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PubMed1993

Experiences with the international standard for clinical electroretinography: normative values for clinical practice, interindividual and intraindividual variations and possible extensions.

The international Standard for Clinical Electroretinography requires a minimum of 5 standard response types. In a sample of 20 healthy subjects, the normative values according to this standard were established. Since the distribution of amplitude and implicit time does not follow a Gaussian distribution, we have found the median value and the 1st to 99th percentile or the 5th to 95th percentile useful for determination of abnormality, presented here separately for intraindividual and interindividual variation. To improve quality and reliability, we propose that individual laboratories extend the minimum standard and record the standard responses as parts of a stimulus series of increasing intensity. The normal value of the b/a ratio can easily be established from the maximum response to the Standard for Clinical Electrophysiology standard flash, pointing to abnormalities especially in circulatory disturbances and in degenerative diseases of the retina. The b/a ratio is between 1.5 and 1.7. If flicker responses are recorded at the 1st and 10th minutes after the onset of the rod saturating adaptation light (25 cd/m2), an increase in amplitude can be observed, which in our sample has a relative value of 1.3. A reduced increase in cone response amplitudes during light adaptation might point to abnormality within the rod/cone interaction. Responses from the cone system can be further differentiated by the use of chromatic stimuli. With appropriate filters, short-wavelength cone-sensitive and long-wavelength cone-sensitive responses can be differentiated also in clinical daily practice, which might be helpful for further differentiation of cone disorders. Regular measurements of intraindividual variability can help to improve the quality of electroretinogram recordings. Medians and ranges between the 1st and 99th and the 5th and the 95th percentiles were determined for all recordings for interindividual, as well as for intraindividual variations.

Adult↗
PubMed1995

A new method for P0.1 measurement using standard respiratory equipment.

The airway occlusion pressure, P0.1, is an index for the neuro-muscular activation of the respiratory system. It has been shown to be a very useful indicator for the ability of patients receiving ventilatory support to be weaned from mechanical ventilation. Since the standard measurement technique for P0.1 determination is technically complex, it is not widely available for clinical purposes. For that reason a P0.1 measurement technique was developed as an integrated function in a standard respirator (Evita, Dräger, Lübeck, Germany). This technique is easy to use and does not need any further equipment. We validated this new technique by comparing it to standard P0.1 measurements in a mechanical lung model as well as in ventilated patients. In the lung model we found a correlation between the Evita measurement and standard measurements of r = 0.99. In 6 ventilated patients the correlation was r = 0.78. Since the Evita P0.1 and the standard measurement had to be performed during two different breaths, this little poorer correlation in patients may be due to a significant breath-by-breath variability in P0.1. Comparing the Evita P0.1 and the standard measurement within one breath resulted in a clearly better correlation (r = 0.89). We conclude that this new measurement technique provides an easy and accurate P0.1 measurement using standard respiratory equipment when tested in a lung model. In patient measurements the method is less precise, which is probably due to the variable waveforms of the inspiratory driving pressure seen in patients, for example when intrinsic PEEP is present.(ABSTRACT TRUNCATED AT 250 WORDS)

Airway Resistance↗
PubMed2000

Loss of standard type of CD44 expression in invaded area as a good indicator of lymph-node metastasis in colorectal carcinoma.

PURPOSE: Recent advances have made possible the treatment of small invasive colorectal cancer by means of polypectomy or endoscopic mucosal resection. CD44 expression in cancer cells was identified as an indicator of lymph-node metastasis, which could be evaluated in specimens removed by colonoscopy. METHODS: The correlation between lymph-node metastasis and the expression of standard-type CD44 in cancer cells was examined immunohistologically using the invaded cancer cells of 61 tissue samples of superficially invasive colorectal cancer. We defined the above as invasive cancer restricted within the colorectal wall. Of the 61 samples, 31 had submucosal invasion and 30 had muscular invasion. RESULTS: Standard-type CD44 expression in the area of invasion in cases with lymph-node metastasis was remarkably down-regulated. In 43 cases with no lymph-node metastasis, 36 (83.7 percent) of patients had CD44 expression in invaded cells, whereas only two of 18 cases (11.1 percent) with lymph-node metastasis had expression of standard-type CD44 in the same area (P < 0.0001). A total of 69.6 percent (16/23) of patients with loss of standard-type CD44 expression in invaded sites were found to have positive metastasis in the lymph nodes. These results suggest that standard-type CD44 in invasive colon cancer cells could suppress metastasis to the regional lymph nodes. CONCLUSION: In cases of invasive colorectal cancer, the loss of standard-type CD44 expression in the invaded area is a sensitive marker for metastasis to the lymph nodes. Further investigation with larger patient groups is required to clarify the reliability of loss of standard-type CD44 expression as an indicator for additional surgery after endoscopic resection of submucosal invasive colorectal carcinoma.

