A multicenter prospective randomized controlled trial investigating the effects of combustion-free nicotine alternatives on cardiovascular risk factors and metabolic parameters in individuals with type 2 diabetes who smoke: the DiaSmokeFree study protocol.

Stopping smoking is crucial for public health and especially for individuals with diabetes. Combustion-free nicotine alternatives like e-cigarettes and heated tobacco products are increasingly being used as substitutes for conventional cigarettes, contributing to the decline in smoking prevalence. However, there is limited information about the long-term health impact of those products in patients with diabetes. This randomized controlled trial aims to investigate whether switching from conventional cigarettes to combustion-free nicotine alternatives will lead to a measurable improvement in cardiovascular risk factors and metabolic parameters over a period of 2 years in smokers with type 2 diabetes. The multicenter study will be conducted in seven sites across four countries. A total of 576 smokers with type 2 diabetes will be randomly assigned (1:2 ratio) to either standard of care with brief cessation advice (Control Arm) or combustion-free nicotine alternatives use (Intervention Arm). The primary end point is the change in the proportion of patients with metabolic syndrome between baseline and the 2-year follow-up. Additionally, the study will analyze the absolute change in the sum of the individual factors of metabolic syndrome at each study time point. Patient recruitment has started in September 2021 and enrollment is expected to be completed by December 2023. Results will be reported in 2026. This study may provide valuable insights into cardiovascular and metabolic health benefits or risks associated with using combustion-free nicotine alternatives for individuals with type 2 diabetes who are seeking alternatives to tobacco cigarette smoking. The study protocol, informed consent forms, and relevant documents were approved by seven ethical review boards. Study results will be disseminated through articles published in high-quality, peer-reviewed journals and presentations at conferences.

Predictive analytics in smart healthcare for child mortality prediction using a machine learning approach.

In developing countries, child health and restraining under-five child mortality are one of the fundamental concerns. UNICEF adopted sustainable development goal 3 (SDG3) to reduce the under-five child mortality rate globally to 25 deaths per 1,000 live births. The under-five mortality rate is 69 deaths per 1,000 live child-births in Pakistan as reported by the Demographic and Health Survey (2018). Predictive analytics has the power to transform the healthcare industry, personalizing care for every individual. Pakistan Demographic Health Survey (2017-2018), the publicly available dataset, is used in this study and multiple imputation methods are adopted for the treatment of missing values. The information gain, a feature selection method, ranked the information-rich features and examine their impact on child mortality prediction. The synthetic minority over-sampling method (SMOTE) balanced the training dataset, and four supervised machine learning classifiers have been used, namely the decision tree classifier, random forest classifier, naive Bayes classifier, and extreme gradient boosting classifier. For comparative analysis, accuracy, precision, recall, and F1-score have been used. Eventually, a predictive analytics framework is built that predicts whether the child is alive or dead. The number under-five children in a household, preceding birth interval, family members, mother age, age of mother at first birth, antenatal care visits, breastfeeding, child size at birth, and place of delivery were found to be critical risk factors for child mortality. The random forest classifier performed efficiently and predicted under-five child mortality with accuracy (93.8%), precision (0.964), recall (0.971), and F1-score (0.967). The findings could greatly assist child health intervention programs in decision-making.

The psychological impact of COVID-19 on healthcare workers in Pakistan.

INTRODUCTION: The COVID-19 pandemic has challenged healthcare facilities and healthcare professionals' stamina and wellbeing. This study examines the psychological impact of COVID-19 on healthcare professionals. METHODS: This analytical cross-sectional study was conducted in July 2020 after institutional review board approval at a tertiary care institution in Lahore, Pakistan. A total of 175 healthcare workers participated following an online Depression, Anxiety and Stress Scale-21 (DASS-21) questionnaire invitation and 41 were excluded following pre-existing mental health conditions. Data was analysed using MS Excel and SPSS Amos 23. Chi-squared test and regression were applied for comparison and impact of confounding variables respectively (p<0.05 was considered significant). RESULTS: Out of 134, 66 (49%) were doctors, 24 (18%) were nurses and 44 (33%) were non-medical professionals. Ninety-five (70%) with age 21-30 years. Male to female ratio was 2:1. Overall mean depression score accounted for 6.89 ± 6.64; anxiety score was 7.28 ± 6.74 and stress score was 8.83 ± 6.93. Mild depression, anxiety and stress was noted in 21 (15.6%), eight (6%) and 27 (20.1%) healthcare workers, respectively. A statistically significant difference (p<0.05) was observed among healthcare workers for depression, anxiety and stress. CONCLUSION: This study demonstrated considerable impact of COVID-19 on mental health of healthcare workers. A well-structured targeted mental health support programme is needed urgently to support and reduce the long-term impact on healthcare workers' mental health and wellbeing.

