Health seeking behaviours, dengue prevention behaviours and community capacity for sustainable dengue prevention in a highly dengue endemic area, Sri Lanka.

INTRODUCTION: Dengue has become a major health problem in globally as well as locally. The delay in health-seeking is significantly associated with complications leading to severe dengue and active engagement of communities needs to minimize the delays in management to control epidemics. The aim of the study was to evaluate the relationship between sociodemographic characteristics and householders' Health-Seeking Behaviours (HSB), Dengue-Prevention Behaviours (DPB), and Community Capacities (CC) for sustained dengue prevention in Sri Lanka, a country with a high dengue endemicity. METHODS: A cross-sectional analytical study was carried out in a district with the highest dengue endemicity from January to April 2019. Of the householders, 532 were chosen randomly. A pre-tested, validated, and interviewer-administered questionnaire was used to assess HSB and DPB. The HSB was assessed using three aspects, initial response for fever management, the duration of blood testing and initial response if suspected dengue. The DPB assessment was evaluated using 'waste, outdoor water container, indoor water container, roof gutter and water storage management'. 'Dengue Community Capacity Assessment Tool', with 14 key items was used to assess the level of community capacity for dengue prevention. Out of the total, ≥ 50% was considered as an "adequate" HSB, DPB and CC. Multiple logistic regression was performed to control confounding effects. The results were expressed as adjusted Odds-Ratios (aOR) and 95% Confidence Intervals (CI). RESULTS: The response rate was 93.2% (n = 496). Among them, 44.6% (n = 221) had adequate overall HSB, and 19.2% (n = 95) had adequate DPB. Householders who have ≤ 4 family members are 1.74 times (aOR = 1.74; 95% CI: 1.17 - 2.61) more likely to have adequate HSB and 1.85 times (aOR = 1.85; 95% CI: 1.11 - 3.09) more likely to have adequate DPB. The age group of 46 to 70 years' individuals (aOR = 1.74; 95% CI:1.12 - 2.92), and who engaged in employment (aOR = 1.68; 95% CI: 1.05 - 2.67) were more likely to have adequate DPB than the group of 18 to 45 years and the non-employed individuals respectively. Of them, 24.6% (n = 122) perceived that they have adequate CC. The householders who have per-capita income < USD 50 are 1.95 times (aOR = 1.95; 95%CI:1.11 - 3.40) more likely to have adequate CC. CONCLUSION: The HSB, DPB and CC need to be improved to change the behaviour for sustainable dengue prevention and community capacity-building programmes need to be conducted in the Kurunegala district, Sri Lanka.

Incidence management system of the healthcare institutions for disaster management in Sri Lanka.

BACKGROUND: Incident management systems and disaster planning processes facilitate maximal use of available resources. Evaluation of the Incident Command System (ICS) is one of the top five key areas of research priority in the field of surge. The study was aimed at assessing the disaster preparedness and ICS of the public healthcare institutions for the disaster management in a disaster-prone district of Sri Lanka. METHODS: A descriptive cross-sectional study was conducted among all public sector healthcare institutions (n = 74), including curative-healthcare institutions (n = 46) which have inward-care facilities for patient care and preventive healthcare institutions (n = 28) in Kurunegala district, Sri Lanka from May-September 2019 using a validated interviewer administered questionnaire which was based on 'CO-S-TR Model' for ICS assessment including 'Clear need for increased capacity (≤25%), Basic level (26 - 50%), Moderate level (51 - 75%) and High level (>75%)'. RESULTS: Focal points for disaster management were nominated by the majority of the curative sector (n = 33; 76.7%) and preventive sector (n = 19; 73.1%) healthcare institutions. A written disaster preparedness and response plans were available in 72% (n= 31) curative sector and 76% (n= 19) preventive sector institutions. The higher proportion of the curative sector institutions had moderate level capacity in the area of providing treatment, and basic level capacities were in the areas of 'staff mobilization, coordination of activities, supplying of special needs, triage of cases and transportation'. There is a clear need for improvement in the areas of communication commanding, management of controlling the incidence and tracking of the cases in the curative sector. The majority of the preventive sector institutions had moderate level capacity in commanding, control, coordination and tracking of cases. The basic level capacity in the areas of staff mobilization, stuff management and triage of cases. There is a clear need for improvement in the areas of communication in preventive sector. Of the public sector healthcare institutions, the higher proportion of the preventive sector (n = 20; 76.9%) and curative sector (n = 29; 67.4%) had basic level overall surge capacity of ICS for disaster management. CONCLUSION: Coordination, communication, commanding, management of controlling the incidence and tracking of cases following outbreaks need to be improved and capacity development programmes could implement to develop the preparedness for future disasters.

