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Comparison of two techniques for obtaining samples for coagulation studies: venipuncture and intraarterial line.

The purpose of this study was to compare blood coagulation values drawn by venipuncture and from an intraarterial catheter. A 10 ml discard was obtained from 50 consecutive patients before obtaining the coagulation sample from the intraarterial catheter, and a 0.5 ml discard was obtained from the venipuncture specimen. A two-tailed t test for related samples was performed. The results revealed no significant difference between the two methods (p less than 0.05). The small differences seen were attributed to sampling error. These results suggest that blood samples obtained from heparinized intraarterial catheters after a 10 ml discard provide an accurate assessment of patients' mean clotting time.

Adult↗

Analysis of polymorphic variation in different types of habitat.

A correlation between the distribution of an organism and features of its environment can be taken as indirect evidence of natural selection. Biologists may therefore collect samples from polymorphic populations at a number of locations, classify the locations into habitat types, and consider whether the distribution of morphs varies with the habitat. Statistical aspects of this type of study are discussed in this paper. A randomization test for habitat effects is proposed and a negative binomial model is suggested for the distribution of morphs from random locations within one type of habitat. Data on the distribution of Cepaea hortensis and C. nemoralis snails in southern England provide an example. For both species there is clear evidence of differences between habitats, although the morph distributions are rather variable within habitats. The negative binomial model suggests that, for the snail data, variation in morph proportions is mainly due to location differences. The binomial sampling error is relatively unimportant unless the sample size at a location is very small. Therefore it is reasonable to analyse morph proportions by standard methods without giving different weights to data from different locations. The snail data are analysed in this way. Discriminant function analyses are used to test for habitat effects. The relationships between C. hortensis and C. nemoralis morph frequencies within one habitat are examined by a canonical correlation analysis.

Animals↗

Equivocal diagnoses in breast aspiration biopsy cytology: sources of uncertainty and the role of "atypical/indeterminate" terminology.

In 1996, a National Cancer Institute committee recommended four categories as uniform terminology for breast fine-needle aspirations (FNAs): benign, malignant, suspicious/probably malignant, and atypical/indeterminate. The latter is a controversial category. This study evaluates the usefulness of the atypical/indeterminate term, and examines sources of diagnostic equivocation in breast FNA. Eight hundred and twenty-two consecutive breast FNAs were previously classified as benign, malignant, suspicious, or unsatisfactory. Two hundred and thirteen (25.9%) cases had surgical follow-up and were classified as true positive (TP), false positive (FP), true negative (TN), false negative (FN), true suspicious (TS), or false suspicious (FS). Slides from FN, FP, TS, and FS were reviewed for interpretative error, poor clarity or preservation, obscuring material, sampling error, or insufficient malignant criteria. Cases were also evaluated as to whether classification as "atypical/indeterminate" would have improved patient care. There were 21/822 (2.6%) FN, 37/822 (4.5%) TS + FS, and 0 FP diagnoses. Seventy percent of suspicious diagnoses showed cancer on follow-up. The majority of FN and suspicious cases were due to sampling problems and insufficient criteria of malignancy. None were deemed more appropriately classified as "atypical/indeterminate" All required surgical confirmation for treatment. All equivocal breast diagnoses are due to similar problems. Splitting them into "suspicious/probably malignant" and "atypical/indeterminate" would not lower the biopsy rate. A simpler three-part terminology of benign, malignant, and suspicious/equivocal, without qualification of the latter favoring benign or malignant, would provide more effective communication and appropriate follow-up. Diagn. Cytopathol. 1999;21:217-222.

Biopsy, Needle↗

An international study of the performance of sample collection from patients.

