By Y. Tamkosch. University of Pittsburgh.

Concurrent use with orthodox medicines There are two problems here: an enhanced activity from the herbal medicine or the orthodox medicine buy cenforce 100mg otc, or both cenforce 100 mg discount, and an intrinsic toxicity quality 100 mg cenforce, real or threatened, from the allopathic ingredient. Aristolochia is an example of a herb that not only is toxic in its own right but also its administration concurrently with allopathic drugs in Chinese herbal preparations (albeit inadvertently) may potentiate its action, causing severe adverse reactions (see below). More recently, the New Zealand Director General of Health advised consumers against taking a Chinese product known as cheng kum because it contained a pharmacy- only antihistamine that could cause drowsiness. They were advertised for use in the treatment of various conditions, including the promotion of joint mobility, healthy skin, as a support during menopause and of benefit while consuming alcoholic drinks. The Ministry of Health made the ruling following complaints from doctors about the product. Another example is the intentional inclusion of steroids in oral175 and topical preparations176 used for the treatment of dermatological conditions. Following reports of positive clinical effects in the treatment of eczema, 11 Chinese herbal creams were analysed. The authors concluded that the risk of adverse reactions with such potent steroids is increased by their inappropriate use and application to areas of thin skin and on the face. It has been suggested that exported herbal remedies have been adulter- ated with synthetic drugs to improve their activity, and their popularity, in western countries. A dangerous evolution in the formulation of a Chinese herbal arthritis cure, Chuifong Toukuwan, manufactured by a laboratory in Hong Kong, has been dsecribed. The European Agency for the Evaluation of Medic- inal Products in London has a working party on herbal medicinal products, with the remit to include pharmacovigilance and the introduction of safety measures throughout member states. Currently, Chinese herbal suppliers are engaged in agreeing guide- lines to ensure that their medicines are of the highest quality and free from adulterants. Although still in its infancy, this approved suppliers’ scheme has provided a framework for future initiatives to increase confidence in the quality of Chinese herbs and herbal products. The aristolochia story – a complex problem180 Severe concerns about the safety of the herb Aristolochia arose in early 1992, when two women presented with extensive interstitial renal fibrosis to doctors in a Belgian clinic that specialised in weight-loss regimens. In the mid-1990s the formula was supplemented by the addition of powdered extracts of Chinese herbs. Subsequently, it was established from an epidemiological survey that Stephania tetrandra was the only herb associated with all the cases of renal disease. Most unexpectedly, the alkaloid normally derived from Stephania – tetrandrine – could not be found in the capsules taken by the affected patients. It was finally concluded that the Stephania tetrandra (han fang ji) must have been inadvertently replaced by Aristolochia fangchi (guang fang ji) in the powdered extracts delivered to Belgian suppliers. Herbal ingredients are usually traded using their common Chinese names and this can lead to confusion during translation. About 185 kg of the substituted han fang ji 168 | Traditional medicine was distributed to practitioners throughout Belgium but it was only one particular clinic that reported problems. The intrinsic nephrotoxic effects of the Aristolochia may have been potentiated in this case by the combination of orthodox drugs administered concurrently. The British National Formu- lary186 states that the use of diuretics for weight loss is inappropriate; this would seem to question the wisdom of including acetazolamide in the product. The Belgian medical authorities have also warned doctors not to prescribe slimming products composed of appetite inhibitors and diuretics. The women may have been more vulnerable to adverse reactions due to a weakening of general health caused by the calorie-controlled diet that they were following. Since 1994 a total of seven cases of Chinese herb nephropathy have been reported in France. In 1998 a case of reversible acute hepatitis in a patient using a Chinese herbal tea was reported in the Netherlands. Also around this time a case was reported in Spain of a patient with renal failure resulting from chronic intake of an infu- sion made with a mixture of herbs containing A. Her only existing medication was a herbal prepa- ration that she had been taking for about 2 years to treat her eczema. Renal function tests and a biopsy revealed substantial tubular atrophy and inter- stitial fibrosis in the cortex. The second patient was a 57-year-old woman who was admitted with renal failure and a 6-month history of anorexia, lethargy, nausea and weight loss. Subsequently, it was found that both patients had been exposed to aris- tolochic acids as a result of ingesting A. Of the 14 samples tested, a raw herbal material and a manufactured clematis product were found to contain Aristolochia. Pharmokinetic data for aristolochic acids 1 and 11 have been studied in rats, mice, guinea-pigs, dogs and humans after oral treatment. After oral administration, aristolochic acid 1 was readily absorbed from the gastrointestinal tract. After oral administration of aristolochic acid 1 to rats, about 91% of the dose was recovered from the excreta, equally divided in the urine and faeces. In vivo and in vitro studies have shown that aristolochic acids are both nephrotoxic and carcinogenic.