Success and challenges of health systems resilience-enhancing strategies for managing Public Health Emergencies of International Concerns (PHEIC): A systematic review protocol.

INTRODUCTION: Health systems resilience is the ability to prepare, manage and learn from a sudden and unpredictable extreme change that impacts health systems. Health systems globally have recently been affected by a number of catastrophic events, including natural disasters and infectious disease epidemics. Understanding health systems resilience has never been more essential until emerging global pandemics. Therefore, the application of resilience-enhancing strategies needs to be assessed to identify the management gaps and give valuable recommendations from the lessons learnt from the global pandemic. METHODS: The systematic review will be reported using the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA-P) protocols guideline. Reporting data on World Health Organization (WHO) health system building blocks and systematic searches on resilience enhancing strategies for the management of Public Health Emergencies of International Concerns (PHEIC) after the establishment of International Health Regulations (IHR) in 2007 will be included. The search will be conducted in PubMed, Scopus, Web of Science and Google Scholar ETHICS AND DISSEMINATION: Ethics approval and safety considerations are not applicable. Pre-print of the protocol is available online, and the screening of the articles will be done using Rayyan software in a transparent manner. The findings will be presented at conferences and the final review's findings will be published in a peer-reviewed international journal and will be disseminated to global communities for the application of successful management strategies for the management of future pandemics. PROSPERO REGISTRATION NUMBER: CRD42022352612; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022352612.

Development of a Risk Prediction Model for endometrial carcinoma among postmenopausal women in the Western province of Sri Lanka.

Introduction: Globally, endometrial carcinoma is the most common reproductive tract cancer among women. Risk prediction model is a simple, low-cost tool to identify women with increased risk of developing endometrial carcinoma. Objectives: The aim of the study was to develop a model to predict the risk of endometrial carcinoma among postmenopausal women in Sri Lanka. Methods: A case control study was conducted. The cases and the controls were defined as postmenopausal women who had and had not been diagnosed as endometrial carcinoma based on histological confirmation respectively. Variable selection was done considering the objectivity and feasibility of the measurements in addition to the statistical criteria. A scoring system [0-9] was designed based on weighted score of each risk predictor. Predictive validity of the model was tested by calibration and discrimination. Receiver Operator Characteristic (ROC) curve was used to determine the cut-off value. Results: The developed model consisted of six predictors; Age >55 years, never conceived, age at menarche ≤11 years, ever experienced postmenopausal bleeding, having family history of any type of cancer among first degree relative, generalized obesity. Discrimination of the model was measured by the area under the ROC curve (0.92, 95% Confidence Interval: 0.88-0.95). Calibration with goodness of fit by Hosmer and Lemeshow test (p=0.72) was satisfactory. The tool demonstrated a good predictive ability with sensitivity of 79.5% (CI: 68.9%-87.3%) and specificity of 90.7% (CI: 86.8%-93.5%) at the cut-off point of 4.5. Conclusions: Model demonstrated good discrimination and well calibration. It can be used in screening of high-risk women for developing endometrial carcinoma.

Risk factors for viral hepatitis A infection in Gampaha District, Sri Lanka: an unmatched case control study.

