“pop-out” method of levonorgestrel implant removal

The “pop-out” technique is a method of levonorgestrel implant removal that uses digital pressure to direct implants through a small skin incision. This technique was developed, theoretically, to cause less bruising and patient discomfort by avoiding the use of instruments. The pop-out technique is the primary method used for levonorgestrel implant removal in the Magee-Womens Hospital resident clinic. We performed a retrospective analysis of levonorgestrel implant removals performed between July 1, 1995, and December 31, 1998. Of the 168 removals included in this analysis, 38 were performed by one of two attending physicians, and 130 were performed by the residents with attending supervision. The average time for removal was 12 ± 5 min (range 2.25–27 min) when the “pop-out” method could be used to remove all six implants, and 14 ± 7 min (range 2.25–59 min) for all removals. The removal time for residents was inversely proportional to the anticipated level of difficulty of the removal and to the number of previous removals performed. The removal time was significantly faster when residents were supervised by one of the attending physicians as compared with the other attending physician. Only 0.7% (7/1,008) of levonorgestrel implants were fragmented during removal. This review shows that the “pop-out” method is a reasonable alternative to other proposed methods of primary implant removal. The difference in the level of expertise of the attending physician may significantly influence removal time when training clinicians in levonorgestrel implant removal.     

Hormonal consequences of “missing the pill”

The hormonal effects of the deliberate omission of a low-dose combined oral contraceptive pill (150 μg levonorgestrel + 30 μg ethinyl estradiol) were studied in 32 apparently healthy women of the fertile age. Four groups of eight subjects each were requested to omit pill-taking on two consecutive days of the study, namely days 9 and 10 (Group I), 11 and 12 (Group II), 14 and 15 (Group III) and 17 and 18 (Group IV), respectively, and the peripheral plasma levels of progesterone (P), levonorgestrel (NOG) and estradiol (E₂) were measured daily for 29 days.The analysis of NOG levels revealed that one subject did not take any pill during the last cycle preceding the study and did not start pill-taking before day 10 of the study cycle. In this subject, a biphasic P profile with significantly, but insufficiently (up to 8.0 nmol/l), elevated P levels was found.In the remaining 31 subjects, the P levels remained invariably below 1.5 nmol/l; however, the mean P levels of days 1–15 were significantly (P < 0.01) higher than those of days 16–29.The assay of NOG levels indicated measurable values in each of the 31 subjects even six days after the discontinuation of pill-taking. From the peripheral NOG levels, an average removal half-life of 29 hours was calculated.The E₂ levels were uniformly suppressed (below 400 pmol/l) in 26 of the 31 subjects (hereafter: “low” E₂-group), whereas five subjects (“high” Eg-group) exhibited a cyclic E₂ profile, with peak levels between 530 and 1200 pmol/l. A linear increase with time in E₂ levels (P < 0.001) was found during the pill-free week in both groups of subjects.     

Norplant® implants in the UK: First year continuation and removals

Norplant^® implants are a long-term, reversible hormonal method of contraception consisting of six flexible capsules placed subdermally in the inner aspect of the nondominant arm. Norplant implants were introduced into the UK in October 1993 although they had been used previously in some countries for up to ten years. The insertion and removal techniques require skills training and therefore it is important to assess early experience with the method.

This survey looks at the first year continuation rate of Norplant implants in the UK from a total of 2,129 insertions. From these insertions, 133 removals were documented and described, using a checklist of features. The continuation rate for Norplant implants use was 96.5% at six months and 85.2% at one year. None of the reasons for discontinuation were of a serious nature. The most common reason given was menstrual change (50.4% of all removals, 3% of all women included in the survey), which is in line with other reported studies.

Of the removals, 71.5% were reported as straightforward (of these 65.6% were completed within 20 minutes). In the first year of use, Norplant implants were associated with high continuation rates and the removal procedure was, in the majority of cases, completely straight-forward.     

