Is it acceptable to video-record palliative care consultations for research and training purposes? A qualitative interview study exploring the views of hospice patients, carers and clinical staff.

BACKGROUND: Research using video recordings can advance understanding of healthcare communication and improve care, but making and using video recordings carries risks. AIM: To explore views of hospice patients, carers and clinical staff about whether videoing patient-doctor consultations is acceptable for research and training purposes. DESIGN: We used semi-structured group and individual interviews to gather hospice patients, carers and clinical staff views. We used Braun and Clark's thematic analysis. SETTING/PARTICIPANTS: Interviews were conducted at one English hospice to inform the development of a larger video-based study. We invited patients with capacity to consent and whom the care team judged were neither acutely unwell nor severely distressed (11), carers of current or past patients (5), palliative medicine doctors (7), senior nurses (4) and communication skills educators (5). RESULTS: Participants viewed video-based research on communication as valuable because of its potential to improve communication, care and staff training. Video-based research raised concerns including its potential to affect the nature and content of the consultation and threats to confidentiality; however, these were not seen as sufficient grounds for rejecting video-based research. Video-based research was seen as acceptable and useful providing that measures are taken to reduce possible risks across the recruitment, recording and dissemination phases of the research process. CONCLUSION: Video-based research is an acceptable and worthwhile way of investigating communication in palliative medicine. Situated judgements should be made about when it is appropriate to involve individual patients and carers in video-based research on the basis of their level of vulnerability and ability to freely consent.

The Development, Validation, and User Evaluation of Foodbook24: A Web-Based Dietary Assessment Tool Developed for the Irish Adult Population.

BACKGROUND: The application of technology in the area of dietary assessment has resulted in the development of an array of tools, which are often specifically designed for a particular country or region. OBJECTIVE: The aim of this study was to describe the development, validation, and user evaluation of a Web-based dietary assessment tool "Foodbook24." METHODS: Foodbook24 is a Web-based, dietary assessment tool consisting of a 24-hour dietary recall (24HDR) and food frequency questionnaire (FFQ) alongside supplementary questionnaires. Validity of the 24HDR component was assessed by 40 participants, who completed 3 nonconsecutive, self-administered 24HDR using Foodbook24 and a 4-day semi-weighed food diary at separate time points. Participants also provided fasted blood samples and 24-hour urine collections for the identification of biomarkers of nutrient and food group intake during each recording period. Statistical analyses on the nutrient and food group intake data derived from each method were performed in SPSS version 20.0 (SPSS Inc). Mean nutrient intakes (and standard deviations) recorded using each method of dietary assessment were calculated. Spearman and Pearson correlations, Wilcoxon Signed Rank and Paired t test were used to investigate the agreement and differences between the nutritional output from Foodbook24 (test method) and the 4-day semi-weighed food diary (reference method). Urinary and plasma biomarkers of nutrient intake were used as an objective validation of Foodbook24. To investigate the user acceptability of Foodbook24, participants from different studies involved with Foodbook24 were asked to complete an evaluation questionnaire. RESULTS: For nutrient intake, correlations between the dietary assessment methods were acceptable to very good in strength and statistically significant (range r=.32 to .75). There were some significant differences between reported mean intakes of micronutrients recorded by both methods; however, with the exception of protein (P=.03), there were no significant differences in the reporting of energy or macronutrient intake. Of the 19 food groups investigated in this analysis, there were significant differences between 6 food groups reported by both methods. Spearman correlations for biomarkers of nutrient and food group intake and reported intake were similar for both methods. A total of 118 participants evaluated the acceptability of Foodbook24. The tool was well-received and the majority, 67.8% (80/118), opted for Foodbook24 as the preferred method for future dietary intake assessment when compared against a traditional interviewer led recall and semi-weighed food diary. CONCLUSIONS: The results of this study demonstrate the validity and user acceptability of Foodbook24. The results also highlight the potential of Foodbook24, a Web-based dietary assessment method, and present a viable alternative to nutritional surveillance in Ireland.

Acceptability of online self-help to people with depression: users' views of MoodGYM versus informational websites.

