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Sponsored by the nonprofit Berlex Foundation, this 6-day Faculty Development Course introduces small groups of new faculty to research design, critical appraisal of the literature, scientific writing, and evidence-based medicine. The course includes didactic presentations, small group discussions, and individual protocol development. Its influence on academic careers is impossible to determine, because defining an appropriate comparison group is not feasible. However, the cumulative effect should be to increase the research expertise of some young faculty in academic departments nationwide. In addition, many participants have introduced the principles of evidence-based medicine in their own teaching programs.

In the late 1960s, states began to liberalize their abortion laws, and a new era in women's health began. Under the leadership of Jack Smith, the Centers for Disease Control and Prevention (CDC) established a voluntary abortion surveillance system that provided the first nationwide information on the numbers and characteristics of women having abortions. Studies of abortion morbidity done by the CDC revealed that suction curettage was safer than sharp curettage, local anesthesia was safer than general anesthesia, free-standing clinics were safer than hospitals, and dilation and evacuation (D&E) was safer than the alternative of labor induction for early second-trimester abortions. This evidence, which contradicted traditional medical tenets, rapidly changed the practice of abortion in the United States. CDC also established a surveillance system for abortion deaths. This demonstrated a rapid improvement in the safety of abortion in the early 1970s. Lessons learned from mortality investigations helped to change practice as well.Today, more is known about the epidemiology of abortion than any other operation in the history of medicine. In the midst of strident debate over the abortion issue, CDC abortion surveillance data have helped to guide judicial rulings, legislative actions, and Surgeon General's reports, which have supported safer choices for women of reproductive age. When medical historians of the future look back on this century, the increasing availability of safe, legal abortion will stand out as a public health triumph.

Objective To review published articles in four U.S. obstetrics and gynecology journals labeled "case-control" studies to estimate the frequency of mislabeling the type of study. Methods I searched PubMed from January 1970 through May 2009, using journal name and "case-control" in the title as search terms. The journals included the American Journal of Obstetrics & Gynecology, Fertility and Sterility, Journal of Reproductive Medicine, and Obstetrics & Gynecology. I reviewed the methods of each report to confirm the study design and calculated the proportion of articles labeled as "case-control" in the title that were not case-control studies. I calculated Fisher's exact 95% confidence intervals around these proportions. Results In the 124 reports identified, the proportion of mislabeled "case-control" studies was 30% overall. It varied from 13% to 36% in the four journals, a 2.8-fold difference in frequency (95% confidence interval 0.9-9.0). The frequency of this mislabeling appears to have increased over time. Conclusion Retrospective cohort studies are often mislabeled as "case-control" studies. This misleads readers as to what was done. Researchers need better training in methods and terminology, and editors and reviewers should scrutinize more carefully manuscripts claiming to be "case-control" studies. Level of evidence III.

Objective: To assess patients’ ability to compare magnitudes of Down syndrome risk at maternal ages of 35 and 40 years, expressed as rates or as proportions. Methods: We used a self-administered, anonymous questionnaire that posed the same comparison in two different formats: 2.6 versus 8.9 per 1000 women (rates) and one in 384 versus one in 112 women (proportions). The study setting included several university-affiliated obstetrics and gynecology outpatient clinics in San Francisco, California. A total of 633 women, whose primary languages were English, Spanish, or Chinese, participated. The main outcome measure was correct identification of the larger of two risks. Results: Women were more successful with rates (463 of 633 respondents, 73%) than with proportions (353 of 633 respondents, 56%). A paired analysis, in which each woman served as her own control, found risk assessment to be significantly better with rates than with proportions (P < .001). Women with little formal education had difficulty understanding risks framed either way. Conclusion: The traditional use of proportions to express risk in genetic counseling lacks scientific basis. Rates were easier to understand than proportions, regardless of respondents’ age, language, and education.

In part because of limited public access, Cochrane reviews are underused in the United States compared with other developed nations. To assess use of these reviews by opinion leaders, we examined citation of Cochrane reviews in the Clinical Expert Series of Obstetrics & Gynecology from inception through June of 2007. We reviewed all 54 articles for mention of Cochrane reviews, then searched for potentially relevant Cochrane reviews that the authors could have cited. Thirty-six of 54 Clinical Expert Series articles had one or more relevant Cochrane reviews published at least two calendar quarters before the Clinical Expert Series article. Of these 36 articles, 19 (53%) cited one or more Cochrane reviews. We identified 187 instances of relevant Cochrane reviews, of which 40 (21%) were cited in the Clinical Expert Series articles. No temporal trends were evident in citation of Cochrane reviews. Although about one half of Clinical Expert Series articles cited relevant Cochrane reviews, most eligible reviews were not referenced. Wider use of Cochrane reviews could strengthen the scientific basis of this popular series.

From 4%-14% of intrauterine device (IUD) users have their IUD removed due to bleeding or pelvic pain in the first year of use. Past studies have analyzed whether baseline patient information can help predict such removals, but no previous analysis has examined whether information provided at the recommended 1-month follow-up visit could improve such predictions. Using data from an international multicenter randomized controlled trial, 89 women with removals for bleeding and pain after the 1-month visit were compared with 2536 continuing users. Logistic regression indicated several significant predictors of removal. Women reporting intermenstrual bleeding since last menses were nearly three times more likely to have removals for bleeding or pain (odds ratio [OR] 2.9; 95% confidence interval [CI] 1.4-5.9). Similarly, those complaining of excessive menstrual flow were 3.5 times more likely to have removals within 12 months (95% CI 1.4-9.2). Women reporting these menstrual problems during scheduled revisits may benefit from counseling and treatment with nonsteroidal anti-inflammatory drugs (NSAID).

The alleged association between induced abortion and breast cancer is one of the most controversial and important questions in women's health today.To help clinicians provide appropriate counseling, we reviewed both the primary data and review articles on this topic. We identified the studies and re

Critical appraisal might be the most important skill to acquire in medical school. Despite its importance, this issue has received little attention in obstetrics and gynecology training. This article describes the approach used at San Francisco General Hospital. We teach critical appraisal in several ways. We provide a series of student seminars that foster critical reading of the literature. Topics range from technology assessment to contraception to sexually transmitted diseases. Evidence-based ward rounds complement the experience. During the rotation, each student formally reviews one topic in women's health using the US Preventive Services Task Force rating system. Although we lack a quantitative assessment of this approach, student feedback has been enthusiastic. Critical appraisal skills enable students to continue their medical education after completion of their formal training.

Summary Background The value of antibiotic prophylaxis before insertion of an intrauterine device (IUD) remains uncertain. We undertook a triple-masked, randomised, placebo-controlled trial to find out whether such prophylaxis reduces the rate of IUD removal within 90 days. Methods 11 clinic sites in southern California enrolled women who requested IUD insertion and were at low risk of sexually transmitted infection according to self-reported medical history. We randomly assigned 1985 participants either 500 mg azithromycin or placebo capsules of identical appearance taken about 1 h before insertion of a Copper T 380A IUD. 118 women did not have an IUD inserted. We followed up 1833 of the remaining 1867 (98%) participants for at least 90 days after insertion. Findings The rate of IUD removal for any reason other than partial expulsion was 3·8% (35/918) in the antibiotic group and 3·4% (31/915) in the placebo group (relative risk 1·1 [95% Cl 0·7–1·8]). The two treatment groups sought medical attention with equal frequency (mean 38 visits per 100 women). During the 90 days after IUD insertion, only one woman from each assignment group had salpingitis, as defined by established criteria. