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PubMed2003

[Evaluation of breast conserving therapy (BCT) standards for invasive and preinvasive breast cancer adapted in RCO in Bydgoszcz].

INTRODUCTION: Prophylactic campaign against breast cancer wide spread by Regional Center of Oncology made significant influx of patients coming to our place and presenting less advanced stages of the mentioned disease. AIM: The aim of this work was estimate of BCT treatment standard for invasivum cancer and preinvasivunm breast cancer treatment standard which was adapted in RCO. MATERIALS AND METHOD: Patients presenting unifocal invasive cancer smaller than 2 cm, stage No, where the minimal margin of more than 1 cm was possible to perform, were qualified to BCT. Minimal surgical border during tumorectomy was 1 cm. We were excluded patients with carcinoma lobulare and carcinoma mucinosum. During qualification to DCIS treatment standard first we must exclusion multifocalis cases based on Anderson classification and Falun consens. In the other cases we based on Van Nuys Prognostic Index (VNPI) considering the patient's age. We have 3 forms of treatment: simplex mastectomy, tumorectomy and tumorectomy with RTG-therapy. To BCT standard were qualified 52 patients. Schematically was attended 45 peoples. We had 5 patients which was attended based on preinvasivum breast cancer treatment standard. RESULTS: The size of breast cancer tumor at the patients which was attended based on BCT standard was 0,5-2 cm. 3 patients was disqualified from BCT because we found second breast cancer focus in histopathological material. We must widen surgical border post tumorectomy in 5 cases. Among 5 patients with preinvasivum cancer was 3 simplex mastectomy and 2 cases tumorectomy with RTG-therapy. CONCLUSIONS: In our opinion BCT treatment standard and breast preinvasivum cancer treatment standard should be using only in high specialty oncological center. It is a guaranty of right qualification and treatment for breast cancer patients.

Adult↗
PubMed2004

The oral NK(1) antagonist, aprepitant, given with standard antiemetics provides protection against nausea and vomiting over multiple cycles of cisplatin-based chemotherapy: a combined analysis of two randomised, placebo-controlled phase III clinical trials.

In early clinical trials, the NK(1) receptor antagonist, aprepitant (EMEND(R)) was shown to improve the protection provided by the best available therapy (hereafter referred to as 'standard therapy': a 5-HT(3) receptor antagonist and dexamethasone) against chemotherapy-induced nausea and vomiting over multiple cycles of cisplatin-based chemotherapy. To further study the sustainment of antiemetic efficacy of aprepitant plus standard therapy over more than one cycle of chemotherapy, we examined combined data from the multiple cycles extensions of two phase III clinical trials of oral aprepitant plus standard therapy for the prevention of chemotherapy-induced nausea and vomiting. Data were pooled from two multicentre, randomised, double-blind, placebo-controlled studies with identical design and treatment regimens. Cancer patients receiving a first cycle of cisplatin-based (>or=70 mg/m(2)) chemotherapy were randomised to one of two treatment groups as follows: the standard therapy group received ondansetron 32 mg intravenously (i.v.) and dexamethasone 20 mg on day 1 and dexamethasone 8 mg twice daily (b.i.d.) on days 2-4. The aprepitant group received aprepitant 125 mg, ondansetron 32 mg i.v., and dexamethasone 12 mg on day 1, aprepitant 80 mg and dexamethasone 8 mg on days 2-3, and dexamethasone 8 mg on day 4. Patients had the option to receive the same blinded treatment for up to five additional cycles. The analysis used a combined exploratory endpoint of no emesis and no significant nausea (i.e. nausea which interfered with a patient's normal activities) over the 5 days following cisplatin, for up to six cycles of chemotherapy. A cumulative probabilities approach incorporating a model for transitional probabilities was used to analyse the data. Tolerability was assessed by reported adverse events and physical and laboratory assessments. Baseline characteristics, reasons for discontinuation, and drop-out rates were similar between groups. In every cycle, the estimated probabilities (rates) of no emesis and no significant nausea were significantly higher (P<0.006) in the aprepitant group: in the first cycle, rates were 61% in the aprepitant group (N=516) and 46% in the standard therapy group (N=522), and thereafter, rates for the aprepitant regimen remained higher throughout (59% (N=89) versus 40% (N=78) for the standard therapy, by cycle 6). Repeated dosing with aprepitant over multiple cycles was generally well tolerated. Compared with patients who received standard therapy alone (a 5-HT(3) antagonist plus dexamethasone), those who received aprepitant in addition to standard therapy had consistently better antiemetic protection that was well maintained over multiple cycles of highly emetogenic chemotherapy

Adolescent↗
PubMed1992

[Standards as basis for medical audit].

