What information and the extent of information research participants need in informed consent forms: a multi-country survey.

BACKGROUND: The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research. METHODS: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important). RESULTS: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be 'moderately important' to 'very important' for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively). CONCLUSIONS: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.

Anti-hyperglycaemic effects of herbal porridge made of Scoparia dulcis leaf extract in diabetics - a randomized crossover clinical trial.

BACKGROUND: Leaf extracts of Scoparia dulcis, is used as a herbal remedy by diabetics worldwide. Fresh Scoparia dulcis porridge elicited a low glycaemic index (GI) and anti-hyperglycaemic effects when fed to diabetic Wistar rats. Commercially produced Scoparia dulcis porridge (SDC) elicited medium GI. Present study was aimed at studying the anti-diabetic effects of consumption of commercially produced S. dulcis porridge. METHOD: A randomized crossover clinical trial with type 2 diabetic patients (n = 35) on medication, with mild and moderate diabetes [fasting blood glucose (FBG) 126-300 mg/dL, age 35-70 years] was conducted. Within the first three months (study period 1) group 1 was the test and group 2 was the control. Following a wash-out period, the two groups were crossed over (study period 2: group 1 - control; group 2 - test). Test group consumed commercially produced SDC for 3 days/week for three months and the control group any other food. At the onset and end of each study period glucose measurements [Fasting Blood Glucose (FBG), HbA1c], lipid measurements (total cholesterol, HDL-C, LDL-C, triglycerides, cholesterol ratios), toxicity parameters (liver enzymes, creatinine, CRP, eGFR) were analyzed by enzyme assay kit methods using a KONELAB 20XT auto analyzer. Significances between groups were analyzed by one way ANOVA (normal distribution) and Mann Whitney test (if the values were not normally distributed). Within group comparisons were carried out by Bonferroni post hoc test. RESULTS: During the crossover clinical trial HbA1c of group 1 decreased from 7.9 ± 0.5 to 6.5 ± 0.3 (p = 0.003) while HbA1c of group 2 decreased from 7.0 ± 0.3to 6.7 ± 0.3 while in the test group. Therefore, both test groups (1 and 2) elicited a decrease in HbA1c compared to respective control groups. Both test groups elicited a non significant decrease in FBG following the intervention (group 1 - from 174 ± 14 to 160 ± 10 mg/dL; group 2 - from 183 ± 13 to 160 ± 7 mg/dL). No significant differences (p >0.05) in insulin, cholesterol measurements (total cholesterol, LDL-C, HDL-C, triglycerides and cholesterol ratios) and atherogenic index between or within groups were observed. All other measurements (AST, ALT, ALP, creatinine, CRP, eGFR) were normal and not significantly different between or within groups. CONCLUSION: Porridge made with SDC leaf extract decreased FBG and HbA1c (p >0.05) of type 2 diabetic patients. The porridge had no effect on cholesterol measurements and no toxicity was observed at the dose tested. Therefore, the SDC porridge can be recommended as a suitable meal for diabetic patients.

Hypoglycaemic activity of culinary Pleurotus ostreatus and P. cystidiosus mushrooms in healthy volunteers and type 2 diabetic patients on diet control and the possible mechanisms of action.

This study determined the oral hypoglycaemic effect of suspensions of freeze dried and powdered (SFDP) Pleurotus ostreatus (P.o) and Pleurotus cystidiosus (P.c), using healthy human volunteers and Type 2 diabetic patients on diet control at a dose of 50 mg/kg/body weight, followed by a glucose load. The possible hypoglycaemic mechanisms were evaluated using rats, by examining intestinal glucose absorption and serum levels of insulin, glucokinase (GK) and glycogen synthase kinase (GSK). The P.o and P.c showed a significant reduction (P < 0.05) in fasting and postprandial serum glucose levels of healthy volunteers and reduced the postprandial serum glucose levels and increased the serum insulin levels (P < 0.05) of Type 2 diabetic patients. The P.o and P.c increased the intestinal absorption of glucose but simultaneously reduced the serum glucose levels (P < 0.05) in rats. Both mushrooms reduced the serum GSK and promoted insulin secretion while P.c increased serum GK (P < 0.05). The hypoglycaemic activity of P.o and P.c makes mushrooms beneficial functional foods in diabetes mellitus. The mechanism of hypoglycaemic activity of P.o and P.c is possibly by increasing GK activity and promoting insulin secretion and thereby increasing the utilization of glucose by peripheral tissues, inhibiting GSK and promoting glycogen synthesis.

