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Results for “Method Acceptability”

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At least 73 records · Page 4Linked to original sources

PubMed1992

Determination of bone mineral density by dual x-ray absorptiometry in patients with uncemented total hip arthroplasty.

Bone remodeling is an expected sequela with total hip arthroplasty (THA). Although there are several methods of estimating bone response in THA patients from radiographs, there are no accurate and generally accepted methods for quantitative determinations in vivo. In this study, we describe an application of dual x-ray absorptiometry (DXA) for measuring bone mineral content and bone mineral density in the proximal femur following THA. DXA is a noninvasive technique with minimal radiation exposure (< 5 mrem). Various aspects of measurement error (accuracy and reliability) of this application of DXA were determined in a series of studies reported here. Accuracy error (how similar are the measured and actual values) was < 1% determined in bone phantoms of four densities. Precision error (how reproducible are the measurements) was also < 1% at all four densities in the phantoms and was only slightly elevated (0.9-1.5%) in repeated measurements of implanted cadaver femora. Precision error in vivo, determined both from multiple replicates on five patients and from duplicate scans on 30 patients, was further elevated but remained < 5%. Contributions to precision error, rotation of the leg, and interoperator variability were assessed; none was found to elevate precision error appreciably. We suggest that DXA is a feasible method for quantifying bone response following THA, and will allow discrimination of small changes (> 5%) not previously measurable.

Absorptiometry, Photon↗

PubMed1987

Laboratory detection of cannabinoids.

Cannabis, or marijuana, has been known and used as a drug for many thousands of years. Recent interest in drug abuse and detection has spurred the development of several methodologies for cannabinoid detection. These methods include immunoassays and chromatography. Laboratories routinely performing cannabinoid testing use two or more methodologies; the accepted method is to screen with one methodology and confirm by a second. These methodologies vary widely in sensitivity, specificity, and time required for analysis. Although therapeutic applications of cannabis constituents often produce undesirable side effects, two cannabinoids, delta 9-THC and nabilone, have been approved for use as antiemetics in chemotherapy. Further investigations of cannabinoid pharmacology and structure-activity relationships may result in the development of promising new therapeutic agents.

Cannabinoids↗

PubMed1975

A long term follow-up of Moore arthroplasty in femoral neck fractures.

Moore arthroplasty was performed for medial femoral neck fractures in 169 patients. The mortality rate was 21.3 per cent within 3 months. The general postoperative complication rate (39.6 per cent) was dominated by cardiopulmonary (17.2 per cent) and thromboembolic (16.0 per cent) events. Of local complications, wound infection was found in 4.7 per cent and osteitis in 3.0 per cent of cases. A total of 60 patients were followed up with a mean observation time of 4.9 years. Of these, 8.3 per cent sustained femoral fractures during this period. The results classified according to the criteria of the American Academy of Orthopedic Surgeons showed 52 per cent excellent or good, 43 per cent fair and 5 per cent poor results. The roentgenological finding of settling or osteolysis along the prosthesis was significantly correlated to reduced hip mobility. Ossification in the prosthetic fenestres gave significantly diminished settling, and was correlated to better hip mobility and less pain. In our opinion, Moore arthroplasty has proved to be an acceptable method for the treatment of femoral neck fractures in elderly patients, as 73 per cent had an acceptable range of motion, 40 per cent managed walking distances of more than 500 m and 70 per cent had minimal or no pain. Although 25 per cent became nursing home patients, this reduction of vitality could be related to the hip arthroplasty in only two cases.

Aged↗

PubMed1989

[Serum determination of N-terminal peptide of type III procollagen as a marker of fibrotic activity].

Among the noninvasive methods proposed for the study of collagen metabolism as an of fibrosis and inflammation, the most widely accepted method is quantitation in serum of the N-terminal peptide of type III procollagen (P-III-Ps). We measured this variable in 87 subjects classified into five study groups: 19 controls (C), 18 alcoholics (E), 15 patients diagnosed as liver cirrhosis (CH), 11 chronic liver disease (HC) and 24 pregnant women (EMB). In our environment, the serum level of P-III-P in the healthy population was 9.12-12.8 ng/ml. In 27.77% of the alcoholics studied (5 cases) the mean value exceeded this level, 19.35 +/- 3.05 ng/ml. Forty percent of the cirrhotics (6 cases) presented the highest values, 26.54 +/- 11.45 ng/ml, while 83.33% of the patients with chronic active hepatitis presented a mean value of 18.53 +/- 3.8 ng/ml. Of the 24 pregnant women, 95.83% (23 cases) had higher than normal values, and concentrations roses in the last trimester of gestation with respect to the previous trimesters. Analysis of the correlations of all the biochemical parameters of liver function with P-III-Ps disclosed a relationship between P-III-Ps and alkaline phosphatase in the groups of cirrhotics and chronic persistent hepatitis (p less than 0.05). We conclude that the N-terminal peptide of type III procollagen is a useful marker of active fibrosis.