BACKGROUND AND OBJECTIVES: Collection of a blood sample from the correct patient is the first step in the process of safe transfusion. The aim of this international collaborative study was to assess the frequency of mislabelled and miscollected samples drawn for blood grouping. MATERIALS AND METHODS: Hospitals in 10 countries provided data on sample error rates during a period of at least 3 months, including the last quarter of 2001. Mislabelled samples were defined as those not meeting local criteria for acceptance by the laboratory. Miscollected samples [wrong-blood-in-tube (WBIT)] were defined as samples in which the blood group result differed from the result on file from prior testing. WBIT rates were corrected for the proportion of repeat samples and for undetectable errors occurring as a result of chance collection of blood from the wrong patient with the same ABO group. Participants also completed a questionnaire on current policies regarding sample collection. RESULTS: A total of 71 hospitals completed surveys describing policies related to sample collection. Sixty-two hospitals provided usable data on the frequency of mislabelled and miscollected samples. Mislabelled and miscollected samples were common. Based on results from over 690,000 samples, the median hospital performance resulted in a rate for mislabelling of 1 in every 165 samples (6.1 per 1000; interquartile range 1.2-17 per 1000). The presence of national patient identification systems in Sweden and Finland was associated with rates of miscollected samples that were too low to estimate. Outside these nations, miscollected samples demonstrating WBIT occurred at a median rate of 1 in every 1986 samples (0.5 per 1000; interquartile range <0.3-0.9 per 1000). There was great variation worldwide in the reported frequency of mislabelled samples, probably resulting from variation in policies for sample acceptance. Miscollected samples occurred at a more constant rate. CONCLUSIONS: The rate of mislabelled samples and miscollected samples is 1000-10,000-fold more frequent than the risk of viral infection. Rates of mislabelled samples and WBIT can be tracked as key indicators of performance of an important step in the clinical transfusion process. WBIT episodes represent important 'near-miss' errors. By providing baseline performance data for the collection of patient blood samples, this study may be useful in formulating future national standards of performance for sample collection from patients.

Blood Group Incompatibility↗

Tissue diagnosis for carcinoma of the pancreas and periampullary structures.

In a county hospital, 217 patients were operated on for suspected cancer of the pancreas (186 patients) and periampullary structures (31 patients). The surgeons' philosophy was to avoid biopsy of the pancreas whenever possible, they often performed radical resection based on clinical judgment alone (8% of the resections were chronic pancreatitis). Follow-up of the 65 patients who were presumed to have carcinoma without histologic proof showed the surgeon's clinical diagnosis to be incorrect in over 7% of the cases (maximum error - 18%). Among patients with carcinoma of the pancreas, one third of the pancreatic biopsies missed the lesion (surgeon's sampling error). Frozen section examination of pancreatic biopsies in 63 patients showed false positive and negative rates of 3% and 4%, respectively (pathologist's sampling or interpretation errors). Two of 31 incisional biopsy of the pancreas resulted in pancreatic fistula; none of 24 needle biopsies did. Otherwise, biopsy of the pancreas did not influence mortality or morbidity after either resection or bypass procedures.

Acute Disease↗

Radiologically guided percutaneous fine-needle aspiration biopsy of the liver: retrospective study of 119 cases evaluating diagnostic effectiveness and clinical complications.

We reviewed 119 percutaneous, radiologically guided fine-needle aspirations (FNA) from 114 patients with liver masses to evaluate diagnostic effectiveness and complications of this procedure. Satisfactory material was obtained in 118 cases (99%), of which 78 were diagnosed as positive (66%), three suspicious (2%), five atypical (4%), and 32 (27%) as negative for malignancy. Compared to surgical biopsy (48 cases) and clinical data, the sensitivity and specificity of FNA for malignancy was 95.1% and 100%, respectively, yielding a positive predictive value of 100% and a negative predictive value of 88.8%. Four cytology cases (3.4%) were false-negatives (FN); all were interpretive errors. Four FN surgical biopsies (8.3%) were sampling errors. Minor complications occurred in three cases (2.5%). We conclude that FNA is safe and effective for determining the malignant potential of liver masses and should be the procedure of choice. Our experience suggests that having a pathologist present in the radiology suite provides optimal patient care.

