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PubMed2003

[Standardization of lung cancer surgery].

A lobectomy with systematic nodal dissection is accepted as the standard radical operation for early-stage lung cancer. When this was established as the standard operation, there was little evidence to confirm that the results after a lobectomy with systematic nodal dissection were superior to those after other procedures. Most thoracic surgeons accepted lobectomy with systematic nodal dissection as the gold standard for lung cancer surgery. Therefore, no randomized, controlled study was conducted to confirm the justification for that procedure. However, numerous reports of nonrandomized trials or practices were published to justify its acceptance as the standard radical operation for stage IA lung cancers. On the other hand, advances in diagnostic equipment including helical computed tomography (CT), magnetic resonance imaging, and position-emission tomography rapidly changed the concept of early-stage lung cancers. Detection of ground glass attenuation by CT and the introduction of the new pathological concept of localized bronchioloalveolar cell carcinoma as an extremely early-stage lung cancer encouraged surgeons to start clinical trials to obtain evidence. Those efforts will create a new standard for lung cancer surgery. Finally, patients will choose a procedure after consideration of his or her own personal situation excluding medical condition. The procedure selected by most patients will become the gold standard. The gold standard will change with changes in society.

Humans↗
PubMed2003

[Prospects for standardization of surgical treatment for breast cancer].

Surgical treatment of breast cancer in general guided cancer surgery in the direction of extensive radical operations until two decades ago. More recently, the trend has been toward conservative, less-extensive surgery. Moreover, breast cancer has become a model case for establishing standardization of surgical care of cancer. The Japanese Breast Cancer Society issued "Guidelines for Breast-Conserving Therapy" in 1999, and the Clinical Research Group for Establishing Guidelines for Standardized Diagnosis and Treatment for Breast Cancer became active in 2002 under the auspices of the Ministry of Health, Welfare and Labor. There are several areas of controversy in terms of surgical care in breast cancer. Examples are yet-immature breast-conserving surgery which is performed with wide variations (15-90%) depending upon the institution, and sentinel lymph node biopsy which must await long-term results before being recognized as standard care. The installation of expensive diagnostic devices indispensable for standardized surgical care might not be necessary at each institution, and it must be noted that postoperative follow-up policies practiced in Japan differ greatly from those recommended by the American Society of Clinical Oncology. Despite the anticipated difficulties, a consensus on what constitutes standardized surgical treatment for breast cancer might be easily reached among breast cancer surgeons. However, it may be somewhat difficult to popularize the standardized surgical treatment among ordinary general surgeons in Japan, since there is a wide disparity in the level of clinical care offered by individual physicians and healthcare institutions. Standardization of medical care guided by the government is mainly designed to reduce healthcare costs, which is instrumental in eliminating unnecessary medical interventions and may in turn shed light on valuable medical care advances. This may be the moment for the Japanese Surgical Society and its members who practice life-saving surgery to lead a genuine national medical reformation.

Breast Neoplasms↗
PubMed2003

Predictors of successful physical readiness testing under the new standard: OPNAV Instruction 6110.1F.

A new physical readiness testing (PRT) instruction, OPNAV Instruction 6110.1F, specifying tougher standards compared with the previous standard was issued in May 2000. The purpose of this research was to describe differences in PRT results under the old and new standards, to describe body mass index (BMI) results, to compare BMI results with body composition assessment results, and to elucidate predictors of successful PRT results under the new standards. Using a retrospective cohort design, cross-sectional analysis was performed on data from 1,564 active duty subjects at the Naval Medical Center Portsmouth. Whereas, under the old standards, the distribution of PRT results was skewed toward high scores, the distribution of scores was normal under the new standards. BMI results demonstrated a problem with obesity in the cohort and correlated poorly with body composition assessment. Predictors of successful PRT were normal/underweight BMI, body composition within standards, officer rank, and age > or = 30 years.

Adult↗
PubMed2002

Clinical-Education-Setting Standards Are Helpful in the Professional Preparation of Employed, Entry-Level Certified Athletic Trainers.

