The effect of tubal sterilization through electrocoagulation on the ovarian reserve

Background

The study was conducted to compare the effects of tubal sterilization through electrocoagulation and the application of mechanical clips on the ovarian reserve.

Study Design

Eighty-eight patients in the reproductive period with the desire of tubal sterilization were included in the prospective, randomized study. The patients were divided into two groups by simple randomization as tubal sterilization through electrocoagulation group and the application of mechanical clips group. Day-3 serum follicle stimulating hormone, luteinizing hormone, estradiol, inhibin-B and antimüllerian hormone and Day-3 total ovarian volume measurements and anthral follicle counts of all patients in the preoperative and 10th postoperative months were compared both within and between the two groups.

Results

A significant difference between the postoperative 10th-month Day-3 total ovarian volumes and anthral follicle counts was detected between the electrocoagulation and mechanical clips application groups.

Conclusion

Tubal sterilization by electrocoagulation is very likely to have an adverse effect on the ovarian reserve in the postoperative period.     

Economic burden of rotavirus disease in children under 5 years in Kazakhstan

Background

We aimed to estimate the societal costs of rotavirus cases among children less than 5 years in Kazakhstan, an upper-middle income country in Central Asia.

Methods

Data on medical, non-medical and indirect costs were collected for 190 patients less than 5 years, hospitalized with severe diarrhea in 2009 in two pediatric hospitals. Data on resource use for moderate and mild diarrhea cases were obtained from published sources. A probabilistic sensitivity analysis was performed to explore uncertainty in cost estimates.

Results

Approximately 4,000 severe, 30,700 moderate, and 122,900 mild rotavirus cases were estimated annually in children <5 years old. The mean societal cost of a severe, moderate and mild rotavirus case was estimated at US$ 454, 82, and 21, respectively. The total annual cost of rotavirus disease was $37.53 million or on average $107.36 for a child under 5 years old in Kazakhstan. Ninety-four percent of total costs (35.13 million) are indirect costs (productivity losses) from fatal cases and parents’ job absenteeism, while direct medical costs account for 2.04 million (5.4%), and direct non-medical for 0.46 million (1.2%).

Conclusions

Rotavirus-associated diarrhea represents a significant economic burden in Kazakhstan, largely due to indirect costs. The costs of rotavirus infections should be considered when planning further preventive actions, including the introduction of rotavirus vaccination.     

Direct costs of a single case of refugee-imported measles in Kentucky

Background

Refugees are highly vulnerable populations with limited access to health care services. The United States accepts 50,000-75,000 refugees for resettlement annually. Despite residing in camps and other locations where vaccine-preventable disease outbreaks, such as measles, occur frequently, refugees are not required to have any vaccinations before they arrive in the United States.

Purpose

We estimated the medical and public-health response costs of a case of measles imported into Kentucky by a refugee.

Methods

The Kentucky Refugee Health Coordinator recorded the time and labor of local, state, and some federal personnel involved in caring for the refugee and implementing the public health response activities. Secondary sources were used to estimate the labor and medical care costs of the event.

Results

The total costs to conduct the response to the disease event were approximately $25,000. All costs were incurred by government, either public health department or federal, because refugee health costs are paid by the federal government and the event response costs are covered by the public health department.

Conclusion

A potentially preventable case of measles that was imported into the United States cost approximately $25,000 for the public health response.

Recommendation

To maintain the elimination of measles transmission in the United States, U.S.-bound refugees should be vaccinated overseas. A refugee vaccination program administered during the overseas health assessment has the potential to reduce the risk of importation of measles and other vaccine-preventable disease and would eliminate costs associated with public health response to imported cases and outbreaks.     

Too many cohorts and repeated measurements are a waste of resources

Objective

Researchers in Health Sciences and Medicine often use cohort designs to study treatment effects and changes of outcome variables over time period. The costs of these studies can be reduced by choosing an optimal number of repeated measurements over time and by selecting cohorts of subjects more efficiently with optimal design procedures. The objective of this study is to provide evidence on how to design large-scale cohort studies with budget constraints as efficiently as possible.

Study Design and Setting

A linear cost function for repeated measurements is proposed, and this cost function is used in the optimization procedure. For a given budget/cost, different designs for linear mixed-effects models are compared by means of their efficiency.

