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BACKGROUND AND AIMS: Smokeless tobacco (ST) use in South Asia is high, yet interventions to support its cessation are lacking. We tested the feasibility of delivering interventions for ST cessation in South Asia. DESIGN: We used a 2 × 2 factorial design, pilot randomized controlled trial with a duration of 26 weeks, including baseline and follow-up (6, 12 and 26 weeks) assessments. SETTING: Two primary health-care facilities each in Dhaka (Bangladesh) and Karachi (Pakistan) and a walk-in cancer screening clinic in Noida (India) took part. PARTICIPANTS: Adult daily ST users willing to make a quit attempt within 30 days. Of 392 screened, 264 participants [mean age: 35 years, standard deviation = 12.5, 140 (53%) male] were recruited between December 2020 and December 2021; 132 from Bangladesh, 44 from India and 88 from Pakistan. INTERVENTIONS: Participants were randomized to one of three treatment options [8-week support through nicotine replacement therapy (NRT, n = 66), a behavioural intervention for smokeless tobacco cessation in adults (BISCA, n = 66) or their combination (n = 66)] or the control condition of very brief advice (VBA) to quit (n = 66). MEASUREMENTS: Recruitment and retention, data completeness and feasibility of intervention delivery were evaluated. Biochemically verified abstinence from tobacco, using salivary cotinine, was measured at 26 weeks. FINDINGS: Retention rates were 94.7% at 6 weeks, dropping to 89.4% at 26 weeks. Attendance in BISCA pre-quit (100%) and quit sessions (86.3%) was high, but lower in post-quit sessions (65.9%), with variability among countries. Adherence to NRT also varied (45.5% Bangladesh, 90% India). Data completion for key variables exceeded 93% among time-points, except at 26 weeks for questions on nicotine dependence (90%), urges (89%) and saliva samples (62.7%). Among follow-up time-points, self-reported abstinence was generally higher among participants receiving BISCA and/or NRT. At 26 weeks, biochemically verified abstinence was observed among 16 (12.1%) participants receiving BISCA and 13 (9.8%) participants receiving NRT. CONCLUSIONS: This multi-country pilot randomized controlled trial of tobacco cessation among adult smokeless tobacco users in South Asia demonstrated the ability to recruit and retain participants and report abstinence, suggesting that a future definitive smokeless tobacco cessation trial is viable.
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Self-management is crucial in mitigating the impacts of a growing non-communicable disease (NCD) burden, particularly in Low and Middle-Income countries. What influences self-management in these settings, however, is poorly understood. We aimed to identify the determinants of self-management in the high NCD region of South Asia and explore how they influence self-management. A systematic mixed-studies review was conducted. Key electronic databases [MEDLINE (1946+), Embase (1974+), PsycInfo (1967+) and CINAHL (EBSCOhost)] in March 2022 (and updated in April 2023) were searched for studies on the self-management of four high-burden NCD groups: cardiovascular diseases, type 2 diabetes, chronic respiratory diseases and depression. Study characteristics and quantitative data were extracted using a structured template, and qualitative information was extracted using NVivo. Quality appraisal was done using the Mixed Methods Assessment Tool (MMAT). Quantitative findings were organised using the Commission on Social Determinants of Health (CSDH) framework and synthesised narratively, supported by effect direction plots. Qualitative findings were thematically synthesised. Both were integrated in a mixed synthesis. Forty-four studies (26 quantitative, 16 qualitative and 2 mixed-methods studies) were included, the majority of which were conducted in urban settings and among individuals with diabetes and cardiovascular diseases. Higher age, education, and income (structural determinants), health-related knowledge, social support and self-efficacy (psychosocial determinants), longer illness duration and physical comorbidity (biologic determinants), and the affordability of medicine (health-system determinants) were key determinants of self-management. Qualitative themes highlighted the role of financial adversity and the social and physical environment in shaping self-management.A complex interplay of structural and intermediary social determinants shapes self-management in South Asian settings. Multi-component, whole-systems approaches could boost self-management in these settings. Key areas include empowerment and education of patients and wider community, design and delivery of bespoke behavioural interventions and a stronger emphasis on supporting self-management in healthcare settings.
