Restructuring critical care services. Part II: A proven assessment and redesign process.
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Critical Care↗
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Results for “harmonization of care”
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US regulatory hurdles: towards international harmonization.
What regulatory requirements must be met before a new medical device can be marketed in the USA? In this article, David Thomas reviews the regulations, examines the impact of recent legislation and looks at the emerging trend towards international harmonization of the regulation of health care products.
Biosensing Techniques↗
Evaluation of the draft international standard for a reference terminology model for nursing actions.
PURPOSE: The purpose of this study was to evaluate the draft ISO reference terminology model (RTM) for nursing actions. Nursing RTM models attempt to include concepts that are universally represented in nursing documentation to improve the depiction of nursing practice in computerized systems. METHOD: Content analysis was used to decompose interventions into words and phrases, which were then mapped to the six model categories used to represent nursing actions in the draft ISO RTM. The decomposition of interventions was applied to nurses' documentation of pain interventions entered into a clinical information system. FINDINGS: Consistent with the ISO standard requirements, all (100.00%) of the interventions contained an word or phrase and a < >. Additional findings are discussed in relation to earlier studies of terminology models. CONCLUSIONS: It is recommended that terminology and information system developers consider this model in their ongoing system development, evaluation, maintenance, and revisions. Further evaluation of the ISO RTM for nursing will contribute to the goals of this specific model and the harmonization and integration with other health care models.
Computational Biology↗
Loss of consciousness from acute quetiapine overdosage.
BACKGROUND: Quetiapine (Seroquel) is a new atypical antipsychotic agent developed for the treatment of schizophrenia. This dibenzothiazepine derivative possesses high affinity for 5-HT2 receptors with lower affinity for D1 and D2 dopamine receptors. In comparison to other antipsychotic agents, quetiapine has less antimuscarinic and alpha1 antagonist receptor activity. Overdose reports outside of clinical trials are limited. We report an intentional overdose of quetiapine by a schizophrenic. CASE REPORT: A 26-year-old female presented to the emergency department following an alleged ingestion of greater than 10,000 mg of quetiapine. At 1 1/2 hours postingestion, the patient was awake, ambulatory, and responded to verbal stimuli. At 2 1/2 hours postingestion, the patient experienced a decreased level of consciousness and responded only to deep pain. Physical findings included sinus tachycardia, pupils 3-4 mm and sluggish, and BP 135/70. Within 16 hours, the patient became awake and alert and was subsequently extubated. Serum electrolytes and blood count were unremarkable. The electrocardiogram at 18 hours postingestion showed a sinus tachycardia, which lasted for approximately 40 hours postingestion. A follow-up electrocardiogram at 42 hours postingestion was normal. CONCLUSION: This ingestion resulted in the loss of consciousness with need for airway protection and persistent tachycardia. Major overdoses of quetiapine warrant close observation in an intensive care setting.
Adult↗
Diagnostic accuracy and cost-effectiveness of contrast echocardiography on evaluation of cardiac function in technically very difficult patients in the intensive care unit.
Echocardiographic assessment of cardiac function can be quite difficult in the intensive care unit and may require transesophageal echocardiography (TEE). We therefore compared harmonic imaging alone or in combination with contrast to TEE in 32 consecutive patients in the intensive care units who were considered technically very difficult (> or =50% of the 16 segments not visualized from any view). Excellent or adequate endocardial visualization was achieved in 13% of segments with fundamental imaging, 34% with harmonic imaging, and 87% with contrast (p < 0.0001); the latter success rate was similar to TEE (87% vs 90%; p = NS). When TEE was used as the standard, agreement in exact interpretation of wall motion increased from 48% for fundamental imaging to 58% with harmonic imaging, and reached 70% with contrast (p <0.0001). Contrast had the best sensitivity (89%) for detecting wall motion abnormalities. Estimation of ejection fraction was possible in 31% with fundamental imaging, 50% with harmonic imaging, and in 97% with contrast. Ejection fraction quantitated by contrast enhancement correlated best with TEE (r = 0.91). Cost-effectiveness analysis revealed that contrast echo was cost-effective compared with TEE in determining regional and global ventricular function, with a cost saving of 3% and 17%, respectively. Thus, contrast echocardiography provides an accurate, safe, and cost-effective alternative to TEE for evaluating ventricular function in technically very difficult studies.
Albumins↗
Harmonization, regulation, and trade: where do we go from here?
The U.S. Food and Drug Administration is increasing its emphasis and participation in international harmonization activities. Forces that have led the agency in this direction include increased trade, the multinational nature of the pharmaceutical industry, trade agreements such as NAFTA and the new GATT World Trade Organization agreement, European activism, and pressures on the industry to control costs. These pressures include intense competition and health care reimbursement controls. The centerpiece of FDA's harmonization initiatives in the pharmaceuticals area is ICH. ICH is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. FDA also works with the World Health Organization and other international organizations to set standards for health care products.
Drug Industry↗
Blue Cross home care benefits: the Michigan experience.