BACKGROUND: Hepatitis A virus (HAV) is one of the commonest food and water borne infectious diseases. The objective of the study was to determine the risk factors of HAV infection in the Gampha District in Sri Lanka. METHODS: This was an unmatched case control study conducted between January 2015 and November 2016 comprising of 504 participants with a case control ratio of 1:1. The study population included individuals of age 1 year and above who were permanent residents of the district. Cases included participants admitted to four secondary care state hospitals with an acute HAV diagnosed by detecting serum anti-HAV IgM antibodies. Controls were randomly selected individuals from the community with serum negative for Anti-HAV IgM and IgG. An interviewer administered questionnaire was used for the data collection and multiple logistic regression was applied to determine the independent risk factors. The results are expressed as adjusted odds ratios (AOR) and 95% confidence intervals (CI). RESULTS: Risk factors for HAV infection were poor knowledge regarding hepatitis (AOR;3.98, 95% CI = 1.97-8.05), unhygienic sanitary practices (OR = 2.73; 95% CI = 1.42-5.23), unhygienic practices related to drinking water (OR = 2.67; 95% CI = 1.37-5.21), residing in urban areas (OR = 5.94; 95% CI = 2.98-11.86) and lower family income (OR = 2.83; 95% CI = 1.30-6.13). CONCLUSIONS: The independent modifiable risk factors for HAV infection were poor knowledge regarding hepatitis, unhygienic sanitary practices, and unhygienic practices related to drinking water. Community awareness must be raised on hygienic practices and safe water drinking practices. Inequities of social determinates of health must be addressed.

Effectiveness of providing health education to caregivers of hospitalized children with asthma for the prevention of recurrent attacks: a quasi-randomized trial.

Objective: To determine the effectiveness of health education intervention for caregivers of children with asthma, focused on preventing recurrent attacks and improving knowledge.Methods: A quasi-randomized trial of 177 caregivers of asthmatic children was conducted in government hospitals in a district of Sri Lanka. At the time of discharge from the hospital, a health education booklet was prepared and given to the caregivers in the intervention group, along with individual explanation and discussion. The caregivers' knowledge of asthma and preventive practices was assessed. The primary outcome was the proportion of children with recurrent attacks of asthma who needed doctor visits during the three month post discharge period. The intention-to-treat principle was applied for data analysis.Results: In comparison to the control group, the intervention group had a 76% significant reduction in visits to the doctor for recurrent attacks (95% CI:45%-90%) and a 75% significant reduction in hospital admissions required for asthmatic children (95% CI:16%-93%) at the end of three months of intervention. The mean score of knowledge of asthma in the intervention group was 1.73 units higher at three months (p < 0.01) and 1.47 units higher at six months (p < 0.01) than the control group. The mean score of preventive practices for asthma in the intervention group was 1.25 units higher at three months (p = 0.02) and 1.15 units higher at six months (p < 0.01) versus the control group.Conclusion: Health education intervention significantly decreased doctor and hospital visits at three months. In addition, caregiver knowledge of asthma and preventive practices also improved.Trial Registration Number: SLCTR/2010/007.

Risk factors for endometrial carcinoma among postmenopausal women in Sri Lanka: a case control study.

BACKGROUND: Endometrial carcinoma burden is on the rise globally. The objective of this study was to determine the risk factors for endometrial carcinoma among postmenopausal women in Western province in Sri Lanka. METHODS: A case control study was conducted recruiting 83 incident cases of endometrial carcinoma and 332 unmatched hospital controls from all the secondary and tertiary care hospitals in the province using consecutive sampling technique. A case was defined as a postmenopausal woman who had been residing in the province for at least a period of 1 year, diagnosed to have endometrial carcinoma with histological confirmation within 3 months of the initiation of data collection of the study. Data were collected using validated interviewer administered questionnaire. Risk factor were identified through multiple logistic regression and results were expressed as adjusted odds ratios (AOR) and 95% confidence intervals (CI). RESULTS: The independent risk factors of endometrial carcinoma are having family history of any type of cancer among first degree relative (AOR = 12.6; 95% CI:5.14-30.9), generalized obesity (BMI ≥25 kg/m2) (AOR = 11.85; 95% CI:5.12-27.4), never conceived (AOR = 3.84; 95% CI:1.37-10.7), age at menarche ≤11 years (AOR = 4.07; 95% CI:1.16-14.2), age > 55 years (AOR = 4.69; 95% CI:2.16-10.2), monthly family income of ≤20,000 Rupees (AOR = 2.65; 95% CI:1.31-5.39), sub-optimal consumption of deep fried food (AOR = 0.17; 95% CI:0.06-0.46), and low level household activities (AOR = 2.82; 95% CI:1.34-5.92). CONCLUSIONS: There were eight independent risk factors of endometrial carcinoma specific for Sri Lankan postmenopausal women identified. Some modifiable risk factors such as generalized obesity, sub-optimal dietary practices and low level physical activities need to be addressed at primary prevention level.