Biomarkers, Tumor↗
PubMed1993

Evaluation of resident performance in an outpatient internal medicine clinic using standardized patients.

OBJECTIVE: To observe and evaluate the performance of primary care internal medicine residents within the outpatient clinic milieu. DESIGN: Longitudinal descriptive study. PATIENTS/PARTICIPANTS: 48 internal medicine resident encounters with two standardized patients at the University of Wisconsin General Internal Medicine Clinics. INTERVENTION: Residents were rated by the standardized patients with a medical skills checklist and an interpersonal skills checklist, and by the staffing physician with a clinical reasoning skills checklist. The investigators reviewed audiotapes of the standardized patient encounters for strategic management skills. MAIN RESULTS: Resident performance on these scales was examined for improvement with years of training; when considered separately, no such effect was seen for either standardized patient case. When the cases were grouped together, however, there was significant improvement on the Clinical Reasoning Instrument. The grouped standardized patient data were compared with data from inpatient faculty evaluations of the residents. Faculty evaluations correlated with standardized patient evaluations of resident performance only on the medical checklist. Finally, comparison of the four assessment scales demonstrated a significant correlation between interpersonal skills, as assessed by the patient, and strategic management skills. CONCLUSION: Resident outpatient performance, measured in a blinded setting, does not improve with year of training. Faculty inpatient assessments of residents correlate with medical "thoroughness" as measured by a medical skills checklist, and interpersonal skills as rated by standardized patients correlate with resident use of strategic medical management.

Adult↗
PubMed2001

Anesthesia standards for facilities and equipment.

PURPOSE: This article will define standards, how they are developed and applied and how they impact on the day to day practice of clinicians. SOURCE: CSA-International, International Electrotechnical Committee (IEC), Organization for International Standardization (ISO). PRINCIPAL FINDINGS: The safety record of the practice of anesthesia has improved over the past 20 yr. This has been brought about by the increase in the knowledge base of physiology and pharmacology, improvements in anesthetic drugs and other medications and through the use of better equipment. However, the introduction of new equipment and the building of new health care facilities has also introduced risks to patient safety. These risks have been created by oversights in design, mistakes in equipment manufacture or facility construction and the need to produce a usable product for the price the health care system can afford. After the anesthetic disasters of the 1960s and 1970s, the need for minimum standards for safety in the design and construction of healthcare facilities and medical equipment were recognized. Canadian anesthesiologists were at the forefront in the development of these standards, and still today members of the Canadian Anesthesiologist's Society are key contributors to the development of both National and International standards. CONCLUSION: Equipment and facility standards have helped improve patient safety over the past 20 yr. However, anesthesiologists need to encourage their governmental regulatory bodies to encourage manufacturer compliance with specific standards.

Anesthesiology↗
PubMed2007

Defining indicators and standards for tourism impacts in protected areas: Cape Range National Park, Australia.

Visitors' perceptions of impacts and acceptable standards for environmental conditions can provide essential information for the sustainable management of tourist destinations, especially protected areas. To this end, visitor surveys were administered during the peak visitor season in Cape Range National Park, on the northwest coast of Western Australia and adjacent to the iconic Ningaloo Reef. The central focus was visitors' perceptions regarding environmental conditions and standards for potential indicators. Conditions considered of greatest importance in determining visitors' quality of experience included litter, inadequate disposal of human waste, presence of wildlife, levels of noise, and access to beach and ocean. Standards were determined, based on visitors' perceptions, for a range of site-specific and non-site-specific indicators, with standards for facilities (e.g., acceptable number of parking bays, signs) and for negative environmental impacts (e.g., levels of littering, erosion) sought. The proposed standards varied significantly between sites for the facilities indicators; however, there was no significant difference between sites for environmental impacts. For the facilities, the standards proposed by visitors were closely related to the existing situation, suggesting that they were satisfied with the status quo. These results are considered in the context of current research interest in the efficacy of visitor-derived standards as a basis for protected area management.

