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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↗

PubMed1985

CT stereotactic biopsy for optimizing the therapy of intracranial processes.

The CT stereotactic method (Mundinger/Birg) and the bioptic results of intracranial processes in 815 cases are reported. In 17% of the cases, no tumor was found, in contrast to the diagnosis established by modern imaging techniques (CT, MRI). The necessity of confirming the diagnosis of intracranial lesions to optimize the treatment plan is pointed out. Low mortality and morbidity rates (0.6 and 3%) make this method acceptable for the patient, since misdiagnoses, mistreatment or omission of treatment can thus be avoided. The accuracy (0.6 mm) of CT stereotactic localization and biopsy makes the method reliable even for small lesions.

Biopsy↗

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↗

PubMed1992

Comparison of three methods for detection of group A streptococci in throat swabs.

Group A streptococci are generally detected in throat swabs by (i) rapid antigen tests, (ii) conventional culture, or (iii) combinations of both. Direct fluorescent-antibody testing of a 2-h enrichment broth (FA/EN) was an accepted method for same-day results before the advent of rapid antigen tests. We compared FA/EN in Todd-Hewitt Broth (THB) with conventional culture and a rapid antigen test, TestPack Strep A (TPS). Nine hundred seventy specimens were evaluated in this study. Cultures were performed for 48 h on sheep blood agar (SBA) incubated aerobically and on a selective agar for group A streptococci (SSA) incubated in 5 to 10% CO2. Following a 2-h incubation, the fluorescent-antibody test was performed. A subculture of the centrifuged sediment from the THB enrichment was also done. In comparison with a positive culture on SBA or SSA or subculture of the THB pellet, the sensitivities and specificities of the different methods were as follows: SBA, 92 and 100%; SSA, 92 and 100%; TPS, 68 and 99%; FA/EN, 88 and 98%. The FA/EN method offers the potential for definitive finalized reports on the same day as specimen collection with greater sensitivity than TPS. This study included sequential plating and rapid antigen testing of a single swab. In a separate set of experiments to validate this study design, it was shown that recovery of streptococci from swabs plated sequentially on five plates did not vary with the order of plating and the actual proportion of organisms recovered from a swab on a single plate was only 1%.

Antigens, Bacterial↗

PubMed1975

[Motivation and education].

It was thought for many years that successful motivation in oral health should be based on the knowledge of epidemiology of caries and periodontal diseases and the methods of prevention. One should learn from mistakes: 95 per cent of the Swiss population "suffers" from caries and periodontal disease but apparently this had little impact on prevention. Simple, world-wide accepted methods of prevention are not used by the majority although they provide a pronounced reduction of caries and gingivitis. The number of Swiss communities which offer adequate preventive programs to schoolchildren ranges between 5 to 10 per cent. Although the budgets of school dental services could be lowered by 75%. Reasons for such failures may be inadequate information of dentists, authorities and the population. Not enough information is spread regarding sugarless sweets, or prevention by fluoride. Unsuccessful motivation probably also lies in the inadequate assignment of the roles ofthe patient, his dentist and the social security. So far only the dentist has formulated oral health duties to the patient, e.g. a better oral hygiene, a reasonable healthy nutrition. In the future the patient should have the right to ask the dentist some questions. Is his dentition at the end of a treatment, healthy and ready to render hygienic efforts effective? Patient, doctor and insurances should know that disease still exists if gingival papillae bleed upon using a toothpick. Absence or presence of gingival bleeding are the criteria for health or disease. A check list of the state of oral health and a signed questionnaire concerning the patient's knowledge of oral health are used to improve motivation of both patient and dentist.

Dental Hygienists↗

PubMedDate not supplied

Pseudoephedrine absorption from controlled release formulations: absorption rate constant estimation methods.

Five methods of absorption rate (Ka) estimation were compared using data from a previously reported bioavailability study: Wagner-Nelson (WN), asymptotic WN (AWN), the Hendeles-Weinberger modification of the WN (HW), nonlinear regression performed on plasma concentration vs time data with fixed elimination rates (NL), and nonlinear regression performed on the cumulative sum of AUCs obtained during WN analysis (AUCNL). The maximum plasma concentration (Cmax) and the time at which Cmax occurred (Tmax) were predicted with each method's respective Ka's, and these were compared to observed values. The WN and HW were consistently biased in their predictions of Cmax and Tmax, providing slower Ka's than any of the other methods. AWN could only be used for the reference treatment. Both NL and AUCNL provided unbiased estimations, but AUCNL had a high level of imprecision. With this set of data, only NL was an acceptable method for accurately estimating Ka.

