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PubMed1997

The effects of standardization and reference values on patient classification for spine and femur dual-energy X-ray absorptiometry.

The effect of two methods for standardizing dual-energy X-ray absorptiometry (DXA) measurements on patient classification by the T-score has been determined for a group of over 2000 patients. The methods proposed by the International DXA Standardization Committee and the European Community's COMAC-BME group were used in conjunction with young reference data from the major DXA manufacturers, the COMAC-BME group and the third US National Health and Nutrition Examination Survey (NHANES III). The two standardization techniques produced dissimilar classifications as measured by the kappa statistic (kappa = 0.34-0.90), especially for the femoral neck, with up to 24.3% of patients reclassified from osteopenic to normal and 18.6% reclassified from osteoporotic to osteopenic when the standardization method was changed. Considering the effects of both reference data and standardization techniques together, there was a wide variation of patient classification, with the number of patients classified as osteoporotic varying from 9.6% to 21.1% for the postero-anterior spine L2-4 region and from 2.3% to 27.6% for the femoral neck. The agreement between different classifications ranged widely, from very poor to excellent (kappa = 0.02-0.98). The creation of standardized reference data must be an important priority in order to harmonize patient management using standardized BMD measurements. The choice of standardization technique, however, must be addressed in light of the results presented here.

Absorptiometry, Photon↗

PubMedDate not supplied

Estimating inestimable standard errors in population pharmacokinetic studies: the bootstrap with Winsorization.

A simulation study was performed to determine how inestimable standard errors could be obtained when population pharmacokinetic analysis is performed with the NONMEM software on data from small sample size phase I studies. Plausible sets of concentration-time data for nineteen subjects were simulated using an incomplete longitudinal population pharmacokinetic study design, and parameters of a drug in development that exhibits two compartment linear pharmacokinetics with single dose first order input. They were analyzed with the NONMEM program. Standard errors for model parameters were computed from the simulated parameter values to serve as true standard errors of estimates. The nonparametric bootstrap approach was used to generate replicate data sets from the simulated data and analyzed with NONMEM. Because of the sensitivity of the bootstrap to extreme values, winsorization was applied to parameter estimates. Winsorized mean parameters and their standard errors were computed and compared with their true values as well as the non-winsorized estimates. Percent bias was used to judge the performance of the bootstrap approach (with or without winsorization) in estimating inestimable standard errors of population pharmacokinetic parameters. Winsorized standard error estimates were generally more accurate than non-winsorized estimates because the distribution of most parameter estimates were skewed, sometimes with heavy tails. Using the bootstrap approach combined with winsorization, inestimable robust standard errors can be obtained for NONMEM estimated population pharmacokinetic parameters with > or = 150 bootstrap replicates. This approach was also applied to a real data set and a similar outcome was obtained. This investigation provides a structural framework for estimating inestimable standard errors when NONMEM is used for population pharmacokinetic modeling involving small sample sizes.

Clinical Trials, Phase I as Topic↗

PubMed2003

Comparison of laparoscopic skills performance between standard instruments and two surgical robotic systems.

BACKGROUND: Our objective was to compare the performance of laparoscopic tasks by surgeons using standard laparoscopic instruments and two surgical robotic systems. METHODS: Eighteen surgeons performed tasks in a training box using three different instrument systems: standard laparoscopic instruments, the Zeus Robotic Surgical System, and the da Vinci Surgical System. Basic tasks included running a 100-cm rope, placing beads onto pins, and dropping cotton peanuts into cylinders; fine tasks included intracorporeal knot tying and running stitches with 4-0, 6-0, and 7-0 sutures. Time (in seconds) required and precision (number of errors) in performing each task were recorded. Analysis of variance with pair-wise comparisons using the Bonferroni method and Friedman's nonparametric test were used for statistical analysis. RESULTS: Standard instruments performed significantly faster than either robotic system on the rope and bead tasks (p <0.05), whereas da Vinci performed significantly faster than Zeus in all three basic tasks (p <0.05). No significant difference in precision was found between standard instruments and the robotic systems on any of the basic tasks. Knot-tying and running-suture time were similar between standard instruments and da Vinci, which were significantly faster than Zeus (p <0.05) for all suture sizes. The robotic systems were similar in precision for fine suturing tasks and were significantly more precise in knot tying (Zeus and da Vinci) and running sutures (da Vinci) than standard instruments (p <0.05). CONCLUSIONS: Basic laparoscopic task performance is generally faster and as precise using standard instruments compared to either robotic system. In performing fine tasks, neither robotic system is faster than standard instruments, although they may offer some advantage in precision.

