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Standards for health promotion in hospitals: development and pilot test in nine European countries.

PURPOSE: To describe the process of development of standards for health promotion in hospitals, including pilot study, method and results. DESIGN/METHODOLOGY/APPROACH: A set of standards for health promotion in hospitals was developed by a task force of the International Network of Health Promoting Hospitals, following the recommendations of the ALPHA programme. The standards were pilot tested and assessed qualitatively and quantitatively in 36 hospitals in nine European countries. Subsequently, standards were reviewed by representatives from the piloting hospitals. A self-assessment tool was produced to evaluate whether hospital managers and professionals perceive the standards to be relevant and applicable and whether they are currently met. Participants provided comments from their national health system perspective and rated the standards. FINDINGS: General comments and specific comments were provided for each standard regarding its relevance, applicability and current level of compliance. A total of 35 standards' criteria were assessed and 86 per cent (30/35) were rated > 80 per cent relevant and applicable, while 14 per cent (5/35) were rated > 60 per cent relevant. The degree of current fulfilment of the criteria, however, was low. RESEARCH LIMITATIONS/IMPLICATIONS: While the standards should be applicable to other regions (South America, Africa, Asia) additional testing may be required to adapt them to prevailing health care challenges. PRACTICAL IMPLICATIONS: The pilot test revealed that the standards are applicable and were considered relevant, and showed that current compliance is low. It also showed that there is a clear need to facilitate continuous monitoring and improvement of compliance. The standards are regarded as being public domain, are applicable to other organisations and can be incorporated into existing quality systems. ORIGINALITY/VALUE: Standards are a common tool for quality assurance in health care, but so far have considered health promotion activities only partly, if at all. The standards for health promotion in hospitals developed by WHO fill this important gap.

Europe↗

Use of performance standards in behavioral health carve-out contracts among Fortune 500 firms.

OBJECTIVE: To determine the prevalence and nature of performance standards in specialty managed behavioral healthcare contracts among Fortune 500 companies. STUDY DESIGN: This was a cross-sectional survey of all companies listed on the Fortune 500 during 1994, 1995, or both. METHODS: From April 1997 to May 1998 we conducted a mailed survey with phone follow-up. Of the 68% of firms that responded, over one third reported carve-out contracts. The survey focused on whether companies had behavioral health carve-out contracts with specialty vendors and characteristics of these contracts, including the use of performance standards. RESULTS: More than three quarters of the Fortune 500 companies reporting specialty behavioral healthcare contracts used at least one performance standard. Most common were administrative standards (70.2%) and customer service standards (69.4%). About half of the companies used quality standards, whereas only a third used provider-related standards. Most (58.8%) companies using performance standards also specified financial consequences. Larger Fortune 500 firms were significantly more likely to use performance standards. Risk contracts and contracts that included all covered employees were also more likely to include some categories of standards. CONCLUSIONS: Administrative and customer service standards may be most common because companies find it easier to specify those standards, especially compared with clinical quality measures. To the extent that employers want to obtain the most value from their behavioral healthcare purchasing, we expect that more will begin to adopt quality standards in their contracts, especially as performance measures become more refined. Reliance on accreditation, however, is an alternative approach for employers.

Behavioral Medicine↗

An international cooperative study evaluating serum thyroglobulin standards.

A number of research laboratories have reported great variability in the levels of serum thyroglobulin (Tg) in normal subjects, the reason for which is not immediately apparent. The present study was designed to determine how important these variations were by submitting three identical standards to all participating laboratories. Three lyophilized human sera (standards A, B, and C) with increasing concentrations of Tg (5.3, 30.6, and 80.6 ng/ml, respectively) were submitted to 37 laboratories (40 assays) in 18 different countries. Standard A gave detectable values in 19 assays. The mean serum Tg concentration was 6.3 +/- 1.4 (+/- SEM) ng/ml (n = 18). Standard B was detected in all but 3 assays. The mean serum Tg concentration in standard B was 15.7 +/- 1.4 ng/ml (n = 37). All laboratories were able to detect Tg in standard C, and reported a mean serum Tg concentration of 36.5 +/- 3.2 ng/ml (n = 40). Lyophilization affected the recovery of Tg in our assay. This was confirmed by a study in which lyophilized standards A, B, and C and frozen standards were analyzed in the same assays. The remarkable finding was that the variability in serum Tg values reported by the various assays was great despite the submission of an identical set of standards of each of the laboratories. Wide interassay variation raises problems with respect to the applicability of threshold levels proposed by certain studies. The latter is particularly germane to the follow-up of patients with differentiated thyroid cancer. It is concluded that the development of a world standard for Tg may be a first and important step toward standardization of Tg assays, and that other components of the assays may need standardization as well.