A multicenter comparative study on the efficacy, safety, and acceptability of the contraceptive subdermal implants Norplant and Norplant-II

In order to assess efficacy, safety, and acceptability of the contraceptive subdermal implants Norplant^® and Norplant^®-II in Mexican women, a comparative phase III clinical trial was undertaken in eight clinics across the country. The study involved 1052 women who were followed-up trimonthly for three years. Cumulative pregnancy rates were 0.29% and 0.34% for Norplant and Norplant-II implants, respectively. Similar overall cumulative discontinuation rates were observed at three years: 50.38% for Norplant capsules, and 50.44% for Norplant-II rods. The main method-related reason for termination was endometrial bleeding irregularity which led to discontinuation rates of 11.94% and 11.62% for Norplant and Norplant-II contraceptive systems, respectively. In 15,279 woman-months of experience accumulated with Norplant implants and 14,092 with Norplant-II implants, there were few adverse events reported. No difference was found between the two groups in either difficulty for implants placement and removal or women's discomfort, even though the time required for insertion and removal of Norplant capsules was longer than for Norplant-II rods. It is concluded that during the first three years of use, both implants systems are equally effective, safe, and acceptable.     

Acceptability of levonorgestrel subdermal implants versus tubal ligation for long-term contraception in a rural population of Zimbabwe

This prospective cohort study of 257 rural Zimbabwean women was designed to compare patient satisfaction with levonorgestrel subdermal implants (Norplant and reg;) versus tubal ligation (TL) as a method of long-term contraception. Women were equally satisfied with both methods. At 1 year, 96% of Norplant users and 97% of the TL group reported being “satisfied” or “very satisfied,” and 98% of Norplant users, and 99% of the TL cohort would recommend their chosen method to a friend or relative. Rating scores at both 6 months and 1 year were high and equal, with women in each cohort rating their method, on average, as 9 out of 10. Norplant users were significantly more likely to rate birth spacing as a reason for satisfaction with their method, whereas women in the TL cohort were more likely to select multiparity. The 1-year continuation rate with Norplant was 90%, with 4% discontinuing in order to have more children. Selecting the most appropriate method depends primarily on the potential desire of the woman to have more children.     

Norplant contraceptive implants: rods versus capsules

Norplant contraceptive implants are silastic implants containing levonorgestrel. When placed subcutaneously in the medial aspect of the upper arm, they release low levels of levonorgestrel in a constant manner over an extended period of time. Comparative studies of two silastic rods versus six capsules containing levonorgestrel were studied in 250 subjects for 4,464 months of use. Only one pregnancy occurred during the study. Side effect patterns were similar in both groups; the major side effect being irregular uterine bleeding. The bleeding, however, was well tolerated by subjects in both groups and discontinuation rate was very low. The two-rod system offers the advantages of easier insertion technique and shorter insertion time as well as ease of removal as compared to the six-capsule system. Norplant contraceptive implants offer a highly effective means of contraception which is particularly suited for women who are concerned about failure and compliance with oral contraceptives. This type of contraception should become well accepted, not only in underdeveloped countries, but in developed countries as well.     

Synthesis and antimicrobial properties of new cepham and penam derivatives with the carboxylic group in the “wrong” β-configuration

The cepham (9) and the penam (10) derivatives, with their carboxylic group in the “wrong” β-configuration, which is opposite to that exhibited by the common penicillins, were synthesized and assayed in vitro for antimicrobial properties. Compounds 9 and 10, tested on Gram-positive and Gram-negative bacteria, both sensitive and resistant to β-lactamase inactivation, exhibited a very poor activity, directed only against non-β-lactamase-producing Gram-positive bacteria. One of the possible explanations for these results may be found in unfavourable steric and electronic effects deriving from the α-oriented methoxy group which is adjacent to the pharmacophoric carboxylic function.     

