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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↗

PubMed2003

[Heart rate variability in patients suffering from essential hypertension with different mapping of left ventricle].

UNLABELLED: ECG monitoring by means of Holter method provides not only information concerning arrhythmias, episodes of ischaemia of the cardiac muscle, but it is also recognised and generally accepted method of investigation of the influence of autonomic system on heart. The aim of the study was to assess the heart rate variability in patients suffering from essential hypertension with different geometry of left ventricle. The studies involved 70 patients, in that 35 women and 35 men (mean age 56.86 +/- 12.3 years). All patients (pts) revealed hypertension, 45 of them mild degree (1 degree), 25 of them moderate degree (2 degrees) according to JNC VI. All patients underwent echocardiography examination, the LV mass was calculated and normalized to the body surface to obtain the LV mass index (LVMI). Based on the LVMI and relative wall thickness (RWT) the type of left ventricle hypertrophy was classified as normal geometry (group 1-17 pts), concentric remodelling (II group--12 pts), concentric hypertrophy (III group--22 pts) and excentric hypertrophy (IV group--20 pts). All of them were submitted to 24-hour Holter monitoring on tape by means of 3-channel registrator MR 45, analysis of ECG tracings was carried out according to Oxfords Optima Jet system. In order to facilitate further analysis, the automatic recording was verified visually and next heart rate variability (HRV) was estimated within 24 hours and separatedly for day hours 6:00-22:00 and night hours 22:00-6:00. CONCLUSIONS: 1. In patients with essential hypertension, hypertrophy and abnormal left ventricular geometry the decrease of parasympathetic activity during day and night hours was observed. 2. The most advanced sympatho-parasympathetic imbalance was noticed in patients with essential hypertension and excentric hypertrophy of left ventricle. 3. The correlations of HRV parameters and LV mass index, the interventricular septum and the left ventricular posterior wall thickness indicate close connection between variables of sympatho-parasympathetic activity and proceeding changes in left ventricle geometry and hypertrophy.

Aged↗

PubMed1996

Use of plasma clearance of inulin for estimating glomerular filtration rate in cats.

OBJECTIVE: To evaluate utility of a method for estimating glomerular filtration rate after a single i.v. injection of inulin. ANIMALS: Cats that were renal intact (n = 3) or had renal mass reduced by partial nephrectomy (n = 6). PROCEDURE: Plasma clearance of inulin (PCln) was taken as the quotient of the administered dose of inulin (150 mg) divided by the area under the plasma inulin concentration versus time curve determined by 3 methods (PCln1-PCln3). Results for PCln were compared with simultaneously obtained values for urinary clearance of exogenous creatinine (CCr), an accepted method for the estimation of glomerular filtration rate (GFR) in cats. RESULTS: Values for PCln were closely related (R2 ranged from 0.951 to 0.972, P < 0.0001 in all instances) to CCr. However, PCln3 provided an estimate of GFR that consistently overestimated CCr. CONCLUSION: Determination of PCln by use of PCln1 and PCln2 provided a reliable estimate of GFR in cats of this study. CLINICAL RELEVANCE: Determination of PCln appears to provide a reliable estimate of GFR in cats with early-stage renal disease and no evidence of derangement of body fluid status. In particular, PCln2, which requires only 3 determinations of plasma inulin concentration, should be considered when an estimate of GFR is sought in a cat with suspected early-stage renal disease.

Animals↗

PubMed1998

[Studies of arrhythmia incidence and heart rate variability in patients suffering from cerebral stroke].

