Five years' experience with levonorgestrel-releasing IUDs

Two levonorgestrel-releasing IUDs and a copper-releasing IUD of the same shape were studied in a randomized comparative study over five years. The levonorgestrel-releasing IUDs released 20 micrograms or 30 micrograms per day. The Pearl index during the 10,600 woman-months of LNG-IUD use was 0.11. The control device releasing copper had a Pearl index of 1.6. The amount and duration of menstrual bleeding was greatly reduced, leading to a high incidence of oligo- or amenorrhea. The continuation rate in this pioneer trial was 53 per 100 users for the levonorgestrel-releasing IUD (LNG-IUDs) and 50 per 100 users for the copper-releasing IUD (Nova T). The removal rates for reasons other than amenorrhea were not significantly different. Discontinuation because of amenorrhea occurred during the first two years, the cumulative termination rate for this reason was 11.6 per 100 users at five years. The LNG-IUDs removed for investigation after five years of use revealed that the devices contained about 40 percent of the original load. The effective lifespan of the device has been demonstrated by this study to be five years; the residual steroid gives an additional safety period of two more years. The LNG-IUD is a highly effective reversible contraceptive method, which strongly reduced the amount and duration of bleeding. During the first two months there is scanty but frequent spotting which, like the high incidence of oligo- and/or amenorrhea, requires counselling of health personnel and women using LNG-IUDs.     

Fifteen years' experience with the Multiload IUD

The Multiload IUD with an exposed copper surface area of 250 mm² (MLCu250) was developed in 1972 and has become one of the most widely used IUDs. Modifications to the MLCu250 include an increase in the area of exposed copper wire to 375 mm² (the MLCu375) and an increase in the diameter of copper wire from 0.3 to 0.4 mm. The Multiload has been evaluated extensively in noncomparative and comparative clinical trials. In these latter studies the MLCu250 performed better than the Cu-7 and TCu-200, and the MLCu375 performed better than the Fincoid or Nova T and about equally as well as the TCu380. Pooled data from over 26,000 insertions of the MLCu250 gave the following 3-year cumulative event rates (per 100 women): pregnancy, 2.0; expulsion, 3.1; removal for pain/bleeding, 7.1. Comparative studies of the Multiload and other IUDs have shown all IUDs in current use are associated with similar rates of pelvic inflammatory disease. IUDs such as the MLCu375 that have larger copper surface areas appear to be associated with lower ectopic pregnancy rates. Follow-up studies of women who have had their Multiloads removed indicate that use of the device does not impair future fertility or affect pregnancy outcome. All IUD users, regardless of the type of IUD used, are at risk of complications. On balance, the benefits of IUD usage far exceed the associated risks.

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Resumen EI DIU Multiload con una expuesta área de cobre de 250 mm² (MLCu250) fue puesto en práctica en 1972 y es uno de los DIU más usados. Las modificaciones del MLCu250 incluyen un aumento a 375 mm² (el MLCu375) en el área expuesta de cobre, y un aumento do 0,3 a 0,4 mm en el diámetro del alambre de cobre. El Multiload ha sido extensamente evaluado en pruebas clínicas no comparadas y comparadas. En estos estudios más recientes, el MLCu250 actuó mejor que el Cu7 y que el TCu200 y el MLCu375 mejor que el Fincoid o el Nova T, y aproximadamente igual que el TCu380. Los datos combinados de más de 26 000 inserciones del MLCu250 han proporcionado las siguientes tasas acumulativas de eventos en tres años (por 100 mujeres); embarazo 2,0; expulsión 3,1; remoción por dolor/sangrado 7,1. Estudios comparativos del Multiload y otros DIU de uso corriente, están asociados a tasas similares de enfermedad inflamatoria pelviana. DIU tales como el MLCu375, que poseen una mayor superficie de cobre, parecen estar asociados con tasas menores de embarazos ectópicos. Estudios de seguimiento en mujeres cuyos Multiload fueron quitados, indican que el uso del dispositivo no perjudica la futura fertilidad ni afecta el resultado del embarazo. Todos las usuarias de DIU, no importa que tipo, corren riesgo de complicaciones. Haciendo un balance, los beneficios del uso de un DIU por lejos exceden los riesgos asociados.