Clinical Competence↗

PubMed1987

Nifedipine gastrointestinal therapeutic system in stable angina pectoris. Results of a multicenter open-label crossover comparison with standard nifedipine.

To compare the clinical efficacy and dose equivalency of standard nifedipine versus a new gastrointestinal therapeutic system (GITS) formulation of nifedipine, 98 patients with chronic stable angina pectoris participated in a 14-week, multicenter, open-label, crossover trial. All patients were administered nifedipine capsules for one month prior to study entry and continued receiving other antianginal, non-calcium blocker medications. Ninety-one patients (93 percent), 80 men and 11 women, mean age 62 +/- 1 years, completed the trial, which included two weeks receiving standard nifedipine followed by 12 weeks receiving nifedipine GITS starting at a dosage equal to the 24-hour total dose of nifedipine capsules and titrated upward as necessary. However, throughout the trial, mean nifedipine dosage was similar on nifedipine GITS compared with standard nifedipine. Angina frequency was significantly less with nifedipine GITS at Weeks 6, 10, and 14 (0.8 episodes/week) compared with baseline with standard nifedipine (1.3 episodes/week, p less than 0.05). Likewise, nitroglycerin consumption was also less at Weeks 6, 10, and 14, but only significantly less at Week 6 (nifedipine 1.2/week versus nifedipine GITS at six weeks, 0.7/week; p less than 0.05). Resting hemodynamic parameters, including systolic and diastolic blood pressure and heart rate, were not significantly different with standard nifedipine versus nifedipine GITS during the 12-week study. Total incidences of side effects were similar for both treatments (standard nifedipine, 16; nifedipine GITS, 17). However, incidence of vasodilator side effects (flushing, dizziness, and light-headedness) was significantly less frequent with nifedipine GITS (standard nifedipine, 12; nifedipine GITS, six; p less than 0.05). Thus, results from this open-label, crossover trial suggest that nifedipine GITS dosing is similar to multidose standard nifedipine with equivalent 24-hour efficacy for nifedipine GITS.

Aged↗

PubMed1995

Ergonomics and international standards: history, organizational structure and method of development.

Egonomics international standards were formally considered in 1973 by a symposium of the International Ergonomics Association (IEA) held at Loughborough University in the UK. Recommendations led to the establishment of ISO TC 159 'Ergonomics', with Germany (DIN) holding the secretariat. Six subcommittees (SC) were established and have worked towards standards. These have been rationalized to the present four subcommittees: SC1, Ergonomics guiding principles; SC3, Anthropometry and biomechanics; SC4, Ergonomics and human system interaction; and SC5, Ergonomics of the physical environment. The subcommittees have over 15 working groups (WG) covering over 50 work items that will lead to ergonomics ISO standards. Over 20 ISO standards have already been produced and a number have been reconfirmed at automatic five-yearly reviews. The organizational structure is presented as well as methods of standards production from proposed work item to international standard. European standards (EN) are produced under CEN TC 122 'Ergonomics', which has 11 working groups. How European Standards are produced and organizational links with ISO TC 159 are described.

Journal Article↗

PubMed1989

A comparison of serial 49-lead precordial ECG maps and standard 6-lead precordial ECGs in patients with acute anterior Q wave myocardial infarction.