OBJECTIVE: To determine the helpfulness of clinical-education-setting standards in the professional preparation of entry-level certified athletic trainers. DESIGN AND SETTING: We developed a 22-item questionnaire based on the 12 standards presented by Weidner and Laurent. Subjects used a Likert scale (0 = no help, 5 = very helpful) to indicate their perceptions of the helpfulness of each standard in preparing them for their roles and responsibilities as certified athletic trainers. SUBJECTS: We surveyed employed, entry-level certified athletic trainers who recently completed Commission on Accreditation of Allied Health Education Programs-accredited athletic training education programs. MEASUREMENTS: Percentage means were computed for the helpfulness ratings of each standard. A percentage mean was computed for the overall contribution of clinical education to professional development. Chi-square analyses were used to assess the differences in helpfulness ratings among respondents. RESULTS: The overall mean score across all standards was 4.17. No significant differences in the helpfulness ratings of any of the respondents were noted regardless of sex, ethnicity, number of clinical-education hours, total semesters of clinical education, settings in which students gained clinical experience, or current employment (P </=.05). CONCLUSIONS: The standards for athletic training clinical-education settings are helpful and should be applied to all settings. Varying standards do not need to be imposed on our different athletic training clinical-education settings.

Journal Article↗
PubMed2003

Comparison of standard large trauma craniotomy with routine craniotormy in treatment of acute subdural hematoma.

OBJECTIVE: To compare the therapeutic effect and indication between standard large trauma craniotomy and routine craniotomy. METHODS: There were 97 patients in the standard large trauma craniotomy group and 110 patients in the routine craniotomy group. The mortality, postoperative ICP (intracranial pressure), ratio of pupil rebound, complication and results of six month follow-up after operation were compared between the two groups. RESULTS: Fifteen patients (15.6%) died in the standard large trauma craniotomy group and 30 (27.7%) in the routine craniotomy group. The postoperative mean ICP was 3.75 kPa+/-1.89 kPa in the standard large trauma craniotomy group and 5.11 kPa+/-1.57 kPa in the routine craniotomy group. The pupil rebound was found in 47 patients (61.0%) in the standard large trauma craniotomy group and in 41 patients (46.1%) in the routine craniotomy group (P<0.01). The rate of complication was lower in the standard large trauma craniotomy group, but no obvious difference in long-term therapeutic effect was found between the two groups. CONCLUSIONS: Standard large trauma craniotomy can attenuate brain hernia and the mortality of the patients with acute subdural hematoma. The incidence of complication can also be decreased. But the long term life quality of the patients can not be improved.

Acute Disease↗
PubMed2004

Judging capacity: paternalism and the risk-related standard.

There is a strong academic and medical consensus on judging patients' decision-making capacity in accordance with the seriousness of consequent risks, and this is supported in certain areas of the law. Supporters of the risk-related standard perceive an asymmetry between the level of capacity required for consent to a treatment, and the level required to competently refuse the treatment, particularly if the probable outcome of refusal is death. Despite the intuitive appeal of the risk-related standard, its opponents propose that when the risks of treatment or treatment-refusal are high, we should not require a higher standard of capacity, but be scrupulous in ensuring that a procedural standard is observed. This article considers both standards, from the point of view of the persons, interests and principles which ethics and the law seek to protect. It argues that a risk-related standard is incoherent, that a rigorously applied procedural standard will minimise paternalistic medical interventions, and that this should be reflected in the law.

Australia↗
PubMedDate not supplied

International standards and guidelines on education and training for the multi-disciplinary health response to major events that threaten the health status of a community.