BACKGROUND: Little is known about the factors that influence acceptability of and adherence to online psychological interventions. Evidence is needed to guide further development of promising programs. OBJECTIVE: Our goal was to investigate users' views of two online approaches to self-help for depression: computerized cognitive behavior therapy (cCBT) and informational websites, in a workplace context. Computerized CBT offers an inexpensive and accessible alternative to face-to-face therapy, and employers have an interest in reducing the working time lost to depression or stress. Yet little is known about how employees, who have actual experience of using online approaches, judge the intervention as a process. METHODS: The qualitative data reported here were collected within an online randomized controlled trial whose participants had diagnosable depression. The experimental intervention was a 5-week cCBT program called MoodGYM, and the control condition was five informational websites about mental health. Data were collected via online questionnaires. There was no evidence of the superiority of either in terms of treatment outcomes. In parallel, using brief rating scales and open-ended questions designed for this purpose, we examined the relative acceptability of each approach over time, including perceptions of cCBT compared to seeing a health care professional. RESULTS: At least 60% of participants held online therapy to be at least as acceptable as seeing a professional about mental health issues, and they were more likely to retain this opinion over time if they used the interactive program, MoodGYM, rather than informational websites alone. Barriers to cCBT use fell into four categories: intrinsic, intrapersonal problems; extrinsic technical problems; generic issues mostly pertaining to perceptions of cCBT; and specific issues about the intervention or control condition. These indicate strategies for improving engagement. CONCLUSIONS: As first-aid for mild to moderate mental health problems, evidence-based computerized approaches have broad acceptability. This could be increased by attending to the barriers noted here and by proactively managing users' expectations at individual and organizational levels. The findings have implications for occupational health providers and others addressing the needs of working-age adults with depression. They also raise methodological issues for online research. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 24529487; http://www.controlled-trials.com/ISRCTN24529487 (Archived by Webcite at http://www.webcitation.org/6O8cCL4mh).

Low Acceptability of Certain Contraceptive Methods among Young Women.

STUDY OBJECTIVE: To examine what predicts low personal acceptability of 4 different contraceptive methods among young women. DESIGN: Cross-sectional survey. SETTING: Urban adolescent contraception clinic in Colorado. PARTICIPANTS: Female clinic patients ages 13-24 initiating contraception from August 2011 to April 2012. INTERVENTIONS AND MAIN OUTCOME MEASURES: Survey participants reported their personal acceptability for oral contraceptive pills, depot medroxyprogesterone, contraceptive implants, and intrauterine devices on a scale from 0 (low) to 10 (high). Responses of 0-4 were categorized as low personal acceptability. Demographic characteristics, reproductive history, and perceived contraceptive satisfaction of friends and family members were incorporated into multivariable and hierarchical logistic regression models to determine distinct predictors of low personal acceptability for each method. RESULTS: Surveys were completed by 1067 women. Participants' mean age was 20 (±2.6) years. Half (552/1067) were white, 26% (277/1067) Hispanic, and 8.5% (91/1067) black. Of participants who were aware of oral contraceptive pills 52% (535/1037) reported low acceptability of this method compared with 74% (645/876) of those aware of depot medroxyprogesterone. Fewer reported low acceptability of intrauterine devices (37% or 303/825) or implant (43% or 356/839), although fewer overall participants had heard of these methods. Each method had unique predictors of low personal acceptability, however, for all method models, significant predictors included knowing someone who had become pregnant while using that method or having a friend who dislikes that method. CONCLUSION: Young women in this study with low personal acceptability of the 4 most common contraceptive methods had distinct demographic and reproductive health characteristics. Perceived negative experiences of friends and family members using contraception appeared most influential.

Female respondent acceptance of computer-assisted personal interviewing (CAPI) for maternal, newborn and child health coverage surveys in rural Uganda.