Adolescent↗

MR-guided biopsy of musculoskeletal lesions in a low-field system.

Thirty magnetic resonance (MR)-guided biopsies were obtained from 20 skeletal and 10 soft-tissue lesions in 31 patients using an open 0.2 T MR system equipped with interventional accessories. The results from aspiration (N = 3), core biopsy (N = 15), and transcortical trephine biopsy (N = 12) were evaluated for accuracy and clinical efficacy. Specimens were successfully obtained from 29 patients. Results were clinically effective in 23 patients, rated definitive in 16, nonconclusive in 9, and unspecific in 2 patients. A false diagnosis due to sampling error occurred in 2 patients, and biopsy sampling was impossible in one case. The best diagnostic yield was achieved from nontranscortical biopsies of osteolytic or soft-tissue masses. Results from transcortical biopsies were less specific due to the predominance of benign lesions. MR fluoroscopy for needle guidance was applied in 13 patients. Complete needle placement inside the magnet could be performed in 16 patients. MR-guided biopsy using an open low-field MR imager is feasible and clinically effective and will become a valuable tool in the management of musculoskeletal lesions. J. Magn. Reson. Imaging 2001;13:761-768.

Adolescent↗

Retrospective analysis of acute inhalation toxicity studies: comparison of actual concentrations by filter and cascade impactor analyses.

Determination of acute inhalation toxicity is usually the initial step in the assessment and evaluation of the toxic characteristic of a substance that may be inhaled. Commonly, data from this bioassays may serve as a basis for classification and labeling and may also be used for the derivation of Emergency Response Guidance Levels. The focus of this analysis is on the comparative measurement of actual total mass concentrations in inhalation chambers obtained from independent filter (or alternative) analyses and cascade impactor analyses and whether the similarity/disparity of concentration measurements found by different equipment and sampling strategies could serve as robust criterion for the identification of inconclusive measurements. Potential artifacts leading to erroneous concentrations include anisokinetic sampling errors, obstructions of filters, errors related to the calculation/measurement of the sampled volume of atmospheres, wall losses or evaporation. The outcome of this analysis supports the conclusion that the mass concentrations obtained by the commonly performed cascade impactor analysis provide an important adjunct to the established procedures. In summary, the similarity of mass concentrations obtained independently by cascade impactor and filter analyses, i.e., sampling equipment with different aspiration efficiencies and collection media, improve the judgment whether the results from atmosphere characterization are 'conclusive' or 'inconclusive.'

Administration, Inhalation↗

Factors predicting disease outcome in early stage adenocarcinoma of the uterine cervix.