Impacts of sensory attributes and emotional responses on the hedonic ratings of odors in dairy products

Consumers often decide to purchase certain items as a result of prompt emotional responses evoked by the products; therefore, it is important to investigate the emotional responses stimulated by food samples, as well as the sensory attributes of the products. The aim of this study was to examine influences of sensory attribute and emotional response on olfactory hedonic ratings of dairy products. Additionally, we compared this effect between women and men subjects. Sensory attributes of six natural odors produced by commercial dairy products were evaluated by 9 trained panelists. In addition, 100 untrained panelists (50 women and 50 men) rated the emotional response stimulated by the 6 odors using 25 paired semantic differential scales and the hedonicity using a 9 cm line scale, respectively. Untrained panelists more liked “sweet aromatics,” “sour aromatics,” “fermented aromatics,” and “rich aromatics” over the other sensory attributes of dairy products. The olfactory hedonic ratings were increased when the odor was more characterized as “fragrant,” “attractive,” “comfortable,” “familiar,” “faint,” “natural,” or “modern.” Specific sensory attributes were found to be related to specific adjective pairs representing the emotional response. Moreover, the ratings of adjective pairs representing emotional response of odors and their influences on hedonic ratings differed significantly between sexes. In conclusion, our findings suggest that the emotional responses as well as the sensory attributes affect the hedonic ratings of odors in dairy products.     

Positive- and negative peer modelling effects on young children's consumption of novel blue foods

Objective: The effects of positive- and negative peer modelling on children's consumption of a novel blue food, presented in each of four snack meals during an “activity” day, were evaluated. It was predicted that: (i) novel food consumption would increase after positive modelling, but decrease after negative modelling; (ii) modelling effects would generalise to a second novel blue food when participants were alone when they ate their snack; (iii) that positive modelling would reverse the effects of negative modelling. Design: A mixed design was employed with random assignment to either Groups A, B, or C (equal numbers of males and females per group). Within groups, each participant received the novel food on four snack occasions. Group A received positive modelling of blue food consumption on the first and third occasions, but were alone when they received the foods on the second and fourth occasions; Group B had negative modelling on the first occasion, positive modelling on the third, and ate alone on the second and fourth; Group C ate alone on all four occasions. To measure generalisation, an additional blue food was presented in all second and fourth “alone” occasions. Participants: Thirty-five 5–7-year olds took part in Study 1, and 44 3–4-year olds in Study 2. Results: All main predictions were confirmed except that positive peer modelling did not reverse the effects of negative modelling in the 3–4-year olds. Conclusion: Negative peer modelling inhibits novel food consumption, and its effects are particularly difficult to reverse in younger children.     

‘U’ technique and standard technique of Norplant removal

Objectives To compare the side effects and time required for Norplant removal between the U technique (using the no-scalpel vas deferens holding forceps) and the standard technique.Materials and methods A randomized controlled clinical trial was carried out of acceptors in family planning clinics in Dr Kariadi Hospital, Semarang, who wanted to have Norplant removal. The Norplant was removed by experienced doctors who had been trained for both the U technique and the standard technique. Removal time, capsule condition and complications were examined.Results From 41 clients in the U technique group and 41 clients in the standard technique group, the removal times were 2.75±1.28 and 6.57±2.93 minutes, respectively (p<0.01). One week after Norplant removal, complications were found in 5 clients, 1 from the U technique group (2.44%) and 4 from the standard technique group (9.76%). Two weeks after Norplant removal no complications were found.Conclusion The U technique was quicker and less complicated compared with the standard technique.

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ResumenObjectivos Comparar los efectos secundarios y el tiempo requerido para el retiro de Norplant con la técnica U y la técnica estándar.Materiales y métodos Un ensayo clínico controlado aleatorizado de aceptadoras en la clínica de planificación familiar Dr. Kariadi Hospital Semarang que deseaban que se retirase el Norplant. El Norplant fue retirado por médicos experimentados que habían sido adiestrados tanto en la técnica U como en la estándar. Se examinaron el tiempo de retiro, el estado de las cápsulas y las complicaciones.Resultados En 41 clientas en la técnica U y 41 clientas en la técnica estándar, el tiempo de retiro fue 2,75±1,28 y 6,57±2,93 minutos (p<0,01) respectivamente. Se detectaron complicationes después de una semana del retiro de Norplant en 5 clientas, 1 caso (2,44%) en la técnica U y 4 (9,76%) en la técnica estándar. Dos semanas después no se detectaron complicaciones.Conclusión La técnica U fue más rápida y señaló menos complicaciones que la técnica estándar.