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Resumé Le dispositif intra-utérin Multiload mis au point en 1972, dont la superficle d'exposition de cuivre est de 250 mm² (MLCu250), est devenu le stérilet le plus largement utilisé. Ce MLCu250 a été modifié d'une part en augmentant la superficie du fil de cuivre exposé à 375 mm² (le MLCu375) et d'autre part en portant le diamètre de ce fil de 0,3 à 0,4 mm. Le dispositif Multiload a fait l'objet de nombreuses évaluations par des essais cliniques non comparatifs et comparatifs. Dans ces derniers, le MLCu250 s'est révélé plus efficace que le Cu-7 et le TCu-200, et le MLCu375 plus efficace que le Fincoid ou le Nova T et à peu près aussi valable que le TCu380. La mise en commun des données relatives à 26,000 insertions du MLCu250 a fait ressortir les taux d'événements suivants cumulés sur trois ans (pour 100 femmes): grossesses, 2,0; expulsions, 3,1; retraits pour cause de douleurs ou de pertes sanguines, 7,1. Les études comparatives portant sur le Multiload et les autres DIU ont montré que tous les dispositifs utilisés couramment sont associés à des taux similaires d'affections pelviennes inflammatoires. Les dispositifs tels que le MLCu375 qui présentent une aire de cuivre plus importante semblent associés à des taux moins élevés de grossesses ectopiques. Des études de sulvi chez les femmes qui s'étaient fait enlever le dispositif Multiload qu'elles portaient ont indiqué que son utilisation ne compromet pas la fécondité ultérieure et n'a pas d'incidence sur l'aboutissement de la grossesse. Toutes les utilisatrices de DIU, sans distinction du type de stérilet employé, sont exposées à des risques. Mais, tous comptes faits, les avantages qu'apporte l'usage de ces dispositifs excèdent de beaucoup les risques qui lui sont associés.

     

Four years' experience with antepartum cardiotocography using telemedicine

We reviewed the first four years of experience with telemonitoring of patients with high-risk pregnancies. Nine peripheral units (eight in Campania, a region of south Italy, and one in Hungary) recorded cardiotocographic traces and transmitted them via modem to an operations centre at the University 'Federico II' in Naples, where the computerized analysis was performed. The medical report was returned to the peripheral unit via fax or email. Four thousand and twenty one traces were recorded: 2674 (67%) from 764 high-risk patients and 1347 (34%) from 499 patients at apparent low risk. The neonatal outcome was good overall. Questionnaires were sent to the operators working at the peripheral units to evaluate the acquisition of specific skills and their level of satisfaction. Sixty-six questionnaires about cardiotocographic trace interpretation were collected. The number of correct answers increased during the study. A total of 33 questionnaires about job satisfaction were collected. The answers showed that the operators gradually overcame their scepticism during the study. A total of 1098 questionnaires were answered by the patients. Their answers showed a moderate level of satisfaction. Telecardiotocography allowed the decentralization of prenatal surveillance.     

Five years' experience with the Telemedicine Information Exchange

The Telemedicine Information Exchange (TIE) has provided comprehensive telemedicine information on the World Wide Web (Web) since early 1995. It received major funding from the National Library of Medicine in 1997. Among other things, the TIE contains six major databases: literature citations; active telemedicine programmes; a 'what's new in telemedicine' column; funding opportunities; forthcoming conferences; and a list of vendors of telemedicine equipment and services. Recent additions include a document delivery service, inaugurated in early 1999. More than 1000 other Web sites link to the TIE, and we have 5000 visitors per month from several countries. Given its relative longevity on the Web, TIE researchers have been in a unique position to observe trends in telemedicine.     

Nine years' experience of telecardiology in primary care

The ITMS telecardiology network started in April 1995. Over nine years, about 7000 peripheral medical users (mainly general practitioners), who were experienced in using transtelephonic electrocardiography and who were spread throughout Italy, conducted teleconsultations with the Telecardiology Centre. A total of 106,942 patients were evaluated. Teleconsultation was carried out for non-cardiac symptoms or routine control for 30,444 patients (28%) and for symptoms suggestive of heart disease for 76,498 (72%). After teleconsultation, 61,908 patients (58%) were reported to have no heart disease, 27,947 patients (26%) had their drug dose adjusted and remained at home, 11,503 patients (11%) were sent to their cardiologist for further investigations and 5584 patients (5%) were urgently hospitalized. Among the hospitalized patients, the echocardiogram demonstrated an ST-elevation coronary syndrome in 1785 patients (32%), a non-ST-elevation coronary syndrome in 2236 (40%) and a life-threatening arrhythmia in 1354 (24%). Telecardiology improves the decision making of general practitioners, avoids unnecessary hospitalizations, reduces the time before treatment in cardiac emergencies, rationalizes health-care costs and promotes home care.     

Four years' experience with home birth by licensed midwives in Arizona.

In 1978, Arizona began licensing lay midwives under regulations designed to maintain adequate standards of care for women desiring a home birth. During four years of this program, 3 per cent of home birth clients were hospitalized for complications and another 15 per cent received postnatal outpatient care, primarily for second degree lacerations. Five per cent of the newborns required medical care after delivery; half of these were hospitalized. Complications declined over the period due to increased experience, close supervision, and continuing education.     