CONTEXT: Adenocarcinoma (AC) and adenosquamous carcinoma (ASC) comprise the second principal histological types of cervical carcinoma. As compared with the squamous cell cancer (SCC), these lesions are far less frequent, and their epidemiology, natural history and prognostic determinants are less well understood. OBJECTIVE: Patients with an early stage AC of the uterine cervix diagnosed in our clinic were subjected to detailed analysis for the prognostic determinants. STUDY SUBJECTS: A series of 94 women with early stage (adenocarcinoma in situ (AIS) to IIB) cervical ACs or ASCs diagnosed and treated in our department during 1995-1999 and subsequently followed-up for a mean of 43.1 +/- 16.2 (S.D.) months. MAIN OUTCOME MEASURES: Patients were examined by colposcopy, Papanicolaou (PAP) smear and biopsy. The stage of the disease (FIGO) and tumour histology in operative specimens were recorded, and univariate (Kaplan-Meier) and multivariate survival analysis (Cox) were run to explore the factors predicting disease outcome. RESULTS: Mean age of the women was 44.2 +/- 2.5 (S.D.) years (range 24-81 years), which is significantly (P=0.000) lower than that (49.9 +/- 14.2) of 464 SCC patients in our material. Minority of the women (38.2%) reported any clinical symptoms, but these correlated with the stage (P=0.041). Screening history was acceptable (i.e. screening interval 3 to 4 years) in 56 women, whereas 28 (29.8%) had no previous PAP smear taken. Interpretation errors were established in 17 (23.6%) and sampling errors in 6 (8.3%) of the 72 smears available for re-screening. No colposcopic lesions were found in 29 (30.9%) women. Follow-up data were available from 72 patients, of whom the disease progressed in four (one died), whereas 68 patients are alive and well at the moment. Patient's age (P=0.000), screening history (P=0.0127), FIGO stage (P=0.001), mode of therapy (P=0.0187), and presence of co-existent squamous cell lesions (P=0.0184) were significant prognostic indicators in univariate survival analysis. Cox's multivariate survival analysis disclosed FIGO stage (P=0.001) and screening history (P=0.006) as the only significant independent predictors of the disease outcome. CONCLUSIONS: The present data emphasise the importance of early cervical AC as a disease of younger women, making early detection of its precursors (AIS) by regular PAP smear screening mandatory in prevention of disease progression. This can only be achieved by increasing the sensitivity of the PAP smear in detecting abnormal glandular cells in asymptomatic women.

Adenocarcinoma↗

Stability of arterial concentrations during continuous inhalation of C15O2 and 15O2 and the effects on computed values of CBF and CMRO2.

Stability of arterial whole blood and plasma concentrations is a basic requirement in the application of the oxygen-15 (15O2) steady-state inhalation technique for measuring regional cerebral blood flow and oxygen use. The level of stability obtainable in practice is reported in the form of retrospectively analysed blood data from 626 consecutive studies in patients with a range of clinical conditions. Serial arterial whole blood and plasma concentrations were measured during both C15O2 and 15O2 inhalations, and coefficients of variation were calculated. In addition, these concentrations were compared with the corresponding values recorded at the start of each study and maximum variations were calculated. For all four concentrations, mean and median coefficients of variation were around 5 and 4%, respectively. Mean and median maximum variations were around 9 and 7%, respectively. The effects of these variations on the calculations of regional cerebral blood flow, oxygen extraction, and oxygen use were estimated. Mean expected errors were found to be between 4 and 9%, and median expected errors between 3 and 6%. Inherent blood sampling errors were assessed from blood volume studies using 11CO-labeled red cells. These errors were found to be less than 3%.

Arteries↗

Management of nonspecific low back pain by physiotherapists in Britain and Ireland. A descriptive questionnaire of current clinical practice.

STUDY DESIGN: A descriptive questionnaire of chartered physiotherapists. OBJECTIVE: To investigate current physiotherapeutic management of low back pain throughout Britain and Ireland. SUMMARY OF BACKGROUND DATA: Physiotherapists play a key role in low back pain management. Although clinical guidelines for best practice have been developed recently, there has been no large-scale attempt to describe current physiotherapeutic treatment approaches within Britain or Ireland. METHODS: After semi-structured interviews (n = 6) and two pilot studies (n = 77) were done, postal questionnaires were distributed to four regional cluster samples of the membership of two physiotherapy professional organizations (n = 2654). After two mailings, a random sample of 90 nonresponders were followed up. Data were analyzed using the Statistical Package for the Social Sciences (SPSS Ltd., Woking, Surrey, UK), and precision of the survey estimates was assessed by calculation of sampling errors and intraclass correlation coefficients for cluster sampling. RESULTS: Results were received from 1548 therapists (total response rate, 58.3%); of these, 813 reported that they were practicing in settings in which they treated patients with low back pain. Analysis of the results indicated the overall popularity of the Maitland mobilization and McKenzie approaches among physiotherapists. Although exercise per se was mentioned frequently by respondents, a marked difference in opinion among therapists regarding the optimal type of exercise for low back pain was obvious. Little evidence was demonstrated of the use of manipulation, fitness programs, or multidisciplinary efforts involving behavioral and physical aspects of treatment. Commonly used methods of electrotherapy were interferential therapy, ultrasound, pulsed short-wave diathermy, and transcutaneous electrical nerve stimulation. CONCLUSIONS: The results of this study emphasize the need to evaluate further and improve the dissemination of findings regarding the effectiveness of specific physiotherapy approaches for low back pain management.