Sero-prevalence of viral hepatitis A in a district of Sri Lanka: a community based cross-sectional study.

BACKGROUND: Hepatitis A Virus (HAV) is one of the most common food and water borne infectious disease prevailing globally. The objective of the study was to determine sero-prevalence of HAV infection in a district of Sri Lanka. METHODS: This was a descriptive cross sectional study conducted on 1403 participants aged 1 year and above selected by multistage stratified (for age group and area of residence) cluster sampling from September 2015 to December, 2016. An interviewer-administered questionnaire was used to collect data and Anti-IgG testing was done to determine sero-positivity. The overall, the age and sex specific sero-prevalence of HAV were calculated with 95% confidence intervals (CI). RESULTS: Of the 1403 participants 1132 were anti HAV IgG positive. Therefore the overall sero-prevalence of HAV infection was 80.7% (95%CI: 78.64-82.76). There were 283 (20.2%) individuals below the age group of 14 years and below and out of them, 204 had anti HAV IgG, therefore sero-prevalence was 72.1% for that age group. The age group 15 years and aboe comprised of 1120 (79.8%) participants and of them 928 had anti HAV IgG, making sero-prevalence 82.9%. The lowest sero-prevalence (66.9%, n = 232) was observed in the age group of 11-20 years followed by 21-30 age group. From age 31 years onwards, the sero-prevalence exceeded 90%, reaching 100% after 71 years. The urban population showed a sero-prevalence of 83% (n = 195) and 80.2% (n = 937) for the rural sector while females had a sero-prevalence of 82.2% (n = 766) and it was 77.7% (n = 366) for males. Thirty-four (3.0%) participants who had sero-positive results (n = 1132) claimed that they have had HAV in the past. CONCLUSIONS: Overall, four fifth of the population was immune to HAV infection in the district of Gampaha.

Sri Lankan clinical practice guidelines: A methodological quality assessment utilizing the AGREE II instrument.

RATIONALE, AIMS, AND OBJECTIVES: Clinical practice guidelines (CPG) play a major role in patient care in Sri Lanka. This study evaluates the methodological quality of the Sri Lankan CPGs developed in 2007. METHODS: A total of 94 CPGs developed by several professional colleges in Sri Lanka in the year 2007 were evaluated by 2 independent reviewers using AGREE II instrument for their methodological quality. Item score being ≤3 points was defined as "poor quality". Each domain score was calculated according to AGREE II. A guideline was labelled as "strongly recommended" if 4 or more domains scored above 60%, "recommended for use with certain modification" if only 3 domain scores were above 60% or if 4 or more domain scores were between 30% and 60%, and "not recommended" if 4 or more domains scored less than 30%. RESULTS: Most (22.3%) guidelines were developed by the College of Pathologists. Most of the guidelines (>55%) poorly reported on all the items, except for items 1, 2, and 22 of AGREE II. Median domain scores [range] and the proportion of the guidelines with domain score of <30% were as follows: domain on scope and purpose (33.3% [2.8%-83.3%]; 42.6%), stakeholder involvement (14.9% [0.0%-61.1%]; 81.9%), rigour of development (6.1% [0.0%-49%]; 98.9%), clarity and presentation (30.5% [8.3%-61.1%]; 46.8%), and applicability (8.3% [4.2%-14.6%]; 100%). All CPGs scored 50% for "editorial independence". Reviewers reported the overall quality was poor in 86 (91.5%). Based on the definitions used in the study, of 94 CPGs, 8 (8.5%) could be recommended to be used with modifications, while 86 (91.5%) could not be recommended for clinical practice. CONCLUSIONS: The methodological quality of the CPGs was poor irrespective of the source of development. Major efforts are essential to update the CPGs according to the principles of evidence based medicine.