UNLABELLED: The 13th World Congress on Disaster and Emergency Medicine, convened in Melbourne, Australia in May 2003, requested the World Association for Disaster and Emergency Medicine (WADEM) to lead the development of "International Standards and Guidelines on Education and Training for "Disaster Medicine". This Paper has been developed by a Working Group of the WADEM Education Committee ("the Working Group") in response to that request from the international "Disaster Medicine" and emergency health community. The main focus of the Working Group is to develop standards and guidelines for education and training in the multi-disciplinary health response to major events that threaten the health status of a community. The contemporary view is that of a multi-disciplinary health response to major events which threaten the health status of a community, including the prevention and mitigation of future events, and taking account of the broader context in which these events occur. It is the vision of the Working Group that evidence-based standards and guidelines for education and training must be developed in a broad sense, for all members of the healthcare community. Rather than purely describing isolated performance indicators, the Working Group agreed that priority be given to explaining the general approach, presenting the conceptual framework, clarifying important principles, and describing the educational needs and training requirements for situations for which there exist a major threat to the health status of a community. It is not the intent to produce an updated educational curriculum for special courses in "Disaster Medicine" by listing levels of theoretical knowledge and clinical skills required for medical doctors, nurses, and paramedics. Nor, does the Working Group think it is useful to repeat requirements and learning outcomes that are part of the normal basic education and training for the various health professionals. The purpose of this Issues Paper is to present an initial summary of current issues relating to an international perspective of "Disaster Medicine" education and training. This summary has been prepared following discussions within the Working Group of the WADEM Education Committee. The paper aims to stimulate debate and form the basis of further of discussion at an international meeting scheduled to be held in Brussels (Belgium) on 29-31 October 2004. The Working Group has structured this Issues Paper into five parts and has identified several key issues for discussion. Part 1: Understanding the contemporary interpretation of the multi-disciplinary health response to major events that threaten the health status of a community. Issue 1: Definitions and terminology in "Disaster Medicine"; Issue 2: Getting to grips with the contemporary concepts and international trends in 'Disaster Medicine"; and, Issue 3: Valuing personal attributes in "Disaster Medicine" practitioners. Part 2: Developing an underlying scientific framework for linking theory to practice in "Disaster Medicine". Issue 4: Creating a scientific framework(s) for "Disaster Medicine". Part 3: Defining a conceptual framework and general principals to develop "International Standards and Guidelines on Education and Training for the Multi-disciplinary Health Response to Major Events that Threaten the Health Status of a Community". Issue 5.: Where are we now? Getting to grips with the contemporary concepts and international trends in "Disaster Medicine" education and training. Issue 6: Where do we want to get to? Identifying contemporary, evidence-based education and training standards and guidelines for 'Disaster Medicine" education and training programs. Issue 7: How do we get there? Overcoming barriers to introducing the International Standards and Guidelines. Part 4: Maintaining the momentum--improving international collaboration. Issue 8: Exploring the feasibility of an ongoing, international, collaborative network of "Centres of Excellence" in "Disaster Medicine" research and/or education. Part 5: Additional input. Issue 9: What other issues would you like to bring to the attention of the Working Group? CONCLUSIONS: The results of the consultation will lead to the development of international standards and guidelines that will be presented and consensus sought during the 14th World Congress on Disaster and Emergency Medicine (WCDEM-14) to be convened in Edinburgh in May, 2005.

Civil Defense↗
PubMed2004

Development of Standards and Criteria for the Selection, Training, and Evaluation of Athletic Training Approved Clinical Instructors.

