Standard reasonable patient

Two rival standards have been applied to determine whether practitioners satisfy disclosure requirements a professional commimity standard and a reasonable patient standard. 

The reasonable patient standard is based on what a reasonable patient must know rather than on what a reasonable practitioner must divulge. Evidence is offered to establish what a pmdent person in the patient s position would have done if adequately informed of all significant risks. Patients no longer must obtain expert testimony, because the issue concerns what they need to know rather than what practitioners are reasonably expected to divnlge. 

The reasonable patient standard has become the subject of much discussion in the medical profession, although studies of professional liability cases have shown that physicians are rarely subjected to infiarmed consent claims. Jurisdictions that have adopted this objective standard are listed in Box 5-3. 

The latter view prevailed but generated yet another set of issues as to whether disclosure rules should be evaluated from the perspective of professionals or patients. Some courts took the narrower view of duty by ruling that professional standards should be used to determine what should be disclosed to patients. Although this theory of "lack of informed consent" was distinct from whether the health care provider had violated the standard of care, most courts, and many legislatures, confined the doctrine s operation to a very narrow set of circumstances consistent with the negligence standard underlying the standard of care in medical cases. Other courts took what is called the broader view and leaned toward the patient s perspective while requiring juries to impose the reasonable patient s view of risk rather than the particular patient s view of risks. 

Compendial approaches are developed to protect the public and guide pharmaceutical manufacturers, prescribers, and dispensers. It is in the best interest of all stakeholders that quality pharmaceuticals be available for immediate patient use. In fact, it is imperative at all stages of drug distribution that the quality be maintained, both from the perspective of patient safety and from the standpoint of customer satisfaction and product liability. For these reasons, pharmacopeial standards throughout the world articulate accepted testing protocols and minimum quality standards to ensure that manufacturers have the tools they need to guarantee the quality of the available drug supply. 

On the other hand, several constituents are routinely analyzed in the same clinical specimen. It would therefore be unpractical to devise special systems for every single type of quantity. For that reason, three standardized procedures for blood specimen collection by venipuncture have been rec-ommended h (1) collection in the morning from hospitalized patients, (2) collection in the morning from ambulatory patients, and (3) collection in the afternoon from ambulatory patients. Table 16-2 summarizes these procedures. 

For patients with fluid deficits, it is safer and more cost-effective to correct fluid abnormalities using standard intravenous fluids (e.g., sodium chloride 0.9% in water, dextrose 5% in water, and lactated Ringer s solution). Minimizing fluid volume in PN may be indicated in patients with fluid overload, such as critically ill patients who receive large-volume resuscitation fluids, patients with oliguric (urine output less than 400 mL/day) or anuric (urine output less than 50 mL/day) renal failure, and those with congestive heart failure. It is reasonable to... 

The formula for calculating the budget of a GP practice must offer an unbiased estimator of the expected level of expenditure if each GP practice had a standard response to the needs of its population. Even if the considerable technical difficulties of establishing this formula could be overcome, the actual expenditure of a GP practice would differ from the budgeted amount due to characteristics of the patients not taken into account in the formula (socioeconomic characteristics, chronic diseases, private coverage and so on), variations in clinical practice between GP practices, random variations in the level of disease and price variations. For a population of 10 000 inhabitants (a reasonable mode for a GP practice) there is a one-third probability that the actual expenditure will deviate more than 10 per cent from a well-designed budget.22... 

The combination of nitrates and hydralazine improves the composite endpoint of mortality, hospitalizations for HF, and quality of life in African Americans who receive standard therapy. A fixed-dose combination product is available that contains ISDN 20 mg and hydralazine 37.5 mg (BiDil). Practice guidelines recommend adding ISDN and hydralazine as part of standard therapy in African Americans with moderately severe to severe HF. The combination may also be reasonable for patients of other ethnicities with persistent symptoms despite optimized therapy with an ACE inhibitor (or ARB) and /Tblocker. The combination is also appropriate as first-line therapy in patients unable to tolerate ACE inhibitors or ARBs because of renal insufficiency, hyperkalemia, or possibly hypotension. 

We are currently on the cusp of a new era in the treatment of cancers whereby we will learn to incorporate new drugs that are likely not cytotoxic on their own but when used in combination with standard chemotherapy and radiation hold the promise of superior tumor responses that will hopefully translate into improved local control and improved survival. At the same time it is reasonable to expect an increased selectivity for malignant cells compared to normal tissues given that many of these targets are either not altered in normal cells or their expression is not usually increased in normal tissues. This leads to the anticipation of no increase in normal tissue toxicities when these novel targeted agents are used to treat patients. 

With regard to reproductive toxicology, standard studies are generally not required before FTIH trials, unless there is reason to believe that there might be a risk for reproductive function based on the nature of the product, the indication, or the intended patient population. 

A population of patients in a cholesterol lowering study have total cholesterol measured at baseline. Assume that total cholesterol is normally distributed with mean, p = 7.0 mmol/1 and standard deviation, s = 1.1 mmol/1 so that the variance is 1.21 (= 1.1 ). We write this as N(7.0, 1.21). For historical reasons we put the variance as the second parameter here. Under these assumptions the following results hold ... 

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