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Like per protocol or as treated estimators cheap zithromax 100 mg otc, they do not appear to be able to provide estimates RANDOMISED CONSENT AND PATIENT of causal effects purchase 100mg zithromax mastercard. And for this reason they can- PREFERENCE DESIGNS not be used to check the (external) validity of the estimates of causal effects provided by the ran- A serious issue in the design of RCTs concerns domised groups cheap 250mg zithromax free shipping. Whether the difference between the amount of information given to the patient the two preference groups is the same as or com- about the aims of the trial 100mg zithromax with mastercard. So-called informed pletely different from that provided within the consent is a prerequisite for most trials but it core RCT discount zithromax 100mg fast delivery, so what? The treatment effect DEPRESSION 309 may, indeed, be different in those patients with- of two people (the patient and the therapist) out a strong preference (i. Added to rest cannot provide the valid information from this are the problems of the choice of adequate which we can test whether it is true. But per- control groups (in particular, the absence of haps readers should see the results of such a trial a convincing placebo) and the impossibility and decide for themselves. In use of a patient preference design is provided the critical appraisal of such trials we should by a recently published trial of counselling for not, perhaps, be searching for methodological depression. The aim been involved in as it does to the trials of other here is not to allow patient preference to influ- investigators). This has been tried by Torg- studies should be fully aware of all the method- erson et al. A meta- pursue all of the possibilities in terms of esti- analysis of a series of trials that have naıvely¨ mating treatment effects, the design offers ways, ignored random therapist effects, for example, at least partially, of testing the validity of the or ignored the structure of a group therapy assumptions necessary for the above CACE esti- trial, simply summarises the faulty analyses of mator, or, equivalently, looking for a poor prog- the originals. Unfortunately, the consumers of nosis/demoralising effect in the potential com- meta-analyses (particularly if they are produced pliers of the control group. Getting preference under the auspices of such august bodies as the information prior to randomisation would also Cochrane Collaboration) seem to place far too improve the precision of the estimates of the much faith in their findings. Consumers need to CACE, but this is well beyond the scope of be aware that the authors of systematic reviews the present chapter – for further information, see are capable of missing subtle (or not so subtle) Fisher-Lapp and Goetghebeur. Con- will also provide a suitable entry to the literature sumers should resist taking the conclusions of the on adjustment for partial compliance (i. Reporting guidelines such as CONSORT46,47 are having a for the estimation of the effects of psychotherapy are difficult. It is not safe to simply assume that substantial impact on the quality of clinical trials, the theoretical and logistical problems are similar and on the appraisal methodologies of system- to those of the average drug trial. Psychotherapy (at least however, the CONSORT recommendations only in its individual form) involves the interaction cover a small part of the key components of the 310 TEXTBOOK OF CLINICAL TRIALS trial. I tute of Mental Health Treatment of Depression Collaborative Research Program (1989). Arch Gen hope the present chapter succeeds in stimulating Psychiat (1989) 46: 971–81. Clinical trials in psychiatry: should REFERENCES protocol deviation censor patient data? Statistical methods for measuring out- tocol deviation patient: characterization and impli- comes. In: Tansella M, Thornicroft G, eds, Men- cations for clinical trials research. In: Wykes T, Tarrier N, Lewis S, eds, Out- Design and Analysis of Clinical Trials. London: come and Innovation in Psychological Treatment Imperial College Press (1999). Estimating causal effects of treatments ucation for depression: a multicentre randomised in randomized and nonrandomized studies. Statistics and causal inference (with conceptual and statistical issues in analysis of discussion). Understand Psychological treatments for cocaine dependence: Stat (2002) 1: 19–29. Intention-to-treat and the cal considerations in group psychotherapy research: goals of clinical trials. Oxford: apist effects for the design and analysis of com- Oxford University Press (2000) 1411–20. Oxford: Oxford University Press come between health professionals for the design (2000) 1421–32. Oxford: Oxford University Press come research: disentangling therapists from ther- (2000) 1259–69. Contr Clin Tri- Institute of Mental Health Treatment of Depression als (1999) 20: 531–46.