OBJECTIVE: To develop standards and associated criteria for the selection, training, and evaluation of athletic training approved clinical instructors (ACIs). DESIGN AND SETTING: A previously developed set of 7 physical therapy clinical instructor standards/criteria and 2 additional standards/criteria developed through a review of the literature were systematically adapted, judged, and revised through a Delphi technique. SUBJECTS: Athletic training education experts currently employed as program directors for entry-level Commission on Accreditation of Allied Health Education Programs-accredited athletic training educational programs and who had the following: a doctoral degree, at least 5 years of supervising athletic training students, and familiarity/experience with clinical instruction in various athletic training clinical education settings. MEASUREMENTS: We used panelists' critiques and ratings to make sequential revisions in a series of 3 Delphi rounds. Standards were rated as to whether they were clear, necessary, and appropriate. We rated criteria for the associated standard as to whether they were useful, helpful, clear, specific, and consistent. RESULTS: We developed a final set of 7 standards and 50 associated criteria to measure these standards. The accepted standards include the following: legal and ethical behavior, communication skills, interpersonal relationships, instructional skills, supervisory and administrative skills, evaluation of performance, and clinical skills and knowledge. CONCLUSIONS: The 7 standards and associated criteria developed in this research project could be used not only for selecting, training, and evaluating an ACI but also for developing an understanding of the requirements of clinical education in general. Further research should include validating these standards/criteria among athletic training ACIs representing different types of clinical settings.

Journal Article↗
PubMedDate not supplied

[Harmonization of hygienic standards with the foreign requirements for the quality of drinking water].

The concept of and criteria for harmonization of hygienic standards with the foreign requirements for the quality of drinking water were developed. On their basis, more than 100 sanitary standards for water substances were harmonized with the WHO and EC recommendations and the USA and Canadian standards for drinking water quality. Thirty sanitary standards were corrected and 12 ones were newly established without making experimental studies, among them 18 for carcinogenic substances. The paper provides evidence for the reliability and effectiveness of the Russian sanitary standardization system as to most standardized water substances. It also presents the harmonized standard normal values included into the documents of the water sanitary legislation of Russia.

Humans↗
PubMed2005

[HL7 standard--features, principles, and methodology].

The mission of HL7 Inc. non-profit organization is to provide standards for the exchange, management and integration of data that support clinical patient care, and the management, delivery and evaluation of healthcare services. As the standards developed by HL7 Inc. represent the world's most influential standardization efforts in the field of medical informatics, the HL7 family of standards has been recognized by the technical and scientific community as the foundation for the next generation healthcare information systems. Versions 1 and 2 of HL7 standard have solved many issues, but also demonstrated the size and complexity of health information sharing problem. As the solution complete new methodology has been adopted that is encompassed in the HL7 Version 3 recommendations. This approach standardizes Reference Information Model (RIM), which is the source of all derived domain models and message structures. Message design is now defined in detail, enabling interoperability between loosely coupled systems that are.designed by different vendors and deployed in various environments. At the start of the Primary Healthcare Information System project in the Republic of Croatia in 2002, the decision was to go directly to Version 3. The target scope of work includes clinical, financial and administrative data management in the domain of healthcare processes. By using HL7v3 standardized methodology we were able to completely map the Croatian primary healthcare domain to HL7v3 artefacts. Further refinement processes that are planned for the future will provide semantic interoperability and detailed description of all elements in HL7 messages. Our HL7 Business Component is in constant process of studying different legacy applications, making solid foundation for their integration to HL7-enabled communication environment.

Ambulatory Care Information Systems↗
PubMed2005

An application of D- and L-aspartic acid mixtures as standard specimens for the chronological age estimation.

Instead of using the control teeth, we tried to prepare standard specimens to derive the equations for calculation of the age (analytical curves) with respect to each kind of tooth of various ages. To prepare standard specimens, we determined the racemization ratio of the teeth of known age that had actually been used for the appraisal of chronological age (total control teeth). Then we mixed commercially available L-Asp and D-Asp in the same D/L ratio as the measured one in the total control teeth. As a result, we were able to obtain the racemization rate equations from the age-specific standard specimens of central and lateral incisors. These equations were closely similar to those derived from actual teeth of known age. Since the racemization rate equations obtained from the standard specimens were satisfactorily reproducible, we assumed that these equations could be used in place of those obtained from the control teeth. Actually, in the age estimation of unidentified corpses from teeth, the use of standard specimens enabled us to estimate the age almost as precisely as estimated using the control teeth. Thus, the present study has demonstrated that in the estimation of chronological age the control teeth can be substituted by the standard specimens. This shows the possibility of using the standard specimens also in other laboratories where the racemization ratio can be measured with sufficient reproducibility.