Study Guide for Fundamentals of Nursing: The Art and Science of Nursing Care purchase cenforce 100 mg with visa, 7th Edition cenforce 100 mg online. Whether problems are present or not cheap cenforce 100 mg free shipping, nurses specialist is the biologic father of their child. It must look for evidence of risk factors, and if seems that he lied to some couples about using identified, aim to reduce or control them, sperm from anonymous donors and deceived thereby preventing the problems themselves. In all situations, nurses must encourage behaviors pregnant when he had simply injected them that promote optimum function, independence, with hormones. Rosemary tells the nurse in her depressed since the death of his wife of 52 years, pediatrician’s office that she is concerned about 6 months ago. Recently, however, that I’m afraid I may be taking it out on her,” he spends all day sitting in a chair and seems to she says. Questioning reveals that Rosemary has have no desire to engage in self-care activities. Both Ted and Rosemary had commented the morning to bathe and “I just don’t seem to before about Sarah’s striking physical resemblance have the energy. Rosemary says, “Whenever I see her traces of previous meals, and he has a strong now I can’t help but see Dr. His adult children have complained thing inside me clenches up and I want to that their normally fastidious father seems not scream. Care Deficit, related to decreased strength and Nursing Diagnosis: Parental Role Conflict endurance, discomfort, and depression, as related to unexpected discovery about their evidence by matted and uncombed hair, new daughter’s biologic father, as evidenced by beard, food particles on face, and strong body parental concern about increased incidence of odor parental yelling and spanking and the anger b. Miss Adams sustained a right-sided cerebral the child evokes in her parents because of her infarct that resulted in left hemiparesis (paralysis physical resemblance to the fertility specialist on left side of body) and left “neglect. Prescott to ensure that he gets tested for colon times a week and was an avid swimmer. Nursing Diagnosis: Anxiety related to constipation Nursing Diagnosis: Body Image Disturbance, and possible bowel alterations related to left hemiparesis (paralysis), as evidenced Mr. Prescott would benefit from patient teaching/ by her ignoring the left side of her body follow- counseling regarding the need for stool testing. After trying to conceive a child for 11 years, Ted nurse could schedule a colonoscopy if ordered to and Rosemary Hines sought the assistance of a check for colon cancer. The nurse should address fertility specialist who was highly recommended the patient’s constipation and check with the by a friend. It was determined that Ted’s sperm primary care provider about scheduling a consult was inadequate, and Rosemary was inseminated with a gastroenterologist. What would be a successful outcome for this ple was told that the donor was healthy and that patient? Prescott states the warning signs of colon mary became pregnant after the second in-vitro cancer and agrees to schedule a colonoscopy fertilization attempt and delivered a healthy 3. Study Guide for Fundamentals of Nursing: The Art and Science of Nursing Care, 7th Edition. Teach patient the proper technique and appli- possible colon cancer cation for an inhaler. Walk with patient the length of the hallway other members of the healthcare team to meet the every 5 hours, encouraging her to rely on the needs of patients walker for support. Teach patient the importance of a well- tive patient advocate to counsel patients with bowel balanced diet and daily exercise; have patient alterations monitor daily caloric intake. Help patient sit up and dangle legs over side of Consults with other healthcare professionals, edu- bed; gradually help patient to stand and take cational materials on colon cancer, diet plans to several steps around the room. Selecting appropriate evidence-based nursing Multiple Response Questions interventions: Nursing interventions should be 1. Initial, ongoing, discharge care nurse quickly assesses safety in the home of a 4. Study Guide for Fundamentals of Nursing: The Art and Science of Nursing Care, 7th Edition. Basic human needs: The nursing care plan scale of 10), related to new administration should concisely communicate to caregivers schedule. Be familiar with standards and agency policies patterns obtained during the nursing history for setting priorities, identifying and recording that are needed to direct daily care (e. Remember that the goal of patient-centered every nursing diagnosis, as well as a place to care is to keep the patient and the patient’s note patient responses to the plan of care; for interests and preferences central in every aspect instance, if the nursing diagnosis is Impaired of planning. What are the should be written to turn patient frequently discharge goals for this patient, and how should and assess for skin breakdown. Trust clinical experience and judgment but be plan of care should record current medical orders willing to ask for help when the situation for diagnostic studies and specified related nurs- demands more than your qualifications and expe- ing care; for instance, if a diagnostic test is rience can provide; value collaborative practice. Respect your clinical intuition, but before estab- measures should be included in the plan of care. Have changes in the patient’s health status selecting nursing interventions, be sure that influenced the priority of nursing diagnoses? Recognize personal biases and keep an open ing to health and illness or the plan of care mind.