A comparison of 265 pairs of standard ECGs and 49-lead precordial maps in 20 patients with ST-segment elevations in anterior ECG leads on admission who eventually were diagnosed as having suffered an anterior Q wave myocardial infarction was carried out to investigate the diagnostic performance provided by the standard ECG in serial studies. Ten patients received intravenous methylprednisolone and 10 were given placebo on admission, and paired map-standard ECG studies were done. ST-segment elevations were taken as an index of ischemic injury and reduction of R wave amplitude or development of Q waves as a marker of developing necrosis. Methods of measurements and derivation of ECG parameters used in the analysis were the same for the standard ECGs and maps. Comparisons of percent change of five ECG-derived variables between 13 time points and admission, as assessed by the six precordial leads of the standard ECGs and the paired 49-lead maps, were made for the entire data base. A separate analysis to assess the performance of the standard ECG was carried out in a comparison of the methylprednisolone and placebo subgroups. In this latter assessment results of comparisons of the standard ECGs from the treatment and placebo cohorts were similar to the conclusions from the comparisons of the corresponding 49-lead maps. Comparisons for the entire 265 pairs of tracings by the two ECG systems demonstrated that the standard ECG is adequate to monitor quantitatively the ischemic injury and necrosis as reflected by the ECG in serial studies throughout the hospitalization and can be effectively employed in lieu of multilead precordial maps in the evaluation of therapeutic modalities for patients with anterior Q wave myocardial infarction.

Body Surface Area↗

PubMed1988

Establishment of atmospheric pollution standards for motor vehicles.

First we classify the various emission standards applying to light vehicles, the conditions under which the emissions are measured and the environmental standards. We then describe the way in which a standard is established according to the basic principles and procedures involved in determining acceptable environmental concentrations in practice. We refer to the economic and political considerations involved in deciding on a standard and, as an example, to the positions adopted by the various parties concerned in France when drafting the 15.05 standard. In response to the atmospheric pollution caused by motor vehicles, all the industrial countries have, some earlier than others, drawn up regulations designed to limit the extent of this pollution, to protect the environment and reduce the public health risk. Both environmental and emission standards are aimed at reducing the risks to the environment and in particular to man, arising From the presence of particular pollutants. The procedure concerned in establishing these standards is a complicated one involving scientific, economic and political considerations; furthermore, there is a great diversity of standards.

Air Pollution↗

PubMed1988

Comparison between brain paste and polymer [125I]standards for quantitative receptor autoradiography.

[125I]standards prepared from grey and white matter from rat brain have been compared to commercially available polymer-based standards using two types of radiation-sensitive film for use in quantitative receptor autoradiography. There was a linear relationship between the natural log of optical density and radioactivity (dpm/mm2) for both types of tissue standard exposed to Hyperfilm [3H] or betamax from 1-14 days. No difference between either the slopes or intercepts of these lines for each period of exposure was identified. There was also no significant difference between the slopes and intercepts of tissue-based standards and the lowest 5 activity levels of polymer standards. Over the complete range of ten radioactivity levels of polymer standards, the linear relationship was lost and a quadratic function was the best model for describing the relationship between 1n optical density and radioactivity. Moreover, a linear relationship between section thickness over the range frequently used in receptor studies (5-20 microns) was observed. These results suggest that the lower activity levels of polymer standards are comparable to tissue standards and can be used for quantitative receptor autoradiography.

Animals↗

PubMed1996

Clinical comparison of the BACTEC 9000 Standard Anaerobic/F and Lytic/F blood culture media.

An 8-month prospective, volume controlled, comparison of Standard Anaerobic/F media with a new anaerobic high blood volume lytic medium (Lytic/F) was performed. A total of 2,092 compliant sets, consisting of an aerobic resin bottle or standard aerobic bottle, Standard Anaerobic/F, and Lytic/F bottle were evaluated. A total of 220 (10.6%) positive specimens were detected from the paired anaerobic bottles. These consisted of 194 true positive and 26 false positive bottles. Of 207 total organisms isolated, 122 were considered clinically significant. A comparison of significant organism recovery revealed 79 isolates in both anaerobic bottles, 7 isolates in the standard Anaerobic/F bottle only, and 36 isolates in the Lytic/F bottle only (p < 0.001). The lytic/F bottle detected significantly more Enterobacteriaceae (p < 0.005) and Streptococci (p < 0.05). There were 24 false positive Standard Anaerobic/F bottles and 2 false positive Lytic/F bottles (p < 0.001). When both bottles were positive the Standard Anaerobic/F bottle was positive 12 hours earlier in 1 instance whereas the Lytic/F bottle was positive 12 hours earlier in 8 instances. The mean time for detection in the Standard Anaerobic/F bottle was 18.2 hours versus 13.2 hours for the Lytic/F bottle. The new Lytic/F anaerobic blood culture media was found to be superior to Standard Anaerobic/F media for both total organism recovery and time to organism detection.

