By C. Inog. Palm Beach Atlantic College.

The two treatments will be patient receives both options and so the analysis given either in the order A followed by B (AB) includes within-patient comparisons which are or the reverse (BA) effective 480mg bactrim. The essential features of a more sensitive than between-patient comparisons buy generic bactrim 480 mg on-line, crossover design are summarised in Figure 2 discount 960 mg bactrim with mastercard. Typically discount bactrim 480mg fast delivery, in the two-period 480 mg bactrim sale, two-treatment crossover trial, for eligible patients there is a run- in stage in which the subject receives neither EQUIVALENCE TRIALS treatment. Following active In certain situations, a new therapy may bring treatment in Period I (in effect either A or certain advantages over the current standard, B depending on the randomisation), there is a possibly in a reduced side-effects profile, easier wash-out interval in which again no treatment administration or cost. Nevertheless, it may not is given, after which Period II commences and be anticipated to be better with respect to the the (other) treatment of the sequence is given. This scenario is never possible: the strict interpretation W Random Korean red a Korean red Patients ginseng s ginseng allocation with h to sequence erectile - of dysfunction Placebo o Placebo treatments u t Source: Reproduced from Hong et al. In the case of equivalence we specify the trials typically fail to detect differences between range of equivalence, (25 g per week in the treatment groups but not necessarily because above example) and then test two null hypothe- no difference exists. We test that the observed difference is statis- two different treatments will ever exert truly tically significantly greater than − ; and that the identical effects. In practice it is much easier to defined and this is a medical question, not a consider a confidence interval for the difference statistical one. For example in a study of weight between the treatment means and draw this on gain in pre-term infants, if two treatments show a graph with the agreed limits of equivalence. Some cases then they may be considered as therapeutically show equivalence, some fail to show equivalence; equivalent. Note that in this example 25 g is some cases show a statistically significant differ- not the mean weight gain that is expected per ence, others fail to show a difference. Note that week – we would hope that would be much it is quite possible to show a statistically signif- more. But if infants receiving one feeding icant difference between two treatments yet also regimen had a mean increase of 150 g per week demonstrate therapeutic equivalence. These are then we would consider an alternative treatment not contradictory statements but simply a real- to be equivalent if the mean weight gain were isation that although there is evidence that one between 125 and 175 g per week. Not equivalent Yes Uncertain Yes Equivalent Yes Equivalent No Equivalent Yes Uncertain Yes Not equivalent Yes Uncertain No −∆ O +∆ True difference Examples of possible results of using the confidence interval approach: −∆ to +∆ is the prespecified range of equivalence; the horizontal lines correspond to possible trial outcomes expressed as confidence intervals, with the associated significance test result shown on the left; above each line is the decision concerning equivalence. Schematic diagram to illustrate the concept of equivalence GENERAL ISSUES 21 The analysis and interpretation can be quite fixed sample size approach might have been straightforward but the design and management curtailed earlier had a sequential design been of equivalence trials is often much more complex. The study procedures and medication all tend to bias accumulating patient data from this trial crossed results towards no difference. Since we are trying an early termination boundary which inferred an to offer evidence of equivalence, poor study advantage to α-interferon. In general, patient-by-patient as the information on the trial therefore, the quality of equivalence trials should endpoint is observed from them. Potentially, the would only be concerned with whether or not the number of preferences could continue indefinitely lower limit of the confidence interval is greater between the upper solid and broken lines or than the non-inferiority margin (− ). SEQUENTIAL TRIALS In contrast to the open sequential design, There has been an implicit assumption in the the closed design of Figure 2. Thus this design has a finite stage and before recruitment commences to the size and a conclusion will always be drawn. This fixed sample size approach Again the solid lines indicate stopping boundaries essentially implies that the data collected during for declaring a statistically significant difference the conduct of the trial will only be examined between treatments and if the broken line is for efficacy once the trial has closed to patient crossed, concluding that no significant difference accrual. However, the vast majority of Phase III was found between the treatments. Neverthe- to decrease the final trial size if the data are less, if one of the factors, say the chemotherapy indicating an advantage to one of the treatments option in the example we discussed previously, and this can be firmly established at an early stage is stopped by crossing a boundary during the or to extend the trial size in other circumstances. Again, the subsequent 22 TEXTBOOK OF CLINICAL TRIALS 20 A significantly better than B 10 0 No significant difference −10 B significantly better than A −20 0 10 20 30 40 50 Number of preferences Open sequential design. The solid lines indicate stopping boundaries for declaring a statistically significant difference between treatments A and B. If the broken boundary is crossed, then the study stops, concluding that no significant difference was found between the treatments. Potentially the number of preferences could continue indefinitely between the upper solid and broken lines or between the lower solid and broken lines; in such a case no conclusion would ever be reached. Open sequential design patients recruited may then be somewhat dif- terms the use of sequential designs is still some- ferent from those at the first stage of the trial. They do not however appear randomised consent design combines aspects of to give an actual clinical example of their use. They were motivated by the difficulties range from difficulties of financing a trial of expressed by clinicians in obtaining consent from uncertain size, making sure the data is fully up- women who they wished to recruit to trials to-date as the trial progresses, to the more tech- with breast cancer.