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Debilitating illnesses Protein-Calorie Deficit such as cancer generic 500mg zithromax free shipping, acquired immunodeficiency syndrome discount 100mg zithromax visa, and Causes Signs and Symptoms chronic lung cheap zithromax 250mg online, kidney purchase zithromax 500 mg online, or cardiovascular disorders often inter- fere with appetite and gastrointestinal (GI) function purchase 500mg zithromax with mastercard. Weight loss with eventual peutic drugs often cause anorexia, nausea, vomiting, diarrhea, tein, carbohydrate, and fat loss of subcutaneous fat 2. Nutritional deficiencies may impair the func- absorb, or use nutrients 2. Increased susceptibility to tion of essentially every body organ, impair wound healing, 3. Acidosis for dietary intake in clients who cannot ingest, digest, absorb, 10. Protein-Calorie Excess Additional water must be given to meet fluid needs. Some products contain extra protein, fiber, calories, or other nu- Causes Signs and Symptoms trients. Obesity fats TABLE 30–1 Water Imbalances Water Deficit Some products are formulated for clients with particular organ impairments (eg, renal insufficiency) or disease processes Causes Signs and Symptoms (eg, diabetes mellitus), and some are contraindicated for clients 1. Oliguria and concentrated and caregivers who purchase the products over-the-counter people who are comatose, urine should read labels carefully or consult a nutritionist. Excessive fluid loss due to membranes tionally incomplete and are designed for short-term use when vomiting, diarrhea, fever, 5. Fever must be provided parenterally for more than a few days, a strenuous physical activity, 8. A combination of from mild confusion to delir- can be designed to meet all nutritional needs or to supplement 1 and 2 ium, convulsions, and coma other feeding methods. Hypovolemic shock if the supply additional calories and essential fatty acids. For nutritional deficiencies due to malabsorption of carbohydrates, protein, and fat, pancreatic Causes Signs and Symptoms enzymes may be given. Low serum sodium and due to endocrine, renal, hematocrit Pancreatin and pancrelipase are commercial preparations cardiovascular, or central 6. Disorientation of pancreatic enzymes (eg, lipase, protease, and amylase). Circulatory overload and pul- The preparations are used to aid digestion and absorption of monary edema if water excess is severe or develops rapidly dietary carbohydrate, protein, and fat in conditions charac- terized by pancreatic enzyme deficiency. These conditions 436 SECTION 5 NUTRIENTS, FLUIDS, AND ELECTROLYTES TABLE 30–3 Intravenous Fluids Type/Characteristics Uses Comments Dextrose Injection Available in preparations containing To provide water and calories The dextrose in D5W is rapidly 2. They are hypertonic and must be given through a central or subclavian catheter. Dextrose and Sodium Chloride Injection Available in several concentrations Maintenance fluids, usually with Frequently used are 5% dextrose in added potassium chloride, in 0. Crystalline Amino Acid Solutions (Aminosyn, Freamine) Contain essential and nonessential As a component of peripheral or Special formulations are amino acids central IV parenteral nutrition, available for use in patients with concentrated dextrose with renal or hepatic failure. Obesity may occur in any group but is more likely to occur in women, minority groups, and poor people. It results from consistent ingestion of more calories than are used, and it sub- OBESITY stantially increases risks for development of cardiovascular disease (eg, hypertension, angina pectoris, myocardial infarc- Overweight and obesity are widespread and increasing in the tion, stroke), diabetes mellitus, dyslipidemias (eg, increased United States, in both children and adults. They are considered major public health problems because of their association with * Weight (pounds) high rates of morbidity and mortality. Nursoy, ProSobee, Soyalac As milk substitutes for infants who are allergic Provide all other essential nutrients for normal Hypoallergenic, milk-free formulas to milk growth and development Contain soy protein Provide 20 calories/oz when mixed as directed Nutramigen Infants and children who are allergic to Nutritionally complete, hypoallergenic formula ordinary food proteins or have diarrhea or containing predigested protein other GI problems PediaSure Children 1–6 years of age Amounts should be individualized Nutritionally complete, for oral use Precision diets These formulas can be given to children if These preparations are ingested or given by Nutritionally complete, high-nitrogen, low- the amount is calculated to provide rec- tube slowly over 4 hours. Requires little digestion and leaves little fecal residue Adults Amin-Aid As a source of protein for clients with acute Provides amino acids, carbohydrates, and a or chronic renal failure few electrolytes Ensure, Isocal, Osmolite As the sole source of nutrients or a supple- 2000 mL daily meets basic nutritional Nutritionally complete ment when food intake is decreased or needs for adults. May be given orally or by tube feeding does not meet nutritional needs MCT Oil Clients with fat malabsorption syndromes Limit use in clients with severe hepatic cirrho- A preparation of medium-chain triglycerides, sis because it may precipitate encephalopa- which are easier to digest than the long- thy and coma. Polycose Increase caloric intake in clients on protein-, Individualize amounts by calories needed and An oral supplement derived from carbohydrate electrolyte-, or fat-restricted diets tolerance. Available in liquid and powder May be mixed with water or other beverages and with foods Portagen For clients with fat malabsorption problems, May induce coma in clients with severe he- Nutritionally complete formula that contains as the complete diet, as a beverage with patic cirrhosis medium-chain triglycerides, an easily meals, or as an addition to various recipes digested form of fat Precision diets These preparations are ingested or given by Nutritionally complete, high nitrogen, low- tube slowly over 4 hours. The carbohydrate residue formulas for oral or tube feedings content may produce hyperglycemia; there- fore, they should not be used in clients with diabetes mellitus. When produces less carbon dioxide than carbo- carbon dioxide accumulates in the body, hydrate metabolism.

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