Medical audit usually implies evaluation of medical practice in order to control whether certain standards are complied with. Research on decision making has disclosed, however, that standards for clinical problem solving are not always easy to establish. It has been difficult to influence doctors to adhere to standards defined by experts. We therefore propose that medical audit should focus more on education than on control. If standards are to be used, the doctors participating in medical audit projects should also help to define the standards. We suggest the following procedure for medical audit projects: observe practice--reflect on it--identify changes--formulate standards--implement changes--evaluate changes--give feedback to the group about the outcome. Standards defined by experts working remote from medical practice, must be replaced by standards based on practical knowledge acquired by doctors with common experience.

Decision Making↗
PubMed2005

[Evaluation of electroencephalography grading standard in severe cerebrovascular disease].

OBJECTIVE: To compare the prognostic value of different electroencephalography (EEG) grading standards of cerebral dysfunction after cerebrovascular diseases. METHODS: The EEG of all the 40 patients who suffered from acute cerebrovascular disease of the cerebral hemisphere were recorded continuously, and three different EEG grading standards (Lavizzari, Synek and Young) were analyzed and compared. RESULTS: All three different EEG grading standards showed significant correlation with outcome (all P<0.001), i. e. the higher the EEG grade was, the poorer the outcome was. Logistic regression showed that the Synek standard was the best for survival rate and comprehensive prognostic accuracy (90.9%, 89.2%, respectively), Young standard (81.8%, 83.8%) was lower than Synek standard in predicting accuracy but higher than Lavizzari standard (75.%, 80.% respectively). CONCLUSION: The EEG grading standard of Synek might well reflect the cerebral dysfunction and appear to be a reliable predictor for outcome.

Adult↗
PubMed2005

[Role of standardization in health care system computerization].

Standardization system includes development, publishing and promotion of standards, as well as their use in practice. Products, services and processes in a variety of human activities should be standardized. The goal of standardization is to achieve a high security level, a high quality, usefulness and effectiveness as well as limitation of variability, ensuring compatibility and replacement (of products), and to eliminate technical problems in the international exchange of people, work, products and services. The leading areas/objects of standardization in medical informatics are electronic health record, classification in health care, communication and message exchange as well as data security and protection of the whole health information system. Technical Committee for Standardization in Medical Informatics (TC215) has so far accepted fifteen standards and prestandards. The affiliate HL7 Croatia works on localization of communication standard HL7 and adaptation to the Croatian requirements.

Computer Security↗
PubMed2005

Proton nuclear magnetic resonance spectroscopy (NMR) methods for determining the purity of reference drug standards and illicit forensic drug seizures.

A rapid, sensitive, accurate, precise, reproducible, and versatile method for determining the purity of reference drug standards and the routine analysis of illicit drugs and adulterants using proton (1H) Nuclear Magnetic Resonance (NMR) Spectroscopy is presented. The methodology uses a weighed sample dissolved in a deuterated solvent or solvent mixture containing a high purity internal standard. The NMR experiment employs 8 scans using a 45 second delay and 90 degrees pulse. In the determination of purity of reference standards, the number of quantitative determinations available is equal to the number of peak groups that are baseline resolved. The relative standard deviation (RSD) of these signals is usually < 1% for pure standards, and the results agree well with other purity determining methods. This method can also aid in the determination of correct molecular weight for standards containing an unknown number of waters of hydration or an unknown number of acids per drug in salts. Because the molar response for the hydrogen nucleus is 1 for all compounds, and since no separation media are used, only one linearity study is required to test a probe. In the presented study, the linearity of the NMR probe was determined using methamphetamine HCl dissolved in deuterium oxide (D2O) with maleic acid as the internal standard (5 mg) for a range of concentrations from 0.033 to 69.18 mg/ml with a resulting correlation coefficient of >0.9999 for all 6 methamphetamine peak groups. The spectra of complex illicit heroin, methamphetamine, MDMA, and cocaine samples are presented, as well as an extensive list of compounds, their solubilities and the solvent(s) and internal standard used.