Awareness and care seeking pattern for symptoms associated with endometrial carcinoma among postmenopausal women in the district of Colombo: a cross-sectional study

Introduction: Variations in endometrial carcinoma awareness among postmenopausal women may explain the variations in care seeking pattern for symptoms associated with endometrial carcinoma. Objectives: To describe the awareness and care seeking pattern for symptoms associated with endometrial carcinoma among postmenopausal women in the district of Colomb Methods: A community based descriptive cross sectional study was conducted among 1168 postmenopausal women in the district of Colombo, using multistage cluster sampling technique. A pre-tested interviewer administered questionnaire was used. Descriptive statistics were used to describe the awareness and care seeking pattern. Results: Of the sample, 83.6% (95% CI: 81.5-85.7, n=977) had heard about endometrial carcinoma. About 56% of women (n=654) were aware that postmenopausal bleeding was a suggestive symptom of endometrial carcinoma. Only 24.0% (n=280) knew that never conceived was a risk factor, 20.6% and 20.9% knew that physical inactivity and obesity were risk factors respectively and 28.0% knew that hormone replacement therapy was a risk factor, for endometrial carcinoma. Of the women, 26.6% (n=311) had experienced some gynaecological symptoms similar to symptoms of endometrial carcinoma during their postmenopausal period. Majority of them had disclosed to the children (n= 155, 49.8%) about the symptoms, 70.7% (n=220) had sought treatment, and the most common reason for seeking treatment was physical discomfort (n=83, 37.8%). A majority had gone to the government hospital (n=75, 34%) to get treatment. Conclusions: Low awareness of common symptoms, risk

Association of Poor Social Support and Financial Insecurity with Psychological Distress of Chronic Kidney Disease Patients Attending National Nephrology Unit in Sri Lanka.

BACKGROUND: Chronic kidney disease (CKD) is associated with high morbidity and mortality. Hence, CKD patients are often in chronic psychological distress. The objective of the study was to describe factors associated with psychological distress of CKD patients attending National Nephrology Unit. METHODS: A descriptive cross-sectional study was conducted among 382 CKD patients above 18 years of age applying systematic sampling. The data was collected using self-administered questionnaires to assess the psychological distress (GHQ-12), social support (SSQ6), coping strategies (BRIEFCOPE), pain (0 to 10 numeric pain rating scale), and physical role limitation due to ill health (SF36QOL). Sociodemographic and disease-related data were collected using an interviewer administered questionnaire and a data extraction sheet. Multiple logistic regression was applied for determining the associated factors. The results were expressed as adjusted odds ratio (AOR) and 95% confidence intervals (95% CI). RESULTS: Percentage of psychological distress was 55.2% (95% CI: 48.4% to 62%). Poor social support (AOR = 1.81, 95% CI: 1.14-2.88), low satisfaction with the social support received (AOR = 4.14, 95% CI: 1.59-10.78), stages IV and V of CKD (AOR = 2.67, 95% CI: 1.65-4.20), presence of comorbidities (AOR = 2.38, 95% CI: 1.21-4.67), within one year of diagnosis (AOR = 2.23, 95% CI: 1.36-3.67), low monthly income (AOR = 2.26, CI: 1.26-4.06), higher out-of-pocket expenditure per month (AOR = 1.75, 95% CI: 1.75-1.99), and being a female (AOR = 2.95, 95% CI: 1.79-4.9) were significantly associated with psychological distress. CONCLUSIONS: More than half of the CKD patients were psychologically distressed. Factors such as financial and social support will be worth considering early because of their modifiability.

Prevalence and associated factors of risky sexual behaviors among undergraduate students in state universities of Western Province in Sri Lanka: a descriptive cross sectional study.

BACKGROUND: Risky sexual behaviors (RSB) are becoming an important problem all over the world. RSB are defined as behaviors leading to sexually transmitted diseases and unintended pregnancies. The objective of this study was to determine the prevalence and associated factors of RSB among undergraduate students in state universities of Western Province in Sri Lanka. METHODS: A descriptive cross sectional study was conducted on1575 second and third year undergraduates using stratified cluster sampling of the selected universities. A pretested self-administered questionnaire was used to assess socio-demographic, knowledge attitudes and behavior on reproductive health. RSB was defined as reporting of one or more following behavior/s; having more than one sexual partner, use of alcohol or inability to use condom or other contraceptive methods in sexual activities. The results were expressed as prevalence and its 95% confidence interval (CI) of RSB. Multiple logistic regression was performed ascertain the association between RSB and possible associated factors. The results were expressed as adjusted odds ratios (AOR). RESULTS: Prevalence of RSB in last 1 year and 3 months periods were 12.4%, (95% CI: 11.8-13.1) and 12.1% (95% CI: 11.5-12.7) respectively. The significantly associated risk factors for RSB were, attended night clubs in last month (AOR = 3.58, 95% CI: 1.29-9.88), alcohol consumption within last 3 months (AOR = 2.67, 95% CI: 1.87-3.80) and good knowledge on condoms (AOR = 2.82, 95% CI: 1.94-4.10). Those who thought religion was very important to their lives (AOR = 0.68, 95% CI: 0.48-0.95) was a protective factor. CONCLUSIONS: Alcohol consumption and attending night clubs were associated with RSB. Necessary measures should be taken to reduce risk behaviors within university to reduce RSB.

