SEARCH · PubMed Health

Results for “Method Acceptability”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 307 records · Page 17Linked to original sources

PubMed2004

Analysis of fetal blood cells in the maternal circulation: challenges, ongoing efforts, and potential solutions.

The invasive procedures amniocentesis and chorionic villus sampling (CVS) are routinely applied in pregnancies at risk for fetal abnormalities and the results obtained are the gold standard for prenatal diagnosis. Because these methods of fetal cell procurement involve a 0.5-2% risk for fetal loss, they are recommended mainly in cases at high risk for fetal genetic or cytogenetic abnormalities. The development of a reproducible, reliable, noninvasive method based on retrieval of rare fetal cells from the maternal circulation will render testing feasible for the general population. Despite intensive investigation, a satisfactory, clinically acceptable method has not yet emerged. Several cell types have been targeted to this end, mostly nucleated red blood cells (NRBC), CD34+ hematopoietic progenitors, and trophoblasts. Although these cell types have been unequivocally proven to be present in the maternal circulation, each bears a significant disadvantage, rendering their application in clinical testing currently impossible: NRBC cannot be expanded in culture, thereby ruling out metaphase chromosome analysis, an essential component of prenatal diagnosis. CD34+ cells do posses the potential for in vitro proliferation, however, they have been found to persist in the maternal circulation after delivery, thereby complicating diagnosis in consecutive pregnancies. Trophoblasts are not consistently detected in the maternal circulation. Moreover, due to the lack of a definitive fetal cell marker and a reliable sorting method, foolproof fetal cell identification of any of these cell types is not possible. This report outlines the obstacles that impede development of a method for noninvasive fetal cell sampling for prenatal genetic diagnosis, along with a description of our efforts to analyze simultaneously two fetal blood cell types, NRBC and CD34+ cells in maternal blood during pregnancy, and the problems encountered. This work and that of others lead us to suggest potential future directions to help develop this important technique.

Aneuploidy↗

PubMed2002

CerbB2 status in breast cancer: pathologic issues.

INTRODUCTION: CerbB2 status determination in breast cancer is currently performed for predictive and prognostic information. However, much has yet to be learned about the accuracy, reproducibility and clinical correlation of the different testing methods available today. This is a review of the testing methods commonly in use and their applications in the management of breast cancer. METHODS: A Medline search for review articles with keywords cerbB2, Her2 testing, immunohistochemistry (IHC), fluorescence in situ hybridisation (FISH) and breast cancer was done. Manual cross-referencing from the afore-mentioned articles and perusal of the package inserts, recommendations and manuals from the manufacturers of various commercially available test kits were also performed. RESULTS: The 2 main methods of testing in use in most routine laboratories are IHC and FISH on formalin fixed, paraffin embedded, breast cancer tissue. There is no single, universally accepted method and the plethora of testing and interpretative protocols has confounded the issue of clinical correlation of cerbB2 status with outcome and patient selection for therapy. The current consensus in the literature is leaning towards FISH; however, as pointed out in this paper, the use of FISH as a routine test in most diagnostic laboratories is not yet a reality mainly due to cost, technical and manpower constraints. In this regard, IHC is by default the preferred choice in many routine laboratories. CONCLUSION: Universal standardisation of testing methods for cerbB2 status determination, together with further clinical studies on the correlation of each method with outcome and response to therapy, will aid in the identification of the ideal method for stratifying patients with breast cancer into prognostic and optimal therapeutic groups.

Adult↗

PubMed1980

Test of a method to determine socially acceptable occlusal conditions.

A method for determining the social acceptability for dental appearance across the full range of occlusal conditions found in a natural population was developed and tested. The strategy used in developing the Social Acceptability Scale of Occlusal Conditions (SASOC) was to present photographs of 100 dental study models to a large sample of high school students (n = 880) and their parents (n = 403) whose responses were measured by a semantic differential instrument. After refinement of the semantic differential instrument scale scores were derived for each study model by computing the mean individual scores. Ranks were assigned to the mean scores. The Pearsonian correlation obtained between parent and student subsamples was 0.95. The reliability and validity of SASOC were assessed. COCSTOC measures of specific occlusal traits for these 100 study models are available. The future task involves the development of a highly reliable regression equation for predicting social acceptability scores from a small number of objective physical measurements.

Adolescent↗

PubMed2005

A method for measuring the effectiveness of simulation-based team training for improving communication skills.