Journal Article↗
PubMed2006

[Low-dose spiral CT versus standard dose CT in detection of pulmonary metastasis from gestational trophoblastic tumor].

OBJECTIVE: The purpose of this study is to investigate whether low-dose spiral chest CT scan can replace standard-dose CT scan in detecting pulmonary metastases for patients with gestational trophoblastic tumor (GTT). METHODS: Totally, 34 GTT patients underwent 56 chest CT scans for the assessment of pulmonary metastasis. All patients received CT examination both at standard-dose (120 KV, 150 mAs, pitch 1, and a standard reconstruction algorithm) and low-dose CT (120 KV, 40 mAs, pitch 2, and a bone reconstruction algorithm) simultaneously each time. The images were interpreted by two radiologists independently. A metastasis by CT image was defined as a nodule within lung parenchyma that could not be attributed to a pulmonary vessel. The number of lesions detected at each dose protocol was recorded. The size of each lesion was measured and categorized as < 5 mm, 5 - 10 mm or > or = 10 mm. The differences in detection of the lesions between the standard- and low-dose CT protocols were compared using Wilconxon signed rank test. RESULTS: 1417 lesions were detected at the standard-dose, whereas 1214 lesions were found by low-dose CT. Lesions < 5 mm detected by low-dose CT were fewer than that detected by standard-dose CT (Z = -3.368, P = 0.000), though there was no statistically significant difference between the standard- and low-dose CT in detecting lesion > or = 5 mm (Z = -0.055, P = 0.957). Moreover, the risk score of the patients was not affected either. The sensitivity of low-dose CT was 69.16% for all size of lesions, 58.50% for < 5 mm, 87.07% for 5 - 10 mm, and 97.01% for > or = 10 mm. The positive predictive value for different sizes of lesion was 80.71% (all sizes), 73.82% (5 mm), 88.86% (5 - 10 mm), and 98.48% (> or = 10 mm), respectively. CONCLUSION: Low-dose chest CT can replace the standard-dose chest CT as a screening and follow-up examination to assess the change in pulmonary metastasis for patients with gestational trophoblastic tumor.

Adult↗
PubMed1991

[Standards of nursing services for private hospitals].

The formalization of nursing quality assurance in private hospitals is of critical importance. The purpose of this study was to formulate national nursing service standards for private hospitals. A structured two phase research technique was utilised to validate the standards by a representative national group of experts. Statistical validity of the standards was calculated by means of a content validity index for each standard. Fourteen (5%) of these standards (N = 275) were rejected and 25 (9%) require reformulation. It is recommended that these standards should serve as optimum standards for nurse administrators in private hospitals, and that these standards be published formally.

Disaster Planning↗
PubMed1990

The comparative effects of recombinant hirudin (CGP 39393) and standard heparin on thrombus growth in rabbits.

