3 purported essence of clinical research

... July 2005; 11(4) :35 3 35 9 52 Institute of Medicine of the National Academies The Future of Drug Safety http://www.nap edu/books/ 030 31 030 45/html/1.html Accessed April 3, 2007 53 Public Health Newswire ... Saf Sept 2002; 11(6): 439 –446 32 FDA news Drug Daily Bulletin Oct 2006; 3( 207) 33 Bombardier C, Laine L, Reicin A, et al Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen ... Accessed October 38 Abenhaim L Lessons from the withdrawal of rofecoxib: France has policy for overall assessment of public health impact of new drugs BMJ Dec 4, 2004; 32 9(7478): 134 2 39 FDA MedWatch:...

Ngày tải lên: 14/08/2014, 11:20

... Warren M, Upshur RE: Designing research in vulnerable populations: lessons from HIV prevention trials that stopped early BMJ 2005, 33 1:14 03- 1406 26 27 28 29 30 31 32 33 34 Anon: ‘Thailand: Extrajudicial ... treaty/en/treaties/html/164.htm 1997 Page of 10 (page number not for citation purposes) Globalization and Health 2007, 3: 10 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 http://www.globalizationandhealth.com/content /3/ 1/10 ... its directive on good practice in clinical trials [33 ] and the Council of Europe has issued a Convention on Human Rights and Biomedicine on biomedical research [34 ] Most recently, UNESCO has developed...

Ngày tải lên: 11/08/2014, 18:20

... traditional clinical research, beginning with the history of the development of clinical research, to traditional clinical research designs, with a focus on clinical trials It includes a discussion of ... chapter I will provide a brief overview of the history of clinical research The chapter will also address the question of why we clinical research; define clinical research ; discuss our quest for ... Ph.D., D.Sc Professor of Epidemiology, Department of Epidemiology School of Public Health, University of Alabama at Birmingham, Birmingham, AL Sue Duval, Ph.D Assistant Professor Division of Epidemiology...

Ngày tải lên: 14/08/2014, 11:20

... 2% 3% 5% 10% 20% 50% 10% 1.8% 97,959 2.7% 64,6 73 4.5% 38 ,044 9% 18,072 18% 8,086 45% 2,095 Treatment effect 20% 30 % 1.6% 1.4% 23, 2 23 9,757 2.4% 2.1% 15 ,33 9 6,447 4.0% 3. 5% 9, 032 3, 800 8% 7% 4 ,30 2 ... School High School >High School CVD Framingham 242,800 73. 5 62,910 5.1 30 20 14 26,700 35 22 13 55 ,30 0 25 28 48 528–582 13 23 64 33 6–451 38 S.P Glasser differences in the representative sample ... trials A clinical trial is one type of clinical research A clinical trial is a type of experimental study undertaken to assess the response of an individual (or in the case of group clinical...

Ngày tải lên: 14/08/2014, 11:20

... placebo effect when found in control groups of patients receiving placebo therapy.27 ,30 ,32 ,33 ,35 ,38 ,61,65 ,33 ,37 ,39 ,40,42,45,65,70 Conversely, the condition of patients receiving placebos has also ... use of sham procedures in clinical trials Crit Care Med Mar 20 03; 31 (3 Suppl):S126– 130 Macklin R The ethical problems with sham surgery in clinical research N Engl J Med Sept 23, 1999; 34 1( 13) :992–996 ... be 30 – 80% .33 A summary of subjective and objective placebo effects in cardiovascular disease is provided in Tables 7.2 and 7 .3 Because of the magnitude of the placebo effect, most studies of...

Ngày tải lên: 14/08/2014, 11:20

... Trials May 1981; 1(4) :36 3 37 6 DeMets DL, Lan KK Interim analysis: the alpha spending function approach Stat Med July 15 30 , 1994; 13( 13 14): 134 1– 135 2; discussion 135 3– 134 6 10 DeMets DL, Pocock ... on OR −0 .33 −0 .38 −0.22 −0.22 −0. 23 0.12 0.197 0.2 03 0.275 0.1 43 0.188 0.098 0.72 0.68 0.81 0.80 0.80 1. 13 [0.49, 1.06] [0.46, 1.02] [0.47, 1 .38 ] [0.61, 1.06] [0.55, 1.15] [0. 93, 1 .37 ] 10 Meta-Analysis ... 15, 1991; 18(6):1 434 –1 438 73 Influence of adherence to treatment and response of cholesterol on mortality in the coronary drug project N Engl J Med Oct 30 , 1980; 30 3(18):1 038 –1041 74 Horwitz...

Ngày tải lên: 14/08/2014, 11:20

... meta-analysis of research Educ Res 1976; 5 :3 8 Petitti DB Approaches to heterogeneity in meta-analysis Stat Med Dec 15, 2001; 20( 23) :36 25 36 33 Begg CB, Mazumdar M Operating characteristics of a rank ... Kumar S Application of evidence-based urology in improving quality of care Indian J Urol 2007; 23( 2):91–96 22 The Problem of Induction (19 53, 1974) http://dieoff.org/page126.htm 23 Smith GC, Pell ... systematic review of randomised controlled trials BMJ Dec 20, 20 03; 32 7(7429):1459–1461 Part II This Part deals with some of the newer approaches in clinical research, specifically research methods...