Anaerobiosis↗

PubMed2004

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

PURPOSE: To compare ultrahigh-resolution optical coherence tomography (UHR-OCT) technology to a standard-resolution OCT instrument for the imaging of macular hole pathology and repair; to identify situations where UHR-OCT provides additional information on disease morphology, pathogenesis, and management; and to use UHR-OCT as a baseline for improving the interpretation of the standard-resolution images. DESIGN: Observational and interventional case series. PARTICIPANTS: Twenty-nine eyes of 24 patients clinically diagnosed with macular hole in at least one eye. METHODS: A UHR-OCT system has been developed and employed in a tertiary-care ophthalmology clinic. Using a femtosecond laser as the low-coherence light source, this new UHR-OCT system can achieve an unprecedented 3-mum axial resolution for retinal OCT imaging. Comparative imaging was performed with UHR-OCT and standard 10-mum resolution OCT in 29 eyes of 24 patients with various stages of macular holes. Imaging was also performed on a subset of the population before and after macular hole surgery. MAIN OUTCOME MEASURES: Ultrahigh- and standard-resolution cross-sectional OCT images of macular hole pathologies. RESULTS: Both UHR-OCT and standard-resolution OCT exhibited comparable performance in differentiating various stages of macular holes. The UHR-OCT provided improved imaging of finer intraretinal structures, such as the external limiting membrane and photoreceptor inner segment (IS) and outer segment (OS), and identification of the anatomy of successful surgical repair. The improved resolution of UHR-OCT enabled imaging of previously unidentified changes in photoreceptor morphology associated with macular hole pathology and postoperative repair. Visualization of the junction between the photoreceptor IS and OS was found to be an important indicator of photoreceptor integrity for both standard-resolution and UHR-OCT images. CONCLUSIONS: Ultrahigh-resolution optical coherence tomography improves the visualization of the macular hole architectural morphology. The increased resolution of UHR-OCT enables the visualization of photoreceptor morphology associated with macular holes. This promises to lead to a better understanding of the pathogenesis of macular holes, the causes of visual loss secondary to macular holes, the timing of surgical repair, and the evaluation of postsurgical outcome. Ultrahigh-resolution optical coherence tomography imaging of macular holes that correspond to known alterations in retinal morphology can be used to interpret retinal morphology in UHR-OCT images. Comparisons of UHR-OCT images with standard-resolution OCT images can establish a baseline for the better interpretation of clinical standard-resolution OCT images. The ability to visualize photoreceptors and their integrity or impairment is an indicator of macular hole progression and surgical outcome.

Aged↗

PubMed2005

PBPC collection techniques: standard versus large volume leukapheresis (LVL) in donors and in patients.