Team behavior and coordination, particularly communication or team information-sharing, are critical for optimizing team performance; research in medicine generally provides no accepted method for measurement of team information-sharing. In a controlled simulator setting, we developed a technique for placing clinical information (probes) with members of a team of trainees participating in a 1-day Anesthesia Crisis Resource Management course and later tested the teams for knowledge of the probes as an indicator of overall team information-sharing. Despite the low level of team information-sharing, we demonstrated construct validity of the probe methodology by the correlation of measured change in team information-sharing from beginning to end of training with self-rated change. There was no statistical difference in "group sharing" from beginning to end of training, despite trainees' survey responses that the course would be useful for their education and practice.

Communication↗

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↗

PubMed2001

Stress echocardiography in the diagnosis of coronary artery disease.

Stress echocardiography (SE) is currently a widely accepted method for the diagnostic and prognostic assessment of coronary artery disease. This article reviews new concepts in SE, such as new stress techniques, new methods of endocardial border detection, strain, tissue Doppler velocities, and others. Although some of these techniques are in their infancy, we believe that they will become widely accepted.

Adenosine↗

PubMed2003

Classification of contact allergens according to potency: proposals.

It is clear that contact allergens vary substantially with regard to the relative potency with which they are able to induce skin sensitisation. Considerations of potency will in the future become a significant factor in the classification of skin sensitising chemicals. It is therefore appropriate to establish what is known of potency and thresholds in the induction of skin sensitisation and the elicitation of allergic contact dermatitis, and to identify approaches that might be available for assessment of relative potency for the purposes of categorising chemical allergens. This paper was prepared by an ECETOC (European Centre for Ecotoxicology and Toxicology) Task Force that had the objective of recommending approaches for the measurement of potency and definition of thresholds for both the induction and elicitation of contact sensitisation. The deliberations recorded here build upon recommendations made previously by an ECETOC Task Force that considered the conduct of standard skin sensitisation test methods for the purposes of hazard identification and risk assessment (ECETOC, Monograph No. 29, Brussels, 2000). The emphasis in this present paper is also on standard and accepted methods for the assessment of skin sensitisation, and for which OECD guidelines are available: the local lymph node assay (LLNA), the guinea pig maximisation test and the occluded patch test of Buehler. For various reasons, discussed in detail herein, attention focused primarily upon consideration of categorisation of chemical allergens and the identification of thresholds with respect to the induction of skin sensitisation, rather than the elicitation of allergic contact dermatitis. It is concluded that although the LLNA is the method of choice for the determination of skin sensitisation potency for the purposes of categorisation, if data are already available from appropriate guinea pig tests then their judicious interpretation may provide information of value in determinations of potency and categorisation. Included here are detailed and specific recommendations for how best the results of the three test methods considered can be used for the categorisation of chemical allergens as a function of skin sensitisation potency.

Allergens↗

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↗

PubMed2001

Mycolic acid analysis by high-performance liquid chromatography for identification of Mycobacterium species.

Mycobacterium tuberculosis is the etiologic agent of tuberculosis and can be accurately detected by laboratories using commercial genetic tests. Nontuberculosis mycobacteria (NTM) causing other mycobacterioses can be difficult to identify. The identification processes are confounded by an increasing diversity of newly characterized NTM species. The ubiquitous nature of NTM, combined with their potential to be opportunistic pathogens in immunocompromised as well as nonimmunodeficient patients, further complicates the problem of their identification. Since clinical case management varies depending on the etiologic agent, laboratories must identify the species in a timely manner. However, only a few identification methods can detect the species diversity within the Mycobacterium genus. Over the last decade, high-performance liquid chromatography analysis of the mycolic acids has become an accepted method for identification of mycobacteria. In this review, we assess its development and usefulness as an identification technique for Mycobacterium species.

Bacterial Typing Techniques↗

PubMedDate not supplied

Urine culture collected from gel-based diapers: developing a novel experimental laboratory method.

BACKGROUND: Urinary tract infection diagnosis is based on urine culture, taken from a midstream collection. Obtaining samples in this manner is difficult in elderly patients suffering from incontinence and in infants. OBJECTIVES: (1) Develop a method for urine collection using gel-based diapers and (2) compare culture results from gel-based diapers with those of the same urine, examined by accepted methods. METHODS: Urine was collected and cultured by standard bacteriologic techniques at the microbiology laboratory of Soroka Medical Center, Beer-Sheva, Israel. Gel-based diapers were manually dampened with the same urine samples, and samples from diapers were cultured 0 to 3 hours after dampening. RESULTS: Comparison showed good correlation between direct urine cultures and cultures obtained from gel based diapers (R = 1.000). Total sensitivity was 100% and specificity 97%. CONCLUSIONS: (1) Urine can be cultured from gel-based diapers and (2) a larger sample of in vivo trials will be needed to make this technique clinically applicable in an outpatient setting.

