The Effect of Physician Oral Health Services on Dental Use and Expenditures under General Anesthesia.

BACKGROUND: Despite early evidence touting the effectiveness of physician-provided oral health services (POHS), recent evidence suggests these services might have little impact on caries-related outcomes in children. General anesthesia (GA) is often used to treat early childhood caries and may be considered the most extreme utilization outcome. We sought to assess the impact of POHS utilization on dental GA utilization and expenditures. METHODS: We used the Medicaid claims of a birth cohort of children born in 2008 in North Carolina (N = 32,558) to determine the impact of POHS on dental utilization and expenditures under GA for individual children. Children were followed until their eighth birthday. We analyzed the association of the number of prior POHS visits with visit-specific outcomes of dental treatment under GA using population-averaged models fit with generalized estimating equations with exchangeable working correlation structure. RESULTS: Children with 2 or more previous POHS visits had reduced odds of GA (odds ratio [OR] = 0.93; confidence interval [CI], 0.87-0.99; P = 0.029) and expenditures ($114; CI,-$152.61 to -$75.19; P < 0.001) compared to those without physician-provided oral health visits, adjusting for age, sex, race/ethnicity, and geographic residence. Dental expenditures did not differ between POHS and non-POHS subjects at non-GA visits. CONCLUSIONS: POHS decreased the odds of having dental GA treatment and dental expenditures at GA visits. The role of physicians in oral health care can reduce the impact on the most severe outcome-treatment under general anesthesia. KNOWLEDGE TRANSFER STATEMENT: The results of this study have important financial implications for state Medicaid programs and disease management programs trying to mitigate the costs of treating early childhood caries under general anesthesia. Children who receive physician oral health care are less likely to use and more likely to save money on general anesthesia to complete dental treatment.

Randomized trial to evaluate contraceptive efficacy, safety and acceptability of a two-rod contraceptive implant over 4 years in the Dominican Republic.

OBJECTIVE: Sino-implant (II) is a contraceptive implant that had a commodity price one-third of the competing products a decade ago. To make Sino-implant (II) more widely available, we conducted a trial to collect safety and efficacy data required for World Health Organization (WHO) prequalification, a quality standard allowing global donors to procure a pharmaceutical product. STUDY DESIGN: This was a randomized controlled trial allocating 650 participants to either Sino-implant (II) or Jadelle®. Participants were seen at 1 and 6 months, and then semiannually. The primary efficacy measure was the pregnancy Pearl Index [number of pregnancies per 100 women-years (WY) of follow-up] in the Sino-implant (II) group during up to 4 years of implant use. RESULTS: For the primary outcome, Sino-implant (II) had a 4-year Pearl Index of 0.74 (95% confidence interval, 0.36-1.37) compared to 0.00 (95% confidence interval, 0.00-1.04) for Jadelle®. The Sino-implant (II) pregnancy rate was significantly higher in the fourth year (3.54 per 100 WY) than in the first 3 years combined (0.18 per 100 WY; p <.001). Total levonorgestrel concentrations were equivalent between groups at month 12, but were 19%, 22% and 32% lower in the Sino-implant (II) group at months 24, 36 and 48, respectively (p <.001 at each time point). Safety and acceptability of the two products were similar, while providers documented significantly higher breakage rates during removal of Sino-implant (II) (16.3% vs. 3.1%; p <.001). CONCLUSION: Based on these results, WHO prequalified Sino-Implant (II) with a 3-year use label in June 2017, 2 years shorter than the 5-year duration of Jadelle®. IMPLICATIONS: WHO prequalification allows global donors to procure Sino-implant (II), which means women in many low resource countries will have greater access to highly effective and acceptable contraceptive implants. Our study noted important clinical differences, including shorter duration of high effectiveness with Sino-implant (II) when compared to the other available two-rod system, Jadelle®. Introduction strategies should include appropriate training on these differences.

Cohort study to evaluate efficacy, safety and acceptability of a two-rod contraceptive implant during third, fourth and fifth year of product use in China.