Some herbal products claim to decrease because it is bulk forming bactrim 480 mg line, produces feelings of fullness generic 480 mg bactrim overnight delivery, and appetite and increase the rate at which the body burns calories discount 480mg bactrim with visa. It may cause esophageal or intestinal However purchase bactrim 960mg free shipping, their effectiveness varies and cheap 960mg bactrim with visa, in most cases, there is obstruction if not taken with an adequate amount of water and no scientific evidence that they work at all. Most supplements may interfere with the absorption of other drugs if taken at for weight loss contain cardiovascular and CNS stimulants that the same time. Adverse effects include nausea, diarrhea, flat- may cause serious, even life-threatening, adverse effects. CHAPTER 30 NUTRITIONAL SUPPORT PRODUCTS AND DRUGS FOR OBESITY 441 Hydroxycitric acid (HCA, found in CitriMax) apparently 2 culate or estimate the BMI; a BMI less than 18. If so, calculate the BMI Laxative and diuretic herbs (eg, aloe, rhubarb root, buck- or use the information in Table 30-5 to estimate the BMI. These products cause a sig- or aggravated by excessive weight, if there is interest in a nificant loss of body fluids, not fat. Adverse effects may in- weight-management program to improve health, and what clude low serum potassium levels, with subsequent cardiac methods, over-the-counter products, or herbal or dietary dysrhythmias and other heart problems. In addition, long-term supplements, if any, have been used to reduce weight. The use of laxatives may lead to loss of normal bowel function and nurse must be very tactful in eliciting information and as- the necessity for continued use (ie, laxative dependency). LipoKinetix, a combination dietary supplement, was re- sessing whether a client would like assistance with weight cently associated with severe hepatotoxicity in 7 young (ages management. If the nurse–client contact stems from a 20 to 32 years), previously healthy people who developed health problem caused or aggravated by excessive weight, acute hepatitis. Five Japan- the client may be more motivated to lose weight and im- ese patients were diagnosed in 1 month or less; two white prove health. Three people • Does the client have symptoms, disease processes, treat- were taking only LipoKinetix; four were also taking other ments, medications, or diagnostic tests that are likely to supplements, which they resumed later without recurrence of interfere with nutrition? The ingredient(s) • Check available reports of laboratory tests, such as serum responsible for the hepatotoxicity was unknown. Nu- tions were considered idiosyncratic, and no other cause of the tritional disorders, as well as many other disorders, may hepatitis was found. With the observation that the five Japanese developed he- patotoxicity more rapidly than the two Caucasians, there is a Nursing Diagnoses possibility that Asians are less able to metabolize and excrete • Imbalanced Nutrition: Less Than Body Requirements this product. As discussed in the early chapters of this text, related to inadequate intake or impaired ability to digest smaller doses of several prescription drugs are needed in this nutrients population because of genetic or ethnic differences in metab- • Imbalanced Nutrition: More Than Body Requirements olism. This principle may also apply to some herbal and related to excessive intake dietary supplements and should be considered in teaching • Deficient Fluid Volume related to inadequate intake clients of Asian descent. Some specific assessment factors include the fol- Planning/Goals lowing: The client will: • What are usual drinking and eating patterns? Does food intake seem adequate • Improve nutritional status in relation to body needs in terms of normal nutrition? Is the client financially able • Maintain fluid and electrolyte balance to purchase sufficient food? What are fluid and food likes • Avoid complications of enteral nutrition, including as- and dislikes? Does the client view nutrition as important in main- • Avoid complications of parenteral nutrition, including taining health? Has there been a re- • Identify the types and amounts of foods to meet nutritional cent change in weight (eg, unintended weight loss)? If needs the client is underweight, assess for contributing factors • Avoid overuse of anorexiant drugs (eg, appetite; ability to obtain, cook, or chew food). Cal- • Avoid unproven weight-loss dietary supplements 442 SECTION 5 NUTRIENTS, FLUIDS, AND ELECTROLYTES PRINCIPLES OF THERAPY Interventions Implement measures to prevent nutritional disorders by pro- Managing Fluid Disorders moting a well-balanced diet for all clients. The • Provide food and fluid the client is willing and able to safest and most effective way of replacing body fluids is to take, at preferred times when possible. Water is probably best, at least • Assist the client to a sitting position, cut meat, open initially. Fluids containing large amounts of carbohydrate, containers, feed the client, and perform other actions if fat, or protein are hypertonic and may increase fluid volume indicated.