Adult↗

PubMed1979

Determination of vitamin D in foods: a review.

Determining vitamin D content in foods is difficult because in natural foods of highest vitamin D activity, and even in vitamin D-fortified foods, only small quantities are present, and many other compounds are extracted along with vitamin D that cause difficulties in purifying the extract or in the spectrophotometry or colorimetry that follows. Several physicochemical methods--such as spectrophotometric, colorimetric, thin-layer chromatographic, adsorption, partition, gas-liquid, and high-performance column chromatographic--have been tried for assay foods for vitamin D, but none of them have been accepted for official or routine use; they are time consuming and expensive, or lack the required sensitivity, precision, or accuracy. Curative biological assays, based on degree of healing of a leg bone of rats previously made rachitic, is the generally accepted method to determine vitamin D content of foods. However, that method also requires too much time and is expensive. The recently developed high-performance liquid chromatographic method may offer the most for establishing a satisfactory physicochemical method for determining vitamin D in foods. Many of the difficulties and problems in assaying foods for vitamin D are discussed.

Animals↗

PubMed1978

An investigation of factors influencing the measurement of creatine phosphokinase activity in serum using coupled enzymatic methods.

1. The factors influencing the measurement of creatine phosphokinase (CPK) activity in serum by coupled enzymatic methods were investigated to establish optimum conditions for this type of assay. Such a study was indicated following observations by the authors of poor performance of commerically produced reagent kits together with the failure of most of the established an well accepted methods to operate under true optimum zero order kinetics in the reaction phase state. 2. The factors invested were the effects of pH, substrate concentrations (creatine phosphate, glucose and NADP+), added auxiliary (hexokinase) and indicator (glucose-6-phosphate dehydrogenase) enzymes, dithiothreitol (DTT) as an activator and conditions of storage of substrate stability. DTT was found to be a suitable activator but not a reactivator of the reaction. The optimum concentrations of creatine phosphate, glucose and NADP+ were found to be 20.0, 20.0 and 2.0 mmol/litre, respectively. Optimum activieies of the enzymes, glucose-6-phosphate dehydrosenase and hexokinase were 1000 and 2000 units/litre, respectively. 3. The between-day precision of the method for measuring serum at pH 6.8 and 30 degrees C at three activity levels under the optimum conditions developed was excellent yielding coefficients of variation ranging from 2.0 to 2.7%.

Creatine Kinase↗

PubMed1977

Tests alternative to the rabbit bioassay for pyrogens.

The rabbit bioassay is currently the only legally acceptable method to test for pyrogenic contamination of parenteral preparations and medical devices designed to enter the parenterum. However, research efforts have recently made available alternative procedures to test for pyrogens which may have significant value in quality control. Part of the reluctance to accept tests other than the rabbit test may be due to the low visibility of emerging understanding of a significant theory of testing in which it is contended that the parameters of sensitivity and specificity are inversely related and that accuracy is an ideal. The rabbit pyrogen assay will detect 1 to 10 ng of enterobacteriaceal endotoxin (ET). The limulus test will detect 0.01 to 0.1 ng/ml of ET; some of the other tests approach the rabbit assay in sensitivity. Since it is current dogma that pyrogen is equivalent to ET, the basis for the use of ET to standardize pyrogen tests is rationalized. The source of ET in practice is bacterial contamination; therefore, numbers of bacteria that contaminate parenteral preparations can be directly related to potential pyrogenicity. Further, viable counts of bacteria in parenteral preparations, prior to sterilization, is a reliable test for pyrogens. Other tests such as nitroblue tetrazolium reduction and actinomycin-D enhancement of lethality of pyrogen for mice deserve consideration in quality control procedures. The limulus test, the most practical of currently available alternative tests for detection of ET and therefore, of pyrogen has application where the rabbit test cannot be used. Therefore, control personnel must learn of the availability, performance and interpretation of the limulus test. Practical considerations must govern the choice of an alternative test when the use of a test other than the rabbit bioassay is indicated.

Animals↗