INTRODUCTION: High maternal and child mortality continues in low- and middle-income countries (LMIC). Measurement of maternal, newborn and child health (MNCH) coverage indicators often involves an expensive, complex, and lengthy household data collection process that is especially difficult in less-resourced settings. Computer-assisted personal interviewing (CAPI) has been proposed as a cost-effective and efficient alternative to traditional paper-and-pencil interviewing (PAPI). However, the literature on respondent-level acceptance of CAPI in LMIC has reported mixed outcomes. This is the first study to prospectively examine female respondent acceptance of CAPI and its influencing factors for MNCH data collection in rural Southwest Uganda. METHODS: Eighteen women aged 15-49 years were randomly selected from 3 rural villages to participate. Each respondent was administered a Women's Questionnaire with half of the survey questions asked using PAPI techniques and the other half using CAPI. Following this PAPI/CAPI exposure, semi-structured focus group discussions (FGDs) assessed respondent attitudes towards PAPI versus CAPI. FGD data analysis involved an immersion/crystallization method (thematic narrative analysis). RESULTS: The sixteen FGD respondents had a median age of 27 (interquartile range: 24.8, 32.3) years old. The majority (62.5%) had only primary level education. Most respondents (68.8%) owned or regularly used a mobile phone or computer. Few respondents (31.3%) had previously seen but not used a tablet computer. Overall, FGDs revealed CAPI acceptance and the factors influencing CAPI acceptability were 'familiarity', 'data confidentiality and security', 'data accuracy', and 'modernization and development'. DISCUSSION: Female survey respondents in our rural Southwest Ugandan setting found CAPI to be acceptable. Global health planners and implementers considering CAPI for health coverage survey data collection should accommodate influencing factors during survey planning in order to maximize and facilitate acceptance and support by local stakeholders and community participants. Further research is needed to generate best practices for CAPI implementation and LMIC; higher quality, timely, streamlined and budget-friendly collection of MNCH indicators could help direct and improve programming to save lives of mothers and children.

Comparative study on the efficacy, acceptability, and side effects of a contraceptive pill administered by the oral and the vaginal route: an international multicenter clinical trial.

The objective of this multicenter randomized clinical trial was to compare the efficacy, acceptability, and occurrence of side effects associated with the oral versus vaginal route of administration of contraceptive pills. Eight hundred nineteen healthy, parous women of reproductive age were recruited at family planning clinics and research centers, members of the South to South Cooperation in Reproductive Health, in seven countries of the developing world. These women were randomly assigned to use either oral or vaginal administration of the same contraceptive pill, which contained 250 micrograms levonorgestrel and 50 micrograms ethinyl estradiol. No statistically significant differences were found in discontinuation rates between the two groups after 1 year. Involuntary pregnancy rates after 1 year were not statistically significantly different between the two groups. The vaginal route of administration appears to be as acceptable and efficacious as the oral route.

PIP: The objective of this multicenter randomized clinical trail was to compare the efficacy, acceptability, and occurrence of side effects associated with the oral versus vaginal route of administration of contraceptive pills. This study started in June, 1987, and data collection extended up to April, 1992, at family planning clinics and research centers, members of the South to South Cooperation in Reproductive Health, in seven countries of the developing world. The 819 subjects were from 17 to 39 years of age, had already had at least one pregnancy, had had regular menstrual cycles for 3 months before, were exposed to the risk of pregnancy, and were not using any other method of contraception. 424 were randomly assigned to use the pills orally (which contained 250 mcg levonorgestrel and 50 mcg ethinyl estradiol), whereas 395 inserted the pills vaginally. 625 subjects completed at least 6 months of use, 326 used the pills orally and 299 used the pills vaginally. 385 subjects completed 1 year of pills use, 201 in the oral group and 184 in the vaginal group. The 1-year discontinuation rate per 100 subjects per year for the oral group was 34.71 +or- 2.42, while it was 36.35 +or- 2.53 for the vaginal group. This difference was not statistically significant. The only single reason of statistically significant difference for discontinuation was "desire for pregnancy" (p = 0.444). Paired value analysis of subjects completing 12 months of study showed that women in the oral group had a statistically significant increase in weight, from a mean of 55.8 kg at admission to a mean of 56.9 kg at 6 months (p 0.05) and 57.3 kg at 1 year (p = 0.05). The mean weight of the vaginal group increased from 56.52 kg to 57.22 kg (p = 0.036) at 12 months. Significantly more complaints of vaginal discharge were recorded in women using the pills by the vaginal route (p = 0.001). However, only one subject discontinued the pills because of vaginal discharge.

Comparative study on the efficacy and acceptability of two contraceptive pills administered by the vaginal route: an international multicenter clinical trial.

