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Clinical research in pediatric nephrology: state of the art.

The goals of clinical research include comparing new and standard treatments, establishing treatment efficacy, defining risk factors for disease, elucidating pathophysiologic mechanisms of disease, and establishing causation. Although the randomized clinical trial has been the "gold standard" in clinical research and is the strongest study design to establish causation for many clinical research questions, an interventional study or "experiment" such as a randomized trial is often not possible. Observational study designs also demonstrate associations between exposures and outcome. To determine whether these associations are likely to be causal, one can assess a number of qualities, first outlined by the British epidemiologist Sir Austin Bradford Hill. These qualities include analogy to what is known; the plausibility, strength and specificity of the association; consistency and coherence across studies; the temporality of the putative cause and effect; and the presence of a biological gradient. The presence of these factors adds weight to the probability that a given association is causal. Systematic reviews and meta-analyses use these factors in combining studies to assess whether associations are cause and effect. Additionally, new methods in the analysis of longitudinal data collected in observational studies can help to determine causation. In this review, we will use recent literature and contemporary topics in pediatric nephrology to illustrate state-of-the-art research methods using classic epidemiological elements needed to establish causation.

Biomedical Research↗

In pursuit of an artful death: discussion of resuscitation status on an inpatient radiation oncology service.

GOALS OF WORK: Consensus has emerged among health practitioners, legal experts, clinical ethicists and the public that end-of-life decisions should be the shared responsibility of physicians and patients. In discussion of withholding cardiopulmonary resuscitation in cancer patients, however, opinion remains divided. We performed a quality assurance investigation on the use of the 'do-not-resuscitate' (DNR) order on an inpatient radiation oncology service to determine how often DNR orders are accompanied by a description of informed consent. PATIENTS AND METHODS: Records of patients admitted 1 July to 31 December 2002 were identified and reviewed to determine the presence or absence of a DNR order. Circumstances surrounding the order, including evidence of informed consent, were determined. MAIN RESULTS: The study population comprised 96 patients admitted 109 times. The median age was 64 years, and in 56.0% of admissions, the patient was female. In 26.8%, the patient had lung cancer. The intent of admission was curative in 53.2%, and palliative in 44.0%. DNR was recorded for 30.2% of patients, and there was evidence of informed consent in 41.4%. In 89.7% admission was with palliative intent. Nine patients (9.4%) experienced cardiac arrest; all were DNR at the time of their event. CONCLUSIONS: While almost one-third of the patients on this inpatient radiation oncology service had documented DNR status, informed consent appeared to have been obtained in fewer than half. Patient involvement in resuscitative decisions should be an ethical obligation. Performed well, this may also allow for exploration of patients' needs at the end of life, to allow the pursuit of what Nuland terms an 'artful death'.

Adolescent↗

Aortoiliac endarterectomy: a lost art?

Endarterectomy was first performed on a superficial femoral artery in 1946 by Cid dos Santos and subsequently on the abdominal aorta by Wylie in 1951. During the 1950s and 1960s, aortoiliac endarterectomy (AIE) was the standard procedure for treatment of aortoiliac occlusive disease. When prosthetic graft material became available, aortobifemoral bypass (ABFB) replaced AIE in most cases because occlusive disease commonly affects the external iliac arteries also, which were difficult to endarterectomize. As a result, aorto-common iliac endarterectomy became almost a lost art. However, we believe there is still a place for AIE in selected patients based on a review of our results with the procedure. We reviewed 205 patients who survived 10 years after undergoing operation for aortoiliac occlusive disease by either aorto-common iliac endarterectomy (n = 39) or ABFB (n = 166). Ten-year primary patency was 89.2% for AIE and 78% for ABFB. Graft infection or aneurysmal formation occurred in 5% of ABFB and 0% of AIE cases. Ten male patients who underwent AIE for leg and hip claudication with positive penile/brachial indices of </=0.6 enjoyed improvement of erectile dysfunction. Twenty of the 39 AIEs were in female smokers with small vessels, localized disease, and elevated triglycerides. Three patients with end-to-side infected ABFB grafts, two with enteric fistula (one ours, two referred), had their grafts removed, followed by AIE with vein patching of their bypass sites. All three patients survived and at 10-year follow-up had patent reconstructed aortofemoral vessels. Since AIE avoids prosthetic material, it is preferable to ABFB in (1) patients whose aortoiliac occlusive disease does not involve the external iliac arteries; (2) male patients with aortoiliac occlusive disease who, in addition to claudication, have erectile dysfunction with penile/brachial indices of </=0.6 and stenotic internal iliac origins; (3) patients with aortoiliac disease including the external iliac arteries who are not candidates for ABFB because of infection risk or small vessels; (4) patients with localized aortoiliac disease; and (5) patients after removal of an infected ABFB graft (with or without an enteric fistula) that had initially been placed end-to-side for aortoiliac occlusive disease.

Aorta, Abdominal↗

Differences in serum LH and FSH levels using depot or daily GnRH agonists in controlled ovarian stimulation: influence on ovarian response and outcome of ART.