Adult↗

PubMed1987

General method validation guidelines for pharmaceutical samples.

Method validation guidelines, which provide an organizational structure for the design and evaluation of a validation procedure, are presented for a wide range of pharmaceutical applications. The validation guidelines are based on the analyte concentration/sample matrix combination to which the method will be applied. These guidelines include the selection of appropriate validation parameters, design considerations for evaluation, and a discussion of acceptance guidelines for the determination of acceptable method performance. A set of tables is included which illustrates the selection and testing procedure and tailors the entire validation process to the specific characteristics of the determination to be made.

Chemistry, Pharmaceutical↗

PubMed1990

A new one-step method for the isolation of human mononuclear cells.

This paper describes a radical new, one-step method for the routine isolation of the mononuclear cells from human blood in high yield and purity. In this procedure the blood sample is mixed with a Nycodenz separation medium prior to centrifugation. Erythrocytes and polymorphogranulocytes are pelleted during centrifugation leaving the mononuclear cells in the supernatant. The method can be used for a wide range of blood sample volumes and can be carried out with greater ease than the currently accepted methods.

Cell Separation↗

PubMedDate not supplied

Single daily dose of carbimazole in the treatment of hyperthyroidism.

BACKGROUND: The antithyroid drugs, methimazole and carbimazole, are conventionally used in divided daily doses. However, these drugs have a longer intrathyroidal than a plasma half-life. We undertook this prospective, controlled study, in an area of mild iodine deficiency, to compare the efficacy of a single daily dose of carbimazole with divided doses in the treatment of hyperthyroidism. METHODS: Nineteen patients with hyperthyroidism received 30 mg of carbimazole daily at bed time (group A) while 14 received 10 mg of carbimazole every 8 hours (group B). These patients were assessed clinically and biochemically by estimation of serum total thyroxine, total triiodothyronine and thyrotropin before and 1, 2, 3, 4 and 6 weeks after treatment. RESULTS: There was no significant difference between mean baseline concentrations of thyroxine and triiodothyronine. After 1, 2, 3, 4 and 6 weeks there was a decline in their concentrations which was similar in both groups (p > 0.05). Euthyroidism was achieved in 4.6 +/- 1.4 weeks (range 2-6 weeks) in group A and in 3.8 +/- 1.2 weeks (range 3-6 weeks) in group B (p > 0.05). CONCLUSIONS: We conclude that carbimazole in a single daily dose is an effective method for treating hyperthyroidism in an area of mild iodine deficiency and its efficacy is comparable to divided dose therapy. This practical and acceptable method of treatment can be specially useful in patients who find it difficult to remember to take divided doses.

Adolescent↗

PubMed1992

Methods for evaluation of regenerative procedures.

A multitude of new procedures and materials are being tested for their ability to promote periodontal wound healing. This review provides an overview of the most well-accepted methods for evaluating periodontal wound healing procedures/materials. Topics discussed include appropriate patient selection, general principles in non-surgical and surgical therapy as they relate to wound healing trials, clinical soft and hard tissue measurements which are generally obtained, an overview of radiographic assessments, and a discussion of the methods and role of histological evaluations in clinical trials. The advantages and disadvantages of the various methodologies are presented. The review concludes with the potential endpoints which can be used in periodontal wound healing studies.

Bone Regeneration↗

PubMed1977

Anal sphincter stretch: a technique to overcome detrusor-sphincter dyssynergia.

Intermittent catheterization has become a well-accepted method of management of the neurogenic bladder following spinal cord injury. Frequently, the presence of detrusor-sphincter dyssynergia interferes with the attainment of acceptable residual urine volumes in patients with upper-motor-neuron bladders. We have recently reported success in overcoming the problems of dyssynergia in some patients utilizing a technique called anal sphincter stretch in which relaxation of the external anal and urethral sphincters is produced by sustained distention of the anal sphincter. This has lessened the need for other measures that usually produce incontinence and has met with good patient acceptance. An update on the results of using this technique is presented. Although we have previously encountered quadriplegics who might have benefited from sphincter stretch, the lack of hand intrinsic muscle function required for the patient to perform it independently has precluded its use. We herein present a device that circumvents inadequate hand function, and which has enabled four C-7 quadriplegics to achieve satisfactory bladder emptying.

Anal Canal↗

PubMed1988

Treatment of metastatic prostate cancer. Factors that influence treatment selection and methods to increase acceptance of orchiectomy.