Results

We found that adding more repeated measures is only beneficiary if the costs of selecting and measuring a new subject are much higher than the costs of obtaining an additional measurement for an already recruited subject. However, this gain in efficiency and power is not very large.

Conclusion

Adding more cohorts or repeated measurements do not necessarily lead to a gain in efficiency of the estimated model parameters. A general guideline for the optimal choice of a cohort design in practice is required and we offer this guideline.     

Estimating the impact of pictorial health warnings and “plain” cigarette packaging: Evidence from experimental auctions among adult smokers in the United States

Objective

To estimate differences in demand for cigarette packages with different packaging and health warning label formats.

Methods

Adult smokers (n = 404) in four states participated in experimental auctions. Participants bid on two of four experimental conditions, each involving a different health warning label format but with the same warning message: (1) text on 50% of pack side; (2) text on 50% of the pack front and back; (3) text with a graphic picture on 50% of the pack front and back; and (4) same as previous format, but without brand imagery.

Results

Mean bids decreased across conditions (1: $3.52; 2: $3.43; 3: $3.11; 4: $2.93). Bivariate and multivariate random effects models indicated that there was no statistically significant difference in demand for packs with either of the two text only warnings; however, demand was significantly lower for both packs with prominent pictorial warnings, with the lowest demand associated with the plain, unbranded pack.

Conclusions

Results suggest that prominent health warnings with graphic pictures will reduce demand for cigarettes. Regulators should not only consider this type of warning label, but also plain packaging policies for tobacco products.     

Contraceptive sterilization use among married men in the United States: results from the male sample of the National Survey of Family Growth

Background

Surgical sterilization has many advantages. Previous information on prevalence and correlates was based on surveys of women.

Study Design

We estimated the prevalence of vasectomy and tubal ligation of partners for male participants in the 2002 National Survey of Family Growth, a nationally representative survey of US residents aged 15-44 years. We identified factors associated with sterilizations using bivariate and multivariate techniques.

Results

The findings revealed that 13.3% of married men reported having had a vasectomy and 13.8% reported tubal sterilization in their partners. Vasectomy increased with older age and greater number of biological children, non-Hispanic white ethnicity, having ever gone to a family planning clinic. Tubal sterilization use was more likely among men who had not attended college, those of older age and those with live births.

Discussion

One in eight married men reported having vasectomies. Men who rely on vasectomies have a somewhat different profile than those whose partners have had tubal sterilizations.     

Cost-benefit analysis of state- and hospital-funded postpartum intrauterine contraception at a university hospital for recent immigrants to the United States

Objective

To examine the hospital and state costs of offering the option of a postpartum intrauterine device (IUD) to an underinsured population of recent immigrants to the United States with Emergency Medicaid (EM) insurance coverage only.

Study Design

This study is a retrospective cohort study comparing the costs of offering a reversible long-acting method of contraception (IUD) postpartum to women with EM and the current policy of covering the obstetrical delivery only. A cost-benefit analysis from the perspective of both the hospital and the state was conducted. A database of EM obstetrical patients from 2002 to 2006 was created from hospital billing records to calculate mean pregnancy costs and revenue, as well as the probability of repeat pregnancy and pregnancy outcome. Probability of IUD uptake and continuation was obtained from hospital records and the literature.

Results

A postpartum IUD program is not cost beneficial from the hospital's perspective, losing 70 cents per dollar spent on the program. However, the state government would save $2.94 for every dollar spent on a state-financed IUD program.

Conclusion

Considering only the direct costs associated with a repeat pregnancy, a program offering the option of postpartum IUD placement to underinsured women would significantly reduce state expenditures on subsequent pregnancies.     

The efficacy and cost-effectiveness of a community weight management intervention: a randomized controlled trial of the health weight management demonstration

Purpose

The study investigated the efficacy and cost-effectiveness of a cognitive-behavioral weight management program, complemented by an interactive Web site and brief telephone/e-mail coaching.

Methods

In 2006-2007, 1755 overweight, non-active-duty TRICARE beneficiaries were randomized to one of three conditions with increasing intervention intensity: written materials and basic Web access (RCT1), plus an interactive Web site (RCT2), plus brief telephone/e-mail coaching support (RCT3). The study assessed changes in weight, blood pressure, and physical activity from baseline to 6, 12, and 15-18 months. (Study retention was 31% at 12 months.) Average and incremental cost-effectiveness and cost-offset analyses were conducted.

