Answers: "Giving IV fluids to trauma victims found harmful", 28 Oct 94, NY Times, p. A9. Journal Article: "Immediate versus delayed fluid resuscitation for hypotensive patients with penetrating torso injuries", W.H. Bickell et al., 27 Oct 94, The New England Journal of Medicine, v. 331. no. 17, pp. 1105-1109. 1a) The two treatments were the immediate-resuscitation group (in which intravascular fluid resuscitation was given before surgical intervention in both the prehospital and trauma-center settings) and the delayed- resuscitation group (in which intravenous fluid resuscitation was delayed until operative intervention). (p.1106-"Methods: Study Interventions") b) The subjects were patients over 16 years of age who were transported to Ben Taub General Hospital with gunshot or stab wounds to the torso and a systolic blood pressure less than or equal to 90 mm Hg. They also did not have a Revised Trauma Score of zero at the scene of the injury, a fatal gunshot wound to the head, and/or minor injuries not requiring operative intervention. There were 598 patients. (p.1105-06- "Methods: Study Subjects" and p.1107-"Results: Characteristics of the Patients"-2nd pgrh) c) Pre-treatment characteristics that were recorded were blood pressure; the Revised Trauma Score (calculated from the Glasgow Coma Scale, systolic blood pressure, and respiratory rate); times at which emergency vehicles were dispatched, arrived at the scene, departed from the scene, and arrived at the trauma center; Injury Severity Score. (p.1106- "Methods: Main Measurements and Secondary Outcome Variables") d) The main outcome measurements were survival of patients and assessment of six defined postoperative complications (wound infection, adult respiratory distress syndrome, sepsis syndrome, acute renal failure, coagulopathy, and pneumonia). (p.1106-"Methods: Main Measurements and Secondary Outcome Variables") 2) Patients injured on even-numbered days of the month were assigned to the immediate-resuscitation group, while those injured on odd-numbered days were enrolled in the delayed-resuscitation group. The researchers did not assign the treatments randomly probably because of the difficulty and confusion to choose which protocol/treatment to use on each patient where time was a factor and each patient was unique. (p.1106-"Methods: Study Interventions") 3) The treatment assignment was blind to the subjects because they did not know that they were an experiment. The treatment assignment was not blind to the doctors because they have to know what to give in the pre-hospital phase. (p.1106-"Methods: Study Protocol") 4) The sample size was calculated on the assumption that death would occur in 35% of patients receiving standard preoperative fluid resuscitation for penetrating torso injuries. On the basis of experimental data and past clinical experience, an estimated 10 to 15% improvement in survival was predicted if fluid resuscitation was delayed until operative intervention. With a two-tailed alpha value of 0.05 and a beta value of 0.2 (meaning that the probability that the true effect is significant is 10-15%) for a hypothesis test, the determination is that approximately 600 patients are needed. (p.1106-"Methods: Statistical Analysis-1st pgrh) 5) The sample size seems reasonable, but it can improve since the main results are close to the cut-off p-value of 0.05 that some error may have occurred. (p.1108-Table 5) 6) The article title does not seem to be a reasonable claim because it implies that all trauma victims were considered and studied, whereas the the study admits that these results only pertain to those with penetrating torso injuries. Plus, the article title also implies that IV fluids do not work at all, while the results do show some indication that the fluids can help (i.e. not all of the immediate-resuscitation group died). (p.1105-"Abstract: Results" and "Abstract: Conclusions") 7) The numbers may be higher if those who died right away were accounted for. In fact, the percentage for the delayed-resuscitation group could be bigger because death and/or complications may be the results of not getting any fluids immediately. (p.1109-Table 6) 8) The null hypothesis is just a comparison of proportions (193/309 to 203/389). The question is if this difference occurred by chance. The observed difference is 8%. Finding the SD of the difference [sqrt(((.62*.38)/309)+(.70*.20)/289)) = 0.035] and dividing this from 8% [.08/.035 = 2.28] give a result that the difference is 2.28 SD's away from zero. The Z-test is performed (two-sided) to give a p-value = 0.04. (p.1106-"Methods: Statistical Analysis") 9) Pregnant women were excluded in the study to make the sample and the results representative and general to the whole population. Plus, there are outside complications that occur during pregnancy that might confound the study. Also moral issues could be involved (risk the life of the baby?) Those in car accidents were excluded because they are more likely not to get penetrating wounds or more likely received wounds that are not serious enough to get IV fluids. (p.1105-"Methods: Study Subjects"-1st pgrh) 10) A possible paragraph would be: "Despite indications that the delayed-resuscitation group appeared to have fewer complications, there was not enough done to study this part of the aspect. People who died immediately after operative intervention were not included in these calculations. Complications might had come from not getting fluids, which could result in death; but these patients were not accounted for in this analysis of the existence of complications." (p.1109-Table 6)