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PubMed1996

Acceptability and discontinuation of Depo-Provera, IUCD and combined pill in Kenya.

This paper reports on a prospective study conducted between June 1990 and June 1992 to determine method acceptability, user satisfaction and continuation rates for three highly effective and reversible contraceptive methods currently available in Kenya: the CuT 380A (IUCD), the injectable, Depo-Provera and the low-dose oral contraceptive pill, Microgynon. A non-randomised sample of volunteer participants was used. One thousand and seventy-six users were followed up for a period of one year or up to the time of discontinuation of the method, whichever came earlier. Analysis revealed method specific differences in users' characteristics. The OC users were younger and had fewer children than the IUCD or Depo-Provera users. The Depo-Provera users were older, and had the largest family sizes. Many OC users (almost 40%) were single, while almost three-quarters of IUCD and Depo-Provera users were married. IUCD users were also more educated compared to OC and Depo-Provera users. Survival analysis was used to calculate cumulative life table discontinuation rates by method for the 12 month period. Discontinuation rates were highest for OC users (80%) and lowest for IUCD users (20%) and intermediate for Depo-Provera users (39%). Ninety percent of OC and Depo-Provera users and 86% of IUCD users said they were satisfied with their respective methods. While OCs are among the most popular family planning methods in Kenya, they are also one of the most problematic, while IUCD has the fewest compliance problems. Service providers need to address the issue of high discontinuation rates among the young OC users.

Adolescent↗
PubMed1996

Preliminary comparison of the polyurethane female condom with the latex male condom in Kenya.

This paper summarizes acceptability data published to date on the innovative female condom, and presents an additional study comparing the acceptability of the female condom and the latex male condom in a sample of low risk women attending private obstetrician/ gynaecologists' clinics in Nairobi, Kenya. Eighty-four percent of all subjects who completed interviewer-assisted questionnaires reported that they liked using the female condom, and more than two-thirds of all the women liked the female condom as much or better than the male condom. Fifty-five percent of the women would use the device in future if it were available. The least liked features were that the device was too large for easy insertion, messy to handle, and reduced sensation. Use became easier and more comfortable with experience. The most liked features were that the device made sex more enjoyable, protected against sexually transmitted diseases and pregnancy, and was under the woman's control. Male partner response was slightly less favourable, and sometimes resulted in women's noncompliance or discontinuation of use, despite the fact that such a device is supposed to empower women. This study provides preliminary data indicating that the female condom is a fairly acceptable method for some Kenyan couples, but recommends further research into safety, cost-effectiveness and hindrances to acceptability.

Adult↗
PubMed2004

[Validation and regulatory acceptance of alternative methods for toxicity evaluation].

For regulatory acceptance of alternative methods (AMs) to animal toxicity tests, their reproducibility and relevance should be determined by intra- and inter-laboratory validation. Appropriate procedures of the validation and regulatory acceptance of AMs were recommended by OECD in 1996. According to those principles, several in vitro methods like skin corrosivity tests and phototoxicity tests were evaluated and accepted by ECVAM (European Center for the Validation of Alternative Methods), ICCVAM (The Interagency Coordinating Committee on the Validation of Alternative Methods), and OECD. Because of the difficulties in conducting inter-laboratory validation and relatively short period remained until EU's ban of animal experiments for safety evaluation of cosmetics, ECVAM and ICCVAM have recently started cooperation in validation and evaluation of AMs. It is also necessary to establish JaCVAM (Japanese Center for the Validation of AM) to contribute the issue and for the evaluation of new toxicity tests originated in Japan.

Animals↗
PubMed1994

Evaluating test methods by estimating total error.

A common procedure for evaluating a test method by comparison with another, well-accepted method has been to use a repeated measurements design, in which several individual subjects' specimens are assayed with both methods. We propose the use of the intrasubject relative mean square error, which is a function of the intrasubject relative bias and the coefficient of variation of the test method, as a measure of total error. We construct for each individual subject a score that is based on how well an individual's estimate of total error compares with a maximum allowable value. If the individual's score is > 100%, then that individual's estimate of total error exceeds the maximum allowable value. We present a distribution-free statistical methodology for evaluating the sample of scores. This involves the construction of an upper tolerance limit to determine whether the test method yields values of the total error that are acceptable for most of the population with some level of confidence. Our definition of total error is very different from that defined in the National Cholesterol Education Program (NCEP) guidelines. The NCEP bound for total error has three main problems: (a) it incorrectly assumes that the standard error of the estimated relative bias is the test coefficient of variation; (b) it incorrectly assumes that the individual estimated relative biases follow gaussian distributions; (c) it is based on requiring the relative bias of the average individual in the population to lie within prescribed limits, whereas we believe it is more important to require the total error for most of the individuals in the population, say 95%, to lie within prescribed limits.