International randomised controlled trial evaluating metabolic syndrome in type 2 diabetic cigarette smokers following switching to combustion-free nicotine delivery systems: the DIASMOKE protocol.

INTRODUCTION: Reducing exposure to cigarette smoke is an imperative for public health and for patients with diabetes. Increasingly, combustion-free nicotine delivery systems (C-F NDS) such as e-cigarettes and heated tobacco products are substituting conventional cigarettes and accelerating the downward trends in smoking prevalence. However, there is limited information about the long-term health impact in patients with diabetes who use C-F NDS. This randomised trial of type 2 diabetic cigarette smokers will test the hypothesis that following a switch from conventional cigarettes to C-F NDS a measurable improvement in metabolic syndrome (MetS) factors will be shown over the course of 2 years. METHODS AND ANALYSIS: The study is multicentre and thus will take place in five locations in four countries in an ambulatory setting. A total of 576 patients with diabetes will be randomised (1:2 ratio) to either a control arm (Study Arm A), in which they will be offered referral to smoking cessation programmes or to an intervention arm (Study Arm B) assigned to C-F NDS use. Participants will be at least 23 years old and of any gender. Patient recruitment will start in February 2021 and is expected to be completed by December 2021. Primary outcome measures include fasting plasma glucose, blood pressure, triglycerides, high-density lipoprotein and waist circumference, while secondary feature absolute change in the sum of the individual factors of MetS and change in each individual factor of MetS measured at each study time point. ETHICS AND DISSEMINATION: The approval of research ethics committee (REC) regarding the trial protocol, informed consent forms and other relevant documents is required to commence the study. Substantial amendments to the study protocol cannot be implemented until the REC grants a favourable opinion. The results of the study are intended to be published as articles in high quality peer-reviewed journals and disseminated through conference papers. TRIAL REGISTRATION NUMBER: NCT04231838. Pre-results stage.

Bradyarrhythmia secondary to vagus nerve stimulator 7 years after placement.

We present a case of a 38-year-old man with a previous medical history of asthma and refractory epilepsy requiring vagal nerve stimulator (VNS) placement 7 years prior to the presentation who was found to be in atrial fibrillation with a rapid ventricular response during a preoperative evaluation, which prompted transoesophageal echocardiography and subsequent cardioversion. In preparation for cardioversion, the VNS was turned off and the patient was cardioverted to normal sinus rhythm. Following cardioversion, the VNS was activated again. During recovery, the patient was experiencing several episodes of first-degree and second-degree Mobitz type-II atrioventricular (AV) block. In response, the VNS was deactivated indefinitely. On interrogation of a loop recorder 2 weeks after discharge, the patient did not have any further evidence of AV conduction delay.

Clinical Characteristics of 47 Death Cases With COVID-19: A Retrospective Study at a Tertiary Center in Lahore.

