Current Issue : July - September Volume : 2012 Issue Number : 3 Articles : 7 Articles
Hypertension, mostly essential as a clinical entity has shown its wide presence across the globe; and calcium, sodium and potassium are invariably said to have pivotal role in its causation. Although a handful of study is conducted worldwide including India, drawing their causative association with hypertension; but such a study was never conducted among population of north-east India. So, with this aim the pioneering study to verify the association of serum sodium, potassium and calcium in essential hypertensive patients as well as their first degree relatives was conducted among 180 subjects of north east India. The study vividly draws significant results statistically (p<0.001); serum sodium was high while serum calcium and potassium were low when compared with normal subjects. The study also very clearly depicts the genetic predisposition of hypertension; serum sodium was significantly high (p<0.001) among the first degree relatives of hypertensive patients, though serum potassium and calcium did not show any significant correlation. This study thus opens new avenue for the prevention as well as management of hypertension....
The warning letter is a communication sent to sponsors, manufacturers and clinical investigators resulting from inconsistencies and inaccuracies found during FDA audits of clinical research-related activities. Warning letters to investigators can have a major impact on that physicianââ?¬â?¢s practice and their affiliated institution. The objective of this research was to analyze the publicly available warning letters that were sent to clinical investigators during the years 1996 to 2011 to identify areas of deficiencies and educate current and future clinical investigators. The data was extracted from letters to Clinical Investigators published in the Electronic Reading Room on the FDAââ?¬â?¢s website.The specific regulationslisted in the letters that were deemed violated by the respective FDA auditor were used for data analysis and termed ââ?¬Å?infractionsââ?¬Â.This data shows common deficiencies in clinical research programs and can assist investigators in developing preventative measures for future clinical research....
Background: Iron deficiency without anemia is related to adverse symptoms that can be relieved by\r\nsupplementation. Since a blood donation can induce such an iron deficiency, we investigated the clinical impact\r\nof iron treatment after a blood donation.\r\nMethods: One week after donation, we randomly assigned 154 female donors with iron deficiency without\r\nanemia, aged below 50 years, to a four-week oral treatment of ferrous sulfate versus a placebo. The main outcome\r\nwas the change in the level of fatigue before and after the intervention. Aerobic capacity, mood disorder, quality\r\nof life, compliance and adverse events were also evaluated. Hemoglobin and ferritin were used as biological\r\nmarkers.\r\nResults: The effect of the treatment from baseline to four weeks of iron treatment was an increase in hemoglobin\r\nand ferritin levels to 5.2 g/L (P < 0.01) and 14.8 ng/mL (P < 0.01), respectively. No significant clinical effect was\r\nobserved for fatigue (-0.15 points, 95% confidence interval -0.9 points to 0.6 points, P = 0.697) or for other\r\noutcomes. Compliance and interruption for side effects was similar in both groups. Additionally, blood donation\r\ndid not induce overt symptoms of fatigue in spite of the significant biological changes it produces.\r\nConclusions: These data are valuable as they enable us to conclude that donors with iron deficiency without\r\nanemia after a blood donation would not clinically benefit from iron supplementation....
Rational drug, though important at all ages, becomes more relevant in elderly. Given the high prevalence of inappropriate prescriptions and related adverse drug events, the present study was undertaken with the aim of finding out the pattern of drugs use and incidence of potentially inappropriate medication (PIM) and related condition in elderly patients by using validated screening tools: STOPP/START criteria We conducted a cross-sectional observational study of 600 patients aged 65 years in a tertiary care hospital. Data was collected using detailed indicators, and prescribing indicator form as per WHO. STOPP along with START criteria was applied to detect inappropriate prescriptions. The result reveals that total of 77 (PIM) and 42 potentially prescribing omissions (PPO) were found. Criteria detect more number of PIM in indoor patients (31%) than outdoor patients (8.6%) Most commonly found PIM were calcium channel blockers with chronic constipation, NSAIDS with hypertension, Beta Blockers with diabetes mellitus and the commonest PPO was statins for diabetic patients with multiple cardiovascular risk factors. Increasing age and polypharmacy are important risk factors associated with inappropriate medications. Therefore STOPP/START criteria may be used not only to enhance prescribing decisions in elderly patients but also as an audit measure of appropriate prescribing. Application of such screening tool to prescribing decision may reduce the use of unnecessary drugs, related adverse drug events, hospital admissions and cost....
