical study claiming efficacy, Dammika Bandara Syrup© gained wide media publicity and political patronage. The producer claimed of Goddess Kali revealing the formula added an anthropological, cultural, and religious complexity to the issue. The demand for the product increased rapidly as a debate raged both in public and in the parliament on utilizing such products in combating COVID-19. The Department of Ayurveda, which is statutorily responsible for regulating CAM/TM had to respond to the situation. The legislation to regulate such indigenous medicinal products was weak, and the crisis deepened as thousands converged to the production facility, defying mobility restrictions introduced to control COVID-19. This led to the Ministry of Health requesting academics to form a team and conduct a clinical trial to prove its efficacy. This paper outlines the process and issues faced during the regulatory approval for the trial in a polarized political environment. Some health professionals accused the researchers of bowing to political pressure and questioned the scientific justification for the trial. However, the team considered this as an opportunity to streamline a path for research into CAM/TM therapies in situations such as COVID-19. Several processes were identified and addressed, such as the provisional registration of CAM preparations, assessing the potential efficacy of a CAM product, confirmation of authenticity and safety, standardization and supervision of production respecting cultural identities, obtaining approval for human use, choice of comparators, and ethical issues. We believe the study has helped set standards and a benchmark for CAM and TM research in Sri Lanka.

Psychometric Properties of an Instrument to Determine the Factors Affecting Treatment Adherence Among Patients Receiving Hemodialysis in Sri Lanka.

Nonadherence is a widespread problem among patients receiving hemodialysis, while contributing factors are underexplored due to lack of a validated instrument. The study aimed to develop and validate a new disease-specific instrument determining the factors affecting treatment adherence behaviors among patients receiving hemodialysis in a Sri Lankan hospital. The content validation process using a modified Delphi technique suggested 42-item instrument with an average Item-level Content Validity Index (I-CVI) of 0.94. Subsequent principal component analysis (PCA) revealed 5 components with 17 items (patient-centered psychological and physical factors, factors associated with health care, hemodialysis therapy-related factors, socioeconomic factors, and factors associated with the continuity of the treatment), explaining 67.24% total variance. The reliability estimate based on Mislevy and Bock for each component greater than 0.8 and overall standardized Cronbach's alpha of 0.605, indicated acceptable internal consistency reliability. Root mean square residual (RMSR) and weighted root mean square residual (WRMR) indices of 0.084 and 0.059, respectively, indicated acceptable model fit. The final 17-item instrument provides a valid measure for the factors affecting treatment adherence behaviors of the patients receiving hemodialysis in a Sri Lankan hospital.

Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial.

BACKGROUND: The first case of a coronavirus 2019 (COVID-19) infection in a Sri Lankan was reported on March 11, 2020. The situation in Sri Lanka changed with the rapid increase of personnel contracting COVID-19 in a naval base camp that housed more than 4000 people. This provided a unique opportunity to study the effectiveness of hydroxychloroquine (HCQ) for post-exposure prophylaxis (PEP), while taking stringent, non-pharmacologic, public health measures to prevent spread. Our aim is to study the effectiveness and safety of HCQ for PEP among naval personnel with exposure to COVID-19-positive patients. METHODS/DESIGN: This is a placebo-controlled, randomized, clinical trial carried out in the naval base camp and quarantine centers of the Sri Lanka Navy, Ministry of Defense, Sri Lanka. Navy personnel who are exposed to a patient with confirmed COVID-19 infection but test negative for the virus on reverse real-time polymerase chain reaction (rRT-PCR) at recruitment will be randomized, 200 to each arm, to receive HCQ or placebo and monitored for the development of symptoms or rRT-PCR positivity for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus for 14 days. DISCUSSION: This trial will provide high-quality evidence of the effectiveness and safety of HCQ as PEP for COVID-19. The study design is unique due to the circumstances of the outbreak in a confined area among otherwise healthy adults, at a relatively early stage of its spread. TRIAL REGISTRATION: Sri Lanka Clinical Trials Registry (SLCTR) SLCTR/2020/011 . Registered on 04 May 2020.