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INTRODUCTION: Illicit smokeless tobacco (ST) trade has seldom been documented despite ST use in at least 127 countries across the world. Based on non-compliance with packaging regulations, we report the proportion of illicit ST products from samples on sale in Bangladesh, India and Pakistan where 85% of global ST users reside. METHODS: We purchased unique ST products from tobacco sellers in two purposively selected administrative areas (division/district) in each of the three countries. The criteria to determine illicit ST products were based on country-specific legal requirements for ST packaging and labelling. These requirements included: 'market retail price disclosure', 'sale statement disclosure', 'pictorial health warning (PHW) pertinence', 'appropriate textual health warning' and 'using misleading descriptors (MDs)'. Non-compliance with even one of the legal requirements was considered to render the ST product illicit. RESULTS: Almost all ST products bought in Bangladesh and India were non-compliant with the local packaging requirements and hence potentially illicit, all products in Pakistan lacked desirable features. The most common feature missing was health warnings: 84% packs in Bangladesh, 93% in India, and 100% in Pakistan either did not have PHW or their sizes were too small. In Bangladesh, 61% packs carried MDs. In India and Pakistan, the proportions of such packs were 32% and 42%, respectively. CONCLUSIONS: Weak and poorly enforced ST control policies may be slowing the progress of tobacco control in South Asia. Standardised regulations are required for packaging and labelling ST. Improving compliance and reducing sale of cheap illicit products may require business licensing and market surveillance.
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INTRODUCTION: Postoperative ileus (poi) is defined as a temporary cessation of bowel movement after a surgical procedure. Cessation of bowel movement not only leads to disturbing constipation but also may lead to nausea, loss of appetite, and food intolerance. Literature reports "sham feeding" (gum-chewing) effect as an increase in chewing and saliva which enhances the gastric emptying and overall motility of gut as a cephalic phase of digestion. Therefore, we aim to assess the effect of adding gum-chewing to the conventional postoperative feeding regimen on restoring postoperative bowel function and length of stay in hospital of patients undergoing elective hip arthroplasty. METHODS AND ANALYSIS: This is a single-center, open-label, parallel design, superiority randomized-controlled trial with 2 treatment arms. The primary and secondary outcomes will be the time interval in hours from the end of surgery until the passage of flatus and the time interval in hours from the end of surgery until the passage of stool. Statistical analysis will be done using STATA software. Length of stay will be calculated by Kaplan-Meier analysis, with unadjusted comparison of groups by Mantel-Cox log rank test. Risk ratios for the time-to-become ileus free and time-to-discharge from hospital will be calculated by Cox regression modeling. P value as 0.05 or less will be taken as significant. ETHICS AND DISSEMINATION: This protocol is exempted from Ethical review at this stage however all the required approvals will be taken from the ethical review committee before starting the study. Informed consent will be taken form the patient to enroll him/her in the study. Results of the study will be disseminated to the study participants, public health, and clinical professionals. The results would also be published in a reputable international journal. TRIAL REGISTRATION: This trial is registered on clinicaltrials.gov with ID: NCT04489875. HIGHLIGHTS: Cessation of bowel movement not only leads to disturbing constipation but also may lead to nausea, loss of appetite, and food intolerance.These patients tend to have more pain scores and dissatisfaction with the surgical management and team.The "sham feeding" (gum-chewing) effect causes an increase in chewing and saliva formation and therefore enhances the gastric emptying and overall motility of gut as a cephalic phase of digestion even in non-gastro or colorectal surgeries.We hypothesize that there is an association between gum chewing and the relief from postoperative ileus in hip arthroplasty patients.