Of course cheap 100mg cenforce free shipping, the survivors of a mass disaster are the initial concern of the responders discount cenforce 100 mg line. Once this priority is accomplished 100mg cenforce amex, the eforts intensify to locate, identify, and return to their families those victims who did not survive. Te response eforts to multiple fatalities include recovery, autopsy as required, dental identifcation in multiple Fatality incidents 247 identifcation, and release of bodies to families or to their country of origin. Embalming may be a consideration, but in respect to religious concerns, should be done only afer identifcation and legal release. In some situations the overwhelming numbers of fatalities or other extenuating circumstances may require mass management and no individual processing. Tis type of body disposition must be defned in planning and training sessions and implemented when the situation warrants. Te direct family members have sufered a tremendous loss with the death in their family, but also could have sufered injuries or sustained signifcant personal property losses. In cases like the 9/11 World Trade Center attacks, we found that the responders who were in the line of fre and the same people depended upon to supply fre and police protection and assistance became part of the missing persons list. Normally local agencies have some emergency management resources in place to begin the initial operation. A large major- ity of responders may be volunteers who feel the need to give aid to families and victims in a time of need. Ofen there are imposters who try to cross the secu- rity lines just to look at the scene. Tis type of security problem must be prevented, and a good protocol for accepting volunteers must be in place. Many governments supply either salaried employees or activated employees to work at a disaster site. Tese contractors work for an entity such as an air carrier or government and provide the requested services. Tis individual is usually a medical examiner, coroner, or assigned emergency management director. It is recommended that all agencies involved have daily meetings to assess the progress of the operation and to determine how each agency is functioning. Te employee working an incident of course sees it as a job, but still will have that deep conviction to serve. Perhaps the simplest way to explain the worker’s need to serve is as a basic human 248 Forensic dentistry desire to assist those who have no other source of aid. Whatever the reason the responders come, the people to whom the services are being rendered should be, and most ofen are, aware of the great sacrifces these responders are making. Te forces of nature are very powerful and can easily destroy man-made objects and take human lives. Transportation of large numbers of people presents the possibility for large-scale injuries and death if an accident occurs. Most of nature’s disasters come very quickly and surprise the unsuspecting population. Weather and seismic predictors have been employed and improved as early warning systems that have the potential to save countless lives. Other than warning and evacuation to safer areas, there are no dependable ways and means to prevent natural disasters. One of the services deemed most needed for the families is a Family Assistance Center to provide the family members with things necessary for their comfort and well-being. Many times transportation accidents involve fuels, toxic container rupture, or other complications creating extreme hazards for the responders. A safety and dental identifcation in multiple Fatality incidents 249 hazmat team is used to maximize responders’ safety and protect the health of the public. Te most common form of terrorism seen in current times involves some sort of explosive device used to kill and maim large numbers of people. Control of the scene and maintaining appropriate chain of evidence is of utmost importance. Tere should be an assigned position for scene security to ensure the integrity of the investigation. In other mass disaster scenarios law enforcement ofcers may be utilized to fll the position due to the nature of their formal training. Each team member should be instructed on the importance of following the instructions of the site security ofcer. Whether it involves a single building or half a city, the barriers controlling the perimeter should be well defned and visible to workers and the public. Experience has shown that it is easier to decrease the area of control than to increase it, making it wise to establish a generous perimeter in the opening phases of the operation. In the past it was found that simple grid sys- tems worked well with fat scenes, similar to an airplane crash on land. It has been found in recent incidents that when dealing with collapsed buildings and water settings, simple grids fail to give adequate information about elevation and return points of reference. A control system needs to be established early in the incident to allow access to the crime scene to only authorized personnel.