OBJECTIVE: Sino-implant (II) is a contraceptive implant approved for 4 years of use in China. We evaluated the contraceptive efficacy during the third, fourth and fifth year, and assessed additional pharmacokinetics (PK), safety, and acceptability endpoints. STUDY DESIGN: We enrolled a cohort of 255 current Sino-Implant (II) users entering their third year and a second cohort of 243 users entering their fourth year. We followed these two cohorts for 12 and 24 months, respectively. To characterize PK endpoints (i.e. levonorgestrel (LNG), sex hormone binding globulin and free LNG index) over 5 years, we collected blood samples in a subset of 50 participants we followed during the third, fourth and fifth year. We also enrolled small cohorts (n = 20) of Sino-implant (II) users entering their sixth month and second year and followed them each for up to 6 months. Our primary efficacy measures were the pregnancy Pearl Indices during Year 3 and 4. Secondary objectives included assessments of PK, safety, acceptability and efficacy in the fifth year. RESULTS: We recorded four pregnancies, with a higher pregnancy rate during Year 3 [1.34 (95% CI: 0.28-3.93)] than Year 4 [0.44 (95% CI: 0.01-2.47)] or Year 5 [0.00 (95% CI: 0.00-2.02)]. The overall pregnancy rate for the third, fourth and fifth years of product use was 0.63 per 100 WY; 95% CI: (0.17-1.62). Mean LNG concentrations remained well above 200 pg/mL (Year 3 = 280.9; Year 4 = 233.6; Year 5 = 270.6). Most participants (93.7%) described their bleeding pattern as acceptable. CONCLUSION: Sino-implant (II) is a highly effective contraceptive method in this population of Chinese women over 5 years. IMPLICATIONS: Sino-implant (II) is a highly effective contraceptive method with an estimated Pearl Index of less than 1% over the third, fourth and fifth years of use in a population of Chinese women of reproductive age.

Performance of Sino-implant (II) in routine service delivery in Madagascar.

BACKGROUND: Sino-implant (II) is a low-cost subdermal contraceptive implant containing levonorgestrel that is currently labeled for 4 years of use. Widely used in China and Indonesia, it has been little studied elsewhere. We conducted a prospective study of Sino-implant (II) use by women in Madagascar. METHODS: We enrolled a total of 621 women 18 or older who had Sino-implant (II) inserted on day of enrollment, some in fixed clinical sites, and some at outreach sites. Half of the women were scheduled for follow-up visits at 3 months and at 12 months postinsertion (active follow-up cohort); the other half were advised to return if they desired care for any problem, thought they were pregnant or wanted the implants removed (passive surveillance cohort). RESULTS: No insertion complications were reported. A total of 384 women returned for an earlier visit, and 351 returned for a later visit, for a total of 419 woman-years of observation. No postinsertion pregnancies or serious adverse events were observed. Twenty-eight implant removals were reported by 12 months, a cumulative removal probability of 7.3 per 100 women. Acceptability of the implants was very high, as was satisfaction with clinic services. CONCLUSIONS: This is the first report on the performance of Sino-implant (II) from outside China and Indonesia and among the first in the English-language literature. These initial data from Madagascar indicate a favorable level of safety, effectiveness and acceptability during the first year of use.

Strategies for communicating contraceptive effectiveness.