Patients with cerebral stroke develop electrocardiographic changes concerning the period of ventricular muscle repolarization and cardiac arrhythmias, which may results in the possibility of acute circulatory arrest. ECG monitoring by means of Holter method provides not only information concerning arrhythmias, episodes of ischaemia of the cardiac muscle, but it is also a recognised and generally accepted method of investigation of the autonomic system. The aim of the study was to assess the incidence of arrhythmias and heart rate variability in patients suffering from recent cerebral stroke. The studies involved 36 patients, in that 22 women (mean age 67.7 +/- 7.2 years) and 14 men (mean age 66.5 +/- 11.3 years) within first 24 hours after cerebral stroke confirmed by computerised tomography (CT). One the basis of CT scan haemorrhagic stroke was diagnosed in 7 patients and ischaemic stroke, after ruling out haemorrhagic stroke and neurological consultations, in 29 patients. Moreover, all patients revealed hypertension, 12 of them mild degree (1 degree), and 21 of moderate degree (2 degrees), and 3 of severe degree (3 degrees). The control group comprised 65 patients suffering from primary hypertension without concomitant cerebral stroke, matching the study group as to sex and age as well as the degree of hypertension. All of them were submitted to 24-hour Holter monitoring on tape by means of 3-channel registrator MR45, analysis of ECG tracings was carried out according to Optima Jet system manufactured by Oxford. In order to facilitate further analysis, the automatic recording was verified visually and next heart rate variability (HRV) was estimated within 24 hours and separately for day hours 6:00-22:00 and night hours 22:00-6:00. In comparison to patients with hypertension, but without stroke, subjects with hypertension and accompanying cerebral stroke more often reveal premature supraventricular beats, pairs of ventricular beats as well as episodes of nonsustained ventricular tachycardia; they also reveal lower 24-hours heart rate variability.

Aged↗

PubMed1997

A new MRI ratio method for in-vivo estimation of signal hypointensity in aging and Alzheimer's disease.

1. Alzheimer's Disease (AD) is accompanied by a disruption in iron metabolism. There is no universally accepted method for detecting brain iron. 2. The authors have developed a novel "ratio" method which uses the red nucleus as an internal reference. We postulated that this method would improve our sensitivity in detecting differences in MRI signal intensities and that it would allow us to measure brain iron deposition. 3. The ratio method reasonably reproduced previous reports of the normal deposition of iron in brain that occurs with aging. It failed to distinguish any differences in three brain areas: putamen, left frontal lobe and whole slice in AD patients versus age and sex matched controls. 4. It also failed to detect differences with AD progression or severity. 5. The ratio method itself warrants further investigation.

Aged↗

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↗

PubMed1996

In search of effective programs to address students' emotional distress and behavioral problems part III: student assessment of school-based support groups.

Emotional distress and behavioral problems are common in high schools. This report describes the efficacy of an in-school program based on participation in volunteer-facilitated peer support groups in addressing these problems. Two hundred and fifty students who experienced such problems participated in weekly 50-minute peer support groups led by adult nonmental health professional volunteers. The students anonymously evaluated their progress and program acceptability using an instrument developed specifically to evaluate the group experience. Analysis of the evaluation of the 131 respondents documented the reliability of a proposed Self-Assessment Questionnaire which showed that participation led to improvement in school, interpersonal, and internal domains. The program was highly accepted and showed other signs of success: half of the alcohol and substance users reduced their intake, and 60% of those who considered dropping out of school continued their education. The results provide preliminary evidence that peer support groups show promise as an economical and well-accepted method for early recognition and management of emotional and behavioral problems in high schools. For some adolescents, these groups may be the only acceptable or available therapeutic modality.

Adolescent↗

PubMedDate not supplied

Prehospital pediatric endotracheal intubation: a survey of the United States.

INTRODUCTION: The standard of practice and teaching for prehospital pediatric endotracheal intubation (PETI) in the United States currently is unknown. The accepted practice of prehospital PETI is of interest because it has contradictory support in the medical literature. HYPOTHESIS: PETI is an accepted method of prehospital airway control in the United States. METHODS: Nationwide mail survey (June 1991 to March 1992) of each state emergency medical service (EMS) agency and all known paramedic training sites. RESULTS: The use of PETI is supported by 100% of state EMS agencies and the American Virgin Islands. Ninety-seven percent (339 of 349) of the responding (349 of 523) paramedic training sites reported that PETI was taught in their programs. The results of the survey did not identify a predominate method for instructing paramedics in PETI. Lectures, mannequins, operating room demonstration, animal models, and cadavers were used in various ways for teaching the skill. CONCLUSION: Endotracheal intubation is an accepted standard in prehospital pediatric care. This standard exists with marginal support in published literature and study of prehospital PETI is needed to define the benefits, risks, and optimal instruction methods for the procedure.