Cell Culture Techniques↗

PubMed2005

The laboratory assessment of partial androgen deficiency of the aging male.

The diagnosis of andropause, currently named partial androgen deficiency of the aging male (PADAM), by the International Society for the Study of Aging Male (ISSAM), is based on the presence of clinical symptoms together with a biochemical evidence of hypogonadism. Thus, the definition of specific diagnostic criteria, both as clinical manifestations and laboratory findings, is fundamental to identify those men for whom androgen replacement therapy should be warranted. Clinical manifestations suspected to be caused by androgen deficiency are numerous (decreased libido and erectile dysfunction, decreased muscle mass and strength, decreased bone mineral density, increased fat mass, depression, fatigue, irritability, etc) and, for these, the linkage to a real hypogonadal state must be confirmed on an individual basis. In this regard, the exact list of reproductive hormones to be evaluated, for screening or for diagnosis confirmation, together with eventual dynamic endocrine test (GnRH, hCG, clomiphene, etc) must be adjusted. Furthermore, the clinician must be aware of the methods and limits of androgen assays in order to be able to specifically select, where possible, those which are validated by comparison to a "gold standard" or accepted method of measurement.

Andropause↗

PubMed1995

Primary inguinal hernia repair in The Netherlands.

OBJECTIVE: To assess the operative methods used in Dutch surgical practice to repair the inguinal floor of the primary hernia. DESIGN: Survey by questionnaire. SETTING: University department of Surgery, The Netherlands. SUBJECTS: All Dutch Surgeons. OUTCOME MEASURES: Answers to questions about the methods of repair used, specific surgical options, and materials. Comparison of training hospitals and district hospitals. RESULTS: Replies were received from 145/155 departments (94%), but from only 448/774 individual surgeons (58%). 192 (43%) used one method alone (Bassini 71, Shouldice 49, McVay 36, Griffith 24 and others 12) and 256 (57%) of surgeons used combinations of 11 different methods. Only 9 used a prosthetic mesh and 7 laparoscopic repair. The Shouldice method was significantly more popular in training hospitals compared with non-training hospitals (36%) (71/199) compared with (20%) (48/249) (p < 0.05). There were many modifications to accepted methods. Only 78% (94/121) of surgeons who said that they did a standard shouldice repair incised the transversalis fascia. 64% (287) of surgeons said that they modified their technique to suit individual patients. CONCLUSION: In the Netherlands there is no standard technique of inguinal hernia repair.

Hernia, Inguinal↗

PubMed1993

[Active closed method of surgical treatment in postinjection purulent complications].

The work analyses the results of treatment of 450 patients with postinjection purulent complications of the soft tissues which accounted for 11.9% of the total structure of purulent diseases. The generally accepted methods were applied in the treatment of 280 patients. In 170 patients various types of active closed methods were used. A differential approach to the choice of closed methods of operative intervention is suggested which allows the terms of treatment to be reduced to one third as compared to those in the traditional methods of treatment. The general terms of incapacity of patients treated by closed methods were 11.32 +/- 0.25 days.

Abscess↗

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↗

PubMed2004

Biochemical, immunological and enzymatic components of saliva in prolonged naso-gastric-fed elderly patients.

BACKGROUND AND AIMS: We have previously shown that naso-gastric tube (NGT)-fed patients harbor pathogenic flora in their oropharynx. The purpose of this study was to examine comparatively the biochemical, immunological and enzymatic components of the saliva of these patients with that of orally-fed counterparts. METHODS: The study group consisted of 19 elderly NGT-fed patients and 18 comparable patients on oral feeding. Unstimulated whole saliva was collected and analyzed according to accepted methods for sodium, potassium, chloride, uric acid, total protein, albumin, amylase, lysozyme, and immunoglobulins, IgM, IgG, IgA, as well as secretory IgA. RESULTS: None of the above tested salivary components significantly differed between the two groups. Only uric acid levels were significantly lower (50%, p < 0.05) in NGT-fed patients. CONCLUSIONS: Uric acid is the main antioxidant component of saliva and, as such, it may be related to pathogenic bacterial colonization of the oropharynx in NGT-fed patients, with the risk of aspiration pneumonia.

Aged↗

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↗