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ResumèObjectifs Comparer les effets secondaires et le temps nécessaire pour le retrait du Norplant, entre la technique en U et la technique standard.Matériels et méthodes Un essai clinique randomisé a été effectué sous contrôle à la clinique de planning familial de l'hôpital Dr. Kariadi de Semarang sur des patientes sollicitant le retrait du Norplant. Celui-ci a été retiré par des médecins expérimentés qui avaient, été formés à la technique de retrait dite en U et à la technique standard. On a relevé les temps de retrait, l'état des implants et les complications survenues.Résultats Pour 41 patientes soumises à la technique en U et 41 patientes à la technique standard, les temps de retrait ont été respectivement de 2,75±1,28 et 6,57±2,93 minutes (p<0,01). Des complications ont été observées une semaine après le retrait de Norplant chez 5 femmes, soit 1 cas (2,44%) pour la technique en U et 4(9,76%) pour la technique standard. Deux semaines plus tard, aucune complication n'a été constatée.Conclusion La technique en U est plus rapide et entraîne moins de complications que la technique standard.

     

A randomized multicenter study comparing the efficacy and bleeding pattern of a single-rod (Implanon) and a six-capsule (Norplant) hormonal contraceptive implant.

To compare the contraceptive efficacy, tolerability, and bleeding patterns, 200 healthy female volunteers received, in an open, comparative, randomized, multicenter study in China, either a single-rod (Implanon) or a six-capsule (Norplant) contraceptive implant for 2 years with an optional extension of up to 4 years. Women were exposed to Implanon for 341.6 woman-years and Norplant for 329.1 woman-years. There were no pregnancies during the study. Per 90-day reference period, the median number of bleeding/spotting days with Implanon decreased from 33.5 in the first period to 19.0-21.5 days in the last year. Similarly, with Norplant, the median number of bleeding/spotting days decreased from 34.5 to 18.0-23.0 days, respectively. The number of bleeding/spotting episodes during year 1 was 2.0 per 90-day reference period with Implanon and 3.0 per period with Norplant (p < 0.05 for periods 1-4). For the remaining 90-day periods, there was no statistical difference between the two groups. In general, there was less frequent bleeding with Implanon compared with Norplant, whereas the incidences of amenorrhea and infrequent bleeding were higher with Implanon than with Norplant. The mean overall incidence of prolonged bleeding fell markedly during the study, from 66.0% in reference period 1 to 27.3% in period 16 with Implanon and from 69.0% to 21.7% with Norplant, respectively. The most common adverse events were related to disturbed bleeding patterns, which were also the major reasons for discontinuation (Implanon n = 8; Norplant n = 14). Normal menses returned in almost all subjects within 3 months after removal of the implants. Implanon was inserted in a mean time of 0.61 min and Norplant in 3.90 min (p < 0.001). Similarly, the mean time required to remove the implant was significantly shorter for Implanon than for Norplant (2.18 min vs 11.25 min, p < 0.001). The maximum time required for removal of the implant was 10 min for the Implanon group and 60 min for the Norplant group. In both groups, blood pressure and hemoglobin were not affected, whereas body weight tended to increase. It can be concluded that both contraceptive systems demonstrated excellent contraceptive efficacy and were well tolerated. Compared with Norplant, there was less frequent bleeding with Implanon, whereas the incidence of infrequent bleeding and amenorrhea was higher. Implanon was significantly quicker to insert and to remove than was the multiple capsule system.     