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Tachycardia purchase bactrim 480 mg fast delivery, hypotension cheap bactrim 480 mg otc, premature diarrhea order 960mg bactrim with mastercard, or diabetic acidosis atrial and ventricular beats Hypermagnesemia 1 order bactrim 480mg on-line. Skeletal muscle weakness and paraly- excessive intake of magnesium salts in and neuromuscular systems bactrim 960mg without a prescription, which block sis, cardiac arrhythmias, hypotension, antacids or cathartics transmission of electrical impulses respiratory insufficiency, drowsiness, 3. When given orally within a few hours after The major indication for use of deferoxamine is oral ingestion of iron preparations, deferoxamine com- acute iron intoxication. It is also used in hemochro- bines with the iron in the bowel lumen and prevents its matosis due to blood transfusions or hemosiderosis absorption. When given parenterally, it removes iron due to certain hemolytic anemias. In these chronic from storage sites (eg, ferritin, hemosiderin) and com- conditions characterized by accumulation of iron in bines with the iron to produce a water-soluble com- tissues, phlebotomy may be more effective in remov- pound that can be excreted by the kidneys. Deferoxamine is more likely to be used in remove 10 to 50 mg of iron per day. The urine becomes clients who are too anemic or hypoproteinemic to tol- reddish brown from the iron content. TABLE 32–5 Chloride Imbalances Causes Pathophysiology Signs and Symptoms Hypochloremic Metabolic Alkalosis 1. Serum chloride <95 mEq/L; arterial ing, gastric suctioning, diuretic drug ther- 2. Paresthesias of face and extremities perspiration, or adrenocortical insuffi- trality in extracellular fluids. Muscle spasms and tetany, which cannot ciency is metabolic alkalosis, a relative defi- be distinguished from the tetany pro- 2. Excessive ingestion of bicarbonate ciency of acid, and a relative excess duced by hypocalcemia or base of base. Retention of carbon dioxide (acid) as a compensatory attempt to restore acid–base balance 5. Fluid loss and decreased plasma volume Hyperchloremic Metabolic Acidosis 1. Increased rate and depth of respiration chloride or ammonium chloride is metabolic acidosis, a relative excess of acid, and a relative deficiency of base. Stored in the liver, spleen, kidneys, A component of vitamin B12, Approximately 1 mg in the Animal foods, including liver, and pancreas which is required for normal form of vitamin B12 muscle meats, and shell- 2. Deficiency of vitamin B12 produces for maturation of red blood cereals contain no cobalt as pernicious anemia. In animals, excess cobalt produces polycythemia, bone mar- row hyperplasia, and increased blood volume. A component of many en- Not established; estimated at Many foods, including liver, neys, bone, and muscle zymes approximately 2 mg shellfish, nuts, cereals, 2. Essential for correct func- poultry, dried fruits and menstrual flow tioning of the central ner- 3. Deficiency occurs with lack of food in- vous, cardiovascular, and take, malabsorption syndromes, and skeletal systems prolonged administration of copper- 3. Important in formation of free IV hyperalimentation solutions red blood cells, apparently 4. Signs and symptoms of deficiency by regulating storage include decreased serum levels of and release of iron for copper and ceruloplasmin (a plasma hemoglobin protein that transports copper); decreased iron absorption; anemia from impaired erythropoiesis; leukopenia. Copper excess (hypercupremia) may occur in women who take oral contraceptives or who are pregnant and in clients with infections or liver disease. A component of tooth Adults (AIs): males 19–>70 y, Beef, canned salmon, eggs. Often enamel 4 mg; females 19–>70 y, Very little in milk, cereal added to community supplies of 2. Strengthens bones, proba- 3 mg; pregnancy and lacta- grains, fruits, and vegeta- drinking water. Accumulates in the body until ap- tention in bones Infants (AIs): 0–6 mo, 0. Fluoride deficiency is indicated by ages 50–60 years may de- Other children (AIs): 1–3 y, are grown.