A life-threatening complication due to pulmonary haemorrhage following hump-nosed viper bite.

BACKGROUND: Hump-nosed viper bite, the commonest venomous snake bite in Sri Lanka, is associated with significant morbidity. Specific anti-venom is not available for hump-nosed viper envenomation which is usually managed with supportive treatment. Pulmonary haemorrhage is an unusual manifestation of hump-nosed viper bite. Here we present a case of hump-nosed viper envenomation which complicated by pulmonary haemorrhage and was successfully treated with systemic steroids. To the best of our knowledge, it has not been reported in the literature before. CASE PRESENTATION: A previously healthy 55-year-old man presented to the local hospital 18 h after a hump-nosed viper bite. He developed bilateral severe pulmonary haemorrhages, evidenced by rapid desaturation which needed intubation and mechanical ventilation, bleeding from the endotracheal tube and bilateral alveolar shadows in a chest x-ray. He had no other bleeding manifestations. Because of the life-threatening situation, he was treated with methylprednisolone pulse therapy. There was a rapid improvement of hypoxia with a resolution of x-ray changes. He was successfully weaned off from the ventilation after 24 h. CONCLUSION: This case highlights the importance of suspecting pulmonary haemorrhage in a patient who develops desaturation and alveolar shadow following hump-nosed viper bite even in the absence of other bleeding manifestation. Early and timely treatment with systemic steroid can be lifesaving in such patients.

Features of Covid-19 patients detected during community screening: A study from a rural hospital in Sri Lanka.

ABSTRACT: We studied the clinical course and virus shedding of all patients referred to Welikanda Hospital, in one month. There were 53 positives for Covid-19 by PCR. 24 (45%) were male, with an age range of 11-94 years. Of these, 41 (77%) were asymptomatic, 9 had cough, 4 had sore throat and six had fever. Pulse, blood pressure, respiratory rate and capillary oxygen were normal in all. A proportion of them had poor prognostic factors: asthma (n=4), hypertension (n=11), age above 60 years (n=9), and diabetes (n=11). Lymphopenia was seen in 20 and elevated CRP in 14. Viral shedding continued beyond 14 days in several persons and continued in symptomatic patients for a significantly longer time than asymptomatic patients. Covid-19 was an asymptomatic or mild illness in this group of people. Several of them continued to be RT-PCR positive even after 14 days. Such cases are an important source of community spread.

Empyema Necessitans due to Interruption of Antituberculosis Treatment.

Empyema necessitans is a rare presentation of tuberculous infection, commonly encountered in immunocompromised patients. The diagnosis can be challenging due to the paucibacillary nature of the condition and nonspecific symptoms. Identifying the organism in culture is the gold standard method of diagnosis. We describe a patient with chronic kidney disease, who developed empyema necessitans due to interruption of antituberculous therapy. Initially, he was started on antituberculous therapy based on a clinical diagnosis of smear-negative pulmonary tuberculous infection; this resulted in Stevens-Johnson syndrome needing a long course of steroid therapy. He later presented with a painful chest lump and was diagnosed as empyema necessitans. Finding the etiology for this rare presentation lead to a diagnostic dilemma, finally confirming the TB infection from the culture. This case highlights the importance of being aware of unusual complications of tuberculous infection in immunocompromised settings.

Renal manifestations of dengue virus infections.

Dengue is a significant health problem in many countries. In recent years, complications involving specific organ systems have been increasingly observed and appear to have important effects on overall dengue related morbidity and mortality. Renal involvement in dengue could potentially cause increased mortality and long term effects. We review the different renal manifestations associated with dengue virus infections and explore their potential underlying pathophysiological mechanisms. The serum electrolyte and urinary abnormalities seen in dengue are discussed and Acute Kidney Injury (AKI) due to acute glomerulonephritis, rhabdomyolysis and haemolytic uraemic syndrome following dengue are explored. Renal manifestations of dengue in patients with chronic kidney disease or a transplanted kidney provides new insights into the pathophysiology of the disease.