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INTRODUCTION: Knee arthroplasty also known as the total knee replacement is an orthopedic surgical procedure done to resurface the knee that has been severely damaged by arthritis. After the completion of the surgical procedure, the skin closure is done. The optimal goal of skin closure after the procedure is to promote rapid healing and an acceptable cosmetic result while minimizing the risk of infection. Skin closure after knee arthroplasty is done by using either of the two widely used sutures i.e., polypropylene (Prolene) sutures or the skin staple sutures. There are no standard guidelines as which type of the suture should be used. The present study aims to compare the incidence of surgical site infections (superficial and deep) for Prolene vs staple sutures in the bilateral knee arthroplasty patients within 6 weeks for superficial and within 90 days for deep infection. METHODS: This study will be conducted as an open blinded, parallel design, equivalence randomized controlled trial. The patients would be selected and randomized in 1:1 ratio to receive either of the two interventions i.e., Prolene or Staples. Patients undergoing unilateral or staged total knee replacement (TKR) were excluded. ANALYSIS: The normality assessment will be done using Shapiro Wilk test. Cox proportional hazard regression will be used to check the univariate and multi-variable associations of independent variables with the outcome. Both intention to treat analysis and per protocol analysis would be performed. ETHICS AND DISSEMINATION: All the required approvals will be taken from the ethical review committee. Informed consent will be taken form the patient to enroll him/her in the study. Results of the study will be disseminated to the study participants, public health and clinical professionals and would also be published in a reputable international journal.The trial is registered at clinicaltrials.gov and UIN of the registry is NCT04492852. HIGHLIGHTS: Post-operative surgical site infections and complications are a major concern nowadays.Skin staples are not widely used as compared to Prolene because they are expensive and not easily available in every hospital.There are no standard guidelines as which type of the suture should be used.The type of sutures is being selected on the orders and wishes of the surgeon at the time of skin closure.
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INTRODUCTION: Since most hip fractures are treated surgically, it is imperative to find an optimum fracture-to-surgery time to decrease the potential complications and enhance postoperative outcomes. In comparison to the vast plethora of literature available on surgical delay and its implications on mortality, very little, if any, research is available on the impact of delayed surgery on postoperative ICU admission. The primary objective of our study is to examine the factors influencing post-surgical ICU admission in order to work on preventive strategies to reduce the potential associated morbidity. MATERIAL AND METHODS: Investigators did a nested case control study in a university hospital. A case was defined as a patient who had postoperative ICU admission while controls were patients who did not have postoperative ICU admission after hip fracture surgery. The primary outcome variable was postoperative ICU admission. The exposure variable was defined as the time to surgery which was categorized into two categories; early and late; the early surgery included patients who were operated within ≤ 48 h and the late included patients who had their surgery >48 h. Information on potential confounders including age, type of the procedure and comorbidities were also obtained. Result reported in-line with STROCSS criteria. RESULTS: A total cohort of 1084 hip fracture surgeries were performed from January 2010 to December 2018. After screening for eligibility criteria, 911 patients were eligible for the final simple logistic regression analysis (48 cases and 863 controls). Our exposure variable i.e. time from admission to surgery showed no difference between cases and controls. The odds of being treated with Hemiarthroplasty among cases admitted in ICU was 2.42 times as compared to controls (aOR = 2.42; 95% C.I. 1.21-4.86). CONCLUSION: Our study did not find an association between surgical delay and post-operative ICU admission after accounting for other covariates and potential confounders.
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Background: Smokeless tobacco (ST) use is common among youth in South Asia where 85% of the world's 300 million ST users live and use the most lethal ST forms. Little is known about the impact of tobacco control policies on the youth ST uptake in those countries. We planned to conduct longitudinal surveys among secondary school students to evaluate existing tobacco control policies on ST uptake and use, and a feasibility study for that prospective, observational cohort study. Study objectives: (1) To demonstrate the feasibility of selection, recruitment and retention of schools and of study participants; (2) To assess the feasibility and acceptability of the study procedure and study tool (questionnaire); (3) To assess if the questionnaire can assess tobacco uptake and use, and the potential predictors of tobacco uptake and use of the envisaged main study. Methods and analysis: The feasibility study will be conducted in two administrative areas within each of three South Asian countries: Bangladesh, India and Pakistan. We will use both quantitative and qualitative data collection methods. Eight eligible secondary schools will be randomly selected within purposively selected sub-districts from each country. We plan to conduct one baseline and one follow up survey among secondary school students, one year apart. At each time point, data on tobacco uptake and the potential predictors will be collected from students via self-administered questionnaires. The qualitative component will be embedded into the study with each round of data collection to assess the acceptability of the study instrument (questionnaire) and data collection methods, via focus group discussions with students and semi-structured interviews with schoolteachers. Recruitment and retention rates, completeness of the questionnaires, frequencies and associations of tobacco use and explanatory variables will be reported. Data gathered from the focus group and interviews will be analysed using the framework approach.