A national survey on availability, price and affordability of selected essential medicines for non communicable diseases in Sri Lanka.

BACKGROUND: Access to medicines is a universal right. Low availability and low affordability of medicines are issues that deny this right to a significant proportion of the world population. The objective of this study was to determine the availability, price and affordability of essential medicines prescribed to treat non communicable diseases in Sri Lanka. METHODS: Methodology was based on the 2nd edition of the World Health Organization Health Action International Manual. A country survey was conducted and facilities representing both public and private pharmacies were selected. A total of 109 facilities was surveyed. At each facility data on the availability and prices of 50 essential medicines for non communicable diseases were collected. Percentage availability, median price of originator brand and lowest priced generic, median price ratio to the International Reference Price were calculated for surveyed medicines. Affordability was determined using the daily incomes of the lowest--paid unskilled government worker. RESULTS: Semi government community pharmacies had the highest (>80%) availability while outdoor pharmacies of public health care facilities, private pharmacies and outdoor pharmacies of private hospital showed a fairly high availability (50 - 80%) of surveyed medicines.Unit price of 76% of selected individual medicines was less than ten Sri Lankan rupees. Out of these 28% of medicines cost less than one Sri Lanka rupee. For 21 of the surveyed medicines the median price ratio to the international reference price was less than one. The prices of originator brands for 14 surveyed medicines were more than five times that of the lowest price generics.Less than a single day's wages was adequate to purchase a month's supply of the lowest priced generic of more than 67% of surveyed medicines. CONCLUSIONS: The availability of selected essential medicines was fairly high in both public and private sectors in Sri Lanka. Most medicines are affordable to the lowest income earners in the community. There were many generic brands and generics available for most of the medicines in private and semi government community pharmacies increasing both availability and affordability.

Anti-diabetic properties of rice-based herbal porridges in diabetic Wistar rats.

The present study aims to investigate anti-hyperglycaemic, anti-hyperlipidaemic and toxic effects of long-term consumption of selected green leafy porridges in a streptozotocin-induced diabetic Wistar rat model. Porridges made with Asparagus racemosus Willd. (AR), Hemidesmus indicus (L) R. Br. W. T. Aiton (HI), Scoparia dulcis L. (SD) and coconut milk porridge (CM) were incorporated into diets of diabetic Wistar rats. Diabetic control (DM) and normal control groups (NC) were provided with standard rat diet. Fasting blood glucose (FBG), HbA1c , C reactive protein (CRP), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), liver enzymes and creatinine were measured. Feed and water intake among diabetic groups were significantly high when compared with those of NC (p < 0.05). All rats in SD (mean = 39 ± 19 g) and NC (mean = 114 ± 7 g) groups gained weight, whereas most rats in other diabetic groups lost weight. Among the diabetic groups, SD group had the lowest mean FBG, FBG increment percentage (45%) and HbA1c (5.8 ± 2.1). FBG increment percentage and HbA1c of SD group were not significantly different to those of NC (38%; 4.7 ± 0.7) (p > 0.05). Among the diabetic groups, lowest TC (119 ± 20.6 mg/dL) and highest HDL-C (33 ± 6.3 mg/dL) were also detected in SD group. Alanine transaminase and creatinine were not significantly different (p > 0.05) among diabetic groups but significant when compared with those of NC. When compared with those of NC, aspartate transaminase levels were significantly (p < 0.05) high in SD, CM and DM groups. Body weight : liver weight and body weight : pancreas weight ratios and CRP were not significantly different among all groups. The study proved that SD porridge reduced weight loss, elicited hypoglycaemic and hypolipidaemic properties, and caused no toxicity in diabetes-induced Wistar rats.

The readiness of the Asian research ethics committees in responding to the COVID-19 pandemic: A multi-country survey.