Data Collection↗
PubMed2002

Comparison of low-dose and standard-dose helical CT in the evaluation of pulmonary nodules.

The purpose of this study was to investigate the diagnostic accuracy of low-dose helical computed tomography by comparing the number of nodules detected at low- and standard-dose CT. The prospective study included 25 patients who were referred to CT scan for the assessment of pulmonary metastases. All patients underwent CT examinations at both standard- (200 mA, 120 kV, collimation 5 mm, table feed 10 mm per rotation) and low-dose (50 mA, 120 kV, collimation 5 mm, table feed 10 mm per rotation). The number of nodules detected at each protocol was recorded. The size of the nodules was measured electronically and categorized as <3, 3-4.9, 5-6.9, 7-9.9, and >/=10 mm. Finally, the nodules detected at only standard- or low-dose CT were assessed for the underlying causes of discrepancy. In 25 patients, 533 nodules were detected at standard-dose, whereas 518 nodules were observed at low-dose CT. There were no statistically significant differences in the number of nodules detected at standard- or low-dose CT ( p>0.05). Four hundred ninety-one (87.7%) nodules were detected at both standard- or low-dose CT, 42 (7.5%) nodules were observed only at standard-dose CT, and 27 (4.8%) nodules were seen only at low-dose CT. The sensitivity of low-dose CT was 92.5% for all nodules, 88.1% for nodules <5 mm, and 97.4% for nodules >/=5 mm. No significant image artifact interfering with nodule detection was observed at low-dose CT. The low-dose CT protocol used in this study provided images of adequate quality; thus, it can be used reliably in the detection or exclusion of pulmonary nodules.

Female↗
PubMed2003

Long versus standard initial steroid therapy for children with the nephrotic syndromeA report from the Southwest Pediatric Nephrology Study Group.

A retrospective cohort study was conducted by the Southwest Pediatric Nephrology Study Group (SPNSG) to address whether a longer initial course of corticosteroids in patients with idiopathic nephrotic syndrome (INS) provides superior protection against relapse without increased adverse effects. In order to be included in the evaluation, patients with INS must have responded to an initial steroid course, either standard or long regimen as defined here, and completed at least 1 year of follow-up. The standard regimen consisted of prednisone 2.0+/-0.3 mg/kg per day or 60+/-10 mg/m(2) per day for 28+/-4 days, followed by alternate-day prednisone for 4-12 weeks. The long regimen consisted of daily prednisone 2.0+/-0.3 mg/kg per day or 60+/-10 mg/m(2) per day for 42+/-6 days, followed by alternate-day prednisone for 6-14 weeks. The primary outcome measure was relapse of NS within 12 months of discontinuing the initial course of prednisone. There were 151 children who met the criteria for the study; 82 received the standard regimen and 69 the long regimen. The two groups did not differ in age, race, blood pressure, serum albumin, or serum cholesterol prior to the initial steroid course. The cumulative prednisone dose was 49% higher in the long regimen group than in the standard regimen group. Relapse within 12 months was reported in 72.5% of patients who received the long regimen versus 84.1% of those who received the standard regimen. The odds ratio for relapse within 12 months was 0.496 (95% confidence interval 0.22, 1.088), long versus standard regimen. This did not reach statistical significance ( chi(2)=3.058, P=0.08). The odds ratio of experiencing at least one side effect was 3.76, long relative to standard regimen ( n=133, P<0.001). Our data suggest that prolongation of the steroid treatment for the initial episode of steroid-sensitive NS may have a beneficial effect, but at the cost of increased side effects. However, definitive conclusions are limited by the retrospective design of the study and the number of patients. This may have caused failure to achieve statistical significance on the basis of a type II error.

Adolescent↗
PubMed2001

A randomized, crossover comparison of standard-dose versus low-dose lenograstim in the prophylaxis of post-chemotherapy neutropenia.