The efficacy and acceptability of two widely used oral contraceptive tablets, one containing 250 mg levonorgestrel and 50 micrograms ethinyl estradiol and the other containing 150 micrograms desogestrel and 30 micrograms ethinyl estradiol, administered by the vaginal route were compared in 1055 women studied over 12,630 woman-months of vaginal contraceptive pill use. This multicenter clinical trial was performed in nine countries of the developing world by the "South to South Cooperation in Reproductive Health," an organization founded by scientists from the Third World working in the area of reproductive health, and the study was developed and coordinated by one of these centers. The findings of this study confirm the efficacy of both these tablets when administered by the vaginal route. Involuntary pregnancy rates at 1 year of 2.78 for subjects in the levonorgestrel group and 4.54 for subjects the desogestrel group showed no statistically significant difference between the two groups. However, total discontinuation rates of 47.01 for subjects in the levonorgestrel group and 56.33 for subjects in the desogestrel group showed a statistically significant difference between the two groups, and discontinuation rates attributable to prolonged bleeding of 0.6 for subjects in the levonorgestrel group and 3.2 for subjects in the desogestrel group were also significantly higher in the group of subjects using the desogestrel vaginal contraceptive pill. Blood pressure remained at admission values throughout treatment. A statistically significant weight increase from admission values occurred in both groups of subjects.

PIP: Efficacy and acceptability of 2 combined oral contraceptive pills administered vaginally are summarized. This is the 1st collaborative trial published by the South to South Cooperation in Reproductive Health. 1055 women participated in 12,630 cycles, in 9 countries, from June 1988 to May 1991. The pills were commercially available tablets containing 50 mcg ethinyl estradiol and 250 mg levonorgestrel (Schering AG, Sao Paulo, Brazil), or 30 mcg ethinyl estradiol and 15 mcg desogestrel (Organon, Sao Paulo, Brazil). Subjects were aged 17-39 younger and of lower parity from Mexico and Dominican Republic and older from Egypt and China. All had at least 1 pregnancy. 675 participated for 6 months, 470 for 1 year, 364 for 18 months, and 210 for 2 years. The 1-year discontinuation rate averaged 47.01% for the levonorgestrel group and 56.33% for the desogestrel group (p = 0.0061); 2-year discontinuation rates were 48.01% and 69.36, respectively, explained in part by higher involuntary pregnancy rates and prolonged bleeding rates in the desogestrel group. The most common medical reasons for stopping contraception were unplanned pregnancy, vaginal or vulval irritation, nausea, vaginal discharge and headache. Vaginal irritation was reported by 1%, 9 in each group. There were 32 pregnancies, 14 in the levonorgestrel and 18 in the desogestrel group. 17 were in missed pill cycles and the rest were method failures, 6 in the levonorgestrel group and 9 in the desogestrel group. The Pearl index varied from 0 in Nigeria to 12.24 in Mexico, and was 2.45 for levonorgestrel vs. 3.74 for desogestrel. There was a wide variation in discontinuation rates by center: Brazil and China had few, while many women from Dominican Republic, Mexico and Zambia left the study. Bleeding problems were common complaints, more so in the desogestrel group. There were 363 women with intermenstrual bleeding (only once in 80%), 148 with spotting (only twice in 65%). Bleeding duration was significantly less in pill cycles than baseline, pressure. Women gained an average of 1 kg over 2 years, more in the desogestrel group. The pregnancy rate of 2.78 is within the range reported for levonorgestrel rings.

Contraception with progestogens and progesterone during lactation.

The growth and development of breastfed infants whose mothers used the contraceptive implants Norplant containing levonorgestrel and the injectable containing norethisterone enanthate were studied. Each group comprised of 120 women who initiated the use during the 5th to 7th week postpartum and were compared with a similar number of IUD using mothers. The breastfeeding performance did not differ between groups. The infants of the three groups performed similarly as regards their physical growth and health as well as the time of acquisition of the various milestones of psychomental development. A vaginal ring releasing 10 mg of the "natural" progesterone per 24 h was tested in breastfeeding mothers. The continuous use of the ring produced a serum level of progesterone around 4 ng/ml. This was effective in augmenting lactational infertility even through the later phases of breastfeeding when such an effect starts to wane off. The use of the ring proved to be acceptable and had no ill-effect on breastfeeding or infant growth or health. Using the natural progesterone as a contraceptive adds a new measure of safety, since the amount of the steroid secreted in the mother's milk will not be effectively absorbed from the infant's gut. These studies suggest the possibility of using two new methods for breastfeeding mothers; Norplant and the progesterone vaginal contraceptive ring. These can be initiated early postpartum, whenever this is considered needed.