Introduction Coronavirus disease 2019 (COVID-19) presents with a wide spectrum of symptoms, ranging from patients being asymptomatic to having life-threatening acute respiratory distress syndrome (ARDS). COVID-19 emerged as a pandemic and has led to multiple causalities worldwide. A better understanding of the clinical characteristics of the COVID-19 patients and their disease course will aid in better management of these patients and hence may positively impact their outcomes as well. Methodology This was a retrospective observational study conducted from April 15, 2020, to August 31, 2020, after gaining institutional review board approval at the University of Lahore Teaching Hospital, Lahore, Pakistan. A total of 47 patients with severe disease who had died due to COVID-19 during this period were enrolled by the consecutive method. Patients were evaluated for their epidemiological, biochemical, clinical, and radiological features. The modified Radiographic Assessment of Lung Edema (mRALE) score was used to calculate the extent of alveolar opacities and percentages of lung involvement in chest radiographs. Furthermore, patients' management plans were also evaluated. Data were analyzed using SPSS Statistics version 23 (IBM, Armonk, NY). Results The mean age of the patients was 61.53 ±13.35 years. The male-to-female ratio was 2:1, and the mean BMI was 28.05 ±3.52 kg/m2. Diabetes was the most prevalent comorbidity among the patients (32, 68.1%), followed by hypertension (six, 12.8%), ischemic heart disease (five, 10.6%), and chronic kidney disease (four, 8.5%) respectively. The predominant symptom observed among patients was cough (95%), followed by shortness of breath (93%), fever (63%), sputum (23%), and gastrointestinal symptoms (6.4%). The mean D-dimer was 1,567.13 ±1,903.77 ng/mL, mean ferritin was 1,730.34 ±1,382.35 ng/mL, mean C-reactive protein (CRP) was 202.59 ±104.97 mg/dl, and the mean neutrophil-to-lymphocyte ratio was 10.50 ±9.58. Bilateral lung involvement was seen among 40 (85.11%) patients whereas unilateral right lung involvement was reported in three (6.38%) and unilateral left lung involvement in four (8.51%) respectively. The mean mRALE score for bilateral lung involvement was 18.78 ±4.89. The mean area radiologically involved in bilateral lung fields was 72.12 ±18.45%, followed by unilateral right lung involvement of 67.87 ±15.97%, and unilateral left lung involvement of 61.38 ±17.95% in the cohort respectively. The most common type of radiological pathology was diffuse ground-glass opacities, which was observed in 18 (38%) patients. Most patients received antibiotics (39, 63.83%), while nine (19%) received tocilizumab, four (8.5%) had antiviral therapy, and three (6.4%) were given plasma treatment. All patients received glucocorticoids and anticoagulation. The most common cause of death was ARDS, which was observed in 12 (25.5%) patients. Conclusion This study significantly demonstrated that most cases were males above 50 years of age with chronic medical comorbidities of diabetes, hypertension, and ischemic heart disease. COVID-19 has a predilection for multisystem involvement leading to mortality. In addition, elevated D-dimer and neutrophil-to-lymphocyte ratio may be indicative of a poor prognosis. A combination of antimicrobials had no positive impact on the outcomes in this cohort. It is difficult to predict the efficacy of tocilizumab and remdesivir as only a few patients in the cohort received these drugs.

Correlation between Microalbuminuria and Hypertension in Type 2 Diabetic Patients.

BACKGROUND: Hypertension is commonly found in patients with Diabetic Kidney Disease (DKD). Microalbuminuria is the first clinical sign of involvement of kidneys in patients with type 2 diabetes. Uncontrolled hypertension induces a higher risk of cardiovascular events, including death, increasing proteinuria and progression to kidney disease. OBJECTIVES: To determine the correlation between microalbuminuria and hypertension and their association with other risk factors in type 2 diabetic patients. METHODS: One hundred and thirteen type 2 diabetic patients attending the diabetic clinic of Shaikh Zayed Postgraduate Medical Institute, Lahore, Pakistan were screened for microalbuminuria and raised blood pressure. The study was conducted from November 2012 to June 2013. RESULTS: Patients were divided into two groups. Group 1, those with normoalbuminuria (n=63) and Group 2, those having microalbuminuria (n=50). Group 2 patients showed higher blood pressure values as compared to Group 1. The results were statistically significant and showed poor glycemic control as a contributing risk factor. CONCLUSION: The study concluded that there is high frequency of hypertension among type 2 diabetics but still much higher among those having microalbuminuria. So, early recognition of renal dysfunction through detection of microalbuminuria and to start treatment without any delay will confer future protection from end stage renal disease as well as hypertension and its complications in type 2 diabetic patients.

Prevalence of microvascular complications in newly diagnosed patients with type 2 diabetes.

