Sushil Garg - University of Minnesota (original) (raw)

Papers by Sushil Garg

Aim We did a population-based cross-sectional study to investigate the prevalence and risk factor... more Aim We did a population-based cross-sectional study to investigate the prevalence and risk factors of gastroesophageal reflux disease (GERD) in a high altitude area. Methods An observational study using a validated questionnaire consisting of demographic, lifestyle and dietary characteristics was administered in an interview based format by two clinicians on a sample of adult population residing in urban area and rural high altitude areas of Ladakh. Presence of GERD was defined as a score of ≥4 using a previously validated symptom score based on the severity and frequency of heartburn and regurgitation. Other factors studied were body mass index (BMI), oxygen saturation levels by pulse oximetry and serum lipid profile. A multivariate analysis was done to find out risk factors for symptomatic GERD. Results Of the 905 subjects analyzed, there were 399 (44.1%) men; 469 (51.8%) were from rural background and 722 (79.8%) lived in areas 3,000 m above sea level. Symptomatic GERD was present in 169 (18.7%) subjects. Regurgitation occurred once a week in 34.8% and heartburn occurred in 42.9% of subjects. Sixteen (9.5%) had moderate-severe disease activity while 153 (90.5%) had mild disease. Three hundred and eighty-eight (42.7%) and 315 (34.8%) subjects had symptom of heartburn and regurgitation (at least once a week), respectively. On multivariate analysis, risk factors for GERD were age ≤50 years (OR: 1.508, 95% CI: 1.028-2.213), sedentary lifestyle (OR: 2.78, 95% CI: 1.016-7.638), lower intake of salt tea (OR: 1.663, 95% CI: 1.014-2.726); whereas the protective factors were no intake of meat (OR: 0.841, 95% CI: 0.715-0.990), intake of fresh fruits ≥1/week (OR: 0.631, 95% CI: 0.409-0.973), and serum LDL ≤150 mg/dL (OR: 0.435, 95% CI: 0.218-0.868). Conclusion This population-based study in a high altitude area in India suggests a high prevalence (18.7%) of GERD. A younger age group, sedentary lifestyle, serum LDL >150 mg/dL, high consumption of meat, low consumption of salted tea and low consumption of fresh fruits were significant risk factors for development of GERD.

Estimation of appropriate sample size for prevalence surveys presents many challenges, particular... more Estimation of appropriate sample size for prevalence surveys presents many challenges, particularly when the condition is very rare or has a tendency for geographical clustering. Sample size estimate for prevalence studies is a function of expected prevalence and precision for a given level of confidence expressed by the z statistic. Choice of the appropriate values for these variables is sometimes not straight-forward. Certain other situations do not fulfil the assumptions made in the conventional equation and present a special challenge. These situations include, but are not limited to, smaller population size in relation to sample size, sampling technique or missing data. This paper discusses practical issues in sample size estimation for prevalence studies with an objective to help clinicians and healthcare researchers make more informed decisions whether reviewing or conducting such a study.

Adalimumab is a fully human monoclonal antibody that binds tumor necrosis factor (TNF)-␣. Its eff... more Adalimumab is a fully human monoclonal antibody that binds tumor necrosis factor (TNF)-␣. Its efficacy as maintenance therapy for patients with ulcerative colitis has not been studied in a controlled, double-blind trial. METHODS: Ulcerative colitis long-term remission and maintenance with adalimumab 2 (ULTRA 2) was a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of adalimumab in induction and maintenance of clinical remission in 494 patients with moderateto-severe ulcerative colitis who received concurrent treatment with oral corticosteroids or immunosuppressants. Patients were stratified based on prior exposure to TNF-␣ antagonists (either had or had not been previously treated with anti-TNF-␣) and randomly assigned to groups given adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week or placebo. Primary end points were remission at weeks 8 and 52. RESULTS: Overall rates of clinical remission at week 8 were 16.5% on adalimumab and 9.3% on placebo (P ϭ .019); corresponding values for week 52 were 17.3% and 8.5% (P ϭ .004). Among anti-TNF-␣ naïve patients, rates of remission at week 8 were 21.3% on adalimumab and 11% on placebo (P ϭ .017); corresponding values for week 52 were 22% and 12.4% (P ϭ .029). Among patients who had previously received anti-TNF agents, rates of remission at week 8 were 9.2% on adalimumab and 6.9% on placebo (P ϭ .559); corresponding values for week 52 were 10.2% and 3% (P ϭ .039). Serious adverse events occurred in 12% of patients given adalimumab or placebo. Serious infections developed in 1.6% of patients given adalimumab and 1.9% given placebo. In the group given adalimumab, 1 patient developed squamous cell carcinoma and 1 developed gastric cancer. CONCLUSIONS: Adalimumab was safe and more effective than placebo in inducing and maintaining clinical remission in patients with moderate-to-severe ulcerative colitis who did not have an adequate response to conventional therapy with steroids or immunosuppressants.