Freeze Drying↗

International standards for test methods and reference sera for diagnostic tests for antibody detection.

International standards are necessary to ensure that the diagnostic tests used by trading partners meet a minimum standard of diagnostic performance. The tests that are used to qualify animals for international movement must provide a degree of confidence that those animals which give negative test results (and therefore qualify for movement) are free of a particular infectious disease agent. Without the development of standards for diagnostic tests, no level of international harmonisation can ever be achieved. International standards for both test methods and sera serve to establish a baseline on which inferences can be made with respect to the diagnostic performance of a given test in a given laboratory. International standard test methods set baseline analytical and diagnostic performance requirements for new reagents or methodologies. International standard sera are primary reference standards and serve as both reference materials for the calibration of test methods and reagents and prototypes for the production of national and working standards. For most serological test methods, three standard sera should be established: a strong positive, a weak positive and a negative standard. These standards are used to calibrate the detection range and analytical sensitivity of the test method. Assays calibrated in this way are more likely to exhibit a diagnostic sensitivity and specificity which parallels that of the standard test method, thus resulting in a higher degree of international harmonisation.

Animals↗

Standards of evidence: criteria for efficacy, effectiveness and dissemination.

Ever increasing demands for accountability, together with the proliferation of lists of evidence-based prevention programs and policies, led the Society for Prevention Research to charge a committee with establishing standards for identifying effective prevention programs and policies. Recognizing that interventions that are effective and ready for dissemination are a subset of effective programs and policies, and that effective programs and policies are a subset of efficacious interventions, SPR's Standards Committee developed overlapping sets of standards. We designed these Standards to assist practitioners, policy makers, and administrators to determine which interventions are efficacious, which are effective, and which are ready for dissemination. Under these Standards, an efficacious intervention will have been tested in at least two rigorous trials that (1) involved defined samples from defined populations, (2) used psychometrically sound measures and data collection procedures; (3) analyzed their data with rigorous statistical approaches; (4) showed consistent positive effects (without serious iatrogenic effects); and (5) reported at least one significant long-term follow-up. An effective intervention under these Standards will not only meet all standards for efficacious interventions, but also will have (1) manuals, appropriate training, and technical support available to allow third parties to adopt and implement the intervention; (2) been evaluated under real-world conditions in studies that included sound measurement of the level of implementation and engagement of the target audience (in both the intervention and control conditions); (3) indicated the practical importance of intervention outcome effects; and (4) clearly demonstrated to whom intervention findings can be generalized. An intervention recognized as ready for broad dissemination under these Standards will not only meet all standards for efficacious and effective interventions, but will also provide (1) evidence of the ability to "go to scale"; (2) clear cost information; and (3) monitoring and evaluation tools so that adopting agencies can monitor or evaluate how well the intervention works in their settings. Finally, the Standards Committee identified possible standards desirable for current and future areas of prevention science as the field develops. If successful, these Standards will inform efforts in the field to find prevention programs and policies that are of proven efficacy, effectiveness, or readiness for adoption and will guide prevention scientists as they seek to discover, research, and bring to the field new prevention programs and policies.

Clinical Trials as Topic↗

Parenteral nutrition with standard solutions in paediatric intensive care patients.

BACKGROUND: Paediatric intensive care patients often require parenteral nutrition (PN). Only very few standard mixtures are available for infants and children. Individual PN solutions need to be compounded manually on the ward, if preparation by the hospital pharmacy is not feasible. Since manual compounding is associated with a greater risk of compounding errors and microbial contamination, the use of standard solutions might be a preferable alternative. METHODS: We evaluated the use of standard solutions on the paediatric intensive care unit of the von Hauner Children's Hospital at the University of Munich over a period of 8 months. PN solutions were either prescribed individually or as standard solutions. We evaluated the frequency of standard solution prescriptions and their modification, compared nutrient intakes with standard vs. individual PN solutions as well as the occurrence of laboratory anomalies. RESULTS: Standard PN solutions were prescribed in 68% of cases, individual PN solutions in 32%. Modifications of standard PN solutions were performed in 54%. The intake of a number of macronutrients and electrolytes was similar with individual and standard PN, but calcium and phosphate intakes were lower with individual total PN. Electrolyte imbalances occurred slightly more often with individual PN than with standard PN (34% vs. 26%, respectively). CONCLUSION: Standard PN solutions were used in the majority of patients on a paediatric intensive care unit. We did not detect indications for inadequacy of standard solutions in the majority of patients reviewed.