The patients are then sorted advantages of such designs are when immediate according to their treatment cheap cenforce 100mg without prescription, the end point mea- high-dose therapy is contraindicated for tolerabil- surements are subjected to a statistical test and an ity reasons purchase cenforce 100 mg visa, and when there is likely to be large interpretation of the effect (or absence thereof) of variations between patients in the tolerability and the drug is made cenforce 100mg discount. The answer is that little can go wrong when there Patients are reviewed during and after comple- are ample patients, plenty of drug available, the tion of a course of therapy which may include choice of dose size has been perfect, the end points programmed changes in dose size. If the drug is are incontrovertible, the measurements are possible well tolerated they may progress to a course of using a rational or absolute scale, there is ample therapy at higher dose. A prospective limit on toxicological coverage for all the dose sizes dosing and the number of courses of treatment is employed and the trialist has an unlimited budget! It is best acceptable efficacy and simultaneous tolerability suited when there is no cast-iron assurance of have been observed. If the treat- among all treated patients in comparison to demo- ments in the first cohort prove to be well tolerated, graphic factors, disease subtypes and so on. A comparable into account a wide variety of dose sizes, and that number of placebo-treated patients to any single contemporaneous placebo formulations will be active-treatment group can be cumulated across needed. Some studies of this type are hybridized several cohorts, each cohort having fewer placebo- with a crossover strategy (see below). Shorter durations of patient par- respond to, lower doses before being exposed to ticipation are also usually associated with less higher doses. Any degree of treatment familiariza- missing data and fewer patients lost for adminis- tion, tachyphylaxis or patient withdrawal rate trative reasons. This can cause serious imbalance among treatment groups and Crossover studies seriously jeopardize the likelihood of achieving a statistically robust result. Crossover studies with Generally, crossover studies are more complicated three or more periods have a substantial advantage than parallel-group designs. Patients are exposed to over two-period designs, when the amount of miss- more than one test medication, in sequential treat- ing data is likely to be large and statistical salvage ment periods, perhaps with periods of no therapy is necessary (Ebbutt, 1984). Active therapies may be different drugs, or different doses of the same drug, or, in complicated studies, both. Ideally, end points should Less common are trial designs that specifically and be measured and unambiguously attributable to adaptively minimize the number of patients needed one of the test regimens. This requires no residual while preserving design integrity for appropriate effects of the previous regimen(s) (see Laska et al. If this involves intervening placebo treat- are now being succeeded by independent treatment ment periods in between test medications, then allocation in pursuit of this goal. All minimization clearly this approach is not possible when placebos designs involve arduous statistical planning, and are ethically unjustifiable. Although the statistical analysis is numbers of treatment periods, assigned using a rather different, they have the same objective, Latin square, have been reported; however, the which is to detect a treatment effect at the earliest logistics and patient retention in such studies are moment possible, using the fewest possible usually difficult, and these ideal designs are likely patients, while retaining statistical robustness. The Dixon ‘Up-Down’ technique was first In later phase studies, if there are still numerous described in the statistical literature in 1947. These toxicological tests, when a quantal response is expose patients to a random subset of all the measured (see Figure 9. Patients or groups of patients are paired verted into quantal responses with appropriate, and then treated with alternative therapies. For example, blood trol chart is developed that records the result of pressure is a continuous variable, but a drug may be each comparison with time, and crossing a bound- deemed effective or ineffective by stating prospec- ary on the chart after an unpredictable number of tively that a desired response is quantal positive paired comparisons gives the trial result. For a trial after a 15 mmHg fall in diastolic blood pressure of a new therapy that can both benefit and harm the within 60 days of commencing therapy. Theoreti- patient, a typical probability control chart forms a cally, this strategy can be implemented with groups ‘double-triangle’ pattern, as shown in Figure 9. The design of control charts is always an ‘adaptive’ trial design, because dose size is prospective, and their shape depends upon the a adapted according to the response of the previous priori expectations of the development team. Whitehead power calculations when assumptions of the size (1999) is the best entry to the literature on this of worthwhile differences in effect are also pro- specialized topic. For example, from a clinical point of view, a small-sized improvement in out- come (perhaps a few percent of patients