Quest to identify geochemical risk factors associated with chronic kidney disease of unknown etiology (CKDu) in an endemic region of Sri Lanka-a multimedia laboratory analysis of biological, food, and environmental samples.

The emergence of a new form of chronic kidney disease of unknown etiology (CKDu) in Sri Lanka's North Central Province (NCP) has become a catastrophic health crisis. CKDu is characterized as slowly progressing, irreversible, and asymptomatic until late stages and, importantly, not attributed to diabetes, hypertension, or other known risk factors. It is postulated that the etiology of CKDu is multifactorial, involving genetic predisposition, nutritional and dehydration status, exposure to one or more environmental nephrotoxins, and lifestyle factors. The objective of this limited geochemical laboratory analysis was to determine the concentration of a suite of heavy metals and trace element nutrients in biological samples (human whole blood and hair) and environmental samples (drinking water, rice, soil, and freshwater fish) collected from two towns within the endemic NCP region in 2012 and 2013. This broad panel, metallomics/mineralomics approach was used to shed light on potential geochemical risk factors associated with CKDu. Based on prior literature documentation of potential nephrotoxins that may play a role in the genesis and progression of CKDu, heavy metals and fluoride were selected for analysis. The geochemical concentrations in biological and environmental media areas were quantified. Basic statistical measurements were subsequently used to compare media against applicable benchmark values, such as US soil screening levels. Cadmium, lead, and mercury were detected at concentrations exceeding US reference values in many of the biological samples, suggesting that study participants are subjected to chronic, low-level exposure to these elements. Within the limited number of environmental media samples, arsenic was determined to exceed initial risk screening and background concentration values in soil, while data collected from drinking water samples reflected the unique hydrogeochemistry of the region, including the prevalence of hard or very hard water, and fluoride, iron, manganese, sodium, and lead exceeding applicable drinking water standards in some instances. Current literature suggests that the etiology of CKDu is likely multifactorial, with no single biological or hydrogeochemical parameter directly related to disease genesis and progression. This preliminary screening identified that specific constituents may be present above levels of concern, but does not compare results against specific kidney toxicity values or cumulative risk related to a multifactorial disease process. The data collected from this limited investigation are intended to be used in the subsequent study design of a comprehensive and multifactorial etiological study of CKDu risk factors that includes sample collection, individual surveys, and laboratory analyses to more fully evaluate the potential environmental, behavioral, genetic, and lifestyle risk factors associated with CKDu.

Nanoparticle Detection of Urinary Markers for Point-of-Care Diagnosis of Kidney Injury.

The high incidence of acute and chronic kidney injury due to various environmental factors such as heavy metals or chemicals has been a major problem in developing countries. However, the diagnosis of kidney injury in these areas can be more challenging due to the lack of highly sensitive and specific techniques that can be applied in point-of-care settings. To address this, we have developed a technique called 'micro-urine nanoparticle detection (µUNPD)', that allows the detection of trace amounts of molecular markers in urine. Specifically, this technique utilizes an automated on-chip assay followed by detection with a hand-held device for the read-out. Using the µUNPD technology, the kidney injury markers KIM-1 and Cystatin C were detected down to concentrations of 0.1 ng/ml and 20 ng/ml respectively, which meets the cut-off range required to identify patients with acute or chronic kidney injury. Thus, we show that the µUNPD technology enables point of care and non-invasive detection of kidney injury, and has potential for applications in diagnosing kidney injury with high sensitivity in resource-limited settings.

Additional perspectives on chronic kidney disease of unknown aetiology (CKDu) in Sri Lanka--lessons learned from the WHO CKDu population prevalence study.