Adolescent↗

Comparison of ultrahigh- and standard-resolution optical coherence tomography for imaging macular pathology.

OBJECTIVE: To compare ultrahigh-resolution optical coherence tomography (UHR OCT) with standard-resolution OCT for imaging macular diseases, develop baselines for interpreting OCT images, and identify situations where UHR OCT can provide additional information on disease morphology. DESIGN: Cross-sectional study. PARTICIPANTS: One thousand two eyes of 555 patients with different macular diseases including macular hole, macular edema, central serous chorioretinopathy, age-related macular degeneration (AMD), choroidal neovascularization, epiretinal membrane, retinal pigment epithelium (RPE) detachment, and retinitis pigmentosa. METHODS: A UHR ophthalmic OCT system that achieves 3-microm axial image resolution was developed for imaging in the ophthalmology clinic. Comparative studies were performed with both UHR OCT and standard 10-microm-resolution OCT. Standard scanning protocols of 6 radial 6-mm scans through the fovea were obtained with both systems. Ultrahigh-resolution OCT and standard-resolution OCT images were correlated with standard ophthalmic examination techniques (dilated ophthalmoscopy, fluorescein angiography, indocyanine green angiograms) to assess morphological information contained in the images. MAIN OUTCOME MEASURES: Ultrahigh-resolution and standard-resolution OCT images of macular pathologies. RESULTS: Correlations of UHR OCT images, standard-resolution images, fundus examination, and/or fluorescein angiography were demonstrated in full-thickness macular hole, central serous chorioretinopathy, macular edema, AMD, RPE detachment, epiretinal membrane, vitreal macular traction, and retinitis pigmentosa. Ultrahigh-resolution OCT and standard-resolution OCT exhibited comparable performance in differentiating thicker retinal layers, such as the retinal nerve fiber, inner and outer plexiform, and inner and outer nuclear. Ultrahigh-resolution OCT had improved performance differentiating finer structures or structures with lower contrast, such as the ganglion cell layer and external limiting membrane. Ultrahigh-resolution OCT confirmed the interpretation of features, such as the boundary between the photoreceptor inner and outer segments, which is also visible in standard-resolution OCT. The improved resolution of UHR OCT is especially advantageous in assessing photoreceptor morphology. CONCLUSIONS: Ultrahigh-resolution OCT enhances the visualization of intraretinal architectural morphology relative to standard-resolution OCT. Ultrahigh-resolution OCT images can provide a baseline for defining the interpretation of standard-resolution images, thus enhancing the clinical utility of standard OCT imaging. In addition, UHR OCT can provide additional information on macular disease morphology that promises to improve understanding of disease progression and management.

Adult↗

The relative accuracies of ECG precordial lead waveforms derived from EASI leads and those acquired from paramedic applied standard leads.

Accurate precordial electrode placement can be difficult in emergency situations leading either to loss of time or diminished accuracy. A possible solution is the quasi-orthogonal EASI lead system, with only five electrodes and easily defined landmarks to provide a derived 12-lead electrocardiogram (ECG). The purpose of this study was to test the hypothesis that precordial waveforms in EASI-derived ECGs have no greater deviation from those in gold standard ECGs, than do the precordial waveforms in paramedic acquired standard ECGs. Twenty paramedics applied the standard precordial electrodes employing the routine procedure. A certified ECG technician applied the 6 standard precordial electrodes in their correct gold standard positions, and the EASI electrodes. 12-lead ECGs were obtained from the paramedics' standard leads, and derived from the EASI leads, for comparison with the gold standard ECG. In each precordial lead recording, 6 computer-measured QRS-T waveform parameters were considered. Differences between deltaEASI-gold standard versus deltaparamedic-gold standard were calculated for every waveform in every lead resulting in 720 comparisons. EASI and paramedic results were "equally accurate" in 47%, the paramedic was more accurate in 31%, and EASI was more accurate in the remaining 22%. The differences from gold standard recording of precordial waveforms in ECGs derived from the EASI leads and those acquired via paramedic-applied standard electrodes are similar. The results suggest that the EASI lead system may provide an alternative to the standard ECG precordial leads to facilitate data acquisition and possibly save valuable time in emergency situations.