PIP: Weight gain and psychomotor development of breastfed infants of Egyptian mothers using Norplant, Cu T-380A IUDs, norethisterone enanthate injectables (NET-EN), Depo Provera and a levonorgestrel minipill were compared in 2 trials. First, groups of 120 women using Norplant and NET-EN were compared to a control group using IUDs, beginning 5-7 weeks postpartum. There were no differences in infant weight gain, mid-arm circumference, triceps-skin-fold thickness, or timing of motor milestones. The mean growth curve of all 3 groups were close to that of the 50th percentile for Egyptian infants. While timing of initiation of supplements was similar in the 3 groups, complete weaning occurred first in the IUD group, second in the Norplant group, and last in the NET-EN users. A second trail compared progesterone implants injected with a trocar that resulted in a blood level of 3 ng/ml for 5 months, with Population Council vaginal rings releasing 10 progesterone/24 hours, and CuT-380A IUDs. Serum progesterone in the ring users averaged 5.2 ng/ml for the 1st 2 weeks, then leveled off at about 4 ng/ml for about 2 months, falling to about 3 ng/ml for the last 3 weeks of use. Each women used 4 rings per year. Evidence of ovulation by ultrasonic vaginal probe and assay of estradiol and progesterone was apparent in 25% of vaginal ring users, compared to 55.9% of controls in the 2nd 6 months postpartum. There was 1 pregnancy in a ring users. The continuation rates were 66.6% for rings and 85.5% for IUDs. The reasons for discontinuation in vaginal ring continuation were logistical problems and unfamiliarity.

Long-acting hormonal contraception.

For 30 years, the combined oral contraceptive pill has been an almost automatic choice for effective contraception in sexually active adolescent women. Nevertheless, consideration of the criteria of a hypothetical "ideal" contraceptive suggests that long-acting progestogen-only methods may have considerable advantages for some adolescents. These would include greater efficacy, easier compliance, avoidance of estrogenic side effects, and potentially greater privacy. The disadvantages of menstrual irregularity, progestogenic side effects including weight gain, and the initial greater medicalization of the method, particularly implants, must be weighed against the wishes and preferences of the adolescent. A number of studies of the uptake and utilization of these methods in adolescence have arisen, particularly from the United States. These are reviewed together with experience from programs in the United Kingdom.

Intrauterine contraception in adolescent women. The GyneFix intrauterine implant.

Pregnancy rates among adolescents have not decreased over the last 10 years, despite numerous efforts. To solve this important health problem, the major strategy recommended is to encourage contraceptive use among sexually active teenagers. An important means of obtaining this is by promoting methods that are not dependent on daily administration in order to avoid noncompliance. One such method (Norplant) has already shown to be much more effective than the combination pill in preventing pregnancy in adolescent women. The frameless intrauterine implant system (fixed, frameless, and completely flexible) has been studied since 1985 in women between 14 and 50 years of age. The results in young nulligravid women confirm its very high effectiveness (cumulative pregnancy rate at 36 months: 1.4%), its low expulsion rate (cumulative rate at 36 months: 0.9%) and its optimal tolerance (cumulative removal rate for medical reasons at 36 months: 2.4%), resulting in a high acceptance of the implant and a high continued use. The system (GyneFix) offers long-term protection (5 years), and its insertion, with or without anesthetic, is easily accomplished in the office. The GyneFix should therefore be recommended as an excellent alternative for birth control pills for young women with low risk for STDs, especially when compliance is a problem, without an increased risk for complications and without systemic side effects. Removal of the device is accomplished by traction on the tail. It can also be used for emergency contraception and for insertion immediately after termination of pregnancy.

Minimizing the problem of poor compliance in adolescents. Clinical experience with a modern low-dose gestodene-containing oral contraceptive.

Adolescents represent a particularly difficult group with respect to compliance. Not only is incorrect pill intake a common problem, but unnecessary discontinuation also occurs regularly. Reasons for poor compliance are varied, but inadequate information and problems with cycle control and weight gain are particularly important. Choosing a well-tolerated oral contraceptive can help to improve compliance, and clinical experience from a large, multicenter trial suggests that monophasic gestodene (75 micrograms gestodene/30 micrograms ethinylestradiol) is a suitable preparation for this group of women. An investigation of 5,602 adolescents with an average age of 16.4 years found good contraceptive reliability and excellent cycle control. The incidence of spotting and breakthrough bleeding was low and declined during the course of the study. The preparation was tolerated well, and the incidence of adverse events was low, with only 4.4% of women withdrawing from the study due to adverse events. An increase in body weight was uncommon. At the end of the study, 85.0% of adolescents rated monophasic gestodene as good and 9.6% as satisfactory.