The aim of this trial was to compare the severity of neutropenia, the frequency of hospital admission for fever or infection, and the use of antibiotics among patients treated with a standard dose of lenograstim (263 microg/day of Euprotin) and others treated with half of this dose (131.5 microg/day) and the cost-effectiveness of each of the two doses. In this single-center study, 44 patients with solid tumors, who were all receiving standard-dose chemotherapy regimens following previous neutropenia or were at high risk of neutropenia, were randomized to receive lenograstim at a dose of 263 microg or 131.5 microg daily in the first cycle and then crossed over to the alternate dose for the following cycle. Crossover to the alternate dose was repeated for patients who received more than two cycles. Lenograstim was administered from day +5 to day +14. The absolute neutrophil count (ANC) was assessed on days +5, +8, +12 and +15 of each cycle. Statistical analysis was performed using a general lineal model for repeated samples. In all, 120 cycles were administered, with a median of 3 cycles (range 1-6). Only 4 patients received only 1 cycle. No statistically significant difference (P=0.324) in ANC was observed between standard-dose (mean 5.3, 10.7, 8.3, 11.4 x 10(9)/l) and low-dose (5.0, 8.6, 5.4, 7.5 x 10(9)/l) treatment at days +5, +8, +12 and + 15. Neutropenia grade III-IV was more common in patients receiving the low than in those receiving the standard dose of lenograstim (20% vs 12%, respectively), but the difference did not reach statistical significance (P=0.1). The incidence of fever and frequency of hospital admission were not affected by the dose of lenograstim: 3 patients presented with fever with the standard dose (all of those were admitted to hospital) and 2 patients with the low dose (1 was admitted). ANC in both groups (standard and low doses) was independent of chemotherapy line (first versus second or more). Lenograstim at a dose of 131.5 microg/day is as effective as the standard dose in limiting the severity of neutropenia and in preventing episodes of fever and hospital admissions after chemotherapy for solid tumors. The lower dose of lenograstim is cost-effective in neutropenia prophylaxis. Starting its administration on day +5 reduces costs while maintaining efficacy.

Adjuvants, Immunologic↗
PubMed2006

Comparison of standard-dose and low-dose gemcitabine regimens in pancreatic adenocarcinoma patients: a prospective randomized trial.

BACKGROUND: A prospective, randomized study was performed to determine whether gemcitabine infusion at a low dose (250 mg/m2) is comparable or superior to the standard-dose infusion (1000 mg/m2) in terms of the survival period, clinical benefit, and frequency of adverse effects in patients with advanced pancreatic adenocarcinoma. METHODS: Twenty-five patients who were histologically proven to have locally advanced pancreatic cancer or pancreatic cancer with distant metastases were initially enrolled in the present study. They were treated with gemcitabine infusion at either a dose of 1000 mg/m2 over 30 min (the standard regimen) on days 1, 8, and 15 of every 4-week cycle or at a dose of 250 mg/m2 over 30 min every week. Survival time, response rate, time to treatment failure, clinical benefit response, and adverse effects were compared between the two groups. RESULTS: Twenty-one patients received gemcitabine for more than 1 month. The median survival period was 7.2 months for patients who received the low-dose infusion regimen, in contrast to 5.2 months for patients administered the standard-dose infusion regimen. The time to treatment failure was 5.6 months for patients in the low-dose infusion regimen, in contrast to 3.4 months for patients in the standard-dose infusion regimen. There were no significant differences in either survival time to time to treatment failure or clinical benefits between the two groups, but the incidence of adverse reactions in patients administered the low-dose therapy was significantly lower than that in patients receiving the standard-dose therapy (P<0.05). In particular, patients in the standard infusion regimen group experienced more hematologic toxicity than those in the low-dose regimen. CONCLUSIONS: These findings suggest that the low-dose gemcitabine infusion regimen can be continuously administered to patients with locally advanced and systemically spreading pancreatic cancer because of its reduced toxicity, resulting in better quality of life and an improved safety profile as compared to the standard infusion treatment regimen.

Adenocarcinoma↗
PubMed2007

Sexual history inquiry and HIV counseling: improving clinical skills and medical knowledge through an interactive workshop utilizing standardized patients.