PURPOSE: To study effects of endogenous LH levels on ovarian response and outcome in ART cycles a controlled study was performed with two patient groups differing in the intensity of pituitary downregulation. METHODS: Group I (n = 27) received 3.75 mg of the GnRH agonist triptorelin acetate depot, group II (n = 54) was given 0.1 mg triptorelin acetate daily, followed by ovarian stimulation with recombinant FSH. RESULTS: After downregulation serum LH and FSH levels were significantly lower in group I. Patients of group I needed significantly higher FSH doses to achieve comparable levels of serum estradiol and preovulatory follicles. The number of retrieved oocytes and transferable embryos was lower in group I. CONCLUSION: Patients with profound endogenous LH suppression by depot GnRH agonists show higher FSH stimulation dose requirements and lower oocyte number and fertilization rate, indicating a need for minimal LH activity in folliculogenesis and oocyte development.

Adult↗

The art of perimetry.

There is no single method of perimetric examination which is applicable to all types of visual field defects. Perimetry is a subjective psychophysical sensory examination. It is not an exact science unless one includes the objective measurement of visual evoked response in the optic cortex. Until such a method becomes clinically available it will be necessary for the perimetrist to determine which techniques to use in a given case and to apply these techniques with sympathetic understanding. This is the art of perimetry.

Carotid Artery Diseases↗

Lyoluminescence dosimetry part II. State-of-the-art.

This is the second part of a review dealing with the development and current state-of-the-art of lyoluminescence dosimetry. Readout equipment described in the review covers a range of devices from simple manually-operated apparatus to semi-automatic machines suitable for loose powders and for encapsulated dosimeters. The survey of dosimetric properties of mannose and glutamine includes response to X- and gamma-rays, electrons, heavy charged particles and to neutrons. Current applications of lyoluminescence dosimetry include radiotherapy, radiation processing of foods and sterilization of medical products, as well as the use of lyoluminescent phosphors for gamma-ray dose intercomparisons in the high-dose range.

Electrons↗

A survey of the state of the art of clinical biochemistry laboratory computerisation.

This paper presents the results of a survey which was recently carried out in order to clarify the current 'state of the art' regarding the use of computers in hospital biochemistry laboratories. Information was obtained by means of a questionnaire which was mailed to a sample of United Kingdom hospital laboratories. The results obtained from the analysis of the data from the questionnaire replies are presented, and conclusions are drawn regarding the implications of hospital laboratory computerisation.

Chemistry, Clinical↗

Risk management in chemical safety: some general observations relating to the state of the art.

Risk management for chemical safety begins with judgement and produces arbitrary regulations. In between, technical risk assessment has value in clarifying the behaviour of particular chemical risk systems. Risk quantification can be useful in some cases and quite misleading in others. In no case can it alone be the decisive factor. In the public's perception, chemicals are feared most for potential insidious exposure in the general environment. Risk management then must deal with high system uncertainty and information heavily influenced by value judgements. The technical contribution to risk assessment is reduced, in real terms, as the decision-making scenario expands with its increasing exposure to system 'noise', interference and misinformation. Improved communication in the system requires the use of simplified language. The suitability of risk estimation methodologies must be assessed in terms of general comprehensibility in the management for chemical safety will remain, perhaps always, more of an art than a science, concerned with an interplay of information that can be 'rationalised' with other information that defies such rationalisation.

Communication↗

Purification of Art v I, a relevant allergen of Artemisia vulgaris pollen.

An allergenic protein from Artemisia vulgaris pollen has been purified to homogeneity. Its molecular weight in native conditions is 47,000. The purified allergen, hereafter denominated Art v I, is a monomeric protein. It is a clinically relevant allergen since, at least, 70% of the individuals allergic to Artemisia vulgaris pollen have specific IgE in serum and in mast cells, demonstrated by ELISA and skin prick tests, respectively.

Allergens↗

Cost-utility in practice: a policy maker's guide to the state of the art.

In recent years QALYs (quality adjusted life years) have achieved considerable fame or perhaps even notoriety in health services policy making. Yet little has been done to date to assess the potential benefit in policy terms of studies that have used cost-utility analysis (CUA). It was in recognition of this fact that this particular investigation was undertaken. An evaluation of 51 cost-utility studies is reported in the paper. Several criteria were applied to each study including aspects of technical and policy relevance. The main findings were: few studies had been undertaken; they were limited to few areas of health care; their technical execution was often of poor quality; the majority of studies used the empirical findings of health state valuations obtained from original developers of different quality of life techniques; and many claimed their results to be 'favourable' (i.e. efficient interventions). This claim, however, is misguided because individual results get fed into generalised QALY league tables which ignore the context of specific studies and use results not performed on a common basis. Consequently, the state of the applied art of CUA is currently open to considerable question.

Cost-Benefit Analysis↗

Medical needs of performing arts students.