BACKGROUND & OBJECTIVE: Microvascular complications are the major outcome of type 2 Diabetes Mellitus progression, which reduce the quality of life, incur heavy economic burdens to the health care system and increase diabetic mortality. The aims of this study were to assess the prevalence of microvascular complications among newly diagnosed type 2 diabetic patients and to analyze the association between these complications and poor glycemic control. METHODS: This cross sectional hospital based study was carried out in Diabetic Clinic of Shaikh Zayed Postgraduate Medical Institute, Lahore Pakistan. The study was conducted from November 2011 to November 2012 among newly diagnosed type 2 diabetic patients. Relevant information of all patients was recorded with the help of a proforma. They were investigated for retinopathy, nephropathy and neuropathy. RESULTS: We have divided the patients into two groups: Group I with good glycemic control (HbA1c <6.5) and group II with poor glycemic control (HbA1c >6.5). In group II microvascular complications were 89.8%. Neuropathy, nephropathy and retinopathy were present in 68.5%, 56.2% and 31.4% respectively. These similar percentages in Group I were 50%, 0% and 31% respectively and are significantly lower. CONCLUSION: The study showed that even in newly diagnosed type 2 diabetic patients who had poor glycemic control, frequency of microvascular complications is much higher as compared to those who had average glycemic control. Thus tight glycemic control does count even in newly diagnosed type 2 diabetics to prevent and minimize the occurrence of complications.

First insulinization with basal insulin in patients with Type 2 diabetes in a real-world setting in Asia.

BACKGROUND: The First Basal Insulin Evaluation (FINE) Asia study is a multinational, prospective, observational study of insulin-naïve Type 2 diabetes mellitus (T2DM) patients in Asia, uncontrolled (A1c ≥ 8%) on oral hypoglycemic agents, designed to evaluate the impact of basal insulin initiation. METHODS: Basal insulin was initiated with or without concomitant oral therapy and doses were adjusted individually. All treatment choices, including the decision to initiate insulin, were at the physician's discretion to reflect real-life practice. RESULTS: Patients (n=2679) from 11 Asian countries were enrolled (mean [±SD] duration of diabetes 9.3±6.5 years; weight 68.1±12.7 kg; A1c 9.8 ± 1.6%). After 6 months of basal insulin (NPH insulin, insulin glargine, or insulin detemir), A1c decreased to 7.7±1.4%; 33.7% patients reached A1c <7%. Fasting blood glucose (FBG) decreased from 11.7±3.6 to 7.2±2.5 mmol/L and 36.8% of patients reached FBG <6.1 mmol/L. The mean daily insulin dose prescribed increased marginally from 0.18 to 0.23 U/kg per day at baseline to 0.22-0.24 U/kg per day at Month 6. Mean changes in body weight and reported rates of hypoglycemia were low over the duration of the study. CONCLUSIONS: Initiation of insulin therapy is still being delayed by approximately 9 years, resulting in many Asian patients developing severe hyperglycemia. Initiating insulin treatment with basal insulin was effective and safe in Asian T2DM patients in a real-world setting, but insulin needs may differ from those in Western countries.

Fixed drug eruption: topical provocation and subsequent phenomena.