Sedentary behavior during leisure time, physical activity and dietary habits as risk factors of overweight among school children aged 14-15 years: case control study.

OBJECTIVE: To determine the risk of sedentary behavior during leisure time, physical activity and dietary habits on overweight among school children aged 14-15 years in Kalutara District, Sri Lanka. RESULTS: School based case-control study was conducted during September to November 2013 including 176 overweight children as cases and 704 children with normal weight as controls. Cases were defined as body mass index for age and sex of ≥ +1SD and controls as those in the range of -2SD to +1SD. Validated instruments were used for data collection. Multiple logistic regression was applied and results were expressed with adjusted odds ratios (OR) and 95% confidence intervals (CI). Risk factors for overweight were insufficient physical activity (OR 1.6, 95% CI 1.1-2.4), watching video/DVD ≥ 2 h (OR 3.1, 95% CI 1.8-5.3), watching television ≥ 2 h (OR 2.6, 95% CI 1.7-3.8) and doing homework ≥ 2 h, (OR 1.8, 95% CI 1.2-2.7). Consuming meat (OR 1.9, 95% CI 1.2-3.1), fish or other sea foods (OR 1.6, 95% CI 1.1-2.8), fast food/fried rice/oily foods (OR 1.9, 95% CI 1.2-2.9), carbonated drinks or sugary drinks (OR 1.9, 95% CI 1.2-2.8), sweets, cookies or ice cream (OR 1.8, 95% CI 1.2-2.9) were dietary risk factors for overweight. Consuming legumes and seeds (OR 0.50, 95% CI 0.3-0.7), vegetables and fruits (OR 0.6, 95% CI 0.4-0.9) were protective factors for overweight.

Micronutrient status and its relationship with nutritional status in preschool children in urban Sri Lanka.

OBJECTIVE: To assess the micronutrient status and its relationship with nutritional status in preschool children. METHODS: In a cross sectional study, anthropometric data and fasting blood samples were obtained from 340 children attending preschool in urban Sri Lanka. Serum concentrations of vitamin D, parathyroid hormone, vitamin A, zinc and haemoglobin were measured. Z-scores of anthropometric indices of height-for-age, weight-for-age and weight-for-height were computed to evaluate the nutritional status. RESULTS: Prevalence of stunting, underweight, wasting and anaemia among children were 7.1%, 16.9%, 21.2% and 7.4%, respectively. Deficiencies of zinc and vitamin A occurred among 67% and 38% of children, respectively. Vitamin D deficiency (<10 ng/mL) and insufficiency (10-20 ng/mL) occurred in 5.0% and 29.1% of children, respectively, and12% had parathyroid hormone levels indicative of hypocalcaemia. Nutritional status was significantly correlated (p<0.05) with vitamin D status [height-for-age (r=0.10), weight-for-age (r=-0.18), weight-for-height (r=-0.12)], and with haemoglobin status [weight-for-age (r=0.11)]. Zinc and vitamin A levels were lower in severe stunting compared with normal height (p<0.05). Significant correlations (p<0.05) were observed between vitamin D and parathyroid hormone (r=-0.12) and between haemoglobin and vitamin A (r=0.01), zinc (r=0.02) and vitamin D (r=0.02) levels. CONCLUSIONS: In the surveyed population, zinc deficiency was high and to a lesser degree vitamin A deficiency and vitamin D insufficiency prevailed. The nutritional status of the children was related to vitamin D status and with haemoglobin status. Zinc and vitamin A levels were low in children with severe stunting. Vitamins A, D and zinc levels were associated with haemoglobin status.

Quality of reporting clinical trials published in five leading Sri Lankan medical journals.