Adult↗

An estimation of the size distribution of amalgam particles in dental treatment waste.

Regulations have been adopted in several countries of the European Union which prescribe that dental treatment waste water must be discharged via an amalgam separator device. Since the effectivity of the device strongly depends on the size of the amalgam waste particles, this size was evaluated in waste water samples from eight dental offices. Per sample, all solid particles were separated from the waste water by pressure filtration, then dried and divided into six fractions by being sieved over five sieves with decreasing mesh width. Of the particles in each fraction, the density was determined by picnometry, the mass by weighing, and the area and width by image analysis. For this analysis, width was defined as the dimension perpendicular to the length of the particles. By combining the density, area, and width determinations of all fractions, we obtained mass distributions per waste particle width of the samples. The proportional amalgam mass of the distributions was estimated with the measured density of the particle fractions and with a number of assumptions for the density of amalgam particles only and of other waste particles only. Each waste sample has its own characteristics with respect to the mass and density of the particle fractions. The size distribution of waste particles has a bimodal shape and consists of a distribution of small (width, 2 to 90 microns) and large particles (width, 160 to 5500 microns). For small particles with a width up to 60 microns, the influence of the assumptions on the estimation of the proportion amalgam of the waste mass distribution is minor when compared with the sampling error. By averaging the estimations over the samples, one can estimate the weight of amalgam particles with a width < 10 microns and < 50 microns, respectively, between 4 and 15% and between 15 and 30%. The smallest particles comprising 5% of the amalgam mass have an estimated width of up to 15 microns.

Dental Amalgam↗

Accuracy of breast frozen section diagnosis in the community hospital setting: a detailed analysis of 628 cases.

The author presents a detailed analysis of 628 breast frozen sections performed at Columbia Hospital over a 35-month period. These 628 frozen sections came from a total of 574 females and 13 males (mean age 55.3 years and range 20.1 to 95.0 years). Frozen section diagnosis was deferred in 18 cases (2.8%) and diagnostic accuracy for presence or absence of malignant neoplasia was 99.2%; one false positive case (pathologist judgement error) and four false negative cases (two sampling errors and two pathologist judgement errors) were detected. Strict diagnostic accuracy for this series was 98.7%. Fifty-three of 223 positive frozen sections (23.8%) were immediately followed by completion mastectomy. The author discusses the philosophy of frozen section technique and concludes that breast frozen section analysis in a busy community hospital setting can meet and even exceed the accuracy level attained at large academic medical centers.

Adult↗

Paired cervical smears: a method of reducing the false-negative rate in population screening.

Cervical smears taken by the wooden Ayre spatula (widely used in the United Kingdom) and by a plastic spatula (Armovical) were compared for their ability to detect dysplastic cervical epithelium and endocervical cells. At the same time, the value of taking duplicate smears was assessed. Paired cervical smears were obtained at a single attendance from 21,352 women, using the 2 types of spatulas in 4 different sequences. Although individually the Armovical proved superior to the Ayre spatula for the collection of endocervical epithelial material, this advantage was not complemented by any marked improvement in its detection of cervical dysplasia. Paired smear sampling, however, was clearly more rewarding in this respect and also allowed the introduction of laboratory quality control, as each preparation of any given pair was examined by a different screener. The false-negative rate was 18.5%: it comprised 11.1% sampling error and 7.4% screening error. It is concluded that paired smear sampling in population screening would significantly reduce the false-negative rate.

Carcinoma in Situ↗

Problems with measurements caused by high concentrations of serum solids.