more than Contemporaneous independent that observed for placebo treatment) may be treatment allocation viewed as very worthwhile in an extremely hetero- geneous patient population when subjected to mul- Taves (1974) has described a study design that tivariate analysis (this is common in large, simple requires an independent coordinator who allocates studies; see below). On the other hand, when each patient, as he or she is recruited to one or other designing a minimization study, the assumption treatment group. The independent coordinator is that the treatment groups will be devoid of rele- allocates each patient so as to minimize the differ- vant differences in baseline characteristics and, ence between the two treatment groups according therefore, clinical significance might only be to prospectively defined patient characteristics, for assumed to follow from a large-sized difference example, age, sex, genotype, disease state or stage, in patient response. This allocation is therefore is assumed to be of interest, as it increases, may also based upon the cumulating characteristics of compensate for the reduction in variability the treatment groups as has developed during the amongst study group samples, and thus have less study to date. Patients are therefore not allocated to than expected impact on the sample sizes needed to a treatment group by the chance of a randomization conduct the clinical trial. Minimization designs are probably under-used Bias in minimization trials can be avoided when by the pharmaceutical industry. Firstly, those performing not well designed for pivotal clinical trials nor for the clinical trial itself, that is administering test diseases with large numbers of prognostic factors, medications and measuring end points, should be where, in any case, large numbers of patients are double-blind and unaware of which treatment the especially needed for a tolerability database. Secondly, the independent controlled clinical trial is a gold standard, then it coordinator need only allocate patients to anon- would be wrong to assert that the independent ymous groups A or B, and the study pharmacist treatment allocation design is the ‘platinum stan- need be the only person who knows which treat- dard’ (pace Treasure and MacRae, 1998). Thirdly, the criteria interested reader is referred to a good published for which the treatment groups should be balanced example (Kallis et al.

Attention The most important goals of treating antisocial be- deficit/hyperactivity disorder is highly correlated with havior are to measure and describe the individual child’s antisocial behavior cheap cenforce 100mg overnight delivery. A child may exhibit antisocial be- or adolescent’s actual problem behaviors and to effective- havior in response to a specific stressor (such as the ly teach him or her the positive behaviors that should be death of a parent or a divorce) for a limited period of adopted instead purchase 100 mg cenforce free shipping. In severe cases buy cenforce 100mg on-line, medication will be ad- time, but this is not considered a psychiatric condition. Children who experience explo- ders have an increased risk of accidents, school failure, sive rage respond well to medication. Ideally, an interdis- early alcohol and substance use, suicide, and criminal ciplinary team of teachers, social workers, and guidance behavior. The elements of a moderate to severely antiso- counselors will work with parents or caregivers to pro- cial personality are established as early as kindergarten. In many cases, parents themselves need is, the degree to which they value, and are motivated by, intensive training on modeling and reinforcing appropri- approval from others. Yet underneath their tough exterior ate behaviors in their child, as well as in providing appro- antisocial children have low self-esteem. A variety of methods may be employed to deliver A salient characteristic of antisocial children and social skills training, but especially with diagnosed anti- adolescents is that they appear to have no feelings. Be- social disorders, the most effective methods are systemic sides showing no care for others’ feelings or remorse for therapies which address communication skills among the hurting others, they tend to demonstrate none of their whole family or within a peer group of other antisocial own feelings except anger and hostility, and even these children or adolescents. These probably work best be- are communicated by their aggressive acts and not neces- cause they entail actually developing (or redeveloping) sarily expressed through affect. One analysis of antiso- positive relationships between the child or adolescent cial behavior is that it is a defense mechanism that helps and other people. Methods used in social skills training the child to avoid painful feelings, or else to avoid the include modeling, role playing, corrective feedback, and anxiety caused by lack of control over the environment. Regardless of the method Antisocial behavior may also be a direct attempt to used, the child’s level of cognitive and emotional devel- alter the environment. Ado- that negative behaviors are reinforced during childhood lescents capable of learning communication and prob- by parents, caregivers, or peers. In one formulation, a lem-solving skills are more likely to improve their rela- child’s negative behavior (e. Few institutions can afford the will