OBJECTIVES: To assess the quality of reporting of clinical trials published in five leading Sri Lankan medical journals. METHODS: Six medical journals were hand searched for clinical trials published from 1982 to 2011. Eligible criteria were all randomized and non-randomized clinical trials conducted in humans. A checklist was developed based on CONSORT and TREND recommendations. Each study was independently evaluated by two reviewers. Outcome measures were presence of checklist items in published reports. RESULTS: Fifteen randomized and 24 non-randomized parallel group trials from 724 studies in five journals met the inclusion criteria. Out of 39 trials, 39 (97%) clearly described the objectives, 16 (41%) defined the periods of recruitment, 7 (18%) reported how sample size was determined, 10 (25.6%) reported the methods to enhance the quality of measurements, 20 (51%) reported baseline demographic and clinical characteristics of each group, 4 (10%) showed flow diagrams, 23 (69%) reported statistical methods used to compare groups for primary outcomes, 21 (54%) reported effect size, 4 (10%) reported its precision, and 20 (51%) interpreted the results in the context of current evidence, and 5 (13%) described the generalizability of the findings. Of the 15 randomized trials, only one (7%) reported sequence generation, 5 (33%) allocation concealment, 9 (60%) reported blinding status of participants or investigators, and 2 (13%) reported intention to treat analysis. CONCLUSIONS: Reporting of several essential recommendations remained suboptimal. Education and training of trial methods and awareness of the CONSORT and TREND statements and more attention to the quality of reporting may improve matters.

Factor structure and reliability of the 30-item Sinhala version of General Health Questionnaire (GHQ).

OBJECTIVE: To determine the factor structure and the reliability of the Sinhala version of the General Health Questionnaire-30 (GHQ-30). METHODS: This was a descriptive study including 368 patients with in the age range of 18-75 years, attending the Out Patient Department (OPD) of Colombo North Teaching Hospital, Ragama, Sri Lanka during the period between June 2009 and September 2010. Sinhala version of GHQ-30 was given to be completed by the participants. Each item of the GHQ was rated on a four-point scale (0-1-2-3). Factor analyses were performed by applying Generalized Least Squares method using oblimin rotation. The internal consistency was assessed by calculating Cronbach's α coefficient. RESULTS: Median age of the study population was 32.5 years (Inter quartile range [IQR]=21 years) and the median GHQ score was 9 (IQR 7). GHQ-30 produced a five factor solution which accounted for 51.6% of the total variance (TV). Factor I (Depression) accounted for 38% of TV, Factor II (Loss of confidence) 5%, Factor III (Insomnia) 4%, Factor IV (Social dysfunction) 2.7% and Factor V (Anxiety) 2%. The Cronbach's alpha coefficients of GHQ-30 was 0.94 indicating satisfactory internal consistency. CONCLUSIONS: GHQ-30 comprises five factors/subscales and it displayed adequate reliability for assessment of psychiatric disorders among Sinhala speaking primary care attendees in Sri Lanka.

Completeness of consent forms in research proposals submitted to an ethics review committee.

This was a descriptive cross-sectional study which analysed the consent forms submitted to the ethics review committee at the faculty of medicine of the University of Kelaniya, Sri Lanka, between January 2007 and December 2008. Of the 145 consent forms reviewed, 94.5% (137) explained the purpose of the study, 77% (111) included a statement that participation was voluntary, 44% (64) stated that refusal of participation did not affect care, 65.5% (95) mentioned the ability to withdraw consent at any time, 79% (115) that confidentiality of records would be maintained and 45.5% (66) that further clarifications were possible. Thirty nine (75%) of 52 eligible consent forms described the potential benefits and 19% (18) of 93 consent forms explained that there were no benefits to the participants. Twenty eight (59%) of 47 eligible consent forms described possible risks or discomfort to patients and 30% (29) of 98 consent forms explained that there were no risks to the participants. In conclusion, essential elements of the consent forms were missing in this study. It is recommended that a checklist of compulsory elements to include on forms be used before proposals are submitted to an ethics review committee.

Sleep deprivation, physical activity and low income are risk factors for inadequate weight gain during pregnancy: a cohort study.