Bias↗
PubMed2007

Guinea pigs in hypersensitivity testing.

The aim of the present paper is to mention steps of development of predictive guinea pig animal models for contact sensitization evaluation in parallel with the development of understanding the mechanism of contact sensitization. The guinea pigs methods are reviewed and the presently accepted methods (Buehler test, Maximization test) are discussed in details. Influences on the outcome of guinea pig sensitization assays are mentioned too. The predictability of the guinea pig methods is compared with predictive methods in mice, with human tests (human repeated insult patch test, HRIPT) and epidemiological data. In the last part, a testing strategy and steps for risk assessment of contact sensitizing potential is proposed.

Animals↗
PubMed1987

Single-stage correction of constriction ring syndrome.

The accepted method of treatment for the constricting ring syndrome of the extremities is serial excision and repair with Z-plasties. A series of 4 patients operated upon in different centers by single-stage excision of the ring and multiple Z-plasty repair is presented. In 1 patient there was absence of a major nerve trunk underneath and distal to a constriction ring. None of the patients suffered any significant circulatory embarrassment. This surgical approach is anatomically sound and clinically safe. It should be considered as an alternative method of treatment to the currently accepted procedure.

Amniotic Band Syndrome↗
PubMed2004

Do patients accept implantable atrial defibrillation therapy? Results from the Patient Atrial Shock Survey of Acceptance and Tolerance (PASSAT) Study.

INTRODUCTION: The Medtronic Jewel AF 7250 is an implantable cardioverter defibrillator with atrial and ventricular therapies (ICD-AT). The ICD-AT is effective in managing atrial tachyarrhythmias (atrial fibrillation [AF]), but patient acceptance remains an issue. This aim of this study was to measure ICD-AT acceptance. METHODS AND RESULTS: ICD-AT acceptance was evaluated in 96 patients enrolled in the "Jewel AF-AF-Only Study" for > or =3 months of follow-up (mean 19 months). Patients were mostly men (72%; age 65 +/- 12 years). Clinical data and a written survey (75% response rate) were used to quantify demographics, AF frequency and symptoms, atrial defibrillation therapy, quality of life (QOL), psychosocial distress, and ICD-AT therapy acceptance. From implant to survey, AF symptom and severity scores decreased by 18% (P < or = 0.05), and QOL (SF-36) scores increased by 15% to 50% (P < or = 0.05). ICD-AT therapy acceptance was high, with 71.3% of patients scoring in the 75th percentile on the Florida Patient Acceptance Survey. ICD-AT acceptance was correlated with the Physical Component Scale and Mental Health Component Scale scores of the SF-36 (r = 0.28 and 0.35, respectively). ICD-AT acceptance was negatively correlated with depressive symptomatology (r =-0.59), trait anxiety (r =-0.48), illness intrusiveness (r =-0.55), and AF symptom and severity scores (r =-0.26). ICD-AT acceptance did not correlate with preimplant cardioversions, number of atrial shocks, AF episodes detected by the device, or device implant duration. CONCLUSION: Most patients accepted ICD-AT therapy. Patients were more likely to accept ICD-AT if they had less psychosocial distress, greater QOL, and lower AF symptom burden.

Adult↗
PubMedDate not supplied

The role of ECVAM in promoting the regulatory acceptance of alternative methods in the European Union. European Centre for the Validation of Alternative Methods.

The roles played by the European Centre for the Validation of Alternative Methods (ECVAM) and its advisory committee, the ECVAM Scientific Advisory Committee (ESAC), in the evolution of alternative methods are described. Particular emphasis is given to the process by which ECVAM and the ESAC assess the scientific validities of alternative methods, and, in appropriate cases, initiate the progression of scientifically validated methods toward regulatory acceptance.

Animal Testing Alternatives↗
PubMed1986

Determination of vitamin B12 in gruel by a radioisotope dilution assay.

The results obtained by a radioisotope dilution (RID) method for the determination of vitamin B12 in gruel were compared with those obtained by a standard microbiological assay with Lactobacillus leichmannii. A commercially available RID assay kit was used. A very high correlation between the results from the RID method and the microbiological method was found when the extraction procedure was the same. Digestion with buffer solution at pH 4.6 was shown to be the most suitable extraction method. The RID assay is an acceptable method for routine determinations of vitamin B12 in gruel.

Biological Assay↗
PubMed1994

Norplant contraceptive acceptability among women in five Asian countries.

