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A theoretical basis for clinically relevant proficiency testing evaluation limits. Sensitivity analysis of the effect of inherent test variability on acceptable method error.

The types and performance characteristics of the present rules for acceptance and rejection of quantitative results by proficiency testing agencies are reviewed. The rates of false acceptance and rejection by peer group evaluation are high when compared with explicit medical usefulness criteria. Accuracy-based target values and fixed limits provide the technologic basis for process control of interlaboratory accuracy, and their efficacy contrasts with that of peer limits. However, uniform criteria for result accuracy are also required. A clinical statistical model predicting the effect of method error on clinical diagnostic accuracy is proposed. A criterion is proposed for result accuracy defined in terms of uniform clinical benefit. The criterion specifies a fixed error limit for each type of application of a medical test that is appropriate for the inherent variability of the test application. Recent College of American Pathologists Survey experience with clinical fixed limits for allowable analytic error calculated by the model is presented.

Diagnostic Tests, Routine

Association between contraceptive method accepted and perception of information received: a comparison of Norplant and IUD acceptors.

In the present study Norplant(R) and IUD acceptors who attended the same counseling sessions have been compared on their perception of the information received at the family planning clinic. The study covered 100 acceptors of each method quota matched by parity and years of schooling. Data were obtained through home interviews. The two groups presented no significant differences when selected socio-demographic characteristics were analyzed. Norplant users recalled more information on this method than did IUD acceptors, and the content of what they remembered was different. This included concepts as important as risk of pregnancy, menstrual and health effects, and method of removal. The results suggest that the intrinsic qualities of the new method and the presence of a group of women motivated to use one with its general characteristics, are not sufficient conditions for its acceptance.

Contraception

Saline lavage: a rapid, effective, and acceptable method for cleansing the gastrointestinal tract.

The standard preparation for cleansing the gastrointestinal tract for diagnostic studies such as barium enema usually involves dietary restrictions, purgatives, and cleansing enemas. This preparation is time consuming, often uncomfortable for the patient, and frequently unsuccessful. In this study, we examined the efficacy of saline lavage (without dietary restrictions or cleansing enemas) as a gentle, alternative method for cleansing the bowel, and compared lavage to the standard castor oil method of bowel preparation. Lavage cleansing was preferred by 75% of patients who had previously experienced a castor oil preparation. Although 11% of patients could not consume an adequate (4-liter) lavage volume, there was no significant difference in preparation success rate between the remaining lavage patients and the castor oil patients. Total preparation time for lavage (3 +/- 1 hr) was 60% less than for castor oil. The anticipated dehydration produced by castor oil and the hydration produced by lavage were confirmed. No significant changes were noted, however, in serum electrolytes with either method of preparation. Additional early studies are promising for the lavage method when used in inflammatory bowel disease patients and as a cleansing preparation for colonoscopy.

Barium Sulfate

[Psychotherapy in schizophrenic psychoses--historical development, effectiveness and currently accepted methods].

Psychotherapy has a long tradition in the treatment of schizophrenic psychosis. Individual therapies--based on psychoanalysis in continental Europe and in the first half of this century due to emigrants in England and the United States--were predominant. The development of family therapy then led to modified forms and in particular group therapy for relatives of schizophrenic patients. There is a variety of treatments available today: assistance in coping with the disease, cognitive therapies and social skill training, psychotherapy based on depth psychology, family therapy and work with the relatives of patients. Some encouraging studies on efficacy are already available. Drug treatment continues to be the dominant form of therapy, but modified psychotherapeutic programs for patients and their relatives have become an important supplement to neuroleptic therapy and relapse prevention, particularly since the "Vulnerability-Stress-Hypotheses" became widely accepted.

Combined Modality Therapy

The contraceptive diaphragm. Is it an acceptable method in the 1980s?

A prospective study of diaphragm users at the Family Planning Association of Victoria was undertaken. Despite the women being well motivated and instructed the pregnancy rate was high (24 per 100 woman years) and the continuation rate was only 35% at 12 months. Three-quarters of the women who became pregnant admitted that they did not use a diaphragm on every occasion. Therefore emphasis must be placed on the committed use of the diaphragm every time coitus occurs. Even so, the diaphragm does not appear to be a very safe method of contraception, and may be better suited to family spacing rather than as a method when high efficacy is required.

Contraception Behavior

[A comparative evaluation of antibiotic-enzyme therapy and of generally accepted methods for treating gonorrhea patients].

The authors analyze the immunity-correcting effect of antibiotic and enzyme therapy in 32 patients with gonorrheal orchidoepididymitis and 31 with gonorrhea relapses and compare it to the results of routine therapy in 60 patients with chronic and complicated gonorrhea. They come to a conclusion that combined administration of proteolytic enzymes and antibiotics more effectively corrects a number of disordered immunity nonspecific defense parameters (blood serum levels of circulating immune complexes and lysozyme).

Anti-Bacterial Agents

Clinical experience with the progestogen-only pill.