Electrocardiography↗

Setting health standards for the 21st century.

OBJECTIVES: To describe the nature, substance, and impact of health standards and to speculate on how they may change during the early years of the 21st century. SUMMARY: The health care system has experienced dramatic changes over the past three decades. Health standards now cover the spectrum from statutes to regulations to guidelines, as well as less compulsory forms, and address every aspect of health, including the availability, quality, and cost of services; the safety, efficacy, and quality of products; the adequacy of processes and analytic methods; and the value and cost-effectiveness of health technologies and services. Standards cover promotion, protection, and gatekeeping functions. They are established in response to specific needs and are driven by social and political agendas; social policy will drive standards development to a greater extent in the 21st than in the 20th century. Technology advances are stimulating new forms of standards, primarily gatekeeping standards. Standards raise the question of compliance. The trend is increasingly toward less compulsory, more discretionary standards, with a greater percentage being established by quasi-official and voluntary bodies. CONCLUSION: 21st century health standards must balance the rights of access with protection from unsafe, ineffective, and poor quality products and services during a period when decisions must be made faster. They must be more flexible, enabling consumers to choose their level of protection. Such standards will pose the same concerns about adequacy, equity, and freedom of choice as health standards pose now. Whether we will use 21st century standards to improve and advance our health as well as systems, products, and services that contribute to health more effectively than we have in the 20th century is a question to ponder.

Forecasting↗

Practical implications of imposing a new world standard population.

OBJECTIVE: The World Health Organization (WHO) has recently introduced a new world standard population for the production of age-standardized rates. In this study we compare cancer rates standardized to this population with those computed using reference populations in current practice, particularly the world standard of Segi (1960), in order to evaluate their adequacy as estimators of relative risk in diverse population groups and over time. METHODS: Incidence and mortality rates standardized using these reference populations were calculated and compared for various cancers. Standardized rate ratios were compared with more efficient methods of approximating relative risk, the Mantel & Haenszel and maximum-likelihood estimators. The differences were tested by taking a synthesis of the relative risks and by taking into account whether effects were homogeneous across age strata or not. RESULTS: There were no statistically significant differences between the relative risk estimates based on direct standardization and those obtained using Mantel & Haenszel (p < 0.99), or maximum-likelihood techniques (p > 0.99), regardless of whether the Segi or the WHO world population was used as the standard. CONCLUSIONS: Ratios of rates age-standardized using the world standard of Segi approximate relative risk as precisely as the WHO standard. For this, and important practical reasons, it is considered unnecessary to replace the Segi standard population for comparisons between cancer rates.

Adolescent↗

Low-dose and standard-dose unenhanced helical computed tomography for the assessment of acute renal colic: prospective comparative study.

PURPOSE: To compare the efficacy of low-dose and standard-dose computed tomography (CT) for the diagnosis of ureteral stones. MATERIAL AND METHODS: Unenhanced helical CT was performed with both a standard dose (260 mAs, pitch 1.5) and a low dose (50 mAs, pitch 1.5) in 121 patients suspected of having acute renal colic. The two studies were prospectively and independently interpreted for the presence and location of ureteral stones, abnormalities unrelated to stone disease, identification of secondary signs, i.e. hydronephrosis and perinephric stranding, and tissue rim sign. The standard-dose CT images were interpreted by one reviewer and the low-dose CT images independently by two reviewers unaware of the standard-dose CT findings. The findings of the standard and low-dose CT scans were compared with the exact McNemar test. Interobserver agreements were assessed with kappa analysis. The effective radiation doses resulting from two different protocols were calculated by means of commercially available software to which the Monte-Carlo phantom model was given. RESULTS: The sensitivity, specificity, and accuracy of standard-dose CT for detecting ureteral stones were 99%, 93%, and 98%, respectively, whereas for the two reviewers the sensitivity of low-dose CT was 93% and 95%, specificity 86%, and accuracy 92% and 94%. We found no significant differences between standard-dose and low-dose CT in the sensitivity and specificity for diagnosing ureter stones (P >0.05 for both). However, the sensitivity of low-dose CT for detection of 19 stones less than or equal to 2 mm in diameter was 79% and 68%, respectively, for the two reviewers. Low-dose CT was comparable to standard-dose CT in visualizing hydronephrosis and the tissue rim sign. Perinephric stranding was far less clear on low-dose CT. Low-dose CT had the same diagnostic performance as standard-dose CT in diagnosing alternative diseases. Interobserver agreement between the two low-dose CT reviewers in the diagnosis of ureter stones and alternative diseases, the identification of secondary signs, and tissue rim sign were high, with kappa values ranging from 0.769 to 0.968. On standard-dose CT scans, the calculated mean effective radiation dose was 7.30 mSv for males and 10.00 mSv for females. On low-dose CT scans, the calculated mean effective radiation dose was 1.40 mSv for males and 1.97 mSv for females. CONCLUSION: Compared with standard scans using 260 mAs, low-dose unenhanced helical CT using a reduced tube current of 50 mAs results in a concomitant decrease in the radiation dose of 81%. Although low-dose CT was limited in its ability to depict small-sized calculi less than or equal to 2 mm, it is still comparable to standard-dose CT for the diagnosis of ureter stones and alternative disease.