BACKGROUND: Knowledge of contraceptive effectiveness is crucial to making an informed choice. The consumer has to comprehend the pros and cons of the contraceptive methods being considered. Choice may be influenced by understanding the likelihood of pregnancy with each method and factors that influence effectiveness. OBJECTIVES: To review all randomized controlled trials comparing strategies for communicating to consumers the effectiveness of contraceptives in preventing pregnancy. SEARCH STRATEGY: We searched the computerized databases MEDLINE, POPLINE, CENTRAL, PsycINFO, and EMBASE for studies of communicating contraceptive effectiveness. We also examined references lists of relevant articles, and wrote to known investigators for information about other published or unpublished trials. SELECTION CRITERIA: We included randomized controlled trials that compared methods for communicating contraceptive effectiveness to consumers. The comparison could be usual practice or an alternative to the experimental intervention. DATA COLLECTION AND ANALYSIS: Data were abstracted by two authors and entered into RevMan. For dichotomous variables, the Peto odds ratio (OR) with 95% confidence intervals (CI) was calculated. For continuous variables, the weighted mean difference (WMD) was computed. MAIN RESULTS: Five trials met the inclusion criteria. In one study, knowledge gain favored a slide-and-sound presentation versus a physician's oral presentation (WMD -19.00; 95% CI -27.52 to -10.48). Another trial showed a table with effectiveness categories led to more correct answers than one based on numbers [ORs were 2.42 (95% CI 1.43 to 4.12) and 2.19 (95% CI 1.21 to 3.97)] or a table with categories and numbers [ORs were 2.58 (95% CI 1.5 to 4.42) and 2.03 (95% CI 1.13 to 3.64)]. One trial examined contraceptive choice: women in the expanded program were more likely to choose sterilization (OR 4.26; 95% CI 2.46 to 7.37) or use a modern contraceptive method (OR 2.35; 95% CI 1.82 to 3.03). No trial had an explicit theoretical base, but each used concepts from common theories or models. AUTHORS' CONCLUSIONS: We have limited evidence about what works to help consumers choose an appropriate contraceptive method. For presenting pregnancy risk data, one trial showed that categories were better than numbers. In another trial, audiovisual aids worked better than the usual oral presentation. Strategies for communicating information should be examined in clinical settings and assessed for effect on contraceptive choice and retention of knowledge. To expand the knowledge base of what works in contraceptive counseling, randomized trials could intentionally use and test theories or models.

Validity of self-reported 'safe sex' among female sex workers in Mombasa, Kenya--PSA analysis.

We assessed the validity of self-reported sex and condom use by comparing self-reports with prostate-specific antigen (PSA) detection in a prospective study of 210 female sex workers in Mombasa, Kenya. Participants were interviewed on recent sexual behaviours at baseline and 12-month follow-up visits. At both visits, a trained nurse instructed participants to self-swab to collect vaginal fluid specimens, which were tested for PSA using enzyme-linked immunosorbent assay (ELISA). Eleven percent of samples (n = 329) from women reporting no unprotected sex for the prior 48 hours tested positive for PSA. The proportions of women with this type of discordant self-reported and biological data did not differ between the enrolment and 12-month visit (odds ratio [OR] 1.1; 95% confidence interval [CI] 0.99, 1.2). The study found evidence that participants failed to report recent unprotected sex. Furthermore, because PSA begins to clear immediately after exposure, our measures of misreported semen exposure likely are underestimations.

How are condoms used in a family planning setting: evidence from Zimbabwe.

OBJECTIVES: (To determine the level and consistency of condom use among family planning clients at three family planning clinics in Zimbabwe.) DESIGN: A prospective cross sectional study. SETTING: The study was carried out at three Zimbabwe National Family Planning Council clinics. SUBJECTS: We interviewed 899 consecutive women seeking family planning services at these three clinics using a structured questionnaire. MAIN OUTCOME MEASURES: The prevalence of condom use among this population of family planning clients and the factors predicting condom use were the main outcome measures. We define dual method use (DMU) as the use of condoms in conjunction with another highly effective contraceptive and dual purpose use (DPU) as the use of condoms for both pregnancy and STI/HIV prevention. We measured self-reported condom use during the last 30 days prior to each interview. RESULTS: The prevalence of condom use among this population of family planning clients was 38%. Of all the study participants, 32% were DMU clients while 5% were DPU clients. Fifty eight percent of the DMU clients and 89% of the DPU clients clients reported consistent condom use respectively. Logistic regression analysis showed that young age and reporting high risk sexual behaviour were predictors of condom use. CONCLUSIONS: The level of condom use among this population of family plannig clients is too low for a country with such a high HIV prevalence. Condom users were more likely to report DMU than DPU. Those reporting DPU were more likely to report consistent condom use.