BACKGROUND: Sexual history and HIV counseling (SHHIVC) are essential clinical skills. Our project's purpose was to evaluate a standardized patient educational intervention teaching third-year medical students SHHIVC. METHODS: A four-hour standardized patient workshop was delivered to one-half of the class each of three consecutive years at one medical school. Approximately 3.5 weeks later, all students engaged in a standardized patient examination including one station assessing SHHIVC, answered an open-ended written exercise following the standardized patient encounter, and completed a written examination including sexual history and HIV-related questions. RESULTS: Workshop participants scored higher than non-participants on SHHIVC items on the standardized patient station (P < .0001), written exam (P < .0001), and open-ended written exercise after the standardized patient encounter (P = .024). CONCLUSIONS: Our SHHIVC curriculum was associated with students demonstrating better clinical skills on a SHHIVC standardized patient examination station and more SHHIVC knowledge on two measures of medical knowledge than students not participating in the SHHIVC educational intervention.

Clinical Competence↗
PubMed2006

Utility in clinical practice of standard vs. high-intensity ERG a-waves.

PURPOSE: Standard ERG a-waves represent contributions from both photoreceptor and inner retinal cells, while the leading edge of the high-intensity a-wave is produced only by photoreceptors. This has raised questions about the value of the a-wave as an indicator of photoreceptor disease, and has led to suggestions for standardizing higher-intensity stimuli. Our objective was to compare the behavior of standard and high-intensity a-waves in clinical practice. METHODS: Standard ISCEV (International Society for Clinical Electrophysiology of Vision) a-waves and high-intensity a-wave responses were recorded under scotopic and photopic conditions from normal subjects and from patients with photoreceptor dystrophies and other diseases. RESULTS: The standard scotopic a-wave amplitude followed the high-intensity a-wave closely among patients with different diagnoses, and the results did not change significantly when cone a-waves were subtracted to isolate rod signals. The only exception was one patient with the enhanced S cone syndrome (ESCS) whose dark-adapted responses were cone-driven. Initial peak times clustered in a small range for both standard and high-intensity responses, and were not very sensitive to disease. CONCLUSION: High-intensity a-waves can show photoreceptor characteristics directly, and may help analyze some rare disorders. However, in our study the amplitude of conventional scotopic a-waves mirrored that of the high-intensity responses quite closely over a wide range of patients. This suggests that for practical purposes even if it is not perfect, the standard ERG is an excellent indicator of photoreceptor disease.

Adaptation, Ocular↗
PubMed2005

Is the standard SF-12 health survey valid and equivalent for a Chinese population?

INTRODUCTION: Chinese is the world's largest ethnic group but few health-related quality of life (HRQoL) measures have been tested on them. The aim of this study was to determine if the standard SF-12 was valid and equivalent for a Chinese population. METHODS: The SF-36 data of 2410 Chinese adults randomly selected from the general population of Hong Kong (HK) were analysed. The Chinese (HK) specific SF-12 items and scoring algorithm were derived from the HK Chinese population data by multiple regressions. The SF-36 PCS and MCS scores were used as criteria to assess the content and criterion validity of the SF-12. The standard and Chinese (HK) specific SF-12 PCS and MCS scores were compared for equivalence. RESULTS: The standard SF-12 explained 82% and 89% of the variance of the SF-36 PCS and MCS scores, respectively, and the effect size differences between the standard SF-36 and SF-12 scores were less than 0.3. Six of the Chinese (HK) specific SF-12 items were different from those of the standard SF-12, but the effect size differences between the Chinese (HK) specific and standard SF-12 scores were mostly less than 0.3. CONCLUSIONS: The standard SF-12 was valid and equivalent for the Chinese, which would enable more Chinese to be included in clinical trials that measure HRQoL.

Adolescent↗
PubMed1993

Guidelines for the development of safety-related standards for consumer products.

Product safety standards, issued by official standardization bodies, play an important part in consumer protection policy. Many of these standards exhibit considerable shortcomings, which limit their applicability and effectiveness. This paper deals with a number of problems in the development of safety standards, in particular for consumer products. Recently published guidelines for safety-related standards are discussed, and additional recommendations are developed. In addition to the traditional problems in standardization, attention is devoted to product information and the generalizability of test results. The analysis and recommendations in this paper do not only apply to standards, but also to other documents containing test methods for consumer products, e.g. for comparative testing, certification, and product development.

Consumer Product Safety↗
PubMed1995

Safety implications of extending some Canadian Motor Vehicle Safety Standards to light trucks and vans.