An analysis of 1,882 Asian acceptors of Norplant implants indicates that method acceptability remained high among the 882 women who used the method for five years. Women who discontinued early from the study were, on average, younger than those who completed five years of use. Also, they had fewer live births and were more likely to desire additional children. Overall, about 70% of the women in these countries found the Norplant implant method to be very favorable. The majority (> 40%) of the women found the ease and duration of use of the method to be most attractive, while menstrual disturbances were the least-liked aspect of the method. Although it was apparent that there are still some potential obstacles to Norplant implant acceptance, most noticeably concerns about menstrual irregularities, interest in continuing the method after five years of use is high. Further research of issues related to Norplant implant acceptability may improve continuation rates and overall client satisfaction.

Adult↗
PubMed1989

Assessment of labial salivary gland changes in patients with rheumatoid arthritis by subjective and quantitative methods.

Biopsy of the minor salivary glands is an accepted method in the diagnosis of Sjögren's syndrome, the most characteristic feature being the prominent inflammatory cell infiltration. However, difficulties exist in the early diagnosis of Sjögren's syndrome. The present study was conducted to analyse by subjective and quantitative methods the morphological changes of the salivary glands in patients with rheumatoid arthritis (RA) frequently complicated by Sjögren's syndrome. The subjects of this study were 71 RA patients (mean age 54 +/- 15 years) and their 45 healthy age-matched controls (mean age 60 +/- 14 years). The histologic parameters evaluated were: inflammatory cell infiltration; acinar atrophy; fibrosis, and fatty infiltration. Statistically significant differences between the RA and the control groups were found in all parameters (p less than 0.001) except the fatty infiltration. This indicates that destruction of the salivary glands including fibrosis and acinar atrophy is associated with RA. Only the fatty infiltration seems to be an age-dependent change. All salivary gland biopsies of the RA patients were photographed and evaluated planimetrically, for the same parameters as in the subjective evaluation. An excellent reproducibility between the two methods was found, thus indicating the applicability of the subjective evaluation in the assessment of early salivary gland changes in RA patients.

Adult↗
PubMed2001

The efficacy of subsurface flow reed bed treatment in the removal of Campylobacter spp., faecal coliforms and Escherichia coli from poultry litter.

The use of poultry waste as a fertiliser on arable land is an accepted method of waste treatment. However, run-off from such practices may result in contamination of the watercourse by human pathogens. In this study the effectiveness of using constructed wetlands as an alternative treatment for poultry manure waste was evaluated. Enumeration of Campylobacter spp., Escherichia coli, total coliforms and total aerobes were carried out on influent and effluent samples from reed beds loaded with poultry waste. For both sequential loading and continuous loading there was a statistically significant mean log reduction of 3.56 and 4.25 for E. coli, 3.2 and 3.88 for coliforms, 3.85 and 4.2 for total aerobic counts and 3.13 and 2.96 for Campylobacter spp., respectively. This method, which has been previously recognised as cost-effective and environmentally acceptable, provides an efficient method for reducing numbers of these bacteria in poultry waste and therefore an effective alternative treatment for such waste or waters containing run off from land previously spread with poultry manure.

Animals↗
PubMed1989

A method for correctly setting the rf flip angle.

Currently the accepted method for setting the correct rf power levels to achieve 90 degrees and 180 degrees rf pulses for MR imaging is to peak the echo amplitude of a rf spin-echo sequence. The echo amplitude of this alpha-2 alpha pulse sequence is proportional to sin3 (alpha) and has a relatively broad maximum. Recently another method for setting the rf flip angle by maximizing the ratio of the stimulated echo to the primary echo amplitudes (in a 3 alpha sequence) demonstrated accuracy similar to that of the spin-echo method using a shorter repetition time. We present a new, more sensitive, and more accurate method for setting the correct rf power levels for 90 degrees and 180 degrees rf pulses. In this method, based upon the stimulated echo pulse sequence, we are able to accurately set the rf power to within +/- 0.1 dB by minimizing the signal amplitude of the third spin echo. This null method works for both selective and nonselective rf pulses of flip angle 90 degrees or 180 degrees, allowing the user to accurately adjust the relative amplitudes of the four rf pulse types within a single pulse sequence.

Calibration↗
PubMedDate not supplied

The incident command system in disasters: evaluation methods for a hospital-based exercise.