Ngày tải lên: 14/08/2014, 11:20

... front-line clinical units Joint Comm J Qual Im 2002; 28:472– 93 32 Zerhouni EA Medicine The NIH roadmap Science 20 03; 30 2: 63 72 33 Zerhouni EA US biomedical research: basic, translational, and clinical ... Drug Saf May 2001; 10 (3) :259–262 56 Barbone F, McMahon AD, Davey PG, et al Association of road-traffic accidents with benzodiazepine use Lancet Oct 24, 1998; 35 2(9 137 ): 133 1– 133 6 57 Handoko KB, Zwart-van ... Public Health 2007; 28:4 13 33 30 Sung NS, Crowley WF, Jr., Genel M, et al Central challenges facing the national clinical research enterprise JAMA 20 03; 289:1278–87 31 Nelson EC, Batalden PB,...

Ngày tải lên: 14/08/2014, 11:20

... wide variety of research contexts Table 16.2 The two by two table HRT and DVT DVT On HRT No HRT Total No DVT Total 33 27 60 1,667 2,2 73 3,940 1,700 2 ,30 0 4,000 Marginal probability of DVT = 60/4,000 ... probability of DVT given you are = 33 /1,700 = 0.0194 or 1.94% on HRT Conditional probability of DVT given you’re = 27/2 ,30 0 = 0.0117 or 1.17% not on HRT Joint probability of HRT AND DVT = 33 /4,000 ... 2007; 26( 23) : 434 4– 435 1 Berry DA Introduction to Bayesian methods III: use and interpretation of Bayesian tools in design and analysis Clin Trials 2005; 2(4):295 30 0; discussion 30 1–294, 36 4–278...

Ngày tải lên: 14/08/2014, 11:20

... 0.05 0.05/0 .30 = 0.17 × 70 /30 × 95 = 0.12 0 .30 − 0.05 = 0.25 1/(0 .30 − 0.05) = 30 /100 = 0 .30 0 .30 /0.05 = 30 × 95/5 × 70 = 8.1 Table 16.6 Comparison of RR and AR Annual mortality rate per 100,000 ... degree of correlation, adapted to the nature of data The rate of change of one variable tied to the rate of change of another is known as a slope The correlation coefficient and the slope of the ... Chance of a Spurious Finding 0.7 0.6 0.5 0.4 0 .3 0.2 0.1 11 13 15 17 19 "Peeks" Fig 18 .3 The chance of spurious findings related to the number of times the data is analyzed during the course of a...

Ngày tải lên: 14/08/2014, 11:20

... 2 23, 225–227, 229, 230 , 232 , 234 –240, 242, 250, 269–271, 2 73, 274, 276, 278, 2 83, 288–291, 294–297, 299, 30 0, 30 2 30 5, 30 9, 31 0, 31 2, 31 4, 31 6 31 8, 32 3, 32 6, 33 5, 33 6, 34 1 overviews 4, 21, 1 63, ... 30 4, 31 7 maturation phase 33 3, 33 4 measurable trait 192 measure of association 172–174, 287, 289, 291, 30 0, 30 2, 30 3, 31 0 measure of precision 168 media 31 , 60, 30 1, 30 2, 33 3 33 7, 35 0, 35 1 Medical ... of a presentation 34 6 student 3, 30 , 35 , 36 , 43, 2 53, 266, 286, 30 1, 31 0, 34 0, 34 1, 34 6 study population 13, 15, 146, 212, 276, 288, 30 1, 30 4, 32 3 subcohort 25 subgroup analysis 31 , 46–48, 133 ,...

Ngày tải lên: 14/08/2014, 11:20

... median (IQR) 38 (33 , 44) 37 (32 , 43) 36 (31 , 42) 0.064 WHO stage III & IV, n (%) 496 (89%) 975 (79%) 4581 (71%)

Ngày tải lên: 20/06/2014, 08:20

... processes are first-order; i.e., the rate of the process depends on the amount of drug present Clinically important exceptions are discussed below (see "Principles of Dose Selection") In the simplest ... half-life As a consequence of this relationship, a plot of the logarithm of concentration vs time is a straight line (Fig 5-2A , inset) Half-life is the time required for 50% of a first-order process ... tissues, the volume of distribution can be far greater than any physiologic space For example, the volume of distribution of digoxin and tricyclic antidepressants is hundreds of liters, obviously...