Depo-medroxyprogesterone acetate as a contraceptive.

PIP: To test its effectiveness as a contraceptive, 150 mg of depo-medroxyprogesterone acetate (DMPA) was administered every 3 months to 752 women for 44 consecutive cycles. Side effects were similar to those seen with other contraceptive agents, the major one being irregular bleeding. During the course of this experiment, ethinyl was administered orally for 7 days of each month. This treatment improved the regularity of bleeding cycles. Although 450 women discontinued usage of DMPA for both drug-related and non-drug-related reasons, this study still showed DMPA to be an effective contraceptive. Only one method-failure occurred during 10,000 months of use; 75% of the women conceived within 12 months after discontinuing DMPA; 1 patient developed a questionable case of thrombophlebitis, but no cases of thromboembolic phenomenon were reported. DMPA, then, is regarded as an effective contraceptive that appears to inhibit the pituitary release of gonadotropins, and to alter the cervical mucus.^ieng

Intrauterine contraceptive devices: a comparison between their use in indigent and private patients.

PIP: Use of intrauterine contraception for an aggregate 8291 months in a group of 706 private patients (mean age 27.5 years, mean number of pregnancies 2.75, 9 nulligravidas) was analyzed and compared briefly with use in a group of 623 women from a lower socioeconomic level. Considering private patients only, 195 (27.6%) had intermenstrual bleeding after IUD insertion and 27 (3.8%) experienced an increase in the amount or duration of menstrual flow. All women had cramping after insertion of the Lippes loop (or Permaspiral in 2 patients); 43 (6.1%) expelled the device. Infection developed in 9 (1.3%), and perforation of the uterus during insertion of the loop occurred in 2 patients. The pregnancy rate for all users was 2.6 pregnancies per 100 years of use. Termination of intrauterine contraception in 216 (30.6%) was because of intermenstrual bleeding (89 women), increased menstrual flow (7), cramping (19), infection (8), spontaneous ejection (22), a sterilizing operation on either spouse (8), pregnancy when IUD inserted (2), pregnancy desired (37), and other personal reasons (6). The IUD continued to be acceptable to 535 (75.8%, including those sterilized or desiring pregnancy) of 706 upper and middle class women an aggregate of 6655 months of use. Private patients compared to clinic ones had a lower incidence of irregular bleeding (195 of 706 vs. 391 of 623), but more of them discontinued intrauterine contraception because of irregular or excessive bleeding (96 or 13.6% of private patients vs. 28 or 4.5% of clinic patients). The infection rate, total expulsion rate, and final rate for discontinuation due to expulsion were lower for private vs. clinic patients (1.3% vs. 8%, 6.1% vs. 15%, and 3% vs. 5.7%, respectively). It was found that the main advantage of the IUD, constant unburdensome protection against pregnancy, was important to both groups and that couples of any social class could effectively use intrauterine contraception. Differences in use are due to lesser dependence on the IUD among upper strata women, who can use other contraceptive methods successfully.^ieng

Immediate postpartum oral contraception.

PIP: Oral contraceptives were administered on Postpartum Day 5 to 363 patients, 83 of whom were breast-feeding, to determine if bleeding quantity could be reduced and menstrual periods established earlier in the puerperium, to evaluate the effect on lactation, and to note if side effects could be minimized by initiating pill usage earlier postpartum; 245 patients, of whom 91 were breast-feeding, served as controls. All of the women were patients at the U.S. Air Force Hospital in Wiesbaden, West Germany. 54% of the lactating mothers on the pill were successfully breast-feeding at 6 weeks compared with 59% of the controls. 87% of the patients taking pills had their 1st menstrual period before 6 weeks postpartum compared with 23% of the controls. No significant decrease in quantity of bleeding was noted. Patients taking the pill did report a weight gain. The uterus returned to normal size sooner in the group taking the pill and there was less breast tenderness. 65% of the multigravida mothers taking the pill thought they had a more favorable postpartum course, 24% saw no difference, and 11% thought their postpartum experience was less favorable. Patient acceptance was excellent and no major porblems were encountered.^ieng

Levonorgestrel subdermal implants. Contraception on trial.