The aim of this study was to compare the ability of standard heparin and recombinant (r-)hirudin, a specific inhibitor of thrombin, to inhibit thrombus growth in a rabbit jugular vein model. Doses of standard heparin and r-hirudin equivalent in prolonging the aPTT were first identified. The ability of these doses to inhibit 125I-fibrin accretion onto preexisting thrombi was then evaluated. 0.5 and 0.75 mg/kg of standard heparin and 0.8 and 1.25 mg/kg of r-hirudin infused over 3 h produced a mean prolongation of the aPTT of 1.5 and 2 times, respectively. In saline treated rabbits 62 +/- 7 micrograms of 125I-fibrin were accreted on the pre-formed thrombi. The lower doses of standard heparin and r-hirudin produced a 125I-fibrin accretion of 44 +/- 5 and 25 +/- 4 micrograms, respectively (p less than 0.01). The two higher doses of standard heparin and r-hirudin produced a 125I-fibrin accretion of 34 +/- 4 and 17 +/- 3 micrograms, respectively (p less than 0.01). The increase in the dose of standard heparin up to 2.5 mg/kg produced a 125I-fibrin accretion of 26 +/- 3 micrograms a 58% reduction when compared with saline. The increase in the dose of r-hirudin up to 5 mg/kg produced a 125I-fibrin accretion of 12 +/- 2 micrograms, an 81% reduction when compared with saline. No further inhibition was observed when the doses of both agents were further increased. We conclude that doses of standard heparin and r-hirudin equivalent in prolonging the aPTT have a different effect on thrombus growth inhibition, r-hirudin being twice as effective as standard heparin. Exclusive inhibition of thrombin without any other inhibiting effect on blood coagulation appears to be sufficient to inhibit thrombus growth. Our results seem to be promising in view of a clinical evaluation of r-hirudin.

Animals↗
PubMed1989

A comparison of Madopar CR and standard Madopar in the treatment of nocturnal and early-morning disability in Parkinson's disease. The U.K. Madopar CR Study Group.

In a double-blind, crossover study, 103 patients with Parkinson's disease and nocturnal and/or early-morning disabilities took a bedtime dose of either Madopar CR (controlled-release levodopa plus benserazide) or standard Madopar, in addition to their usual daytime levodopa regimen. The mean optimum dosages were as follows: Madopar CR, 2.4 125 mg capsules; standard Madopar, 2.2 125 mg capsules. Assessment by daily patient diary and the doctor's record showed that nocturnal and early-morning disability was reduced by both treatments compared with at the start of the study, the difference being statistically significant. Improvement occurred in a similar number of patients when taking Madopar CR or standard Madopar (nocturnal disability improved in 61% on Madopar CR, and 57% on standard Madopar: early-morning disability improved in 46% on Madopar CR, and 44% on standard Madopar) and the percentage of patients wishing to continue on each treatment was also similar (64% on Madopar CR, and 55% on standard Madopar). However, in two-thirds of all cases, both doctor and patient felt that there was a difference between the treatments. Both Madopar CR and standard Madopar were of benefit to patients with nocturnal disability and, to a lesser extent, to those with early-morning problems. However, some patients responded better to Madopar CR and some to standard Madopar.

Activities of Daily Living↗
PubMed1967

The second International Standard for Oxytetracycline.

The National Institute for Medical Research, London, was requested by the WHO Expert Committee on Biological Standardization to establish a second International Standard for Oxytetracycline, since stocks of the first International Standard were depleted. A batch of 500 g of oxytetracycline dihydrate obtained in 1963 was distributed into ampoules in 125-mg amounts; the ampoules were filled with dried nitrogen and sealed. The usual procedure of exhaustively drying the material was omitted since removal of water of hydration adversely affects stability of oxytetracycline dihydrate. The proposed replacement material has been assayed biologically in terms of the first International Standard in 9 laboratories in 7 countries by means of plate-diffusion and turbidimetric assays.Significant heterogeneity of the potencies obtained by the different laboratories and within 3 laboratories was not attributable to any known differences in assay technique; the weighted mean potencies obtained by all laboratories were within a range of +/-2% of the over-all mean potency.The potency of the second International Standard is approximately 3% less than that of the first International Standard but no significant difference in composition or purity could be detected by a variety of chemical and physical analytical methods. The material has been established as the second International Standard for Oxytetracycline with a defined potency of 880 IU/mg. The International Unit of Oxytetracycline is defined as the activity of 0.0011364 mg of the second International Standard of Oxytetracycline.

Oxytetracycline↗
PubMed1969

The need to standardize descriptive cataloging.