The recent emergence of an apparently new form of chronic kidney disease of unknown aetiology (CKDu) has become a serious public health crisis in Sri Lanka. CKDu is slowly progressive, irreversible, and asymptomatic until late stages, and is not attributable to hypertension, diabetes, or other known aetiologies. In response to the scope and severity of the emerging CKDu health crisis, the Sri Lanka Ministry of Health and the World Health Organization initiated a collaborative research project from 2009 through 2012 to investigate CKDu prevalence and aetiology. The objective of this paper is to discuss the recently published findings of this investigation and present additional considerations and recommendations that may enhance subsequent investigations designed to identify and understand CKDu risk factors in Sri Lanka or other countries.

Update on uncertain etiology of chronic kidney disease in Sri Lanka's north-central dry zone.

INTRODUCTION: This manuscript updates a review previously published in a local journal in 2012, about a new form of chronic kidney disease that has emerged over the past two decades in the north-central dry zone of Sri Lanka, where the underlying causes remain undetermined. Disease burden is higher in this area, particularly North Central Province, and affects a rural and disadvantaged population involved in rice-paddy farming. Over the last decade several studies have been carried out to estimate prevalence and identify determinants of this chronic kidney disease of uncertain etiology. OBJECTIVE: Summarize the available evidence on prevalence, clinical profile and risk factors of chronic kidney disease of uncertain etiology in the north-central region of Sri Lanka. METHODS: PubMed search located 16 manuscripts published in peer-reviewed journals. Three peer-reviewed abstracts of presentations at national scientific conferences were also included in the review. RESULTS: Disease prevalence was 5.1%-16.9% with more severe disease seen in men than in women. Patients with mild to moderate stages of disease were asymptomatic or had nonspecific symptoms; urinary sediments were bland; 24-hour urine protein excretion was <1 g; and ultrasound demonstrated bilateral small kidneys. Interstitial fibrosis was the main pathological feature on renal biopsy. The possibility of environmental toxins affecting vulnerable population groups in a specific geographic area was considered in evaluating etiological factors. Pesticide residues were detected in affected patients' urine, and mycotoxins detected in foods were below maximum statutory limits. Calcium-bicarbonate-type water with high levels of fluoride was predominant in endemic regions. Significantly high levels of cadmium in urine of cases compared to controls, as well as the disease's dose-related response to these levels, has drawn attention to this element as a possible contributing factor. Familial clustering of patients is suggestive of a polygenic inheritance pattern comparable to that associated with diseases of multifactorial etiology. CONCLUSIONS: Available data suggest that chronic kidney disease of uncertain etiology is an environmentally acquired disease, but to date no definitive causal factor has been identified. Geographic distribution and research findings suggest a multifactorial etiology.

The costs in provision of haemodialysis in a developing country: a multi-centered study.

BACKGROUND: Chronic Kidney Disease is a major public health problem worldwide with enormous cost burdens on health care systems in developing countries. We aimed to provide a detailed analysis of the processes and costs of haemodialysis in Sri Lanka and provide a framework for modeling similar financial audits. METHODS: This prospective study was conducted at haemodialysis units of three public and two private hospitals in Sri Lanka for two months in June and July 2010. Cost of drugs and consumables for the three public hospitals were obtained from the price list issued by the Medical Supplies Division of the Department of Health Services, while for the two private hospitals they were obtained from financial departments of the respective hospitals. Staff wages were obtained from the hospital chief accountant/chief financial officers. The cost of electricity and water per month was calculated directly with the assistance of expert engineers. An apportion was done from the total hospital costs of administration, cleaning services, security, waste disposal and, laundry and sterilization for each unit. RESULTS: The total number of dialysis sessions (hours) at the five hospitals for June and July were 3341 (12959) and 3386 (13301) respectively. Drug and consumables costs accounted for 70.4-84.9% of the total costs, followed by the wages of the nursing staff at each unit (7.8-19.7%). The mean cost of a dialysis session in Sri Lanka was LKR 6,377 (US$ 56). The annual cost of haemodialysis for a patient with chronic renal failure undergoing 2-3 dialysis session of four hours duration per week was LKR 663,208-994,812 (US$ 5,869-8,804). At one hospital where facilities are available for the re-use of dialyzers (although not done during study period) the cost of consumables would have come down from LKR 5,940,705 to LKR 3,368,785 (43% reduction) if the method was adopted, reducing costs of haemodialysis per hour from LKR 1,327 at present to LKR 892 (33% reduction). CONCLUSIONS: This multi-centered study demonstrated that the costs of haemodialysis in a developing country remained significantly lower compared to developed countries. However, it still places a significant burden on the health care sector, whilst possibility of further cost reduction exists.