Results

Participants experienced significant weight loss (− 4.0%, − 4.0%, and − 5.3%, respectively, in each RCT group after 12 months and − 3.5%, − 3.8%, and − 5.1%, respectively, after 15 to 18 months), increased physical activity, and decreased blood pressure. Cost-effectiveness ratios were $900 to $1100/quality-adjusted life year (QALY) for RCT1 and RCT2 and $1900/QALY for RCT3. The cost recovery period to the government was 3 years for RCTs 1 and 2 and 6 years for RCT3.

Conclusion

A relatively inexpensive cognitive-behavioral weight management intervention improved patient outcomes. Extrapolation of savings for the entire TRICARE population would significantly reduce direct medical costs.     

Comorbidity scores for administrative data benefited from adaptation to local coding and diagnostic practices

Objective

The Charlson and Elixhauser indices are the most commonly used comorbidity indices with risk prediction models using administrative data. Our objective was to compare the original Charlson index, a modified set of Charlson codes after advice from clinical coders, and a published modified Elixhauser index in predicting in-hospital mortality.

Study Design and Setting

Logistic regression using two separate years of administrative hospital data for all acute nonspecialist public hospitals in England.

Results

For all admissions combined, discrimination was similar for the Charlson index using the original codes and weights and the Charlson index using the original codes but England-calibrated weights (c = 0.73), although model fit was superior for the latter. The new Charlson codes improved discrimination (c = 0.76), model fit, and consistency of recording between admissions. The modified Elixhauser had the best performance (c = 0.80). For admissions for acute myocardial infarction and chronic obstructive pulmonary disease, the weights often differed, although the patterns were broadly similar.

Conclusion

Recalibration of the original Charlson index yielded only modest benefits overall. The modified Charlson codes and weights offer better fit and discrimination for English data over the original version. The modified Elixhauser performed best of all, but its weights were perhaps less consistent across the different patient groups considered here.     

Cost effectiveness of contraceptives in the United States

Background

The study was conducted to estimate the relative cost effectiveness of contraceptives in the United States from a payer's perspective.

Methods

A Markov model was constructed to simulate costs for 16 contraceptive methods and no method over a 5-year period. Failure rates, adverse event rates and resource utilization were derived from the literature. Sensitivity analyses were performed on costs and failure rates.

Results

Any contraceptive method is superior to “no method”. The three least expensive methods were the copper-T intrauterine device (IUD) (US$647), vasectomy (US$713) and levonorgestrel (LNG)-20 intrauterine system (IUS) (US$930). Results were sensitive to the cost of contraceptive methods, the cost of an unintended pregnancy and plan disenrollment rates.

Conclusion

The copper-T IUD, vasectomy and the LNG-20 IUS are the most cost-effective contraceptive methods available in the United States. Differences in method costs, the cost of an unintended pregnancy and time horizon are influential factors that determine the overall value of a contraceptive method.     

Will ethylene oxide sterilization influence the application of novel Cu/LDPE nanocomposite intrauterine devices?

Background

Copper/low-density polyethylene (Cu/LDPE) nanocomposite intrauterine device (IUD) is an implanted medicinal device that must be sterilized before use. Sterilization processes act either chemically or physically, leading to a lethal change in the structure or function of organic macromolecules in microorganisms. Given the nature of their action, sterilization might also attack the macromolecules of polymers by the same mechanisms, resulting in changes in surface functional groups and in the internal structure of the polymer. If sterilization leads to changes in surface functional groups and in the internal structure of the LDPE matrix, which will influence the mechanical property and cupric ions release rate of novel Cu/LDPE nanocomposite IUDs, potential clinical application will be limited. Therefore, it is necessary to study the influence of ethylene oxide sterilization on the potential clinical application of novel Cu/LDPE nanocomposite IUDs.

Study Design

The influence of ethylene oxide sterilization on the internal structure, surface functional groups, mechanical property and cupric ions release rate of novel Cu/LDPE nanocomposite IUDs was studied using differential scanning calorimetry, attenuated total reflection Fourier transform infrared spectroscopy, tensile testing and absorbance measurement.