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For example discount bactrim 960 mg without a prescription, sterile equipment and techniques are required for injection of any drug buy discount bactrim 960 mg on line. Follow label instructions regarding mixing or other aspects Some drugs require specific techniques of preparation and ad- of giving specific drugs order bactrim 480mg amex. Look for improvement in signs and symptoms order bactrim 960mg on-line, laboratory In general safe 480mg bactrim, the nurse should know the expected effects and when or other diagnostic test reports, or ability to function. Ask questions to determine whether the client is feeling Specific observations depend on the specific drug or drugs being better. Look for signs and symptoms of new problems or worsening severity of adverse reactions vary among drugs and clients. Check laboratory (eg, complete blood count [CBC], elec- drugs being given. Ask questions to determine how the client is feeling and whether he or she is having difficulties that may be associated with drug therapy. Consider a possible interaction when a client does not more drugs concurrently and the number of possible interactions experience expected therapeutic effects or develops adverse is very large. Look for signs and symptoms of new problems or wors- drugs (eg, warfarin, sedatives, cardiovascular drugs). Anticipate the questions a client might ask about a drug How Can You Avoid This Medication Error? With children, what are some potential difficulties with cillin, rather than 100 mg, which should be administered every 8 hours. Carefully reread the order and recalculate the dosage drug administration, and how can they be prevented or ordered. With older adults, what are some potential difficulties with drug administration, and how can they be prevented or minimized? For older adults, explain what is meant by start low, go slow and why it is a good approach to drug therapy. Why is client teaching about drug therapy needed, and what information should usually be included? Describe at least three important nursing considerations the danger of potential drug toxicity is high. This is especially for clients who have renal or hepatic impairment or crit- true for a drug like digoxin that has a narrow therapeutic range. Decreased protein binding may result in higher blood levels of digoxin, causing toxicity. For the home care nurse assisting with a medication reg- liver and kidneys are often immature in the low-birth-weight in- imen, what are some likely differences between the nurs- fant. It is prudent, especially with the very young and the very ing care needed by a child and an adult? Why do nurses need to know the therapeutic and adverse Facts and Comparisons. Journal of the Americal Pharmaceutical Association, 40(2), dietary supplements? Nerve cell bodies usually The central nervous system (CNS), composed of the brain occur in groups or clusters, called ganglia or nuclei. A clus- and spinal cord, acts as the control center for regulating phys- ter of cell bodies or nuclei with the same function is called ical and mental body processes. Afferent or sensory neurons a center (eg, the vasomotor and respiratory centers in the carry messages to the CNS; efferent or motor neurons carry messages away from the CNS. A dendrite has a branching structure with constantly receives information about blood levels of oxygen many synapses or sites for receiving stimuli or messages, and carbon dioxide, body temperature, and sensory stimuli and which are then conducted toward the cell body. An axon is a sends messages to effector organs to adjust the environment to- finger-like projection that carries impulses away from the cell ward homeostasis. The end of the axon branches into presynaptic fibers that functions (eg, thought, learning, reasoning, problem solving, end with small, knob-like structures called vesicles. Many axons are covered body, and components of the CNS have complex interactions by a fatty substance called myelin. Although various components of brain func- protects and insulates the axon.

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