Orchiectomy is the preferred method for treating patients with metastatic adenocarcinoma of the prostate (MAP) because it is safer and more reliable than estrogen therapy. Nonetheless, a survey of Northern California urologists showed that 57 percent of their patients with MAP were treated with diethylstilbestrol (DES) rather than orchiectomy. Factors which determined treatment selection include the physician's belief that estrogen therapy was either equally (35%) or more (22%) effective than orchiectomy and the patients' rejection of orchiectomy even if it were recommended to them (20-30%). The survey also showed that previous attempts to increase the acceptability of orchiectomy by performing a subcapsular procedure have failed because urologists do not believe the procedure is effective (45%), or that subcapsular orchiectomy provides a satisfactory cosmetic result (20%). Recent laboratory and clinical investigations have shown that complete and subcapsular orchiectomy were equally effective in reducing serum testosterone. Patient acceptance of subcapsular orchiectomy may be increased by utilizing the term testicular curettage, which does not imply castration, to describe the procedure and by implantation of intracapsular testicular prostheses to restore normal testicular anatomy after the testicles' hormone-producing tissue has been removed.

Adenocarcinoma↗

PubMed1991

Chronic anal fissure. A new method of treatment by anoplasty.

Chronic anal fissure is a common condition usually treated by maximal anal dilatation or lateral subcutaneous sphincterotomy. The following method is based on a common surgical principal; to widen a stenosed tube a longitudinal incision is made across the stenosed area and this is sutured transversely as in pyloroplasty. This method of anoplasty is simple and appears to have no resultant complications. Further studies are necessary before its value can be established compared to the presently accepted methods of treatment.

Anal Canal↗

PubMed1987

[Clinical research studies from the ethical and legal point of view].

Relevant cases that had come to public knowledge and critical analysis of medical research on human beings prompted the USA to introduce the provision of approval by a committee and other forms of administrative control. In the 70's, ethics commissions were set up in Central Europe in compliance with the recommendations of the revised Helsinki-Tokyo Declaration. In Austria, the guiding principles are now legally safeguarded by the Pharmaceuticals Act, whereby general principles of research on human beings such as benefit-risk calculation and consent of the test person are laid down by statute. The risks involved in a novel method of treatment must nowadays be shared by the patient, which presupposes that the patient must be adequately informed. Notwithstanding the patient's consent, however, the risk must be socially acceptable, meaning that the experiment must be scientifically relevant and carried out in compliance with accepted methods and rules. The concept of cumulative justification is demanded today; it consists of the scientist's freedom of research, the test person's right to self-determination and the benefit-risk calculation. Ethics commissions composed of researchers themselves are invaluable consultant bodies for the scientist when soberly viewing his own particular project and who must himself undertake to observe the generally accepted principles regulating research on human beings. Only positive control by the medical profession itself will, in the long run, be able to effectively stave off an ever increasing encroachment of legislative and state control upon medical research.

Ethics, Medical↗

PubMed1990

Modified rotational acetabular osteotomy (RAO) for advanced osteoarthritis of the hip joint in the middle-aged person. First report.

Classical methods for pelvic osteotomy, such as those of Salter, Pemberton, Chiari, and Wagner, have been developed for reconstruction of the subluxed hip joint in children and young adults. Regarding pelvic osteotomy involving a middle-aged patient, however, there are not as many operation methods to consider, and it is difficult to choose the most suitable technique for alleviating advanced osteoarthritis. Based on current practice, total hip replacement (THR) seems the accepted method, though it presents problems such as loosening, sinking, and infections; because of these factors physicians hesitate to recommend THR surgery, particularly if the patient is otherwise healthy and appears to have many good years ahead of him. As an alternative, we have been developing and improving the acetabular osteotomy, based on Tagawa's rotational acetabular osteotomy (RAO) and Wagner's acetabular osteotomy (type II). In this paper we present the results of a modified RAO operation performed on 50 middle-aged patients with an average age of 42 years and 2 months (31-61). The average follow-up was 3 years and 3 months (1-9 years). In 82% of patients the result was satisfactory (41 of 50 cases). A similar osteotomy technique has been used by Eppright and Wagner. We feel that our method achieves a more favorable result for an older patient with severe osteoarthritis, since both the surgery and the follow-up rehabilitation are more comprehensive. A modified acetabular osteotomy should not be regarded as merely an alternative to total hip replacement, but as the preferred choice for hip-joint reconstruction.

Adult↗

PubMed1990

Method validation revisited: a chemometric approach.

A validation procedure is presented that satisfies the FDA requirements of accuracy (including precision repeatability), sensitivity, linearity, dynamic range, and homoscedasticity, all with a single set of data. The procedure utilizes the corrigible error correction (CEC) technique comprised of three response curves--standard, Youden one-sample, and method of standard additions (MOSA) plots, from a total of 15 to 18 X,Y data pairs. For the bias component of accuracy, the systematic bias error of the method is quantitatively separated into its constant and proportional error components. The overall constant systematic error is further separated into the system (blank) and analyte-matrix (sample) components. The CEC data also provide an internal, i.e., in situ corrected assay for the sample for comparison with alternative method data. Statistical diagnostic tests are used for the final evaluation of the method acceptability, specifically in deciding whether or not the systematic error indicated requires a root source search for its removal or is simply a calibration constant of the method.