Transplantations of autologous and allogeneic peripheral blood progenitor cells (PBPC) are able to assure a complete hematopoietic and immunologic reconstitution in patients. PBPC are collected by leukapheresis technique after prior mobilization therapy, but procedures and results remain still highly variable and are poorly characterized. An optimum regimen for PBPC collections has not yet been recommended, but 2-3 total blood volumes (TBV) of the donor or patient are regarded as a standard. Another promising technique is large volume leukapheresis (LVL) with processing of 3-6 TBV of donor or patient. The aim of this paper is to find the most efficient and safe collection technique for an individual donor or patient and, consequently minimize the number of procedures required. Finding the optimal collection procedure would be helpful while considering which method would be preferred in an individual donor or patient with respect to the result of mobilization, health state and required yield of CD 34+ cells for transplantation. We evaluated the results in a total of 134 standard and LVL procedures, which were performed in 21 well mobilized donors (Group I), in 65 well mobilized patients (Group II), and in 14 weakly mobilized patients (Group III) with hemato-oncological diseases. A precollection concentration of CD 34+ cells in peripheral blood higher than 20 x 10(3)/mL was considered to be the criterion for efficient mobilization. Such levels of concentration indicating the start of PBPC collections could be easily reached in Group I of donors and Group II of well mobilized patients. Heavily pretreated patients at advanced stages of disease (Group III) did not respond to mobilization sufficiently and had a concentration of CD 34+ cells lower than 20x10(3)/mL. LVL technique made it possible to obtain higher numbers of CD 34+ cells than in the standard collection in well mobilized donors (Group I), well mobilized patients (Group II), and even in weakly mobilized patients in Group III. In donors and well mobilized patients (Group I and Group II) it was possible to collect sufficient amounts of CD 34+ cells for allogeneic or for autologous transplantation from one LVL collection. The median yield of CD 34+ cells from one LVL collection was 5.5 x 10(6)/kg b.w. in donors, and 6.0 x 10(6)/kg b.w. in well mobilized patients. Due to the linear dependence of the yield of collected CD 34+ cells on the concentration of CD 34+ cells in blood, it can be used as a simple prediction of the success of collection in Group II (correlation coefficient 0.93 for standard procedures, and correlation coefficient 0.88 for LVL). In Group III of weakly mobilized patients the standard collections were usually ineffective and the relationship between the yield of CD 34+ cells/kg in the product and the precollection concentration of CD 34+ cells was much less significant (correlation coefficient 0.56 for standard procedures and correlation coefficient 0.66 for LVL). The median of CD 34+ cells collected from one standard procedure was only 0.7 x 10(6)/kg but using LVL the median increased to 1.4 x 10(6)/kg. Our results prove that the yield of CD 34+ cells in the product can be enhanced by large volume leukapheresis (LVL). Based on the results obtained, we recommend LVL in all donors and patients who can tolerate it due to a greater chance of collecting higher yields of progenitor cells while minimizing adverse reactions. LVL procedures should also be preferred in weakly mobilized patients where it is not possible to collect sufficient amounts of CD 34+ cells for transplantation using the standard regime. In weakly mobilized patients LVL provides a greater chance to at least collect a minimum amount of CD 34+ cells necessary. LVL should be used in circumstances where extremely high doses of CD 34+ cells has to be prepared, e.g. planned "tandem" transplantations or manipulations with a graft in which a significant loss of cells is expected.

Adolescent↗

PubMed1995

Diagnostic accuracy of heart rate-adjusted ST segments compared with standard ST-segment criteria.

We compared the accuracy of ST segment/heart rate (ST/HR) index with that of standard criteria (> or = 0.1 mV horizontal/downsloping ST depression 80 ms after the J point) in 121 patients who had undergone angiography (49 with > or = 1 lesion with > or = 50% stenosis) and 50 clinically normal subjects. All exercise tests used the Cornell protocol and computer measurements of maximal ST depression 80 ms after the J point. Thresholds with equal specificity to standard criteria were determined for ST/HR index using each of the 2 normal groups (those who were normal by angiography and those who were clinically normal). In using only patients who underwent angiography, we found that the ST/HR index had a sensitivity that was not significantly greater than that of standard criteria (standard criteria 51%, ST/HR index 59%; p = 0.21). However, the receiver-operating characteristic curve area increased from 64 +/- 4 to 68 +/- 4 (p < 0.02). When clinically normal subjects were used instead of patients without angiographic disease, there was a clearly discernible improvement in sensitivity of ST/HR index over standard criteria (standard criteria 51%, ST/HR index 69%; p < 0.05). The associated curve areas were 69 +/- 4 and 79 +/- 3 (p < 0.001). Therefore, accuracy of the ST/HR index was marginally better than standard criteria only in patients who underwent angiography. When clinically normal subjects were used, the accuracy of the ST/HR index was definitely better than standard criteria. We conclude that the demonstration of improved accuracy of the ST/HR index depends on the population being tested.

Adult↗

PubMed2000

How well does chart abstraction measure quality? A prospective comparison of standardized patients with the medical record.