Emergency Medical Services↗

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↗

PubMed2003

Description of a photoelastic coating technique to describe surface strain of a dog skull loaded in vitro.

There are several methods of determining strain in the facial skeleton on loading in vitro. This article describes an alternative photoelastic coating technique adapted from the commonly accepted method used by engineers to study surface strains in objects. In applying this method to the stomatognathic system, because the masticatory apparatus is loaded by muscular contraction an opposite reaction load should be distributed throughout the skeletal structure. This load distribution should slightly deform the bones to which the muscles of mastication are attached. An understanding of the resulting strain generated in the facial skeleton is important because strain distribution on loading reflects how the loads applied during mastication are partially dissipated. Preliminary descriptive results are presented, suggesting that anatomic structures influence the distribution of strain on loading. The technique described should allow in vitro investigation of the mechanical environment into which osseointegrated implants are placed and may aid in understanding their behavior.

Animals↗

PubMed2003

The predictive value and inter-observer variability of donor chest radiograph interpretation in lung transplantation.

OBJECTIVE: Currently the relationship between the evaluation of the donor chest radiograph and the final disposition of potential donor lungs is unknown, yet potential lung donors receive frequent x-rays. We sought to clarify the role donor chest radiographs and donor lung acceptability. METHODS: We conducted a retrospective review of 84 potential organ donors. Radiographs were reviewed separately by three thoracic surgeons and three pulmonologists and either accepted or rejected with no other information. Data was analyzed by Kappa statistic to judge inter-observer variance and it was compared to actual outcome to determine predictive value. RESULTS: The Kappa statistics for observer agreement was 0.149 among the surgeons, 0.510 among the pulmonologists, and 0.336 overall, representing slight, moderate and fair agreement respectively. The reviewers' decisions to accept or reject a lung concurred with the actual clinical outcome 64.2% of the time. The positive predictive value of an accept decision was found to be 78.3% and the negative predictive value of a reject decision was 36.3%. CONCLUSIONS: This study suggests that evaluation of the donor chest x-ray is a highly subjective process and demonstrated the limited role the radiograph presently holds in the determination of organ suitability.

Case-Control Studies↗

PubMed2000

Efficacy and tolerability of mesalazine foam enema (Salofalk foam) for distal ulcerative colitis: a double-blind, randomized, placebo-controlled study.

BACKGROUND: Rectal formulations of mesalazine are the treatment of choice in mildly to moderately active ulcerative colitis. A new foam formulation of mesalazine was developed to improve both drug delivery and patient acceptance. METHODS: In this multicentre, randomized, double-blind, parallel-group study, 111 patients with mildly to moderately active proctitis, proctosigmoiditis, or left-sided ulcerative colitis received mesalazine foam enema or placebo enema (2 g mesalazine per day) for 6 weeks. Disease activity was monitored on the basis of the Clinical Activity Index, Endoscopic Index, Histological Index, and global efficacy assessment by the investigators. Safety assessments included the recording of adverse events, laboratory variables and vital signs. RESULTS: Clinical remission was more frequent in the mesalazine group than the placebo group (65% vs. 40%; P=0.0082), particularly in patients with mild disease and patients with proctosigmoiditis. The frequency of patients with an endoscopic remission was higher in the mesalazine group (57%) than in the placebo group (37%). Similarly, 59% of patients receiving mesalazine but only 41% of those receiving placebo showed an improved Histological Index. The foam enemas were generally well-tolerated, and no treatment-related changes on laboratory variables and vital signs were noted. CONCLUSIONS: Mesalazine foam enema was well-tolerated and was more effective than placebo in the treatment of patients with distal ulcerative colitis.

Adult↗

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↗

PubMed2003

Videoconferencing for practice-based small-group continuing medical education: feasibility, acceptability, effectiveness, and cost.