Adult↗
PubMed2000

HIPAA update: standards for health care electronic transactions finalized.

The Department for Health and Human Services (HHS) has issued the final rule that will govern electronic exchanges of financial and administrative information in the health care industry. About 400 different formats currently exist for electronic health care claims. Once compliance with this rule is required (October 2002 for most health care entities to which the rule applies), a physician will be able to submit an electronic claim in the standard transaction format to virtually any health plan in the United States and the health plan will have to accept it. Under the rule, an electronic transaction involves information exchanges between two parties to carry out financial or administrative activities related to health care. Thus, health plans will be able to pay physicians, authorize services, certify referrals, and coordinate benefits using a standard electronic format for each transaction. Conflicting state laws will be superseded by the standards, although HHS is developing an exception process pursuant to HIPAA. HIPAA required HHS to adopt data and format standards, if possible, that were developed by private sector standards development organizations accredited by the American National Standards Institute (ANSI). When conducting a transaction covered by the rule, physicians are required to use applicable medical data code sets as specified in the implementation specification that is valid at the time the health care is furnished. Local and proprietary codes currently used by health plans can no longer be used in electronic transactions governed by the rule after the compliance date (October 16, 2002, except for small health plans, which have until October 16, 2003). This summary of the Standards for Electronic Transactions should not be construed as legal advice or an opinion on specific situations. Please consult an attorney concerning your compliance with HIPAA and the regulations promulgated thereunder.

Journal Article↗
PubMed1975

[Evaluation and standardization of radioimmunoassays].

The term "standardization" may be applied to RIA methods to indicate the "definition of quality characteristics" the level of which must be defined on the basis of the evaluation of the "analytical procedure/specific reagents" system. Each laboratory, by applying a suitable long-term quality control system, must assure the consistent maintenance of the "standardization status" established for all mehtods it uses. As a matter of fact, in the case of RIA, materials are used that have a limited stability, that cannot be produced in large quantities, and that possess a complex composition not always well defined chemically. However, a remarkable role in the standardization process belongs to the producers of special reagents intended for RIA. In order to help the standardization of RIA methods, some programs of inter-laborator cooperation have been worked out in recent years. Among them mention is specifically made of three studies regarding the dosage of insulin: the most recent of them is devised and coordinated by the Instituto Superiore di Santià in cooperation with the Laboratory of Clinical Physiology of the National Research Council of Pisa. The availability of standardized materials is estremely important: for antigens, some materials are already in existence, but it is desirable that the various manufacturers shall follow more uniform criteria in their standardization. As far as the application of the RIA methods in the diagnostic field is concerned, the need exists for the use of standardized basic schemes that would include and unambiguously express all the useful information available in order to define better the clinical significance of the analytical data obtained.

Adrenocorticotropic Hormone↗
PubMed1991

Peer review. Part 1: Attitudes to internal and external standards.

Two peer review groups of ten general practitioners each reviewed their management of headache and fatigue. Each group used internal standards which they had set for the review of one condition and external standards set by the other group for the other condition. Data for the review was collected from the general practitioners' case notes and presented to them. The following year their management was again reviewed. The attitudes of the general practitioners to the use of both internal and external standards in peer review were measured using written questionnaire. There was no statistically significant difference in attitude to the two different types of standards. The attitudes of the general practitioners to external standards from a variety of sources were also measured. External standards developed by other peer review groups of general practitioners were significantly more acceptable (p less than 0.05) than standards developed by hospital specialists or the Department of Health.

Attitude of Health Personnel↗
PubMed1991

Standard compliance. The process and art of preparation.