OBJECTIVES: No universally accepted methods for objective evaluation of the function of the Incident Command System (ICS) in disaster exercises currently exist. An ICS evaluation method for disaster simulations was derived and piloted. METHODS: A comprehensive variable list for ICS function was created and four distinct ICS evaluation methods (quantitative and qualitative) were derived and piloted prospectively during an exercise. Delay times for key provider-victim interactions were recorded through a system of data collection using participant- and observer-based instruments. Two different post-exercise surveys (commanders, other participants) were used to assess knowledge and perceptions of assigned roles, organization, and communications. Direct observation by trained observers and a structured debriefing session also were employed. RESULTS: A total of 45 volunteers participated in the exercise that included 20 mock victims. First, mean, and last victim delay times (from exercise initiation) were 2.1, 4.0, and 9.3 minutes (min) until triage, and 5.2, 11.9, and 22.0 min for scene evacuation, respectively. First, mean, and last victim delay times to definitive treatment were 6.0, 14.5, and 25.0 min. Mean time to triage (and range) for scene Zones I (nearest entrance), II (intermediate) and III (ground zero) were 2.9 (2.0-4.0), 4.1 (3.0-5.0) and 5.2 (3.0-9.0) min, respectively. The lowest acuity level (Green) victims had the shortest mean times for triage (3.5 min), evacuation (4.0 min), and treatment (10.0 min) while the highest acuity level (Red) victims had the longest mean times for all measures; patterns consistent with independent rather than ICS-directed rescuer activities. Specific ICS problem areas were identified. CONCLUSIONS: A structured, objective, quantitative evaluation of ICS function can identify deficiencies that can become the focus for subsequent improvement efforts.

Communication↗
PubMed1989

A double buffy coat method for red cell removal from ABO-incompatible marrow.

Hemolytic reactions caused by transfusion of ABO-incompatible marrow can be ameliorated by either reduction of isohemagglutinins in the recipient or depletion of incompatible red cells from the harvested marrow. This article describes a rapid and reliable method for removal of incompatible marrow red cells on a blood cell processor using a double buffy coat technique. In five allogeneic bone marrow transplants, the maximum value of transfused incompatible red cells was 8.8 ml. There was no evidence of a hemolytic transfusion reaction in any patient. The median cell recovery for nucleated marrow cells and progenitor cells was 77 and 104 percent, respectively. Engraftment occurred at a median of 13 days (range, 11-21 days) after transplantation. The double buffy coat method of red cell depletion is an acceptable method for processing ABO-incompatible marrow.

ABO Blood-Group System↗
PubMed2004

A comparison of electroejaculation and epididymal sperm collection techniques in stallions.

The purpose of this study was to evaluate 2 methods of semen collection that could be used as terminal procedures in stallions with irreparable conditions, such as fractures or colic. Electroejaculation was attempted under general anesthesia. Forty-eight hours later, the ponies were castrated and 2 different epididymal sperm collection techniques were attempted by using a flushing or floating method. Additionally, the effect of supplemental seminal plasma was evaluated. Experimentally, electroejaculation was found to be a safe but ineffective method of terminal semen collection. Viable sperm cells were successfully recovered with both types of epididymal collection. The flotation method was least cumbersome and showed a tendency to be superior to flushing in terms of sperm motility and percentage of cells passing through glass wool/sephadex filtration, although differences did not reach significance. The addition of seminal plasma to epididymal spermatozoa prior to cryopreservation was of no value. In conclusion, either method of epididymal sperm collection is an acceptable method of terminal semen collection.

Anesthesia↗
PubMed2005

[Evaluation of the protozoa found in fecal samples using the trichrome staining method.].

The morphological diagnosis of intestinal protozoa is a widely accepted method today. A permanent staining method is preferred since it can visualize the morphological details of protozoal cysts and it allows the stool specimens to be reevaluated later. In this study, 2141 stool specimens sent to the clinical microbiology laboratory of the Gazi University Hospital were examined using the trichrome staining method. We determined 181 parasitic organisms in 165 (7.70%) of these 2141 specimens. Helminthic organisms were detected in seven of these samples. Protozoa were found in 174 specimens evaluated with the trichrome staining method. In our study, trichrome staining was found to be 87.93% successful in the identification of intestinal protozoa. In conclusion, it was seen that the trichrome staining method could make a reliable diagnosis possible when used in addition to the direct examination of the stool specimens in the identification of intestinal pathogenic and nonpathogenic protozoa to the species level.

English Abstract↗
PubMedDate not supplied

Conversion from intravenous procainamide to oral sustained release tablets in cardiac patients.

There is as yet no established method for converting from intravenous to oral sustained release procainamide (Procan SR; Parke-Davis Canada Inc). The pharmacokinetics of simultaneous discontinuation of intravenous procainamide and administration of oral sustained release procainamide was studied in six patients with ventricular tachyarrhythmias. Patients were converted after ensuring that steady-state concentrations were achieved with intravenous procainamide. Serum procainamide levels were obtained at the time of conversion and 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 h after conversion. The mean steady-state concentration (23.7 +/- 8.9 mumols/L) and the adjusted mean serum procainamide concentration with Procan SR (25.3 +/- 7.9 mumols/L) were not significantly different. This indicated that the serum procainamide concentration obtained with the intravenous infusion was not compromised when the patients were switched to oral therapy. Although mean percentage serum procainamide concentration fluctuation was 102.6 +/- 92.5, all patients tolerated the conversion well. Therefore, the method used in this study is an acceptable method of conversion.

Administration, Oral↗