Acute Disease↗

On the importance and validity of medical accreditation standards.

In late 1997, the authors conducted a national survey of communities of interest about the importance and clarity of 44 accreditation standards applied to teaching, learning, and evaluation in medical schools by the Liaison Committee on Medical Education (LCME). Questionnaires were mailed to deans and educational administrators at U.S. medical schools; current LCME members and surveyors and those who had served during the preceding five years; a random selection of residency program directors drawn from both general practice and speciality disciplines; sample groups of medical students and residents; and a cohort of practicing physicians not affiliated with academic medical institutions. Altogether 1,659 questionnaires were mailed, and 701 responses were received (42%). The recipients were asked to use a five-point Likert scale to rate each of the 44 standards both for its perceived importance as an indicator of the quality of undergraduate medical education and for the clarity with which the standard's intent was conveyed. Although the mean ratings of importance all fell in the "moderately important" and "highly important" areas across the respondent groups, the ratings divided into three groups, semantically and statistically. At the high end for importance are standards dealing with fundamental qualities of students, instruction, and the structuring of resources. At the low end of the importance scale are standards dealing largely with matters of process. The ratings for clarity were systematically lower than the ratings for importance, and in some cases the rating for clarity were even more widely discrepant with the ratings for importance. Individual comments by respondents about certain standards were critical of their complicated construction and of confusion about their meaning and measures of compliance. One or more of these hallmarks--being rated of lower importance or clarity, and being the target of criticism by survey respondents--distinguished most of the standards that earlier study had shown are often neglected by surveyors. The predictive validity of each of a number of standards was examined by testing the association between the standard (or its derivative) and outcomes expressed in annual student and school questionnaires and compiled in databases of the Association of American Medical Colleges and the American Medical Association. The result was a mixed bag, confounded by the absence of specific dimensions of many accreditation standards (independent variables) and the lack of discriminating measures of outcome (dependent variables). Nevertheless, the LCME's accreditation standards are believed to be important by those most affected by them. And beyond validating that medical accreditation is guided by relevant standards for teaching, learning, and evaluation, the results of this study point to ways by which the process can be made more precise and useful.

Accreditation↗

College students lack knowledge of standard drink volumes: implications for definitions of risky drinking based on survey data.

BACKGROUND: College students tend to pour single servings of beer and liquor that are larger than commonly used standards. The reasons for this are unknown. Students might overpour because they lack knowledge of standard serving sizes. Alternatively, they might know how much alcohol to pour but simply have difficulty pouring the correct amounts. Misperceptions of standard serving sizes could lead to inaccuracies in self-reported consumption. If this is the case, then the validity of students' responses on alcohol surveys and the definitions of risky drinking that are based on them would be called into question. This study examined how college students define standard drinks, whether their definitions are similar to the definitions commonly used by alcohol researchers and government agencies, and whether their definitions of standard drinks are related to the sizes of the drinks that they pour. The study also examined whether feedback regarding the accuracy of their definitions of standard drinks leads students to alter their self-reported levels of consumption. METHODS: Students (N = 133) completed an alcohol survey and performed tasks that required them to free-pour a single beer, glass of wine, shot of liquor, or the amount of liquor in a mixed drink. Roughly half of the students received feedback regarding their definitions of standard drinks. All students then were resurveyed about their recent levels of consumption. RESULTS: With the exception of beer, students incorrectly defined the volumes of standard servings of alcohol, overestimating the appropriate volumes. They also overestimated appropriate volumes when asked to free-pour drinks. Positive relationships existed between students' definitions of standard drinks and the sizes of the drinks that they free-poured. Feedback regarding misperceptions of standard drink volumes led to an increase in levels of self-reported consumption, suggesting that students' original estimates of their alcohol consumption were too low. CONCLUSIONS: Despite the recent focus on alcohol education and prevention at the college level, college students have not been taught how to define standard drinks accurately. They tend to overstate the appropriate volumes, leading them to overpour drinks and underreport levels of consumption. Self-reported consumption levels are altered by feedback regarding the accuracy of students' definitions of standard drinks. The findings raise important questions about the validity of students' responses on alcohol surveys and the definitions of risky drinking that are based them.