The primary purpose of most regulatory agencies is to insure that standards for patient care are defined and adequately supported by policy, procedure, and organizational structure. In addition, the regulatory agency evaluates the effectiveness of the organization in implementing and monitoring the standards for providing safe, quality patient care. The objectives of regulatory agencies do not differ significantly from the major responsibilities of nursing administration. Despite similar accountabilities between the surveyor of the regulatory agency and the nurse administrator of an organization, there may be a great deal of anxiety and stress before an accreditation visit. A method of understanding the standards, developing tools to monitor compliance with the standards, educating staff regarding the standards, and assuring nursing practice is in compliance with the standards is presented. A mechanism for organizing materials and information for the survey that will be effective for ongoing monitoring of standards is also discussed.

Humans↗
PubMed1991

Assessment of the performance of general practitioners by the use of standardized (simulated) patients.

A study was undertaken whereby a set of standardized (simulated) patients visited general practitioners without being detected, in a health care system where doctors had fixed patient lists. Thirty nine general practitioners were each visited during normal surgery hours by four standardized patients who were designed to be indistinguishable from real patients. The objective of the study was to see whether the actual performance of general practitioners, as assessed by standardized patients, met predetermined consensus standards of care for actual practice. The patients presented standardized accounts of headache, diarrhoea, shoulder pain and diabetes. The mean group scores of the doctors on the predefined standards of care for the different complaints ranged from 33 to 68%. The results show that standardized patients may be the method of choice in the assessment of the quality of actual care of doctors. It is hypothesized that the substandard scores of the doctors do not reflect inadequate competence, but are a result of the difference between competence and performance.

Clinical Competence↗
PubMed1990

Apolipoprotein assays: standardization and quality control.

A correct approach to standardization, accuracy-based methods, and well-defined quality assurance programs is indispensable for the definition of international reference intervals of apo A-I and apo B. Variability in the immunochemical determination of apo A-I and apo B can be due to both preanalytical and analytical variations, and standardized laboratories should evaluate and minimize each source of error in determining the reference intervals. A key requirement to reduce the variation between measurement techniques is the use of a common protocol for the calibration of the different methods. The basis of a calibration system is the primary standard with the absolute mass accurately determined. The primary standard is indispensable in assigning an accurate target value to reference materials with a reference method in which the primary standard immunochemically reacts the same as the protein in plasma. The reference material, which must behave immunochemically the same as the patient's sample in all methods, is then used to assign a target value to the calibrator in each method and system. Following this procedure, all assay results can be traced back to the primary standard via the serum reference material. The development and distribution of reference and quality control materials, which do not exhibit matrix effects between methods, is fundamental for the standardization process.

Apolipoprotein A-I↗
PubMed1989

Additive effect of dDAVP and standard heparin in increasing plasma t-PA.

The aim of this study was to evaluate the existence of an additive effect between standard heparin and dDAVP in the enhancement of endogenous fibrinolysis. Eight healthy volunteers were studied in a randomized double blind placebo controlled cross-over trial. The volunteers were treated i.v. with dDAVP, 0.4 micrograms/kg, over 15 minutes followed by an i.v. bolus dose of either standard heparin, 5,000 I.U., or saline. A 48 hour wash-out period was adopted. The infusion of dDAVP followed by standard heparin resulted in a higher increase in plasma t-PA activity, t-PA antigen, circulating t-PA specific activity and FPLA when compared with dDAVP followed by saline. The difference was already statistically significant at 15 minutes after the infusion of dDAVP and lasted for up to 60 minutes after the end of the infusion of dDAVP. Plasma PAI 1 showed a slightly higher decrease after dDAVP plus standard heparin than after dDAVP plus saline but this difference was not statistically significant. No statistically significant changes of fibrinogen and alpha 2-antiplasmin levels were observed. As expected, the infusion of standard heparin resulted in an increase in plasma anti-Xa activity and in a prolongation of aPTT. Our results demonstrated an additive effect of dDAVP and standard heparin on the increase in circulating t-PA, the effect of dDAVP being potentiated and prolonged by heparin. This observation could prospect a combined use of dDAVP and standard heparin in the prophylaxis and treatment of thromboembolic diseases.

Adult↗