apply the learned behavior at school, and a vicious comprehensiveness and intensity of services required to cycle sets in: he or she is rejected, becomes angry and at- support and change a child’s whole system of behavior; tempts to force his will or assert his pride, and is then in most cases, for various reasons, treatment is terminated further rejected by the very peers from whom he might (usually by the client) long before it is completed. Schools “mutual avoidance” sets in with the parent(s), as each are frequently the first to address behavior problems, and party avoids the negative behaviors of the other. Conse- regular classroom teachers only spend a limited amount quently, the child receives little care or supervision and, of time with individual students. Special education especially during adolescence, is free to join peers who teachers and counselors have a better chance at instituting have similarly learned antisocial means of expression. The fact that peer groups have such a strong influence on behavior The adult with antisocial personality disorder dis- suggests that schools that employ collaborative learning plays at least three of the following behaviors: and the mainstreaming of antisocial students with regu- •Fails to conform to social norms, as indicated by fre- lar students may prove most beneficial to the antisocial quently performing illegal acts, and pursuing illegal oc- child. By judi- • Is deceitful and manipulative of others, often in order ciously dividing the classroom into groups and explicitly to obtain money, sex, or drugs. See also Antisocial personality disorder; Conduct dis- order; Oppositional-defiant disorder; Peer acceptance • Exhibits reckless disregard for safety of self or others, misusing motor vehicles or playing with fire. Further Reading • Is consistently irresponsible, failing to find or sustain Evans, W. The Behavior Management Handbook: Setting An individual diagnosed with antisocial personality Up Effective Behavior Management Systems. Boston: disorder will demonstrate few of his or her own feelings Allyn and Bacon, 1989. New York: Free Press, ity disorder with abuse, either physical or sexual, during 1965. Those with a parent with an anti- tion of Explanations of Delinquent Behavior, 2nd ed. Understanding Black Adolescent Male Vio- substance abuser, or have an extensive criminal record. Afrikan World In- Antisocial personality disorder is associated with low so- fosystems, 1992. Treatment Antisocial personality disorder is highly unrespon- Antisocial personality sive to any form of treatment. Although there are med- disorder ications available that could quell some of the symptoms A behavior disorder developed by a small percent- of the disorder, noncompliance or abuse of the drugs pre- age of children with conduct disorder whose be- vents their widespread use. Also ment programs are long-term, structured residential set- known as sociopathy or psychopathy. Some form of dynamic About 3% of males and 1% of females develop anti- psychotherapy is usually given along with the behavior social personality disorder, which is essentially the adult modification. Anxious few relationships in his or her life and is unable to trust, feelings interfere with a person’s ability to carry out nor- fantasize, feel, or learn.

It is identified by ness and is able to sense how physical signs order cenforce 100mg fast delivery, emo- pattern and by interaction with the larger whole” tional conveyances discount cenforce 100mg on-line, spiritual insights cenforce 100mg discount, physical (Newman, Sime, & Corcoran-Perry, 1991, p. Newman, Sime, and Corcoran-Perry (1991) Knowledge is arrived at through pattern recogni- concluded that the knowledge generated by the tion and reflects both the phenomenon viewed and particulate-deterministic paradigm and the inter- the viewer. In a later work, Newman (1997a) larger unitary field that combines person, family, asserted that knowledge emanating from the uni- and community all at once. A nurse operating out tary-transformative paradigm is the knowledge of of the unitary-transformative paradigm does not the discipline and that the focus, philosophy, and think of mind, body, spirit, and emotion as separate theory of the discipline must be consistent with entities, but rather sees them as an undivided each other and therefore cannot flow out of differ- whole. Newman states: Newman’s theory (1979, 1990, 1994a, 1997a, The paradigm of the discipline is becoming clear. The nurse and client things to attending to the meaning of the whole, from form a mutual partnership to attend to the pattern hierarchical one-way intervention to mutual process of meaningful relationships and experiences in the partnering. In this way, a patient who has had a of health that focuses on power, manipulation, heart attack can understand the experience of the and control and move to one of reflective, compas- heart attack in the context of all that is meaningful sionate consciousness. It reveals a world in his or her life, and through the insight gained, that is moving, evolving, transforming—a process. The old paradigm pro- practice and conduct research out of a unitary- poses methods that are analogous to trying to ap- participatory paradigm, which sees the process of preciate a loaf of warm bread by analyzing flour, the nursing partnership as integral to the evolving water, salt, yeast, and oil. No matter