“Live, Learn and Play”: Building strategic alliances between professional sports and public health

Public–private partnerships allow communities and corporate entities to pool resources to address a mission of relevance to their common constituency or consumer base. Collaborations between public health and professional sports may present unique opportunities to improve health outcomes related to physical activity since athletes are fitness icons, both for adults and children. There are many “win–win” opportunities, as sports venues regularly host huge numbers of spectators, offering food and entertainment, providing hours of exposure, and introducing new ideas for engaging fans in order to remain a competitive draw. In 2008, the San Diego Padres embarked on a communitywide fitness initiative, FriarFit, including incorporating 10-minute Instant Recess™ breaks during their Sunday homestand pre-game shows. Many lessons have been learned that may be useful to others mounting such initiatives, such as: there is more at stake in cost-benefit and risk-benefit assessment for sports executives, requiring greater caution and circumspection than is typical for public health projects; the core business of the corporate entity must be accommodated without undermining the health objectives; and health aims must be addressed in a way that is financially viable and delivers tangible value for profit-making concerns, in terms of marketing, revenues or brand enhancement.     

Regional risk factors for health inequalities in Scotland and England and the “Scottish effect”

This paper uses data from the Scottish Health Survey 2003 and the comparable Health Survey for England 2003 to look at whether Scotland's poor health image and mortality profile is reflected in regional inequalities in prevalence of four risk factors for cardiovascular disease: fruit and vegetable consumption, smoking, obesity and diabetes. It also looks at the “Scottish effect” – how much of any difference between and within Scotland and England remains once socio-demographic factors have been taken in to account. The paper then uses regional analyses to determine the extent to which areas within England and Scotland contribute to their national health advantage and disadvantage. All 2003 strategic health authorities in England and Scottish health boards were compared with Greater Glasgow health board as the reference category.The results showed that significant geographic variation in the risk factors remained once individual economic status was taken into account, but the relationship was complex and varied in strength and direction depending upon risk factor involved and gender of respondent. A small number of areas had significantly lower odds of fruit and vegetable consumption of five portions or more a day in men, compared with Greater Glasgow. In contrast some areas had significantly higher odds of fruit and vegetable consumption for women compared with Greater Glasgow.There was greater geographic variation in the odds of smoking in women than in men. Respondents in the south west and southeast of England (areas which usually show health advantage) did not show significantly lower odds of smoking compared with Greater Glasgow once socio-economic variation, age and urban residence was taken into account. It was respondents from central England that had lower odds of smoking than might be expected. Obesity stood out as the single risk factor that had demonstrated a “Scottish effect” in women only.     

Indexes and boundaries for “quantitative significance” in statistical decisions

Boundaries for S, representing a “quantitatively significant” or “substantively impressive” distinction, have not been established, analogous to the boundary of , usually set at 0.05, for the stochastic or probabilistic component of “statistical significance”. To determine what boundaries are being used for the “quantitative” decisions, we reviewed pertinent articles in three general medical journals. For each contrast of two means, contrast of two rates, or correlation coefficient, we noted the investigators' decisions about stochastic significance, stated in P values or confidence intervals, and about quantitative significance, indicated by interpretive comments.

The boundaries between impressive and unimpressive distinctions were best formed by a ratio of 1.2 for the smaller to the larger mean in 546 comparisons, by a standardized increment of 0.28 and odds ratio of 2.2 in 392 comparisons of two rates; and by an r value of 0.32 in 154 correlation coefficients. Additional boundaries were also identified for “substantially” and “highly” significant quantitative distinctions.

Although the proposed boundaries should be kept flexible, indexes and boundaries for decisions about “quantitative significance” are particularly useful when a value of δ must be chosen for calculating sample size before the research is done, and when the “statistical significance” of completed research is appraised for its quantitative as well as stochastic components.     