Experience with the progestogen-only pill (POP) in a family planning clinic is presented. From the clinic records, 408 women were identified who had opted to use a POP. Of these, 50 women had used the POP during lactation and these were excluded from the analysis. The remaining 358 women used the POP for up to 150 months, giving a total of 18,125 women-months of use. Three pregnancies occurred, giving a Pearl Index of 0.2 per 100 women-years. Non-menstrual side effects were minor and were reported by 77 women. For the women who discontinued the POP, the main reason was menstrual irregularity (47.5%). However, despite the long-term use by most of the women, almost 40% maintained a mostly regular menstrual pattern. Our findings suggest that the POP provides a very acceptable method of oral contraception for many women and that it should be more actively promoted.

Adult

Interruption of early pregnancy by an anti-progestational compound, RU 486.

RU 38-486 (17 beta-hydroxy-11 beta-(4-dimethylaminophenyl)-17 alpha-(1-propynyl)estra-4,9-dien-3-one), an antiprogestational compound, was given to 33 women seeking termination of pregnancy. The patients were divided into two groups, 24 patients in group I with amenorrhoea up to 7 6/7 wk = 55 days, and 9 patients in group II with 8-10 wk amenorrhoea. The patients received 200 mg orally per day for 4 days. The start, duration and amount of bleeding were determined for 14 days. beta-HCG, plasma progesterone, estradiol and cortisol were determined at day 0 and day 7. All patients started to bleed during treatment. The frequency of complete abortion was 79% (19 out of 24 patients) in group I. In group II 33% (3 out of 9 patients) had a complete abortion. Most of the patients experienced only minor side-effects in terms of mild uterine pain and bleeding as in a spontaneous abortion. However, 2 patients in group II with 8 and 9 2/7 wk amenorrhoea suffered from heavy bleeding, requiring blood transfusion and curettage. In the patients with complete abortion, beta-HCG, estradiol and progesterone decreased significantly within 1 week. Cortisol concentrations remained within the normal range at day 0 and day 7. Treatment with RU 486 provides an acceptable method of early abortion, especially in women who refuse operative treatment and prefer a 'spontaneous abortion'. In 22 women RU 486 was administered from day 24 to day 27 of the menstrual cycle as a late 'morning-after pill' in the same dosage. All women except one started to bleed before day 28 and observed a normal menstrual period. One woman stayed amenorrhoeic for 2 months; she was not pregnant but apparently had an anovulatory cycle with a low progesterone level.

Abortion, Induced

A long-term study of mortality in men who have undergone vasectomy.

BACKGROUND: Vasectomy is a reliable and widely accepted method of contraception, but there is some uncertainty and few data about a possible long-term adverse effect on health. METHODS: We examined the relation between vasectomy and mortality rates from cardiovascular disease, cancer, and all causes in a retrospective cohort of husbands of members of the Nurses' Health Study. In 1989 we obtained data by questionnaire on 14,607 men who had undergone vasectomy as of 1976 and 14,607 men who had not. RESULTS: Among the men who were free of cancer at the start of the study, 1052 died: 446 of cardiovascular disease, 341 of cancer, and 265 of other causes. Vasectomy was associated with reductions in mortality from all causes (age-adjusted relative risk, 0.85; 95 percent confidence interval, 0.76 to 0.96) and mortality from cardiovascular disease (relative risk, 0.76; 95 percent confidence interval, 0.63 to 0.92). Vasectomy was unrelated to mortality from all forms of cancer (relative risk, 1.01; 95 percent confidence interval, 0.82 to 1.25). Among men who had a vasectomy at least 20 years earlier, the procedure had no relation to mortality from all causes (relative risk, 1.11; 95 percent confidence interval, 0.92 to 1.33) or that from cardiovascular disease (relative risk, 0.85; 95 percent confidence interval, 0.63 to 1.16). However, mortality from cancer was increased in men who had a vasectomy at least 20 years earlier (relative risk, 1.44; 95 percent confidence interval, 1.07 to 1.92). The excess risk of cancer in these men was due primarily to lung cancer. None of the observed associations were confounded by smoking habits, body-mass index, alcohol consumption, or educational level. CONCLUSIONS: Vasectomy is not associated with an increase in overall mortality or mortality from cardiovascular disease. Our study also found no increase in overall mortality from cancer after vasectomy, but there was an apparent increase in the risk of cancer 20 or more years after vasectomy that requires further study.

Adult

Control of ticks.

A number of different acaricides provide highly effective control of tick populations on dogs and cats. These acaricides are formulated as sprays, dips, dusts, or shampoos for use on the animal. Further protection of the animal from reinfestation with ticks can be achieved with the use of acaricide-impregnated flea and tick collars. Some of these acaricides are registered with the EPA for indoor and outdoor use as controls for free-living populations of ticks. Caution should be used when applying these materials. The label directions for the application of the acaricide and disposal of the acaricide containers should always be followed. Removal of underbrush and leaf litter, thinning trees, and frequently mowing grasses help reduce the number of free-living ticks. Any reduction in the amount of wildlife food sources and cover areas potentially decreases populations of ticks and thus reduces the potential of these ticks parasitizing a dog or cat. Application of an acaricide for area-wide control of free-living ticks in the spring, summer, and autumn also reduces the number of ticks. New approaches to area-wide control of ticks by use of acaricides that are focused on controlling the ticks attached to small mammal hosts are discussed. Although research has shown that reductions in tick numbers can be achieved using these methods, acceptance of these methods by regulatory agencies and the public requires further research.

Animals