PURPOSE: Despite widespread reliance on chart abstraction for quality measurement, concerns persist about its reliability and validity. We prospectively evaluated the validity of chart abstraction by directly comparing it with the gold standard of reports by standardized patients. SUBJECTS AND METHODS: Twenty randomly selected general internal medicine residents and attending faculty physicians at the primary care clinics of two Veterans Affairs Medical Centers blindly evaluated and treated actor-patients (standardized patients) who had one of four common diseases: diabetes, chronic obstructive pulmonary disease, coronary artery disease, or low back pain. Charts from the visits were abstracted using explicit quality criteria; standardized patients completed a checklist containing the same criteria. For each physician, quality was measured for two different cases of the four conditions (a total of 160 physician-patient encounters). We compared chart abstraction with standardized-patient reports for four aspects of the encounter: taking the history, examining the patient, making the diagnosis, and prescribing appropriate treatment. The sensitivity and specificity of chart abstraction were calculated. RESULTS: The mean (+/- SD) chart abstraction score was 54% +/- 9%, substantially less than the mean score on the standardized-patient checklist of 68% +/- 9% (P <0.001). This finding was similar for all four conditions and at both sites. "False positives"-chart-recorded necessary care actions not reported by the standardized patients-resulted in a specificity of only 81%. The overall sensitivity of chart abstraction for necessary care was only 70%. CONCLUSIONS: Chart abstraction underestimates the quality of care for common outpatient general medical conditions when compared with standardized-patient reports. The medical record is neither sensitive nor specific. Quality measurements derived from chart abstraction may have important shortcomings, particularly as the basis for drawing policy conclusions or making management decisions.

Ambulatory Care↗

PubMed2001

A comparison of international silica (alpha-quartz) calibration standards by Fourier transform-infrared spectrophotometry.

Seven international silica (alpha-quartz) standards were examined for relative purity to the US National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 1878 Respirable alpha-quartz by Fourier Transform-Infrared Spectrophotometry (FT-IR). The standards examined have been used in North America, the UK, Australia and Germany. The 189 samples analyzed included NIST-SRM 1878, Min-U-Sil 5, Ottawa Silica Sand, Sikron F-600, A9950 (AUST 1), DQ12-Robock, DQ12-Bergbau. Size distributions of the standards were determined by Coulter Counter to be broadly similar with equivalent spherical volume median diameter ranging between 1.2 and 3 microm. The results showed the standards to differ by as much as 30% in relative purity. Consequently, an internationally agreed upon calibration standard is urgently needed. Min-U-Sil 5 based NIST-SRM 1878 or Sikron F-600 are the two most likely candidates. Any agreed standard must have a well characterized size distribution and closely match the respirable dust criteria. It should also be studied by both infrared spectrophotometry and X-ray diffraction techniques.

Calibration↗

PubMed1982

Comparison of standardization techniques for colorimetric analyses on a centrifugal analyzer.

The influences of the mode of standardization and the type of standard on the precision of four mechanized methods performed on a centrifugal analyzer are described. Experimental results show that the mode of standardization -- variable, using a standard in each analytical batch, and constant, using a direct relationship between concentration and absorbance -- must be objectively selected. If the variable mode is chosen, the type and level of standard must be carefully chosen and absorbance of assays of the standard must be carefully monitored for good quality control. It is recommended that the optimum standardization technique and standard, where applicable, should be assessed and subsequently documented in evaluations of methods, kits and instruments.

Centrifugation↗

PubMed2003

Economics of reducing menstruation with trimonthly-cycle oral contraceptive therapy: comparison with standard-cycle regimens.