Chronic kidney disease of unknown aetiology in Sri Lanka: is cadmium a likely cause?

BACKGROUND: The rising prevalence of chronic kidney disease (CKD) and subsequent end stage renal failure necessitating renal replacement therapy has profound consequences for affected individuals and health care resources. This community based study was conducted to identify potential predictors of microalbuminuria in a randomly selected sample of adults from the North Central Province (NCP) of Sri Lanka, where the burden of CKD is pronounced and the underlying cause still unknown. METHODS: Exposures to possible risk factors were determined in randomly recruited subjects (425 females and 461 males) from selected areas of the NCP of Sri Lanka using an interviewer administered questionnaire. Sulphosalicylic acid and the Light Dependent Resister microalbumin gel filtration method was used for initial screening for microalbuminuria and reconfirmed by the Micral strip test. RESULTS: Microalbumnuria was detected in 6.1% of the females and 8.5% of the males. Smoking (p < 0.001), alcohol use (p = 0.003), hypertension (p < 0.001), diabetes (p < 0.001), urinary tract infection (UTI) (p = 0.034) and consumption of water from wells in the fields (p = 0.025) were associated with microalbuminuria. In the binary logistic regression analysis, hypertension, diabetes mellitus, UTI, drinking well water in the fields, smoking and pesticide spraying were found to be significant predictors of microalbuminuria. CONCLUSIONS: Hypertension, diabetes mellitus, UTI, and smoking are known risk factors for microalbuminuria. The association between microalbuminuria and consumption of well water suggests an environmental aetiology to CKD in NCP. The causative agent is yet to be identified. Investigations for cadmium as a potential causative agent needs to be initiated.

Could ochratoxin A in food commodities be the cause of chronic kidney disease in Sri Lanka?

Ochratoxin A (OA) is a naturally occurring mycotoxin with nephrotoxic properties that can contaminate plant food products. OA concentrations were assessed in commonly consumed food items in the North Central Province of Sri Lanka, where chronic kidney disease is diagnosed at epidemic proportions. Ninety-eight randomly selected food samples were analysed. Mycotoxin was detected in the extract by using a MycoMonitor Ochratoxin A ELISA assay kit (Helica Biosystems Inc., USA). The levels of OA found in these food commodities were below the recommended statutory maximum limit and are unlikely to be a potential risk factor for nephropathy in the North Central Province of Sri Lanka.

Chronic renal failure in North Central Province of Sri Lanka: an environmentally induced disease.

This study was conducted to determine the aetiology of chronic renal failure (CRF) in the North Central Province of Sri Lanka. Patients (n=183) with CRF of unknown aetiology were compared with controls (n=200) who had no evidence of chronic renal dysfunction. Exposure to possible risk factors were determined by an interviewer-administered questionnaire. Being a farmer (P<0.001), using pesticides (P<0.001), drinking well water (P<0.001), a family history of renal dysfunction (P=0.001), use of ayurvedic treatment (P<0.001) and a history of snake bite (P<0.001) were risk factors for CRF of unknown aetiology. Using logistic regression analysis, a family history of chronic renal disease, taking ayurvedic treatment and history of snake bite were found to be significant predictors for CRF of unknown aetiology. There is evidence to support an environmental aetiology to CRF in Sri Lanka.