When they were introduced to the world market in the 1980s, levonorgestrel subdermal implants offered the promise of an exciting alternative to traditional hormonal contraception. They provide highly effective, long-acting protection from pregnancy, without the need for user compliance. Broad acceptability of the drug has been reported throughout the world. Recently, however, the implants have met with opposition. The drug is associated with a variety of adverse effects, and removal of implants can be problematic. Serious events have been reported in women using levonorgestrel subdermal implants, although causal relationships have not been demonstrated. Additionally, concerns have been raised over the potential for coercive use of the drug. Numerous law suits have been filed alleging serious problems with implants. As a result, the drug has received considerable negative media attention. Before the controversy over levonorgestrel subdermal implants erupted, contraceptive development had declined, resulting from limitations to profits and funding, legal threats, and changes in the insurance industry. The levonorgestrel subdermal implant experience may serve to accelerate this trend. While the introduction of levonorgestrel subdermal implants offered an alternative to the current array of medical contraception, its experience may serve to dampen future contraceptive development efforts. Costly litigation and much controversy involving the implants have acted to create disincentives to further research and development of new methods of medical contraception.

Psychologic effects of vasectomy in voluntarily childless men.

Forty-four childless men and 51 vasectomized parents were compared as to their childhood backgrounds, marital satisfaction, social/emotional adjustment, physical and emotional problems attributed to the vasectomy, and attitudes toward vasectomy as a means of birth control. The findings suggested that for young married men, firmly committed to childlessness and in agreement with their wives regarding the necessity of the operation, vasectomy appears to be as physically and psychologically safe as in married parents for at least a two-year period. There were differences in the childfree men and fathers in styles of adjustment, with the childfree reporting themselves to be more independent, mobile, and less tied to tradition; these differences were seen as being more related to choosing a childfree life style than to the choice of vasectomy as a contraceptive method.

PIP: A comparative study was conducted to determine whether vasectomy produces different physical and/or psychological effects in childless men and fathers. Subjects were 51 married vasectomized fathers and 44 married vasectomized, voluntarily childless men matched in age, education, and time of the vasectomy. All the vasectomies were performed at the Planned Parenthood Association of Maryland vasectomy clinic between 1971 and 1975. Determinants and results of the procedure were similar for both groups. All subjects indicated concurrence of the wife. Prior contraceptive methods used and practice levels were similar, with both groups using condoms at a higher rate than for the general population. Both groups reported a 5-10% short- or long-term complication rate. The childfree men reported themselves more independent and mobile and less tradition-bound than the fathers; these differences are attributed to their childlessness and not to the choice of vasectomy. The study findings show vasectomy to be physically and psychologically safe in both childless men and fathers.

Twenty-eight-day oral contraceptives: physician and user attitudes.

A 28-day regimen of oral contraceptives that uses seven iron tablets (each containing 75 mg of ferrous fumarate) instead of seven sugar placebos was designed to encourage user compliance. To determine professional and user attitudes toward the 28-day regimen, 192 obstetrician-gynecologists and 469 women who used oral contraceptives were surveyed. Over two-thirds of the physicians stated that they approved both the 28-day regimen and the inclusion of the seven iron tablets. Over 80% of the women surveyed expressed approval of a 28-day regimen that included seven iron tablets.

PIP: A 28-day cycle of low-dose oral contraceptives (OCs) that uses 7 placebo sugar tablets after the 21 active hormone tablets is prescribed by the majority of physicians who dispense OCs. Given concern that users may not accept the sugar tablets, a packet that uses 7 iron tablets rather than sugar placebos has been developed. To assess professional and user attitudes toward this option, 192 obstetrician-gynecologists and 469 OC users were surveyed in 1986-87. 130 (69%) of the physicians surveyed indicated a preference for a 28-day OC regimen over a 21-day regimen and 71% indicated they would prefer 7 iron tablets to 7 sugar placebos. The 469 user respondents completed 6 cycles of a 28-day OC regimen containing 7 75-mg tablets of ferrous fumarate. 84% of these women liked the idea of using iron tablets as a convenient way to maintain the contraception schedule. Of the 150 women who had previously taken OCs on a 21-day schedule, 86% indicated a preference for the 28-day regimen. Given these high rates of patient and professional acceptability and the potential of iron-containing placebo tablets to enhance user compliance, this option should be made available to all women who present for OC use.