A questionnaire was administered to 71 college students enrolled in dance, drama, and musical theater programs to assess health care problems, injuries, risk-taking behaviors, and sources of care. Many desired help with depression, fatigue, and chronic bone or joint pain, although 37% identified no regular physician. Thirty-nine students reported 87 injuries involving the back, foot, ankle, and knee; 12% sustained injuries at least monthly; and 72% of injuries occurred in class. The incidence of eating disorders appears to be low, as assessed by indirect measures such as body weight, oligomenorrhea, diet pill or laxative use, and scores on a body image index. The 30-day prevalence of tobacco use was 26%; marijuana, 11%; and alcohol, 71%. This survey suggests that performing arts students have important unmet health care needs.

Adolescent↗

Tongue piercing (oral body art).

Oral body art is a relatively recent fashion in the West where jewelry is inserted in the oral soft tissues. A patient who had tongue-piercing is presented, and the subject of oral piercing reviewed.

Adult↗

New legal rules for an old art of healing: the case of Zairian Healers' Association.

Legitimacy of traditional medical practice could be recognized by modern legal codes in Africa through quite simple procedures. However, legal recognition of traditional medicine implies also the examination of more fundamental aspects of "laws regarding the art of healing': for example, what legal status can be given to cultural categories such as witchcraft, spirits and magic? To ritual therapeutics used concurrently with herbal remedies? To diagnostic procedures such as divination? This paper insists on the fact that both dimensions in traditional medicine, natural and meta-natural, must be assumed within the official legal framework. Western-oriented codes of law, such as they generally exist in African States, are limited in their capability to integrate the African medical conceptions. This limitation is discussed in this text.

Delivery of Health Care↗

Three bodies of practice in a traditional South Indian martial art.

This paper describes three interconnected conceptions of the body in kalarippayattu, the martial tradition of Kerala, South India. It traces continuities and discontinuities among concepts and practices recorded in classic source texts and contemporary martial practice for each of the three 'bodies of practice'. The first is the fluid body of humors and saps. The second is the body as superstructure composed of bones, muscles, and vital spots (marma-s), which supports the fluid body. The concepts and practices of the first two bodies are based on the regional tradition of Ayurveda. They constitute the external physical body (sthula-śarira). The third, subtle or interior body (suksma-śarira) is thought to be encased within the physical body. It provides an experiential map of practice and is the basis for higher stages of meditation. The long-term practice of the martial art (1) makes the body fluid so that healthful congruence of the humors occurs, (2) establishes an intuitive and practical knowledge of vital points (marma) useful in fighting (prayogam) and in treating injuries, and (3) purifies the subtle body and awakens the internal vital energy (prana-vayu) that is manifest as the power (śakti) of the master in combat or medical practice. The paper concludes with a discussion of the interrelationship between these three concepts of the body in the accomplished practice of the martial practitioner.

Body Fluids↗

Growth and development of state of the art care for people with congenital heart disease.

For 40 years the American College of Cardiology has been a responsible organization in promoting the art and science of cardiac care for people of all ages. This review chronicles the leapfrogging of medical and surgical creativity and contributions to saving lives and making those lives healthy through informed care for people with congenital heart disease.

Cardiac Surgical Procedures↗

Art hazards.

The diseases associated with art forms range from trauma (vibration syndrome, flying objects, etc) and heat exposure, to heavy metal and solvent exposure. Specific substances such as ozone, cadmium, and molybdenum have unique diseases associated with them. Sadly, artists may not have the medical knowledge to know how to deal with or avoid hazards. They and their immediate families often may be at risk. Many artists are not educated in what protective gear to use and do not have the money to purchase the specialized equipment for their particular work, or they refuse to wear protective gear because they are uncomfortable in the conditions encountered in the workplace. Education is often required for the use of the protective gear (respiratory, eyewear, contact protection). To make matters worse, artists are poorly protected from toxins. Government regulations are not adequate to protect self-employed artists. Laws regulating children's exposure do not address long-term toxicity. Most artists with acute problems present to the ED first. An awareness of the occupational hazards to which self-employed artists are exposed will prevent the treating physician from overlooking important clues. When an artist presents with unusual symptoms, the physician must get a complete occupational history and must have the patient bring a list or samples of any substances to which he or she has been exposed. In essence, artists are a group of enthusiastic, hardworking people that can be protected by a keen awareness of these basic principles by the treating physician.

Adult↗

Medicine, practice and guidelines: the uneasy juncture of science and art.

While physicians are often portrayed as scientists, the defining character of medical practice is its being both science and art. Indeed, despite drawing on the ever-expanding knowledge base and range of therapies, medical practice remains fundamentally an interpersonal experience, drawing on the dynamic and rich interaction between practitioner and patient. With the goal of situating clinical practice guidelines in a broader context, we briefly explore models of medicine and the nature of clinical practice. The implications of these for guideline development and implementation are then examined as we present guidelines as an opportunity for enhancing medical practice and increasing both patient and practitioner satisfaction.

Humans↗