Background: COVID-19 is a highly challenging infectious disease. Research ethics committees (RECs) have challenges reviewing research on this new pandemic disease under a tight timeline and public pressure. This study aimed to assess RECs' responses and review during the outbreak in seven Asian countries where the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) networks are active. Methods: The online survey was conducted in seven Asian countries from April to August 2021. Two sets of online questionnaires were developed, one set for the chairs/secretaries and another set for the REC members.The REC profiles obtained from the REC members are descriptive in nature. Data from the chairs/secretaries were compared between the RECs with external quality assessment (SIDCER-Recognized RECs, SR-RECs) and non-external quality assessment (Non-SIDCER-Recognized RECs, NSR-RECs) and analyzed using a Chi-squared test. Results: A total of 688 REC members and 197 REC chairs/secretaries participated in the survey. Most RECs have standard operating procedures (SOPs), and have experience in reviewing all types of protocols, but 18.1% had no experience reviewing COVID-19 protocols. Most REC members need specific training on reviewing COVID-19 protocols (93%). In response to the outbreak, RECs used online reviews, increased meeting frequency and single/central REC. All SR-RECs had a member composition as required by the World Health Organisation ethics guidelines, while some NSR-RECs lacked non-affiliated and/or layperson members. SR-RECs reviewed more COVID-related product development protocols and indicated challenges in reviewing risk/benefit and vulnerability (0.010), informed consent form (0.002), and privacy and confidentiality (P = 0.020) than NSR-RECs. Conclusions: Surveyed RECs had a general knowledge of REC operation and played a significant role in reviewing COVID-19-related product development protocols. Having active networks of RECs across regions to share updated information and resources could be one of the strategies to promote readiness for future public health emergencies.

Is adherence to national guidelines for parenteral empiric antibiotic therapy effective? Experience from a Sri Lankan center.

INTRODUCTION: Guidelines for the selection of empirical antibiotics have been developed to improve patient outcomes and reduce unnecessary antibiotic use. We assessed the extent of adherence to the national guidelines for the selection of parenteral empirical antibiotics for three selected infections at a tertiary care center. METHODOLOGY: A prospective cross-sectional study was conducted in medical and surgical wards of a tertiary care hospital in Sri Lanka. Adult patients with a positive culture for a lower respiratory tract infection (LRTI), skin and soft tissue infection (SSTI), or urinary tract infection (UTI) and who were prescribed parenteral empirical antibiotic therapy by the attending physician were included. Bacteria were identified and antibiotic susceptibility was determined by standard microbiological methods. Adherence to the guidelines was defined as prescribing the empiric antibiotic concordant with the national guidelines on the empirical use of antibiotics. RESULTS: A total of 160 bacterial isolates were obtained from 158 patients with positive cultures, the majority were from UTIs (n = 56). The selection of empirical antibiotics was concordant with the national guidelines in 92.4% of patients and 29.5% of the bacterial isolates obtained from these patients were resistant to the prescribed empiric antibiotic. Only 47.5% (76/160) of the bacterial isolates were sensitive to the empiric antibiotic and therefore can be considered an appropriate antibiotic prescription. CONCLUSIONS: Empirical antibiotic guidelines should be updated based on the latest surveillance data and information on prevailing bacterial spectra. Antibiotic prescribing patterns and guideline concordance should be periodically evaluated to ensure whether antimicrobial stewardship programs are moving in the right direction.

Appropriateness of the Empirical Antibiotics Prescribed and Their Concordance with National Guidelines for Three Selected Infections among Cancer Patients in a Tertiary Care Centre in Sri Lanka.