how much we definition of health for the patient (Litchfield, come to know these ingredients separately, we will 1993, 1999; Newman, 1997a) and is synchro- not know the texture, smell, taste, and essence of nous with participatory philosophical thought the loaf of bread that has just come out of the oven. For example, the smell of the loaf of bread provides one insight Essential to Margaret Newman’s theory is the belief into its nature, the texture provides another, and so that each person exhibits a distinct pattern, which on. Newman’s Theory of Health as Expanding Consciousness and Its Applications 221 consciousness. To explain this phenomenon, Each person exhibits a distinct pattern, Newman (1994a, 1997b) draws on the work of Ilya which is constantly unfolding and evolving Prigogine (1976), whose theory of Dissipative as the person interacts with the environ- Structures asserts that a system fluctuates in an or- ment. Pattern is information that depicts derly manner until some disruption occurs, and the the whole of a person’s relationship with system moves in a seemingly random, chaotic, dis- the environment. Nurses see this all the time—the patient mation that depicts the whole of a person’s rela- who is lost to his work and has no time for his fam- tionship with the environment and gives an ily or himself, and then suddenly has a heart attack, understanding of the meaning of the relationships an experience that leaves him open to reflecting on all at once (Endo, 1998; Newman, 1994a). Insights gained a manifestation of consciousness, which Newman through this reflection give rise to transformation (1994a) defines as the informational capacity of the of his life pattern, which becomes more creative, re- system to interact with its environment. Nurses also see this in To describe the nature of pattern, Newman people diagnosed with a terminal illness that causes draws on the work of David Bohm (1980) who said them to reevaluate what is really important, attend that anything explicate (that which we can hear, see, to it, and then to state that for the first time they feel taste, smell, touch) is a manifestation of the impli- as though they are really living. The expansion of cate (the unseen underlying pattern) (Newman, consciousness is an innate tendency of human be- 1997b). In other words, there is information about ings; however, some experiences and processes the underlying pattern of each person in all that we precipitate more rapid transformations. There is also information tual partnership with their patients to reflect on about their underlying pattern in all that they tell their evolving pattern. The insights gained in this us about their experiences and perceptions, includ- process lead to an awakening and transformation to ing stories about their life, recounted dreams, and a higher level of consciousness (Endo, 1998; Endo, portrayed meanings. Reflecting on the meaning of 1994; Litchfield, 1993, 1999, 2004; Moch, 1990; these conditions can be part of the process of Neill, 2002a, 2002b; Newman, 1995; Newman & expanding consciousness (Newman, 1994a, 1997a, Moch, 1991; Noveletsky-Rosenthal, 1996; Pharris, 1997b). Pattern recognition is a profound act of nurse Newman (1999) points out that nurse-client re- caring in that it focuses on knowing the patient, lationships often begin during periods of disrup- family, and/or community at a very deep level tion, uncertainty, and unpredictability in patients’ (Newman, 2002b). When patients are in a state of chaos because the context of a caring nurse partnership, which is of disease, trauma, loss, etc. The pattern will be revealed at a higher level of Endo (1998) in her work in Japan with women organization. Newman (1999) states: To explain the concept of a choice point more clearly, Newman draws on Arthur Young’s (1976) The “brokenness”of the situation. Young in partnership with clients and dance their dance, suggests that there are seven stages of binding and even though it appears arrhythmic, until order begins unbinding, which begin with total freedom and un- to emerge out of chaos. We know, and we can help restricted choice, followed by a series of losses of clients know, that there is a basic, underlying pattern freedom. After these losses comes a choice point Emergence of new order at higher level of organization Period of disorganization, unpredictability, uncertainty (response to Normal disease, trauma, loss, etc. Newman’s Theory of Health as Expanding Consciousness and Its Applications 223 and a reversal of the losses of freedom, ending with Potential Freedom Real Freedom total freedom and unrestricted choice. These stages can be conceptualized as seven equidistant points on a V shape (see Figure 15–2). Beginning at the uppermost point on the left is the first stage, poten- Binding Unbinding tial freedom. In this stage, the individual is sacrificed for the sake of the col- lective, with no need for initiative because every- thing is being regulated for the individual. The Centering De-centering third stage, centering, involves the development of an individual identity, self-consciousness, and self- determination. Pattern is higher than form; the The process of expanding consciousness is pattern can manifest itself in different forms. In this characterized by the evolving pattern of the person- stage the person experiences the power of unlimited environment interaction (Newman, 1994a).