Adolescent↗

Estimates of the health risk reductions associated with attainment of alternative particulate matter standards in two U.S. cities.

As part of its periodic re-evaluation of particulate matter (PM) standards, the U.S. Environmental Protection Agency estimated the health risk reductions associated with attainment of alternative PM standards in two locations in the United States with relatively complete air quality data: Philadelphia and Los Angeles. PM standards at the time of the analysis were defined for particles of aerodynamic diameter less than or equal to 10 microm, denoted as PM-10. The risk analyses estimated the risk reductions that would be associated with changing from attainment of the PM-10 standards then in place to attainment of alternative standards using an indicator measuring fine particles, defined as those particles of aerodynamic diameter less than or equal to 2.5 microm and denoted as PM-2.5. Annual average PM-2.5 standards of 12.5, 15, and 20 microg/m3 were considered in various combinations with daily PM-2.5 standards of 50 and 65 microg/m3. Attainment of a standard or set of standards was simulated by a proportional rollback of "as is" daily PM concentrations to daily PM concentrations that would just meet the standard(s). The predicted reductions in the incidence of health effects varied from zero, for those alternative standards already being met, to substantial reductions of over 88% of all PM-associated incidence (e.g., in mortality associated with long-term exposures in Los Angeles, under attainment of an annual standard of 12.5 microg/m3). Sensitivity analyses and integrated uncertainty analyses assessed the multiple-source uncertainty surrounding estimates of risk reduction.

Air Pollutants↗

Drunk or sober? Learned conformity to a behavioral standard.

OBJECTIVE: This research tested the hypothesis that behavioral standards in a drinking situation are learned. METHOD: Two groups of male social drinkers (N = 12) were reinforced with verbal feedback (FB) for matching either a "sober" (S) or an "intoxicated" (I) behavioral standard under repeated doses (0.62 g/kg) of alcohol. The criterion measure was time to perform a trial on a psychomotor tracking task. A fast, efficient time (115 seconds) defined the S standard. A slow, inefficient time (150 seconds) defined the I standard. The behavioral effect of standards was tested during a final FB training session under alcohol, and during retention under a placebo and under alcohol, with FB absent. RESULTS: S and I groups approximated their respective standards when reinforced, and these standards were retained when reinforcement was subsequently withheld. Under placebo, group S displayed sober performance comparable to their drug-free baseline, whereas Group I's performance was significantly impaired. These group differences remained significant under alcohol, and the drug effect impaired each group's performance to a similar degree. CONCLUSIONS: Prior reinforcement of a standard under alcohol can lead to the display of that standard when alcohol is expected or received. The consistent difference in the groups' performance under placebo and under alcohol suggests that learned standards may add an effect on behavior in a drinking situation that is distinct from the drug effect. Retention of group standards under alcohol in the absence of reinforcement confirms that these standards were learned and were not simply a response to situational demand.

Adult↗

[Standards, Options and Recommendations (SOR): clinical practice guidelines for diagnosis, treatment and follow-up of cutaneous melanoma. Fédération Nationale des Centres de Lutte Contre le Cancer].