The primary objective of this research was to evaluate the implications of extending specific Canadian Motor Vehicle Safety Standards (CMVSS) to light trucks and vans (LTVs). This was accomplished through the examination of the potential safety-related benefits of these standards comparing the injury frequencies and severities of the light trucks and vans and the passenger cars (PCs). The standards considered, which currently apply to passenger cars but not to LTVs, are the head restraint (CMVSS 202), side door strength (CMVSS 214), and roof crush strength (CMVSS 216) standards. The comparison was effected by means of logit models developed from multidimensional tables with injury frequency and severity as dependent variables. There are indications that installing head restraints in light trucks and vans could reduce or prevent minor neck injuries and that modest benefits could be achieved by extending the roof crush standard to the LTVs. It was also determined that the side door strength standard may not necessarily be as beneficial to LTVs in conditions in which the vehicle is struck on the side by another LTV. It is suggested that the general public be made aware of the differences in safety standards between LTVs and PCs.

Accidents, Traffic↗
PubMed1991

Increasing the yield of ventricular tachycardia induction: a prospective, randomized comparative study of the standard ventricular stimulation protocol to a short-to-long protocol and a new two-site protocol.

Programmed ventricular stimulation with a standard protocol that used up to three extrastimuli was compared prospectively with a short-to-long protocol and a two-site protocol in 77 consecutive patients undergoing electrophysiologic study in an attempt to increase the yield of ventricular tachycardia (VT) induction. The short-to-long protocol uses a train of eight stimuli at a short cycle length and up to two extrastimuli. The two-site protocol is similar to the standard protocol but delivers the last extrastimulus via a second spatially separated right ventricular catheter. Patients were divided into two groups based on indications for study: group 1 included 45 patients with syncope, nonsustained VT, or both, and group 2 included 32 patients with a history of sustained VT, sudden cardiac death, or both. The yield of VT induction with the short-to-long protocol was less than that with the standard protocol. In none of the patients in group 1 in whom the standard protocol results were negative did the short-to-long protocol produce sustained VT. Only two patients, both in group 2, had sustained arrhythmias induced by the short-to-long protocol when the standard protocol results were negative: one had sustained VT induced and one with long QT syndrome had ventricular fibrillation (VF) induced with the short-to-long protocol. However, the short-to-long protocol failed to induce sustained VT in seven patients in whom the standard protocol produced sustained VT. All seven of these patients required three extrastimuli with the standard protocol for induction of VT.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1992

Evaluation of changes in standard electrocardiographic QRS waveforms recorded from activity-compatible proximal limb lead positions.

Proximal limb lead positions are currently used for activity-compatible electrocardiographic monitoring of myocardial ischemia. Two previously described systems for alternate limb lead placement were studied in patients with and without QRS evidence of healed anterior or inferior myocardial infarction. An innovative method was used to simultaneously record 6 standard and 6 modified limb leads, and 3 standard and 3 modified precordial leads on a standard digital electrocardiograph. Both alternate lead placement systems showed rightward frontal plane axis shift and diminished Q-wave durations in lead aVF compared with those of their simultaneous standard controls. Furthermore, potential differences between the standard distal limb lead sites and 5 more proximal sites were explored along each limb. Differences along the left arm were accentuated relative to those along the right arm owing to differences in proximity of the arms to the myocardium. Along the lower limb, and anterior site showed less deviation from standard than did a more lateral site. It is imperative that recordings from alternate sites be labeled accordingly so that their output cannot be confused with that obtained from standard sites.

Arm↗
PubMed1979

A standard on human response to vibration--one of a new breed?

Human response to vibration is used as an example for consideration of the requirements of standards in the human factors field. It is suggested that standards relating to people may be concerned primarily with the design of equipment for optimum satisfaction of users, and that this demands a different approach to standards if they are to be effective. It is argued that a clear distinction should be made between standards intended to protect people from harmful conditions, standards intended to minimise the risk of people being harmed, and standards intended to give advice and information. In the case of human response to vibration it is suggested that standards should relate to agreed methods of measurement and assessment, limitations to preserve health, limitations to be applied in specific situations in order to prevent the risk of accidents, together with a data base for designers to work from.

Journal Article↗