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Adult↗
Has the Quick or the Owren prothrombin time method the advantage in harmonization for the International Normalized Ratio system?
Prothrombin time (PT) is the most commonly used coagulation test in health care. We sought here to compare two major PT methods (Quick and Owren) for harmonization of International Normalized Ratio (INR) results. We measured PT with an ACL 7000 analyser. We used three Owren and three Quick reagents for PT, and estimated the International Sensitivity Index (ISI) for each reagent using two local and two manufactured ISI calibrator sets. The coagulation time was measured using five different normal plasmas to assess variation for every reagent and both methods. We studied the analytical bias for every reagent and both methods at INR = 1.0 and INR = 2.5. The mean percentage coefficient of variation of the Owren reagent ISI was 2.40% and that of the Quick reagent ISI was 12.85%. The mean percentage coefficient of variation of normal plasma seconds for the Owren method was 2.54% and that for Quick was 4.02%. The absolute error at INR = 1.0 and INR = 2.5 was 0.00 and 0.04 INR for Owren, and 0.01 and 0.16 INR for Quick. The Owren PT method has the advantage over the Quick PT method in ISI calibration, normal plasma variation, within-run analytical variation and absolute error at INR = 2.5. The INR system is more demanding on analytical quality than earlier units (Ratio,%). The data would indicate that the Owren PT method has advantages over the Quick PT method in harmonization of the INR system.
Calibration↗
Public-health psychiatry in today's Europe: scope and limitations.
BACKGROUND: Public-health psychiatry is concerned, on the one hand, to ensure access to mental health services for all persons in need and, on the other hand, to advance knowledge of the social and environmental risk factors of mental disorders, and to establish a basis for preventive action. It is unclear how far current European Community (EC) policies will serve to achieve these objectives. This study aimed to review the mental health reform policies adopted in European countries since 1970, and to identify the main factors impeding progress in practice and research. METHOD: The relevant publications and statistical documentation for EC countries over the period in question were analysed. RESULTS: Despite a broad consensus on principles and aims, the implementation of mental health reforms in EC countries has been slow. Progress is subject to constraints imposed by service infrastructures, reductions in state responsibility, changing public attitudes, and growth of relative poverty. Much inferential evidence has accumulated on the importance of social risk factors such as unemployment and socio-economic deprivation, but most studies have had to rely on analysis of ecological correlations, based on administrative data, and there is an urgent need for more direct research making use of case- control and cohort study designs. CONCLUSIONS: EC harmonization will lead to improved mental health care only if the basic principles of public-health psychiatry are adopted and put into practice.
Community Psychiatry↗
Minimizing postinsertion problems: a procedure for removable partial denture placement.
A procedure for removable partial denture placement has been described. This procedure involves correction of pressure spots and overextensions, harmonizing of occlusion, and patient home-care instructions. Use of this procedure does not eliminate the need for postinsertion observations. Postinsertion adjustments, however, may be minimized by careful attention to each step at the placement visit.
Dental Occlusion, Balanced↗
Management of acute urinary retention.
Acute urinary retention (AUR) is a common urological emergency, characterized by a sudden and painful inability to pass urine. There is high variability within and among countries in its management, which can be explained not only by differences in access to care but also by a lack of harmonization and consensus on the best way to proceed. Immediate treatment consists of bladder decompression, usually by a urethral catheter, although a suprapubic catheter offers several advantages not often exploited by urologists. Until recently, secondary management consisted almost exclusively of prostatic surgery within a few days (emergency surgery) or a few weeks (elective surgery) after a first AUR episode. The greater morbidity and mortality associated with emergency surgery, and the potential morbidity associated with prolonged catheterization, has led to the increasing use of a trial without catheter; this involves catheter removal after 1-3 days, allowing the patient to void in 23-40% of cases, and surgery, if needed, at a later stage. Alpha1-adrenergic blockers given before catheter removal improve the chances of success. A high prostate-specific antigen level and postvoid residual urine volume, and response to alfuzosin treatment after a first AUR episode managed conservatively, may help to identify patients at risk of an unfavourable outcome.
Adrenergic alpha-Antagonists↗
Health technology assessment in Switzerland.
Switzerland has a mixed public and private healthcare system. All citizens are enrolled in compulsory basic health insurance. A 1996 law allows people to choose among different sickness funds and managed care plans. The federal government is empowered to act on important health issues, but the 26 cantons have prime responsibility in health care and social welfare. They have their own laws on health care, hygiene, hospitals, and social welfare. These laws are not harmonized. The system is complex, with a mix of public (mainly hospitals) and private (mainly doctors' offices) providers. The health services are decentralized. Ambulatory care was traditionally provided in doctors' offices, but the last decade has seen the development of centers for day surgery, group practices, and managed care plans. Decisions on placement, location, and extension of services are decentralized. The payment system is very complex. Current trends include global budgets, cost analyses, and prices related to patient categories. However, coverage policy is developed centrally and includes both traditionally established services and new technologies. New technologies are added to the list only after evaluation by the Federal Coverage Committee. The coverage process integrates health technology assessment (HTA). Coverage can be granted in stages, including limited coverage and temporary coverage. Technologies and coverage can be reevaluated on the basis of registries or assessment information. The structure of the Swiss healthcare system does not lend itself to the establishment of a national HTA program. However, recent moves include the development of a coordinating mechanism for HTA in Switzerland.