Rethinking “Harmonious Parenting” Using a Three-factor Discipline Model

Diana Baumrind's typology of parenting is based on a two-factor model of “control” and “warmth”. Her recommended discipline style, labeled “authoritative parenting”, was constructed by taking high scores on these two factors. A problem with authoritative parenting is that it does not allow for flexible and differentiated responses to discipline situations. It is argued that a simpler, and more adequate, approach would be to switch to a model of discipline with a third factor, labeled “tolerance”. Parents of the most socially competent children are adept at knowing when they have a problem and when they do not. An example of the latter would be when a child expresses negative affect while complying fully with a request. Baumrind's notion of authoritative parenting was a useful “dialectic”, demonstrating that control and warmth are independent and equally necessary behaviors, but it did not go far enough. Baumrind's category of harmonious parenting (high warmth, moderate control, high tolerance), which she sees as an anomaly, should be substituted for authoritative parenting as the preferred discipline pattern.     

Evaluation of liver function and lipid metabolism following Norplant implant removal

A final evaluation of this longitudinal study involving 100 Singaporean women shows that, besides a significantly elevated bilirubin level, there is no other evidence of hepatocellular dysfunction with the use of Norplant implants. The elevated bilirubin levels remained significantly elevated six months after removal of the implant. Despite this, all values of bilirubin remained within the clinical range for the population studies.As regards lipid metabolism, total cholesterol, LDL-cholesterol and total triglycerides continued to remain below the pre-insertion mean at six months post-removal. The HDL-cholesterol showed a significant increase following removal of the implants. As a result, the HDL-cholesterol/(total cholesterol-HDL-cholesterol) ratio continued to remain above 0.200. This indicates that Norplant implants are not directly contributory to cardiovascular risk.

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Resumen Una evaluación final del estudio longitudinal efectuado en 100 mujeres de Singapur mostró que, aparte de niveles significativamente elevados de bilirrubina, nada indicaba que la función hepatocelular estuviera afectada por la utilización de implantes Norplant. Los altos niveles de bilirrubina continuaban siendo significativamente elevados a los seis meses del retiro de los implantes. A pesar de ello, los valores de bilirrubina no excedieron nunca de los límites de la gama clínica de los estudios de cohortes.En cuanto al metabolismo de los lípidos, el colesterol total, el colesterol LDL y los triglicéridos totales continuaban siendo, a los seis meses del retiro, inferiores al promedio antes de la inserción. Se observó un aumento significativo del colesterol HDL después del retiro de los implantes. Por consiguiente, la relación colesterol HDL/colesterol total se mantuvo por debajo de 0.200, lo cual indica que los implantes Norplant no contribuyen directamente, al riesgo cardiovascular.

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Resumé Une évaluation finale de létude longitudinale effectuée sur 100 femmes à Singapour a montré qu'en dehors des niveaux significativement élevés de bilirubine, rien n'indiquait que la fonction hépatocellulaire avait été perturbée par l'utilisation des implants Norplant. Les hauts niveaux de bilirubine étaient encore significativement élevés six mois après le retrait des implants. Malgré cela, les valeurs de bilirubine n'ont jamais dépassé les limites de la gamme clinique constatées lors des études cohortes. En ce qui concerne le métabolisme des lipides, le cholestérol total, le cholestérol LDL et les triglycérides totaux, ils étaient encore, six mois après le retrait, inférieurs à la moyenne avant l'insertion. On a observé une élévation significative du cholestérol HDL après le retrait des implants. En conséquence, le rapport cholestérol HDL/cholestérol total s'est maintenu audessus de 0.200, ce qui laisse penser que les implants Norplant ne contribuent pas directement au risque cardiovasculaire.

     

« Sécurité alimentaire » en milieu hospitalier : de la logique de crise à la logique de progrèsFood safety in hospital: of the logic of crisis to the logic of progress

Food safety in hospital is an essential preoccupation of hospital administrator. Rules have strongly changed since 1993 with publication of the directive “hygiene” 93/43/CEE. Registration in French Law have gained the “new approach” in food safety by setting objectives and laying down HACCP method. Under the aegis of CLANs, new objectives in food hygiene are centred around labelling and putting place of HACCP method right into care units.