Synphasic tablets in Canadian practice: a phase-IV multicenter study.

The performance of a low-dose triphasic oral contraceptive (OC) in the first four cycles of use was evaluated by 1,326 primary-care physicians and specialists across Canada in a phase-IV postmarketing trial. Data were available from 5,460 women who completed 19,756 cycles of use with Synphasic. The incidence of intermenstrual bleeding characteristically decreased over the four cycles to 10% in women who were first-time users of OCs, to 14% in women who had previously used OCs but had discontinued use until this trial, and to 16% in women who had switched from another OC to Synphasic. The women reported a low incidence of headache, nausea, weight gain, breast complaints, and acne while receiving Synphasic. The results demonstrate good endometrial control with Synphasic and a high level of patient acceptance.

Impact of patient counseling on acceptance of the levonorgestrel implant contraceptive in the United Kingdom.

Patient counseling is an important aspect of family planning. Patient choice, compliance, and satisfaction with a contraceptive method depend heavily on the counseling experience. This is especially true in the United Kingdom where contraceptives are provided to patients at no direct cost to them. Women are therefore more likely to choose a contraceptive option based on perceived desirability as opposed to cost. We surveyed physicians from six family planning centers in the United Kingdom who have extensive experience with levonorgestrel contraceptive implants with respect to counseling issues and patient acceptability of levonorgestrel implants. The physicians reported on their experience with 521 women. They acknowledged the need for and importance of counseling, and these centers provided preinsertion counseling 100% of the time. Primary responsibility for counseling was handled by the physician who spent, on average, 19 minutes per patient discussing the advantages and risks of levonorgestrel implants. Physicians felt that the majority of women (82%) accepting levonorgestrel implants had a positive experience. The incidence of bleeding irregularities was consistent with that reported in clinical trials, and this did not substantially affect the postinsertion acceptability of the product. Effective counseling is no doubt responsible for the high level of patient acceptance of these side effects. In a review of the literature, we found counseling to be a significant factor in a woman's tolerance of contraceptive-induced bleeding irregularities, which are frequently experienced with levonorgestrel implants. The results of our survey support the literature findings.

Quinacrine pellet nonsurgical female sterilization in Wonosobo, Indonesia.

OBJECTIVE: To evaluate the efficacy, safety, and acceptability of two monthly transcervical applications of quinacrine, 252 mg, and ibuprofen, 55.5 mg, as pellets for sterilization. DESIGN: Prospective clinical study. SETTING: Family planning clinic of a referral hospital. PATIENT(S): Two hundred normal women who requested sterilization and volunteered for this method. INTERVENTION(S): Each woman received quinacrine, 252 mg, and ibuprofen, 55.5 mg, transcervically as pellets in the proliferative phase of two consecutive menstrual cycles from August 1992 to October 1993. MAIN OUTCOME MEASURE(S): Life-table pregnancy failure rates and incidence of complications and side effects. RESULT(S): The pregnancy failure rate was 2.0 per 100 women at 24 months. There were no serious complications, and side effects were transient. CONCLUSION(S): Intrauterine insertion of quinacrine pellets is a safe and acceptably effective method of nonsurgical female sterilization.

PIP: A female sterilization regimen involving transcervical insertion of pellets containing 252 mg of quinacrine and 55.5 mg of ibuprofen in the proliferative phase of 2 consecutive menstrual cycles was found to be safe, acceptable, and effective. Subjects included 200 healthy volunteers (mean age, 33.2 years) who presented to a family planning clinic in Central Java Province, Indonesia, seeking sterilization. The insertion procedure (Kimia Farma) is similar to that for the Copper-T IUD. Only 3 women declined the second insertion. One month after insertion, side effects included lower abdominal pain (58.0%), fever (13.5%), and leukorrhea; however, these rates decreased to 0.5%, 2.0%, and 2.0%, respectively, 1 year after the second insertion and to 0.5%, 0.0%, and 1.6%, respectively, after 2 years. During the 2-year study period, 4 women became pregnant 4, 5, 14, and 18 months after the second insertion. The cumulative pregnancy rate was 1.0% 0-12 months after insertion and 2.0% in the second year. One of these women selected pregnancy termination; no malformations were noted in the 3 infants delivered. Quinacrine sterilization has the potential to meet the unmet need for female sterilization in developing countries without access to trained personnel and sophisticated surgical equipment.