Background: The emergency department (ED) visit provides a great opportunity to initiate interventions for\r\nsmoking cessation. However, little is known about ED patient preferences for receiving smoking cessation\r\ninterventions or correlates of interest in tobacco counseling.\r\nMethods: ED patients at 10 US medical centers were surveyed about preferences for hypothetical smoking\r\ncessation interventions and specific counseling styles. Multivariable linear regression determined correlates of\r\nreceptivity to bedside counseling.\r\nResults: Three hundred seventy-five patients were enrolled; 46% smoked at least one pack of cigarettes per day,\r\nand 11% had a smoking-related diagnosis. Most participants (75%) reported interest in at least one intervention.\r\nMedications were the most popular (e.g., nicotine replacement therapy, 54%), followed by linkages to hotlines or\r\nother outpatient counseling (33-42%), then counseling during the ED visit (33%). Counseling styles rated most\r\nfavorably involved individualized feedback (54%), avoidance skill-building (53%), and emphasis on autonomy (53%).\r\nIn univariable analysis, age (r = 0.09), gender (average Likert score = 2.75 for men, 2.42 for women), education\r\n(average Likert score = 2.92 for non-high school graduates, 2.44 for high school graduates), and presence of\r\nsmoking-related symptoms (r = 0.10) were significant at the p < 0.10 level and thus were retained for the final\r\nmodel. In multivariable linear regression, male gender, lower education, and smoking-related symptoms were\r\nindependent correlates of increased receptivity to ED-based smoking counseling.\r\nConclusions: In this multicenter study, smokers reported receptivity to ED-initiated interventions. However, there\r\nwas variability in individual preferences for intervention type and counseling styles. To be effective in reducing\r\nsmoking among its patients, the ED should offer a range of tobacco intervention options....
Introduction: Blacks are more likely than whites to refuse potentially curative surgery for early stage non-small\r\ncell lung cancer (NSCLC). We sought to compare survival among blacks and whites in this population, as patients who\r\nrefuse the surgery are expected to be different from others. Also, racial differences are known to exist in the end-of-life\r\ncare preferences.\r\nMethods: Surveillance, Epidemiology, and End Results (SEER) database was used to create a cohort of 970\r\npatients diagnosed with stage I and II NSCLC between 1988 and 2002 who refused surgery. The outcome was\r\noverall and lung cancer-specific survival, while race was the key predictor variable. Kaplan-Meier survival analysis\r\nwas performed to estimate crude survival differences. Potential confounders were adjusted for in Cox-proportional\r\nregression analysis.\r\nResults: A majority (78%) was white and 11% were blacks. In the crude analysis of all-cause mortality, blacks\r\ntended to have lower mortality than whites (p-value 0.075). In the adjusted model, blacks had 19% lower risk of\r\nmortality than whites (HR 0.81, 95% C.I. 0.67, 0.99, p-value 0.045). There were no differences in cancer-specific\r\nmortality in either crude or adjusted analysis. Females, individuals who receive radiotherapy and those with higher\r\neducation in a county had lower risk of overall and cancer-specific mortality.\r\nConclusions: Among patients who refused surgery for early stage NSCLC, blacks have a lower risk of all-cause\r\nmortality than whites, but there are no differences in the cancer-specific mortality. This should be interpreted with\r\ncaution due to lack of chemotherapy data and information on quality of life....
The issues discussed in this article emerged from a study that explored the decision-making processes used by research participants when deciding to participate in human subjects� research. We discuss the current research and regulatory environment and its influences on participant decision-making. The results of this study create a framework for understanding the challenges of the current informed consent process and offers insights into what may be needed to create an environment that allows research participants to make more enlightened decisions....
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