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of the French Cancer Centres (FNCLCC), the 20 French Cancer Centres and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature systematic review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines according to the definitions of Standards, Options and Recommendations for the management of patients with cutaneous melanoma. METHODS: Data have been identified by literature search using Medline - until December 1998 - and the personal reference lists of the expert group. Once the guidelines were defined, the document was submitted for review to national and international independent reviewers and to the medical committees of the 20 French Cancer Centres. RESULTS: The main recommendations for the management of cutaneous melanoma (CM) are: 1) The primary prevention of melanoma is based on a reduction in exposure to ultraviolet rays (solar or artificial). 2) The diagnosis of CM requires the surgical removal and histological examination of the lesion (standard). 3) The pathological report must include the diagnosis of primary malignant melanoma, the maximum thickness of the tumour in millimeters (Breslow), the clearance of surgical margins, the level of invasion (Clark), the presence and extension of regression and the presence of any ulceration (standard). 4) The standard treatment of a primary melanoma without lymph node involvement is based on surgery that must ensure adequate margins depending on the thickness of the tumour (standard, level of evidence B). 5) After surgery of a stage I melanoma, there is no indication for additional treatment outside a prospective therapeutic study (standard, level of evidence B, French Consensus Conference). 6) For a local recurrence without node involvement, in the absence of other metastases, surgical excision is the standard treatment. 7) In the case of metastatic regional lymph nodes, a complete regional lymphadenectomy is required. There is no indication for additional treatment outside a prospective therapeutic study (standard, level of evidence B). The inclusion of these patients in controlled studies of immunotherapy is recommended. 8) There is no standard therapeutic strategy for metastatic melanoma. Conventional palliative treatment is chemotherapy with dacarbazine (level of evidence B). 9) Follow-up is based on physical examination (standard). Patient information must encourage self-surveillance. Clinical surveillance and self-detection are indicated in all cases throughout life (standard).

Follow-Up Studies↗

Report of a collaborative study to establish the international standard for parvovirus B19 serum IgG.

With the introduction of commercial test kits and the wider availability of parvovirus B19 antibody testing, greater standardization is required. Moreover, with a B19 vaccine in the early stages of development, there will be long-term need of accurate measurement of parvovirus B19 antibody levels following natural infection and vaccination. A collaborative study was carried out to assess the suitability of a freeze-dried preparation designated 93/724 to serve as the International Standard for parvovirus B19 serum IgG. The proposed standard, which is a pool of sera from six U.K. blood donors, was assayed along with three coded samples. One was the proposed standard (Preparation A), one a pool of three donor sera (Preparation B) and the third an individual donor serum (Preparation C). These preparations were sent to nine laboratories in seven countries who tested them in 10 different enzyme immunoassays. There were no differences in the antibody content expressed relative to that of the proposed standard in assays using native or recombinant antigen. However, antibody was not detected in serum from an individual blood donor (Preparation C) in assays performed using kits which contained recombinant VP1 but not VP2. This highlights the differences which may be obtained in commercial kits which contain different antigens. The results of this study demonstrated that the proposed standard coded 93/724 is suitable to serve as the International Standard for parvovirus B19 serum IgG and this material has been established as the International Standard for parvovirus B19 IgG by the World Health Organization with an assigned unitage of 100 lU per ampoule. The standard, which is a pool of what can be assumed to be convalescent sera, will be suitable for standardizing diagnostic tests for use in seroprevalence studies and for assessing immunity. An additional standard will be required to standardise tests specifically for the detection of IgM and the diagnosis of acute infection.

Antibodies, Viral↗

Use of an improved internal-standard method in the quantitative sterol analyses of phytoplankton and oysters.

Most work reporting the sterol composition of living organisms has not been done quantitatively, although good quantitative data are available for fatty acids and many other cellular components using an internal-standard method that compensates for errors during gas chromatographic analysis. In this paper, we report on the use of 7-stigmastenyl acetate as an internal standard for sterol analysis in two species of phytoplankton and oysters produced with two different diets. This internal-standard method provides an internal standard for this entire process of analysis, not just the gas chromatographic analysis. When analyzing 50-microgram samples of cholesterol acetate after hydrolysis and acetylation, about 30% of the sample was lost, resulting in a 30% error using the older external-standard method. Using the internal-standard method, the analysis error was less than 2%. Losses of sterol during analysis apparently are greater with plant and animal samples than with pure sterol standards. This internal-standard method was shown to be extremely useful, especially for samples with less than 500 micrograms of sterol. Finally, the standard error in sterol analysis is much lower when the internal-standard method is used, allowing statistical distinctions that are not possible otherwise. Use of 7-stigmastenyl acetate as an internal standard offers several advantages over the use of cholestane.

Animals↗