Results

Ethylene oxide sterilization did not have any influence on the internal structure, surface functional groups, mechanical property and cupric ions release rate of novel Cu/LDPE nanocomposite intrauterine devices.

Conclusion

Ethylene oxide sterilization will not affect the potential application of novel Cu/LDPE nanocomposite IUDs.     

Association between characteristics of current menses and preference for induced amenorrhea

Background

Several studies suggest that many women would prefer to avoid menses altogether, but few studies have examined the social or clinical predictors of such preference.

Study Design

In total, 1224 healthy women of reproductive age were surveyed in Brazil, Germany and the United States regarding social, menstrual and reproductive characteristics and preferences for various dimensions of menstruation, including the ideal interval between menses. The extent to which a preference to never bleed was predicted by current experiences with menses was evaluated.

Results

Long menses, menstrual pain and a perceived high cost of pads and tampons were predictive of preferring amenorrhea over all other menstrual patterns after controlling for age, parity and education. Independent significant associations were also found with increasing degrees of life stress and ever use of injectable contraceptives.

Conclusion

A negative experience with menstruation, a high ranking of life stress and ever use of injectable contraception were independently associated with a preference to avoid menses altogether.     

The safety,efficacy and acceptability of task sharing tubal sterilization to midlevel providers: a systematic review

Background

Task sharing is an important strategy for increasing access to modern, effective contraception for women and reducing unmet need for family planning.

Objective

The objective was to identify evidence for the safety, efficacy or acceptability of task sharing tubal sterilization to midlevel providers.

Search strategy

We searched PubMed, Cochrane and Popline for articles in all languages using the following key words: task sharing, tubal sterilization, midlevel providers, task shifting.

Selection criteria

All studies reporting on any measure of safety, efficacy or acceptability of tubal sterilization performed by any cadre of midlevel providers.

Data collection and analysis

Data were independently abstracted by two authors and graded using the United States Preventive Services Task Force rating for evidence quality. Heterogeneity of outcome measures precluded a meta-analysis.

Main results

Nine studies of fair to poor quality reported on safety and acceptability outcomes. Generalizability of findings is limited by inadequate sample size and lack of statistical comparisons. No study reported on long-term efficacy outcomes.

Conclusions

Well-designed clinical trials, of adequate sample size, are urgently needed to establish the safety, efficacy and acceptability of task sharing tubal sterilization to midlevel providers.     

Costs and impact of meningitis epidemics for the public health system in Burkina Faso

Background

Epidemic meningococcal meningitis remains a serious health threat in the African meningitis belt. New meningococcal conjugate vaccines are relatively costly and their efficiency will depend on cost savings realized from no longer having to respond to epidemics.

Methods

We evaluated the cost and impacts to the public health system of the 2007 epidemic bacterial meningitis season in Burkina Faso through a survey at the different level of the health system. A micro-economic approach was used to evaluate direct medical and non medical costs for both the public health system and households, as well as indirect costs for households.

Results

The total national cost was 9.4 million US$ (0.69 US$ per capita). Health system costs were 7.1 million US$ (1.97% of annual national health spending), with 85.6% for reactive vaccination campaigns. The remaining 2.3 million US$ was borne by households of meningitis cases. The mean cost per person vaccinated was 1.45 US$; the mean cost of case management per meningitis case was 116.3 US$ when including household costs and 26.4 US$ when including only health sector costs. Meningitis epidemics disrupted all health services from national to operational levels with the main contributor being a large increase in medical consultations.

Conclusions

Preventive meningococcal conjugate vaccines should contribute to more efficient use of funds dedicated to meningitis epidemics and limit the disruption of routine health services.     

Blockade of tubal patency following transcervical administration of polidocanol foam: initial studies in rhesus macaques

Objective

To demonstrate the feasibility of polidocanol foam (PF) as a nonsurgical method of female permanent contraception using a nonhuman primate model.

Study Design

Four groups of adult female rhesus macaques underwent either transcervical treatment with 5% PF directly into the uterine cavity, treatment with inert (methylcellulose, MF) foam or no treatment followed by removal of the reproductive tract for histologic evaluation. Untreated animals were included in Group 1 (n= 3). Group 2 animals (n= 4) were treated once with MF. Group 3 (n= 7) received a single, and Group 4 (n= 5) received multiple monthly treatments with PF; in these 2 groups, baseline tubal patency was assessed either laparoscopically by chromopertubation (CP) or by hysterosalpingography.