OBJECTIVE: To evaluate whether, and under what circumstances, trimonthly-cycle oral contraceptive pill (OCP) therapy is cost saving over standard-cycle OCP therapy for reducing the severity of menstrual-related symptoms. METHODS: We created three economic models, with each model representing a unique cost perspective (societal, private third party, and patient), to estimate the incremental annual costs associated with women taking trimonthly-cycle rather than standard-cycle OCP. Direct costs considered were costs for OCP prescriptions, female hygiene products, generic over-the-counter pain relievers and iron tablets, home pregnancy tests, and physician visits for menstrual-related concerns. Indirect costs considered were lost wages due to menstruation-related disability and opportunity costs of physician visits. We derived base-case and sensitivity range estimates from prior literature, public use data, expert opinion, and cross-sectional survey data that we collected from 59 adult women taking standard-cycle OCP visiting a large, community-based gynecology office. All costs were adjusted to 2002 US dollars. RESULTS: Under base-case assumptions that both regimens were equivalently priced (1.16 US dollars/pill) and trimonthly OCP reduces hygiene product use by 50%, annual societal costs per person were 460 US dollars for trimonthly OCP and 501 US dollars for standard OCP (incremental cost savings = 41 US dollars). Assuming no difference in monthly drug copayment costs between the two regimens (5.00 US dollars), annual private third-party costs were nearly identical at 365 US dollars per regimen. Annual patient costs were 95 US dollars for trimonthly OCP and 136 US dollars for standard OCP. Trimonthly OCP remained cost saving to society as long its price remained below a 9% premium to standard OCP prices. The degree to which trimonthly OCP reduces hygiene product use also significantly influenced the cost difference between the two regimens. CONCLUSION: Compared with standard-cycle OCP, trimonthly-cycle OCP appears to be associated with significant societal and patient cost savings. These savings are highly conditional upon trimonthly OCP being priced similarly to standard OCP.

Adolescent↗

PubMed1993

When does a guideline become a standard? The new American Society of Anesthesiologists guidelines give us a clue.

So when does a guideline become a standard? The answer is when an inexpensive, reliable device comes onto the market, the technology and concept of which have already been adopted by a group who specialize in the concept of intubation--anesthesiologists. A guideline becomes a standard of care when the device behind the guideline is available and readily usable as a practical matter by members of other medical specialties who have cause and reason to consider its use. By the time a piece of technology is recognized by legislators or insurance company underwriting departments as a necessary tool in the arsenal of a group of medical professionals, essentially as a standard of care, it is too late in the sense that the damage will already have been done because the malpractice suits that motivated the legislative or underwriting change already will be inescapably present. The mandation of a standard of care by legislative or insurance underwriting fiat certainly ensures the existence of the standard and will serve to require the use of the procedures, techniques, or technology so mandated. Before the mandation by law, however, the profession must recognize the matriculation of the idea to the guideline to the standard. Waiting for adoption of the standard by law or insurance company underwriting departments gives the plaintiff's trial bar "an edge," in that they are able to assert that a standard exists that the physicians are ignoring.(ABSTRACT TRUNCATED AT 250 WORDS)

Anesthesiology↗

PubMed1984

Interposed abdominal compression CPR versus standard CPR in prehospital cardiopulmonary arrest: preliminary results.

Recent studies evaluating interposed abdominal compression cardiopulmonary resuscitation (IAC-CPR) have demonstrated a significant increase in cardiac output, mean arterial pressure, and cerebral perfusion compared with standard CPR. A clinical evaluation of IAC-CPR effectiveness on resuscitation outcome has not been reported. A prospective, randomized study comparing IAC-CPR with standard CPR for resuscitation of prehospital cardiopulmonary arrest was developed utilizing the Milwaukee County Paramedic System. When the paramedics arrive, standard CPR is initiated or continued, and countershocks are delivered when appropriate. The patients are randomized into IAC-CPR and standard CPR groups immediately following endotracheal intubation. Abdominal compression force is standardized to 100 mm Hg +/- 20 mm Hg by using a simple airfilled bladder and gauge to monitor each compression. Resuscitations are conducted according to standard advanced cardiac life support guidelines through continuous radio-telemetry contact with a base physician. Since October 1983, 140 patients have qualified for the study group. Seventy patients had standard CPR and 30% (21/70) were admitted to the emergency department with a rhythm and pulse, as were 34% (24/70) of the patients treated with IAC-CPR. The difference between study groups was not significant. To determine if abdominal compression increases regurgitation, the frequency of emesis before and after intubation was analyzed. No significant difference was found between the IAC-CPR and standard CPR groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Abdomen↗