Because there are too many ways to describe a book, its presence may not be discovered in a bibliography or catalog. Standardized descriptive cataloging is needed to solve this problem and also to eliminate wasteful duplication of cataloging. The Anglo-American Cataloging Rules and the COSATI Standard disagree on choice of main entry, and the Library of Congress does not follow the AACR all of the time. But the essence of standardized cataloging is widespread availability and general acceptance of the data, regardless of principles followed. Local adaptations in standard cataloging data are necesary, but those which affect all copies of a book, not just unique features of particular copies, must be made available for use by all libraries by correction of the standard cataloging data. The national structure for communicating standard cataloging data today is mainly printed tools, but tomorrow local library terminals on-line to a shared computer data bank may provide the instantaneous access needed. The problem of getting the wider community of library users to standardize their citation practices is more difficult to solve, but hope for improvement lies in making access to standard data easier.

Cataloging↗
PubMed1981

Role of JCAH standards in negligence suits.

Court cases in which the Standards of the Joint Commission on Accreditation of Hospitals have been introduced into evidence are reviewed to examine the various legal roles of the Standards and to consider some implications of this for the hospital and for the hospital pharmacist. Following a review of the Darling case, the role of the Standards in establishing a legal duty is examined with emphasis on a case involving medication handling where it was held that a hospital may be liable for damages resulting from failure to comply with JCAH Standards. The Standards have also been used to assist in creating a national standard of due care by abrogating the locality or community rule. Miscellaneous uses of the Standards are also discussed. The product institutional pharmacist will be thoroughly familiar with JCAH Standards applicable to activities related to medication handling and take steps to assure that every effort is made to comply with these requirements.

Accreditation↗
PubMedDate not supplied

Steady-state pharmacokinetics of enteric-coated naproxen tablets compared with standard naproxen tablets.

In this open-label, randomized, cross-over study, 24 healthy volunteers (12 men and 12 women) received either enteric-coated (EC) naproxen tablets 500 mg twice daily or standard naproxen tablets 500 mg twice daily for 7 days. In each of the two study periods, blood sampling began on day 8, after one last dose of the study drug was administered, to determine and compare steady-state pharmacokinetics for each of the two naproxen formulations. The plasma half-life of naproxen averaged 16.3 and 16.9 hours following EC naproxen and standard naproxen treatments, respectively. Mean time to maximum plasma concentration (Tmax) was greater for EC naproxen than for standard naproxen (4.0 vs 1.9 hours), while the maximum observed plasma concentration (Cmax) was slightly, but not significantly, smaller (94.9 vs 97.4 micrograms/mL, respectively). The mean values for average plasma concentration (Cave) and minimum plasma concentration for EC naproxen were 70.4 and 60.6 micrograms/mL, respectively, compared with 63.9 and 44.1 micrograms/mL for standard naproxen. The mean plasma fluctuation about the mean was greater for standard naproxen than for EC naproxen (85.3% vs 49.3%), while the mean area under the plasma concentration-time curve (AUC) was smaller for standard naproxen (766.8 vs 845.0 micrograms x h/mL). At steady state, EC naproxen was similar to standard naproxen tablets with respect to Cmax, Cave, Cmax:Cave, 0- to 12-hour AUC, and half-life but differed in Tmax. In addition, fluctuations about Cave in plasma levels were considerably lower with EC naproxen than with standard naproxen.

Administration, Oral↗
PubMedDate not supplied

Health Level Seven (HL7): standard for healthcare electronic data transmissions.

The nursing profession needs computer-formatted data that can be exchanged within and between agencies. The exchange of electronic data, both in the United States and in the international community, requires agreement on the format of the data elements to be exchanged. The Health Level Seven (HL7) standard is a proposed voluntary standard for healthcare applications that addresses the way information is exchanged electronically. This brief article will provide background information regarding the development and status of HL7 and its implications for nursing. From the clinical perspective, nurses follow standards of care developed by professional organizations. These standards facilitate clear communication among nurses, consumers, and members of other disciplines. Similarly, the electronic transmission and exchange of clinical information must have a standard to ensure that messages arrive and are decoded correctly. Many standards for electronic data already exist; financial transactions such as banking are familiar examples. The theme of the 1990 Symposium on Computer Applications in Medical Care (SCAMC), was Standards in Medical Informatics. Many pertinent papers and workshops were presented. However, references to electronic data standards are found primarily in conference proceedings and technical manuals. Thus, although activity is widespread, and events are rapidly moving in the healthcare industry, most of the information is not yet widely available. It seems timely, therefore, to provide background material to nurses in order for them to participate in the process.