Results

Group 1 (untreated) and Group 2 (MF) animals had normal tubal histology. In contrast, Group 3 and 4 females treated with PF showed evidence of tubal damage. In Group 4, bilateral tubal blockade was noted on CP after two (n= 2) or three (n= 3) treatments. Histologic analysis confirmed complete tubal occlusion (loss of epithelium, fibrosis) in three of these animals, and one showed significant tubal damage localized to the intramural segment. Nontarget (cervix, vagina, endometrium, ovary) reproductive tissues were unaffected. While similar tubal changes were observed after a single treatment (Group 3), endometrial hemorrhage was also noted as an acute change.

Conclusion

PF is a promising candidate agent for nonsurgical permanent female contraception. The histologic features of PF occlusion are confined to the intramural portion of the tube.

Implications

This study in rhesus macaques supports further development of transcervical administration of PF as a nonsurgical approach to permanent contraception. A nonsurgical method could reduce risks and costs associated with surgical female sterilization and increase access to permanent contraception.     

Strengthening the reliability and credibility of observational epidemiology studies by creating an Observational Studies Register

Objective

To evaluate the need for the creation of a system in which observational epidemiology studies are registered; an Observational Studies Register (OSR).

Study Design and Setting

The current scientific process for observational epidemiology studies is described. Next, a parallel is made with the clinical trials area, where the creation of clinical trial registers has greatly restored and improved their credibility and reliability. Next, the advantages and disadvantages of an OSR are compared.

Results

The advantages of an OSR outweigh its disadvantages.

Conclusion

The creation of an OSR, similar to the existing Clinical Trials Registers, will improve the assessment of publication bias and will provide an opportunity to compare the original study protocol with the results reported in the publication. Reliability, credibility, and transparency of observational epidemiology studies are strengthened by the creation of an OSR. We propose a structured, collaborative, and coordinated approach for observational epidemiology studies that can provide solutions for existing weaknesses and will strengthen credibility and reliability, similar to the approach currently used in clinical trials, where Clinical Trials Registers have played a key role in strengthening their scientific value.     

The cost-effectiveness of a modestly effective HIV vaccine in the United States

Background

The recent RV144 clinical trial showed that an ALVAC/AIDSVAX prime-boost HIV vaccine regimen may confer partial immunity in recipients and reduce transmission by 31%. Trial data suggest that efficacy may initially exceed 70% but decline over the following 3.5 years. Estimating the potential health benefits associated with a one-time vaccination campaign, as well as the projected benefits of repeat booster vaccination, may inform future HIV vaccine research and licensing decisions.

Methods

We developed a mathematical model to project the future course of the HIV epidemic in the United States under varying HIV vaccine scenarios. The model accounts for disease progression, infection transmission, antiretroviral therapy, and HIV-related morbidity and mortality. We projected HIV prevalence and incidence over time in multiple risk groups, and we estimated quality-adjusted life years (QALYs) and costs over a 10-year time horizon. We assumed an exponentially declining efficacy curve fit to trial data, and that subsequent vaccine boosters confer similar immunity. Variations in vaccine parameters were examined in sensitivity analysis.

Results

Under existing HIV prevention and treatment efforts, an estimated 590,000 HIV infections occur over 10 years. One-time vaccination achieving 60% coverage of adults could prevent 9.8% of projected new infections over 10 years (and prevent 34% of new infections in the first year) and cost approximately $91,000/QALY gained relative to the status quo, assuming $500 per vaccination series. Targeted vaccination strategies result in net cost savings for vaccines costing less than $750. One-time vaccination of 60% of all adults coupled with three-year boosters only for men who have sex with men and people who inject drugs could prevent 21% of infections for $81,000/QALY gained relative to vaccination of higher risk sub-populations only. A program attaining 90% vaccination coverage prevents 15% of new HIV cases over 10 years (and approximately 50% of infections in the first year).

Conclusions

A partially effective HIV vaccine with effectiveness similar to that observed in the RV144 trial would provide large health benefits in the United States and could meet conventionally accepted cost-effectiveness thresholds. Strategies that prioritize key populations are most efficient, but broader strategies provide greater total population health benefit.