Delivery of Health Care↗
Sick autonomy.
Complex social and economic forces have placed patient autonomy at the center of medical ethics, and thereby displaced an older ethic of physician beneficence. This development arose, and is sustained, by waning trust in the traditional doctor-patient relationship. As patients have increasingly become clients and consumers, a contract basis for medical care has put the ancient covenant of care in jeopardy. Here, a philosophical approach to harmonize the apparent conflicting claims of patient autonomy and physician beneficence is offered by demonstrating that autonomy need not be understood as protecting a threatened identity. If persons are regarded as atomistic, certain defensive notions of individualistic rights-based autonomy prevail; if a relational construction of personal identity is employed instead, then respect for autonomy becomes part of a wider morality of relationship and care. By reconfiguring trust within this latter understanding of personhood, bioethics better balances its concerns over choices and actions with those of relationship and responsibility. Neither atomistic autonomy nor the ethics of responsibility can claim hegemony, for they are mutually interdependent, and a complete account of medicine's moral axis requires that they be integrated. This reorientation is crucial for reasserting the ethos of clinical medicine, whose fundamental mandate remains the care of others.
Ethics, Medical↗
Nutritional management in acute respiratory failure.
Nutrition in the intensive care unit is receiving increased attention. Patients with acute respiratory failure from primary lung disease are often initially malnourished, or become malnourished secondary to increased metabolic demands or inadequate nutritional support. Adverse effects of malnutrition on lung function include decreased respiratory muscle function, decreased ventilatory drive, and altered lung defense mechanisms. Nutritional support should be strongly considered if the patient has evidence of malnutrition by nutritional assessment or has a high likelihood of becoming malnourished by virtue of severe, prolonged critical illness. General nutritional goals in the intensive care unit include maintenance of body weight and lean body mass. Proper nutritional therapy includes assessment of adequate caloric requirements and appropriate protein, carbohydrate, and fat composition of the nutritional support. Nutritional therapy should be closely monitored with body weight and nitrogen-balance measurements.
Acute Disease↗
Antenatal testing, mobile outpatient monitoring service.
At Good Samaritan Medical Center in Phoenix, Arizona, a group of perinatal nurses examined the potential for improving care for antepartum, high-risk pregnant women on restricted activities in their homes. An antenatal testing, mobile outpatient monitoring service was developed and implemented within three months. The goal is to reduce frequent admissions to the hospital caused by the interruption of bed rest for weekly and biweekly outpatient evaluation and monitoring. The service has resulted in reduced hospital admissions and improved patient awareness of the need for and adherence to activity restrictions.
Ambulatory Care↗
Network of child psychiatry services in south-eastern Europe.
This article concerns the organisation of child psychiatry services in the region of south-eastern Europe. It is evident that the situation in different countries varies widely, from well-organized systems to a complete absence of professionals in the field of child psychiatry. Furthermore, the article will discuss the necessity to carry out reform in order to organize mental health care for children and adolescents. The emphasis is on the tendency to harmonize standards as much as possible in all countries of the region. The lack of proper legislation on mental health care is also pointed out. The article concludes with information on the first concrete actions, carried out by professors from the Children's Clinic at the Eppendorf University in Hamburg and the Deutsche Akademische Austausch Dinst (DAAD), which provides education by gathering representatives of child psychiatry services from the entire region. The goal is to define and agree on concrete ways of service networking for the entire region. An emphasis is placed on the education of professionals.
Adolescent↗
Quality assurance in a public health agency.
Quality assurance (QA) activities in public health programs typically are fragmented. The Division of Public Health of Maricopa County in Phoenix decided to develop a comprehensive QA program in 1981 that involved both the development of clinical protocols and the formalization of procedures for planning, executing, and following up on QA studies. A clinical protocols committee was formed to generate protocol manuals that serve as the principal criteria source for QA studies. A QA committee was also established to set guidelines for studies and to supervise their execution. Thus far, the QA program has resulted in a significant increase in QA activities within the public health division and improvements in many aspects of patient care.
Arizona↗
Motivations for parent care: the case of filial children in Korea.
This study identified five major types of motivation for parent care in a survey of 130 filial Koreans: respect for parents, filial responsibility, harmonization of the family, repayment of debts, and filial sacrifice. The meanings of these qualitative dimensions of parent care in the cultural context of Korea are discussed. Filial motivations reflect the values Koreans are aspiring for today that consolidate the caring relationships between adult children and their elderly parents. Both the importance of nurturing filial mortality and the need for advancing traditional values associated with the caring relationships are also discussed.
Adult↗