Ngày tải lên: 06/07/2014, 08:20

... fluorouracil after oral ingestion of UFT The uracil component slows the metabolism ch 03. qxd 8/ 13/ 2001 1 :33 PM Page 233 C YTOKINES 233 of fluorouracil and reduces production of the toxic metabolite, 2-fluoro-␤-alanine, ... L/hr/m2 20 30 % of a dose Primary route of excretion FATE Absorption EXCRETION Biliary 40–60% of a dose Primary route of excretion ch 03. qxd 8/ 13/ 2001 1 :33 PM Page 239 DNA I NTERCALATING D RUGS 239 DAUNORUBICIN ... administration, with an absorption half-life of about hr IM or SC ch 03. qxd 236 8/ 13/ 2001 1 :33 PM Page 236 A NTINEOPLASTICS doses of 10 million IU produce peak serum levels of 100–200 IU/mL within hr; the...

Ngày tải lên: 09/08/2014, 15:20

... difficulties of forward pressure with those of a lack of red reflex Logically, therefore, all of the above mentioned advice should be observed A forceps technique is preferable because the cortex is often ... because of the direct action of the tip energy it may push the nuclear material away from the tip Cavitation This occurs just ahead of the tip of the phaco probe and results in an area of high ... varying degrees of angle of the bevel, curvature of the tip, and internal dimensions The standard tip (Figure 4.5) is straight, with a 0, 15, 30 , or 45° bevel at the end At its point of attachment...

Ngày tải lên: 10/08/2014, 00:20

... interconnecting the nuclei of separate erythroblasts (Fig 30 a, ultrastructure Fig 30 b) Multinucleated erythroblasts characterize the type II form of CDA (Fig 30 c – e) Approximately 15 % – 20 % of all red cell ... hemolytic disease of the newborn (HDN), a consequence of fetomaternal Rh incompatibility Examination of the infant’s blood usually reveals large numbers of erythroblasts These cells 83 · Bone Marrow ... multinucleation of erythroblasts affecting all maturation stages (Fig 30 f – h) Giant cells with 10 – 12 nuclei are observed IV 102 Chapter IV · Blood and Bone Marrow Fig 30 a IV Fig 30 b Fig 30 a – b...

Ngày tải lên: 10/08/2014, 08:20

... Pathological repeat number 6 35 9 35 Dentatorubropallidoluysian atrophy 38 –62 6 38 14 31 12 39 4–17 7 35 3 35 SCA SCA SCA SCA SCA 36 –100ϩ 39 – 83 32–77 62–86 21 30 37 –200 49–88 Table 7.2 Trinucleotide ... disorders Box 5.1 Risk of Down syndrome in livebirths and at amniocentesis Maternal age (at delivery or amniocentesis) All ages Age 30 Age 35 Age 36 Age 37 Age 38 Age 39 Age 40 Age 44 Liveborn ... Trichorhinophalangeal Smith–Magenis Chromosomal deletion 22q11 22q11 15q11- 13 15q11- 13 7q11 17p 13 11p 13 16p 13 20p12 8q24 17p11 Numerical abnormalities of the sex chromosomes are fairly common and their effects...

Ngày tải lên: 10/08/2014, 14:22

... difficulties of forward pressure with those of a lack of red reflex Logically, therefore, all of the above mentioned advice should be observed A forceps technique is preferable because the cortex is often ... because of the direct action of the tip energy it may push the nuclear material away from the tip Cavitation This occurs just ahead of the tip of the phaco probe and results in an area of high ... varying degrees of angle of the bevel, curvature of the tip, and internal dimensions The standard tip (Figure 4.5) is straight, with a 0, 15, 30 , or 45° bevel at the end At its point of attachment...

Ngày tải lên: 10/08/2014, 20:21

... reduction of stress, enhancement of positive emotional states and enhanced imaginal processing that often occur during clinical applications of hypnosis may be contributing factors Spiegel (19 93) suggests ... multifactorial nature of hypnotic analgesia Pain, 60, 39 ±47 Kisser, R S et al (19 83) Acupuncture relief of chronic pain syndrome correlates with increased met-enkephalin levels Lancet, 2, 139 4± 139 6 Krippner, ... Dissociation of self-concept or selfconsciousness? Imagin., Cogn Personal., 9, 32 1 32 4 80 INTERNATIONAL HANDBOOK OF CLINICAL HYPNOSIS Laidlaw, T M., Booth, R J & Large, R G (1994) The variability of Type...

Ngày tải lên: 10/08/2014, 20:21

... 2001 ( 63. 6) Sepsis [3] 1091 (34 .7) Severe sepsis [3] 928 (29.5) Septic shock [3] 462 (14.7) Presence of venous central lines 2272 (72.2) Presence of pulmonary artery catheter 481 (15 .3) Mechanical ... included 38 33 patients, 17 .3% of whom developed severe sepsis Actual hospital mortality for these patients was 44% Of the patients, 11% were still hospitalized at months Spanish study of organ ... 1951 (62) Mean SAPS II score [1] 34 SOFA score values [2] at inclusion SOFA maximum SOFA mean during study period ICU duration of stay (days) Hospital duration of stay (days) 15 Dr Arthur Slutsky...

Ngày tải lên: 12/08/2014, 19:21