OBJECTIVE: To determine the usefulness of topical provocation in detecting the incriminated drug causing fixed eruption. DESIGN: Quasi-experimental study. PLACE AND DURATION OF STUDY: Department of Dermatology, Shaikh Zayed FPGMI, Lahore, from November 2002 to December 2005. PATIENTS AND METHODS: Three hundred and five, clinically diagnosed cases of Fixed Drug Eruption (FDE) of either gender and of any age were subjected to topical provocation with different drugs by using concentration of 1% (n=203), 2% (n=210) and 5% (n=235) in white soft paraffin. Drug ointment of one strength was applied one at a time on normal skin of flexor surface of right or left forearm. The effects of tests on involved and uninvolved skin were observed for 48 hours. The changes in lesions like erythema, hyperpigmentation, itching, burning or appearance of new lesion were considered a positive response. In case of no change, the patients (n=5) were subjected to oral provocation test, by giving half to full therapeutic dose of the suspected drug depending upon the severity of the initial attack. A patient who exhibited see-sawing phenomenon with 5% metamizole TPT was given oral challenge with same drug. Control topical tests were repeated in equal number of normal persons with various drug ointments and in patients of FDE with white soft paraffin on normal and affected skin. RESULTS: One hundred and thirty-seven patients were males and one hundred and sixty-eight patients were females. Maximum number of patients belonged to third decade. With 1% drug preparations 12 out of 316, with 2% drug preparations 28 out of 422 and with 5% drug preparations, 312 out of 523 TPTs were positive. The comparison revealed a highly significant association (Chi-square 448.1 and p < 0.000) among various strengths of preparations and positive response. Sulphamethoxazole was found to be the most commonly incriminated cause of FDE applied in 5% concentration yielded sensitivity rate of 91% compared to 4% with lower concentrations. Positive patch test was also observed with oxytetracycline. Five patients who were given oral provocation with different drugs were found to be positive to tinidazole, dapsone, propylphenazone, belladonna and phenobarbitone. Interesting phenomena like earlier reactivation of lesion situated distal to site of application of preparation, marching, see-sawing (with oral metamizole) and lightening observed, are not yet reported in literature. CONCLUSION: Topical provocation test with 5% drug concentration applied on normal skin of patient with FDE is a possible first line investigation in finding the incriminated drug.

Frequency of anti-HCV antibodies in patients with lichen planus.

OBJECTIVE: To determine the frequency of anti-HCV antibodies, identify risk factors associated with HCV infection and to screen asymptomatic carriers in patients with lichen planus. DESIGN: A prospective study. PLACE AND DURATION OF STUDY: This study was carried out in the out patient department of Dermatology, Shaikh Zayed Hospital, Lahore, from October, 1999 to September, 2001. SUBJECTS AND METHODS: A total of 184 clinically diagnosed cases of lichen planus (LP) were selected for the study. Blood samples of all the patients were tested for anti hepatitis C virus antibodies (anti-HCV Ab). Polymerase chain reaction for hepatitis C virus was done in patients with positive anti-HCV Ab. Transcutaneous liver biopsy was performed in 7 patients with positive HCV-RNA. The histopathological results were evaluated using validated Metavir and Knodell scoring systems. RESULTS: Out of 184 LP patients, 43 (23.4%) were anti-HCV antibodies positive. Females were predominantly affected and male to female ratio was 1:5.1. Maximum positivity for anti-HCV was observed in age group 31-40 years (39.53%) followed by 41-50 years (25.58%). Eighty-one percent patients had history of dental treatment and 63% had received multiple injections for various ailments. Forty percent patients had family history of jaundice while 26% had jaundice in the past. Ten out of 16 anti-HCV antibody positive patients, checked for HCV-RNA, had high levels of virus in blood. Transcutaneous liver biopsy done in 7 patients revealed underlying liver disease at various stages. Four patients treated with alpha-interferon and ribazole therapy for liver disease, showed marked improvement in their skin disease. CONCLUSION: A high prevalence of HCV infection was detected in patients with lichen planus. Patients with lichen planus should be screened for HCV carrier state.

Prevalence of hepatitis C in patients on maintenance haemodialysis.

OBJECTIVE: To find the prevalence of hepatitis C in patients on maintenance haemodialysis. DESIGN: A case control study. PLACE AND DURATION OF STUDY: Haemodialysis unit at Sheikh Zayed Postgraduate Medical Institute, Lahore, Pakistan in December 1999. PATIENTS AND METHODS: Fifty patients who were on maintenance haemodialysis were screened for anti HCV antibody. Fifty normal individuals who did not have any identifiable risk factors were also screened for anti HCV antibody. The relative risk and prevalence was calculated for the patients on maintenance haemodialysis. RESULTS: Sixty-eight percent of the patients on maintenance haemodialysis were found to be positive for anti HCV antibody. Prevalence in normal individuals was 10 percent and relative risk for the patients on maintenance haemodialysis was 6.8. CONCLUSION: Hepatitis-C is endemic among patients on maintenance haemodialysis and prevalence is much higher in developing countries as compared to developed world.