Administration, Topical↗

PubMed1986

Determination of bone turnover by urinary excretion of 99mTc-MDP.

Two methods of estimating bone turnover were investigated. The 24 h whole body retention (WBR) of intravenously injected 99mTc methylene disphosphonate (99mTc-MDP), a precise, accurate, and generally accepted method, was compared with a new, simple, measurement involving assessment of the 24 h urinary excretion (UE) of 99mTc-MDP. The WBR and UE were measured in 50 normal subjects, 10 patients with thyrotoxicosis, and 10 patients with chronic renal failure. The precision was 4.8% and 2.7%, respectively, and the two methods were highly significantly correlated (r = 0.99, SEE = 2.9%, p less than 0.001). In addition, urinary 99mTc-MDP excretions at 0 h-4 h (UE4) and 0 h-8 h (UE8) after injection were calculated in 49 subjects. The estimation of WBR from UE4 or UE8 was considerably poorer than from UE (for UE4: r = -0.83, SEE = 8.7%, and for UE8: r = -0.90, SEE = 6.8%) and the precision of UE4 and UE8 was 7.2% and 7.8%, respectively, and greater than those of both UE and WBR. It is concluded that the UE bone turnover measurement may become a simple, radiation dose-saving method to diagnose and monitor the treatment of metabolic bone diseases.

Adult↗

PubMed1988

Clinical and biochemical assessments of damage due to perinatal asphyxia: a double blind trial of a quantitative method.

Using conventional criteria, a series of 26 infants was selected for intrapartum asphyxia from about 4000 deliveries over one year at a single hospital to assess the efficacy of a new biochemical method. Tissue damage was estimated from urinary excretion of hypoxanthine, an important and central intermediate in purine metabolism. The overall pattern showed agreement between the grading (by previously accepted methods) of asphyxia in the perinatal period and our new biochemical approach. The association with handicap at one year of age following asphyxia was complex. This biochemical technique could be used to exclude postasphyxial damage as a cause of clinical disturbances and to select a small group (0.1% of all births) who require further investigation for rarer disorders which may also cause long term handicap.

Asphyxia Neonatorum↗

PubMedDate not supplied

Detection of cytomegalovirus antibody in stored blood products using latex agglutination.

The detection of antibody to cytomegalovirus (CMV) in donor sera is one effective method for the prevention of posttransfusion CMV infection in seronegative recipients. A passive latex agglutination test (CMV Scan, Hynson, Wescott & Dunning, Baltimore, MD) has been shown to be an acceptable method of screening sera from the blood donor population. The procedure for this test, however, does not permit the testing of stored donor blood products. To evaluate the feasibility of testing blood components at various times during storage, the authors examined 25 CMV-positive and 25-CMV negative samples of CPDA-1 plasma from 50 units each of platelets and red cells. Plasma samples from platelets stored at 22 degrees C were tested on each of the 5 days of storage. Samples from red cell units stored at 2 to 6 degrees C were tested on storage Days 1, 2, 4, 6, 8, 10, 12, and 14. Of 250 tests done on plasma from platelet units, there were 123 true-positive and 123 true-negative results (sensitivity and specificity, 98.4%). Of 400 tests on plasma from red cell units, there were 200 true-positive and 198 true-negative results (sensitivity, 100%; specificity, 99.5%). These data show that the CMV Scan test can be used reliably to test segments of CPDA-1 plasma from platelets stored for up to 5 days and from red cells stored for up to 14 days.

Antibodies, Viral↗

PubMed1990

Use of homology domains in sequence similarity detection.

We have found the detection of homology domains using a nonlinear similarity score and the DD algorithm to be a useful approach for identifying similarity between sequences and evaluating potential homology. There are several reasons for the success of the method. (i) Homology domains are identified by a rigorous method that guarantees they will be locally optimal. (ii) The relative significance of different homology domains can be directly compared using the nonlinear similarity score. (iii) Different cost matrices can be used in the calculation of the similarity score. (iv) Relatively long sequences can be compared in a single pass as storage requirements are proportional to the shorter of the two sequences being compared. (v) The method has proved to be very sensitive in practice. (vi) The boundaries of authentic regions of homology are accurately identified. (vii) The information required to define a homology domain (its location, size, similarity score, etc.) can be stored in a compact data structure, facilitating the sharing of homology domain data among different software tools. (viii) The method can be applied to similarity searches of the nucleotide and protein sequence data banks. These properties make the identification of homology domains for studying sequence similarity a useful companion to other accepted methods, such as dynamic programming based analyses.

Animals↗