INTRODUCTION: Small-group, practice-based learning is an effective and well-accepted method of continuing medical education (CME). However, one limitation is that many physicians work in communities with fewer than the minimum number recommended for an effective learning group. Videoconferencing has the potential to remove this limitation. The purpose of this study was to evaluate the feasibility, acceptability, effectiveness, and cost of conducting practice-based, small-group CME learning by videoconference. METHODS: Through a videoconferencing link, 10 learners in three communities were guided through four practice-based learning modules by a trained facilitator at a fourth site. Data were collected through evaluation questionnaires, direct observation by the research team, pre- and post-knowledge tests, a focus group, and an interview. RESULTS: A total of 31 learners participated in the four modules. Videoconferencing was generally well accepted by learners. The facilitator and research team observers noted that muting microphones, video quality, audio quality, and audio lag all somewhat hindered discussion. Overall, the facilitator found moderating by videoconference only slightly more difficult than a face-to-face session. There was evidence of knowledge gain, with post-test scores being 20% higher than pretest scores (p = .006). Learners reported nine practice changes from taking the modules. At commercial rates, telecommunications costs per videoconferenced module were approximately CAN$1,200. DISCUSSION: Videoconferencing has the potential to bring the benefits of small-group, practice-based learning to many physicians; however, strict attention to videoconferencing techniques is required. Cost is also an important consideration.

Attitude of Health Personnel↗

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↗

PubMed2000

Contraceptive failure: levels, trends and determinants in Matlab, Bangladesh.

This study investigated the levels, trends and determinants of contraceptive use-failure in Matlab, Bangladesh, using a set of prospective data on 25,960 women of reproductive age. The data were extracted from the Record Keeping System (RKS) of Matlab for the period 1978-94. If there was any live birth during the use or within 7 months after the discontinuation of use, it was considered as a failure. The life table technique and hazard model were used as analytical tools. The results suggest that use-failure for pills, IUDs (TCu 200) and injectables and other temporary methods increased from 1978 to 1988, but began to decline after 1988. The cumulative probability of first-method failure within 1 year of method acceptance of the cohort of 1990-94 acceptors was 12.9% for pills, 2.0% for IUDs, 0.5% for injectables, 22.0% for condoms and 13.4% for 'other' methods (sampoon, foam, jelly and traditional methods). For pills, condoms and 'other' methods, the likelihood of failure declined with the duration of use; by contrast, the probability of an IUD failure increased over time, peaking at 3 years of use. The injectables maintained a low likelihood of failure regardless of the duration of use. The quality of Community Health Workers' (CHWs) performance was associated with the risk of failure of all temporary methods except condoms; women's background characteristics associated with failure varied by method. The effect of the quality of the CHWs' performance and the background variables on failure did not change much over time. It is felt that contraceptive failure deserves the serious attention of programme managers and policy makers to make the Bangladesh national family planning programme more successful.

Adult↗

PubMed1996

Evaluation of a single injection method, using iohexol, for estimating glomerular filtration rate in cats and dogs.

OBJECTIVE: To evaluate the utility of a method for estimating glomerular filtration rate (GFR) after single IV administration of iohexol. DESIGN: The plasma clearance of iodine (PCI), taken as the quotient of the administered dose of iodine (300 to 600 mg of l/kg of body weight) divided by the area under the plasma iodine concentration versus time curve determined by 4 methods (PCI1-PCI4). The results for PCI were compared with simultaneously obtained values for the urinary clearance of exogenously administered creatinine (CCr), a widely accepted method for the measurement of GFR in cats and dogs. ANIMALS: Cats and dogs that were renal intact (n = 5 cats; n = 1 dog) or had renal mass reduced by partial nephrectomy (n = 5 cats; n = 7 dogs). RESULTS: Values for PCI were closely related (R2 values ranged from 0.947 to 0.992; P < 0.0001 in all cases) to CCr. Despite this close correlation between CCr and PCI, the 95% confidence interval for the difference between PCI3 and CCr included values that exceeded 1.4 ml/min/kg, which represents 50% of the mean value for CCr in renal-intact cats. CONCLUSIONS: Determination of PCI provided a reliable estimate of GFR in cats and dogs of this study. However, differences between 1 of the methods (PCI3) and CCr are clinically important, emphasizing the need to use more than simple linear regression analysis and correlation coefficients when attempting to validate new measurement techniques. CLINICAL RELEVANCE: The determination of PCI provided a reliable estimate of GFR in cats and dogs of this study.

Animals↗