There have been numerous reports of spectrophotometric and volume problems caused by elevated levels of lipids in blood. The offending lipids, primarily triglycerides, not only cause turbidity leading to optical aberrations when added to analytical reagents, but also result in short-sampling errors leading to the measurement of inaccurate volumes of sample. Numerous methods have been developed to clear the lipemia, including ultracentrifugation organic solvent extraction, chemical precipitation and, most recently, enzymic hydrolysis. Although the latter procedures eliminate the optical problems, they do not deal with the volume dilution error created by the triglycerides. In turn, corrective mathematics have been developed to compensate for the inaccurate pipetting caused by the elevated lipids in a sample; however, these empirical calculations are not truly accurate at high concentrations of total lipids. This monograph will describe the problems caused by the presence of elevated lipids and the means available for treating them.

Blood Chemical Analysis↗

Fine-needle aspiration cytology of salivary glands: diagnostic pitfalls--revisited.

Fine needle aspiration cytology (FNAC) of salivary gland lesions is a safe, effective diagnostic technique. Several amply illustrated reviews are available in the English literature. The reported diagnostic accuracy varies between 86% to 98%. The sensitivity ranges from 62% to 97.6% and specificity is higher from 94.3% to 100%. In this present study, we have analyzed 172 cases of salivary gland aspirates and the histopathological diagnosis was available in 45 cases. There was discordance in cytological and histopathological diagnosis in nine cases. Five cases had discrepancies in benign versus malignant diagnosis with four cases being false negative. The errors in these FNA diagnoses were due to sampling error, observational error and interpretational error. Therefore, this study illustrates high diagnostic accuracy of FNAC in salivary gland lesions and shows that FNAC offers valuable information that allows the planning of subsequent patient management.

Adolescent↗

Detection of cytomegalovirus (CMV) in granulocytes by polymerase chain reaction compared with the CMV antigen test.

To compare the sensitivity and suitability of detection of active cytomegalovirus (CMV) infection by using monoclonal antibodies against CMV antigen (antigen test to detect antigenemia) and the polymerase chain reaction (PCR; to detect viral DNA) in granulocytes, 19 heart and 2 lung transplant recipients were closely monitored by these tests for at least 3 months after transplantation. All patients were CMV seropositive or had a seropositive donor. In total, 201 samples were tested; 46 were positive by both tests, 9 samples showed only antigenemia, 54 samples were positive by PCR only, and 102 samples were negative by both tests. PCR was positive earlier after transplantation in eight patients, whereas antigenemia was positive earlier after transplantation in one patient. In another four patients, both tests were positive at the same time. PCR was, on average, positive for a longer period of time. Discordant results showing a positive antigen test and a negative PCR were partly due to sampling error; some were positive by PCR on retesting. Samples which were negative by the antigen test and positive by PCR were taken at the beginning or at the end of an active CMV infection. In two patients, no active CMV infection was detected by the antigen test, cultures of urine and saliva, or serology, although PCR was positive for a long period of time in the two patients.

Antigens, Viral↗

Quantitative measurement of indomethacin crystallinity in indomethacin-silica gel binary system using differential scanning calorimetry and X-ray powder diffractometry.

Differential scanning calorimetry (DSC) and X-ray powder diffractometry (XRPD) methods were developed for the quantitative analysis of the crystallinity of indomethacin (IMC) in IMC and silica gel (SG) binary system. The DSC calibration curve exhibited better linearity than that of XRPD. No phase transformation occurred in the IMC-SG mixtures during DSC measurement. The major sources of error in DSC measurements were inhomogeneous mixing and sampling. Analyzing the amount of IMC in the mixtures using high-performance liquid chromatography (HPLC) could reduce the sampling error. DSC demonstrated greater sensitivity and had less variation in measurement than XRPD in quantifying crystalline IMC in the IMC-SG binary system.

Calibration↗