AIM: To determine the possible risk factors for inadequate gestational weight gain. METHODS: A population-based cohort study was carried out in Sri Lanka from May 2001 to April 2002. Pregnant women were recruited on or before 16 weeks' gestation and followed up until delivery; the sample size was 710. Trimester-specific exposure status and potential confounding factors were gathered on average at the 12th, 28th and 36th weeks of gestation. Maternal weight was measured at the first antenatal clinic visit and at delivery. Inadequate weight gain was defined as weight gain below the Institute of Medicine recommendations in 2009. Multiple logistic regression was applied and the results were expressed as odds ratios (OR) and 95% confidence intervals (95% CI). RESULTS: The risk factors for inadequate weight gain were low per-capita monthly income (OR 1.63, 95% CI 1.03, 2.58), multiparity (OR 1.96, 95% CI 1.34, 2.87), sleeping <8 h/day during the second, third, or both second and third trimesters (OR 1.60, 95% CI 1.05, 2.46), standing and walking ≥5 h/day during the second trimester (OR 1.50, 95% CI 1.04, 2.15), and the newborn being of the male sex (OR 1.50, 95% CI 1.04, 2.16), controlling for the effect of body mass index and gestational age. CONCLUSIONS: Risk factors for inadequate gestational weight gain were low income, being multiparous, sleep deprivation, physical activity in terms of standing and walking, and the male sex of baby.

Maternal haemoglobin level at booking visit and its effect on adverse pregnancy outcome.

AIMS: To determine the effect of maternal haemoglobin levels at booking visit on pregnancy outcome. METHODS: A prospective study was carried out at two Medical Officer of Health areas in a district in Sri Lanka, including 817 pregnant mothers who were followed up until delivery. Maternal haemoglobin level was measured according to specified standard protocols. The reliability and the accuracy of haemoglobin measurements were assessed and were found to be satisfactory. Pregnancy outcome was defined in terms of miscarriage, maternal morbidities, preterm birth (PTB), low birth weight (LBW) and small for gestational age (SGA) infants. Potential confounding factors for each pregnancy outcome were also assessed. Multiple logistic regression was applied and the results were expressed as odds ratios (OR) and 95% confidence intervals (95% CI). RESULTS: The prevalence of anaemia (Hb < 11 g/dL) was 7.1% (95% CI 5.4-8.9%). Anaemia during pregnancy was not significantly associated with any of the pregnancy outcomes studied. Reference range for haemoglobin measurements among mothers with normal pregnancy outcome was 10.4-13.9 g/dL. Haemoglobin level of >13.9 g/dL had a significant adverse association with maternal morbidities (OR 3.0; 95% CI 1.03-8.90) and LBW (OR 3.95; 95% CI 1.30-12.0) compared with the reference range. CONCLUSIONS: Although anaemia during pregnancy was not adversely associated with any of the pregnancy outcomes, Hb level of >13.9 g/dL was adversely associated with maternal morbidities and LBW.

Maternal sleep deprivation, sedentary lifestyle and cooking smoke: Risk factors for miscarriage: A case control study.

AIMS: To determine risk factors for miscarriage. METHODS: A case control study was carried out at the gynaecological wards and antenatal clinics of the De Soysa Maternity Hospital in Sri Lanka. A case was defined as that of mothers with a confirmed diagnosis of partial or full expulsion of the fetus during the first 28 weeks of gestation. Controls comprised ante-natal clinic attendees whose period of gestation was <28 weeks and carrying a viable fetus. Two hundred and thirty cases and 504 controls were selected. A pre-tested interviewer-administered questionnaire and modified life events inventory were used to gather data. Multivariate logistic regression was applied separately for first and second trimester miscarriages and the results were expressed as odds ratios (OR) and as 95% confidence intervals (95% CI). RESULTS: Sleeping < or =8 h/day (OR:3.80, 95% CI:1.01-14.3) was found to be a risk factor for first trimester miscarriage controlling for the effect of period of gestation. Sleeping < or =8 h/day (OR:2.04, 95% CI:1.24-3.37), standing < or =3 h/day (OR:1.83, 95% CI:1.08-3.10), exposure to cooking smoke (OR:3.83, 95% CI:1.50-9.90) and physical trauma during the pregnancy (OR:43.2, 95% CI:4.55-411.4) were found to be risk factors for second trimester miscarriage controlling for the effect of period of gestation. CONCLUSIONS: Sleep deprivation, a sedentary lifestyle, exposure to cooking smoke and physical trauma during pregnancy were risk factors for miscarriage. Most of the risk factors are therefore modifiable.