Six years' experience with interdisciplinary review teams in health technology assessment in Norway

OBJECTIVES: The aim of this study was to evaluate the use of interdisciplinary review teams that have been the main and central work form in making health technology assessments at the Norwegian Centre for Health Technology Assessment. METHODS: Evaluation questionnaires were sent to all 112 participants in the 17 review teams for the period of January 1998 to June 2003 after completion of the literature assessment. Questions were on the theme/mandate of the assessments, composition of the review team, organization of the work, the working method, and update of the report. RESULTS: The teams ranged from 4 to 14 persons regarded as opinion leaders in their field. The project periods lasted from 4 to 33 months. In all, fifty-five participants gave fifty-eight responses (51.8 percent) to the questionnaires. A total of 83 percent thought the theme was well argued, and 62 percent thought the mandate for the assessments was sufficiently clear. Approximately 80 percent were positive to the composition of the review team. In all, 22 percent expressed that the work method was too extensive and 43 percent wanted more tuition. General comments were that the working method gave competence in assessing medical literature, relevant professional training, and tuition in a working method that ensured the legitimacy of their work. CONCLUSIONS: The review team participants were satisfied with most aspects of the work. The Norwegian Centre for Health Technology Assessment will continue using interdisciplinary review teams in making health technology assessments.     

Five years' experience with long saphenous catheterisation for chronic venous access

The five-year experience by one surgical team of the implantation of 419 chronic venous access catheters in 368 adults and children is reported. The majority of the catheters were required for the management of malignant disease but some were used for long-term home parenteral nutrition. The inferior vena cava was cannulated through the long saphenous vein in 181 cases and the superior vena cava by the jugular or cephalic veins in 238. Mean catheter lives of over one year, with individual lives of more than three years were achieved by both routes. The overall infection rate was 18%. No excess of thrombotic or infective complications was observed in patients with long saphenous vein catheters. It is suggested that the long saphenous vein is an appropriate route for chronic venous access for chemotherapy in most patients.     

Five years' experience with a small intracervical/intrauterine levonorgestrel-releasing device

OBJECTIVE: A randomized study was performed to compare the efficacy, safety and acceptability of a new model of an intracervical/intrauterine contraceptive device (ICD) releasing 20 microg of levonorgestrel (LNG) per day. METHODS: The LNG-ICD was inserted in Group I into the cervical canal and in Group II into the uterine cavity. Group I included 151 women (age, 18-43 years) whereas Group II included 147 (age, 19-43 years). The number of nulliparous women was 145. RESULTS: The 5-year results are presented here. The results showed a total continuation rate of 50%; the continuation rate in the cervical group and that in the uterine group were 53.6% and 46.3%, respectively--the difference being statistically insignificant (p=.3593). The main reason for termination was a wish for pregnancy, which is explained by the relatively young age and degree of nulliparity of the study population. During the first year, two pregnancies occurred in both groups. Two of these were ectopic, one in each group. The other two occurred after unnoticed expulsions. Thereafter, no pregnancies occurred. The cumulative gross rate for pregnancy was 1.3 and the Pearl index at 5 years was 0.425. The total expulsion rate was relatively high (11.1%). Expulsions occurring during the first few months of the first year were related to insertion. Removals because of bleeding and because of amenorrhea were low, the combined gross rate being 5.7 and the Pearl rate 1.8 at 5 years. Also, the gross rate of infection was low (0.7). The continuation was high in spite of a high rate of removals for planning pregnancy (15.4). CONCLUSIONS: The method is safe and effective. There were only minor differences between the groups. There were no perforations and the incidence of infection was low. The device can also be used by young nulliparous women.     

Four years' experience of teleconsultations in daily clinical practice

In the four-year period from 2000, the Department of Informatics and Telemedicine of the Donetsk R&D Institute of Traumatology and Orthopaedics organized 210 teleconsultations. In 91 cases the Institute was the enquiring party and in 119 the consulting one. Teleconsultations were carried out for 137 male and 73 female patients aged between one month and 85 years. A review of the results showed that the reliability of diagnosis of different traumas and diseases made using digital images was 88%. The efficiency of implementing the recommendations provided by remote consultants was 88%. We developed an algorithm to select the most suitable telemedical technique for a clinical situation. We also developed a list of indications for clinical teleconsultation. The optimum equipment for clinical teleconsultations consists of a PC, digital camera, dial-up Internet line and printer. Asynchronous formal and informal Internet-based teleconsultations are most expedient for routine clinical practice, supplemented by realtime teleconsultations where necessary.