Fermi-liquid breakdown in the paramagnetic phase of a pure metal.

Fermi-liquid theory (the standard model of metals) has been challenged by the discovery of anomalous properties in an increasingly large number of metals. The anomalies often occur near a quantum critical point--a continuous phase transition in the limit of absolute zero, typically between magnetically ordered and paramagnetic phases. Although not understood in detail, unusual behaviour in the vicinity of such quantum critical points was anticipated nearly three decades ago by theories going beyond the standard model. Here we report electrical resistivity measurements of the 3d metal MnSi, indicating an unexpected breakdown of the Fermi-liquid model--not in a narrow crossover region close to a quantum critical point where it is normally expected to fail, but over a wide region of the phase diagram near a first-order magnetic transition. In this regime, corrections to the Fermi-liquid model are expected to be small. The range in pressure, temperature and applied magnetic field over which we observe an anomalous temperature dependence of the electrical resistivity in MnSi is not consistent with the crossover behaviour widely seen in quantum critical systems. This may suggest the emergence of a well defined but enigmatic quantum phase of matter.

Evolution of Fermi-liquid interactions in Sr2RuO4 under pressure.

We have measured the temperature and field dependence of the resistivity of the unconventional superconductor Sr2RuO4 at pressures up to 3.3 GPa. Using the Shubnikov-de Haas effect, we find that the Fermi surface sheet believed to be primarily responsible for superconductivity becomes more two-dimensional with increasing pressure, a surprising result that is, however, consistent with a recent model of orbital-dependent superconductivity in this system. Many-body enhancements and the superconducting transition temperature all fall gradually with increasing pressure, contrary to previous suggestions of a ferromagnetic quantum critical point at approximately 3 GPa.

Retrospective vs. prospective coital frequency and menstrual cycle length in a contraceptive effectiveness trial.

PURPOSE: To determine how well information at enrollment would predict coital frequency and menstrual segment length during a prospective contraceptive effectiveness trial. METHODS: We compared retrospective reports of monthly coital frequency and menstrual segment (cycle) length with prospective information for women participating in a contraceptive trial of the Reality((R)) female condom. RESULTS: Participants reported slightly higher mean monthly coital frequency and slightly longer menstrual segments prior to the study than during the study (12.6 acts vs. 12.0 acts per month and 30.8 days vs. 28.4 days). We examined the actual distribution of differences between the retrospective and prospective measures and found considerable variability. Among the 195 participants studied, parous women were less likely to predict accurately menstrual segment length (OR 0.4; 95% CI 0.3--0.9), while older women were more likely to predict accurately coital frequency (OR 1.9; 95% CI 0.9--3.3). CONCLUSIONS: Coital frequency and menstrual segment length vary considerably over time. Hence, prospective data collection is essential to accurately characterize these variations and to properly interpret results from contraceptive trials and other studies concerned with fecundability and hazards of reproduction.

Provider knowledge about emergency contraception in Ghana.

In 1996, the Ministry of Health in Ghana included emergency contraception (EC) in its newly issued National Reproductive Health Service Policy and Standards. A short survey was conducted in the summer of 1997 to evaluate health providers' knowledge of EC. Of the 325 providers interviewed, about one-third (34%) had heard of EC. No provider had sufficient knowledge to prescribe EC correctly. A well-coordinated training programme for providers will have to precede successful introduction of EC in Ghana. Moreover, a dedicated product may be critical for the successful introduction of EC in a country like Ghana, where provider knowledge is low.

PIP: In 1996, the Ministry of Health in Ghana included emergency contraception (EC) in its newly issued National Reproductive Health Service Policy and Standards. This paper reports a short survey conducted to evaluate the success of these early efforts to introduce EC into Ghana and evaluate health providers' knowledge of EC. Short structured interviews were conducted with health care providers at a sample of family planning outlets in two regions of Ghana. Findings revealed that health providers' knowledge about EC is low. Out of the 325 people interviewed, only about one-third (34%) had heard of EC. Furthermore, no provider had sufficient knowledge to prescribe EC correctly. Two policy implications can be drawn from this research: 1) well coordinated training of providers will have to precede a successful introduction of EC in Ghana; 2) a dedicated product may be critical for the successful introduction of EC, where providers' knowledge is low.