Computer Communication Networks↗
PubMed1993

Development of standards for providing prescription drugs by mail.

The development and implementation of practice standards for a mail-service pharmacy are described. Literature, licensing regulations, and existing national practice standards were reviewed. Selected mail-service pharmacies were surveyed on their practice standards. Patients who had received prescription drugs by mail from a university hospital pharmacy were asked their opinions of the service in a telephone survey. Based on the information gathered, a set of practice standards was drafted. The draft was considered by a panel of experts who reached a consensus on mail-service pharmacy practice standards. The standards were implemented at a university hospital's outpatient pharmacy. Standards of practice for mail-service pharmacies were developed and applied at a university hospital outpatient pharmacy. Other pharmacies may find the standards useful.

Drug Prescriptions↗
PubMed1993

[Standard formulas of parenteral nutrition. A study of their use in a general hospital].

The goal of the study was to evaluate the use of parenteral nutrition formulas with standardized g. of nitrogen, carbohydrates and lipids, and to analyze whether the nutritional requirements of the patients treated in our hospital were covered by said formulas or whether it was necessary to change and/or standardize a new formula. To do so, a review was made of 5.646 parental nutrition mixtures prepared in the Pharmacy Service and patterned by the Nutrition Service from April, 1991, to May, 1992, for 308 adult patients. The distribution of the mixtures by services, diagnoses and the frequency of the different standard formulas were studied, comparing standard formula frequency with that of non-standard formulas. Findings showed that 41.9% of nutrition mixtures were patterned in surgery, and the most common diagnosis, cancer, appeared in 24%. Of the mixtures, 67.6% were preestablished formulas, and 32.4% were non-standard formulas. The order of frequency among standard formulas was: basic standard formulas, stress formulas, initial formulas, peripheral formulas, hemodialysis formulas and low-volume formulas. All covered the nutritional needs of a large share of the patients for the different pathologies in which they were indicated. Nevertheless the question of designing a new formula to cover a greater number of situations was raised. Protocolization should take place rationally, to meet the hospital's most frequent pathologies, and effectiveness should be evaluated after tracking and checking each patient.

Adult↗
PubMed1996

Consensus minimum standards for use in a trainer's report for summative assessment in general practice.

BACKGROUND: Summative assessment of general practitioner registrars is to be introduced in September 1996, one component of which will be a report by the trainer. Standards must be set and guidance provided as to the most appropriate ways of obtaining evidence for the trainer's assessment. AIM: The first aim of this study was to set consensus minimum standards for 30 items that are likely to form the content of a trainer's report; the second aim was to provide a consensus view on the most appropriate methods of assessment to be used by trainers. METHOD: A consensus conference was held in March 1995 during which the 30 items were discussed by a group of 30 general practitioners, of whom 27 were experienced trainers. This resulted in a draft document that was circulated to the conference attenders and other experts for consultation. RESULTS: Draft minimum standards were produced for all 30 items after the consensus conference with a mean of 2.5 standards for each item. Of those involved in the consultation exercise, 82% replied. Most of the revisions suggested at this stage were of a minor nature; the only major revision was to divide one item into two, resulting in a final total of 31 items. All but one of the 80 standards could be assessed by direct observation; 41 (51%) could be assessed by tutorial-based discussion and 61 (76%) by methods specific to that standard. Trainers or their practice partners were viewed as acceptable sources of evidence for all items and hospital consultants and primary health care team members were viewed as acceptable for just over half of the items. CONCLUSION: Standards for use by trainers when providing a general practitioner report for the summative assessment of registrars have been developed by consensus conference and have been subjected to review by consultation. Acceptable methods by which registrars could be assessed against these standards, and suitable personnel who could provide evidence, have also been suggested.

Education, Medical, Graduate↗