Outdated documents should be and the data were recorded buy 100mg cenforce visa, analyzed and accu- retrieved and identified as historical generic 100 mg cenforce with amex. Altered data: Data that have been legitimately nal facilities) is strongly encouraged purchase 100mg cenforce mastercard. A wealth of obtained, but that have been subsequently chan- information about approaches, needs and expecta- ged to bias the results. Omitted data: The non-reporting of data, which forthcoming inspections and for formulating has an impact on study outcome, for example, responses to inspection reports. Fabricated data: Data that have been deliber- lish systems and procedures which ensure that a ately invented without performing the work, for company is always ready for an inspection. Their current organizational charts and job descriptions, independent and objective perspective of the situa- contracts in place with all external providers and so tion will be important to provide an unbiased view on. Fraudulent practices in clinical trials can lead to trial subjects being exposed to safety risks, to sub- 13. Application of risk assess- Language in which the audit will be conducted ment and management methods may be helpful to and the audit report will be written where this is identify high-risk areas in the company’s clinical different from the language of the auditor and/or research environment. For each individual audit, it is useful to prepare an audit plan to provide the auditee with an over- view on the audit components and the conduct of Audit-related correspondence the audit. It is to inform the auditee in writing of the planned common practice in clinical research to draw up audit and to agree on a mutually feasible audit an audit plan and distribute this information prior date. Type and scope of the audit; organizational and After the audit, a letter to the auditee should functional units and processes to be audited. Audit team Names, roles and responsibilities of the audit team members and technical experts accompa- Prior to the audit, the audit team needs to be estab- nying the audit team, if appropriate. The lead auditor must be nominated and to confer periodically to exchange audit observa- responsibilities for the individual team members tions and information to assess the audit progress. Technical experts should be independent of informed without delay in case serious deficien- the auditee and activities to be audited. In any case, cies are uncovered which may pose a high risk the responsibility for the audit will rest with the for either trial participants or the clinical data. Likewise, if the audit scope cannot be covered during the scheduled time for the audit, the auditee and/or the sponsor must be notified and Audit tools appropriate action should be determined (e. Checklists, audit Audit notes, audit evidence, audit questionnaires and sampling plans are useful findings and audit conclusions tools and should be prepared prior to the audit. All information collected during an audit is questionnaires are very useful to record audit considered audit evidence. Information sources in observations, they should never restrict the extent an audit are, for example, document review, inter- and scope of audit activities and allow for flexibil- views and observation of activities. Audit observations are only consid- Opening meeting ered audit findings if it is determined after compar- ison with audit criteria that these are not or An opening meeting should be held with the audi- insufficiently fulfilled. And finally, audit conclu- tee and his/her management, if appropriate, and sions can be drawn to assess whether the audit those responsible for the functions and processes to findings impact the validity of the clinical data be audited, in order to confirm the audit plan and and the safety of the trial subjects. The purpose of the meeting is also to confirm that documents to be audited and Closing meeting individuals to be interviewed are available. It is good auditing practice at the termination of the audit to conduct a closing meeting with the auditee Communication during the audit to present the audit findings and conclusions. This is also the last opportunity for the auditee to clarify Depending on the duration of the audit, interim potential misunderstandings by the audit team and meetings with the auditees may be necessary to to provide requested documentation. The lead discuss interim results, ideally at the closure of auditor should chair this meeting and, if applicable, each audit day. Format and layout of audit report which should then be disseminated to the reports vary greatly between companies and can recipients as agreed with the sponsor. The lead auditor is responsible for that they should not be made publicly available or preparing the audit report and should be assisted by distributed to persons outside the company. Ideally, the audit report ulatory authorities should not routinely be pro- should be prepared as soon as possible after the vided with audit reports. It is kind of a ‘neutral’ audit, if appropriate; document and does not make reference to deficien- cies or findings observed during the audit. It merely identification of the auditee and organizational documents that an audit has taken place and is and functional units and processes audited; issued by the lead auditor at the termination of the audit. The auditee and/or recipient of the audit criteria and reference documents; audit report are responsible for initiating follow-up activities. Both approaches are value-adding uates if trial procedures are accurately, completely, and ensure that clinical trials are conducted accord- clearly and consistently described in the protocol so ing to accepted principles, that trial participants are that misinterpretations are prevented. The information sheet and informed consent ling, recording, processing, analysis and reporting. These audits evalu- information on protocol and informed consent ate whether a system (e. Also, delegation of responsibilities and few investigator sites to conduct a 100% review of tasks is discussed at this stage of the audit. Access should be system allows evaluating the retrieval procedures restricted to authorized personnel and should be of trial documents to ensure that the documents are controlled.