A transitional model of barrier methods compliance with unbalanced loss to follow-up.

Differential loss to follow-up can substantially influence the evaluation of treatment effects on a dichotomous outcome of interest in longitudinal trials. The use of transitional models incorporating loss to follow-up as an additional category of response and the nature of the correlated responses can provide a comprehensive view of a trial with unbalanced loss to follow-up. Under the Markov assumption, transitional models estimate the probability of changing from one outcome to another outcome between follow-up visits. Patterns of the response variable can be described by the estimated transition probabilities. The effects of intervention and covariates on the outcome of interest can also be estimated using a conditional likelihood function or a multinomial logit regression. Data from a randomized barrier method study designed to compare the proportion of participants using barrier methods consistently in two counselling groups are used to illustrate the proposed model.

How well do male latex condoms work? Pregnancy outcome during one menstrual cycle of use.

To evaluate the contraceptive effectiveness of male latex condoms, we assembled a cohort of 300 women relying on male latex condoms for contraception and followed them prospectively for one menstrual cycle. None of the 234 women who completed the study and reported at least one act of intercourse conceived (one cycle pregnancy rate 0%; 95% CI 0%--2%). Given the pattern of intercourse during the cycle and 3 different sets of conception probabilities for different days of the cycle, we would have expected between 32 and 36 pregnancies if no condoms had been used. Thus, the prevented fraction due to condom use (effectiveness) is 100% and the lower bounds of the 95% CI are between 89% and 90%. For this cohort, male latex condoms were an effective method of contraception. This cost-efficient approach of evaluating contraceptive effectiveness shows promise for post-marketing studies.

Syndromic management of urethral discharge in Ghanaian pharmacies.

OBJECTIVES: To evaluate the training of pharmacists in Accra, Ghana, in the syndromic management of STIs. METHODS: We randomly selected 50 pharmacy outlets that had received the training (intervention) and 50 outlets that had not received the training (no intervention). Simulated clients described the symptoms of urethral discharge to the first pharmacy staff encountered and completed a standardised questionnaire after each encounter. RESULTS: Correct drug provision for urethral discharge improved with the educational intervention but remained relatively low (no intervention 18%; intervention 39%; p < 0.05). More encouraging, treatment for gonorrhoea was usually correct without the intervention (64%) and improved further in the intervention outlets (76%). The treatment for chlamydia was less often appropriate but also improved (31% and 41%). Condom promotion was poor, with almost no outlets offering condoms. CONCLUSIONS: The current training led to improvements in the treatment of urethral discharge. Future training needs to be improved, especially with regard to condom promotion. Moreover, since less than one third of simulated clients were seen by pharmacists, the training should be expanded to other pharmacy staff. With enhanced training of all pharmacy staff, the role of pharmacy outlets in STI management and prevention in Ghana and elsewhere can be optimised.

The real problem with male condoms is nonuse.

PIP: Male latex condoms are considered to be the most effective method in reducing the risk of sexually transmitted disease (STD) and HIV transmission if properly used during sexual intercourse. Several studies were documented citing the effectiveness of latex condoms. Although one study reported condom failure due to breakage and slippage, this does not put the user at risk of STD/HIV transmission, because such mechanical failure occurs before intercourse or during removal (nonclinical breakage and slippage). Most importantly, condom users who report more frequent condom breakage and slippage can be counseled to develop skills to avoid behaviors that may place them at increased risk. Aside from condom breakage and slippage, a possible explanation for the observed failure of condoms to protect against STD/HIV transmission is the respondent's behavior of not providing valid information about their consistency in use. Based on the studies conducted on STD/HIV transmission, a frequently listed cause of condom failure was the type of condom being used during sexual intercourse and the user's failure to properly use the condom.^ieng