BACKGROUND: Prophylactic and empirical antibiotic use is essential in cancer patients due to the underlying immune deficiencies. We examined the spectrum of causative bacteria and the appropriateness of empirical antibiotic prescription for three selected infections in cancer patients. Methodology. A descriptive cross-sectional study was conducted at the National Institute of Cancer (NIC), Sri Lanka, from June 2018 to February 2019. Bacterial isolates obtained from adult cancer patients with a diagnosis of lower respiratory tract infections (LRTI), skin and soft tissue infections (SSTI), or urinary tract infections (UTI) were included. Causative bacteria were identified and the antibiotic susceptibility was determined by standard microbiological methods. Empirical therapy was defined as appropriate if the isolated pathogen was susceptible in vitro to the given antibiotic. RESULTS: A total of 155 bacterial isolates were included in the analysis. LRTI were the most prevalent infections (37.2%, 55/148) encountered during the study period. Majority (90.9%) of the isolated bacteria were ESKAPE pathogens. Klebsiella pneumoniae was the most frequent pathogen causing LRTI (42.4%, 25/59), whereas Escherichia coli (32%, 16/50) and Staphylococcus aureus (26.1%, 12/46) predominated in UTI and SSTI, respectively. Meropenem was the most prescribed empirical antibiotic for LRTI (29.1%, 16/55) and SSTI (26.6%, 11/43) while it was ceftazidime for UTI (36%, 18/50). Only 20.6% (32/155) of the isolated bacteria were susceptible to the empirical antibiotic prescribed while 48.4% (75/155) were resistant to them. The prescribed empirical antibiotic did not have the spectrum of activity for the isolated bacteria in 29% (45/155) of cases. CONCLUSION: High resistance rates were observed against the prescribed empirical antibiotics. National empirical antibiotic guidelines should be revised with updated data on causative organisms and their susceptibility patterns to ensure appropriate empirical antibiotic prescription.

A national survey of antibacterial consumption in Sri Lanka.

INTRODUCTION: Optimizing the use of antibacterial medicines is an accepted strategy to combat the antibacterial resistance. Availability of reliable antibacterial consumption (ABC) data is a prerequisite to implement this strategy. OBJECTIVES: To quantify and describe the national ABC in Sri Lanka and to examine any differences in the consumption between public and private sector. METHODS: The methodology for this survey was adapted from World Health Organization (WHO) methodology for a global programme on surveillance of antimicrobial consumption. Aggregate data on national consumption of systemic antibacterials (J01- Anatomical Therapeutic Chemical Classification (ATC) for 2017 were retrospectively extracted from all available data sources and classified using ATC classification. Quantity of consumption was converted to Defined Daily Doses (DDDs). Data are presented as total consumption and comparison between the public and private sector. Selected key quality indicators of ABC were compared between these two sectors. FINDINGS: From the available data sources, the total ABC in 2017 was 343.46 million DDDs. Private sector consumption accounted for 246.76 million DDDs compared to 97.96 million DDDs distributed to entire public sector by the Ministry of Health. Beta-lactam-penicillins antibacterial group accounted for 58.79% in public sector compared to 27.48% in private sector while macrolides, quinolones and other beta-lactam antibacterials accounted for 60.51% in the private compared to 28.41% in public sector. Consumption of Reserve group antibacterials was negligible, and limited to private sector. Watch category antibacterials accounted for 46%, 24% and 54% of the total, public and private sector consumption, respectively. CONCLUSIONS: A disproportionately higher use of broad spectrum and Watch category antibacterials was observed in the private sector which needs further study. This national consumption survey highlights the need and provides the opening for establishment of ABC surveillance in Sri Lanka.

Anti-Inflammatory Activity of Pleurotus ostreatus, a Culinary Medicinal Mushroom, in Wistar Rats.

Context. Pleurotus ostreatus (P.o) is a culinary mushroom which is commonly called as "oyster mushroom" belonging to the Basidiomycetous fungi of the order Agaricales and family Pleurotaceae. OBJECTIVES: The present study investigates the anti-inflammatory potential of P.o) is a culinary mushroom which is commonly called as "oyster mushroom" belonging to the Basidiomycetous fungi of the order Agaricales and family Pleurotaceae. Materials and Methods. Anti-inflammatory activity was evaluated using suspensions of freeze-dried and powdered (SFDP) P.o) is a culinary mushroom which is commonly called as "oyster mushroom" belonging to the Basidiomycetous fungi of the order Agaricales and family Pleurotaceae. P.o) is a culinary mushroom which is commonly called as "oyster mushroom" belonging to the Basidiomycetous fungi of the order Agaricales and family Pleurotaceae. P.o) is a culinary mushroom which is commonly called as "oyster mushroom" belonging to the Basidiomycetous fungi of the order Agaricales and family Pleurotaceae. in vivo and in vitro assays. RESULTS: At doses of 500-1000 mg/kg, the SFDP of P.o) is a culinary mushroom which is commonly called as "oyster mushroom" belonging to the Basidiomycetous fungi of the order Agaricales and family Pleurotaceae. P.o) is a culinary mushroom which is commonly called as "oyster mushroom" belonging to the Basidiomycetous fungi of the order Agaricales and family Pleurotaceae. P.o) is a culinary mushroom which is commonly called as "oyster mushroom" belonging to the Basidiomycetous fungi of the order Agaricales and family Pleurotaceae. P.o) is a culinary mushroom which is commonly called as "oyster mushroom" belonging to the Basidiomycetous fungi of the order Agaricales and family Pleurotaceae. in vitro assays. P < 0.05). Dose-dependent inhibition of NO production was seen with in vitro assays. P.o) is a culinary mushroom which is commonly called as "oyster mushroom" belonging to the Basidiomycetous fungi of the order Agaricales and family Pleurotaceae. r = 0.95; P < 0.05). Dose-dependent inhibition of NO production was seen with Discussion and Conclusion. The promising activity of culinary mushroom P.o against inflammation suggests its potential application as a functional food during inflammatory conditions.P.o) is a culinary mushroom which is commonly called as "oyster mushroom" belonging to the Basidiomycetous fungi of the order Agaricales and family Pleurotaceae.

Awareness of clinical trial registration among healthcare professionals: An observational study.

AIM: Prospective registration in a freely accessible public platform is a key step in the ethical conduct of clinical trials. Little is known of the awareness of clinical trial registration among the scientific community. This study aimed to assess awareness of clinical trial registration among participants attending a medical congress in Sri Lanka. METHODS: Knowledge of trial registration was assessed using a self-administered questionnaire, which spanned domains such as involvement in research, and knowledge and perceptions regarding trial registration. A knowledge score was calculated and correlated with demographic variables. RESULTS: Of 251 survey respondents, 53.4% were male, 74.9% were below the age of 40 years, and 56.6% were currently engaged in research. Registration was considered necessary for trial publication by 73.3%, and 70.5% agreed that trials should be registered prospectively. Most achieved a knowledge score of 'Acceptable' (41%) or 'Good' (19.9%). Mid- or advanced career stages, postgraduate training, current involvement in research, and recent research publications/presentations were correlated with higher knowledge scores (P < 0.05). Beneficial effects considered to be associated with trial registration were access to findings of all trials (61.4%), access to negative results (47.8%), preventing trial duplication (69.3%), and preventing multiple publications (70.1%). Increasing research workload (49.8%), additional restrictions on research conduct (52.2%), and the possibility of 'intellectual theft' (56.2%) were seen as potential negative effects. CONCLUSIONS: Most participants were aware of the need for prospective registration as a requirement for publication of clinical trials. Concerns were expressed regarding several perceived negative effects of trial registration.

Dietary Habits of Type 2 Diabetes Patients: Variety and Frequency of Food Intake.

The objective of the present study was to observe the dietary patterns and food frequencies of type 2 diabetes patients attending the clinics of the Family Practice Center of the University of Sri Jayewardenepura, located in a highly urbanized area in Sri Lanka. An interviewer administered questionnaire based cross-sectional study was conducted among randomly selected 100 type 2 diabetes patients [age 35-70 years; mean age 55 ± 9 (males = 44; females = 56)]. The data were analyzed by SPSS version 18.0 software. Vegetables, fatty foods, and poultry consumption were in accordance with the national guidelines. A significant percentage (45.5%) consumed rice mixed meals for all three meals and only 67% consumed fruits at least once a day. Majority (71%) consumed full-cream milk and sugar intake (77%) was in accordance with the guidelines. Noncaloric sweetener usage was nonexistent. Daily green leafy vegetable intake and the quantity consumed were inadequate to obtain beneficial effects. From the study population, 44% [females 50%; males 36%] of the patients were either overweight or obese. However, only 60% of those patients accepted that they were either overweight or obese. Only 14% exercised daily while 69% never exercised. Study revealed the importance of educating patients with type 2 diabetes on dietary changes and more importantly the involvement in regular physical exercises.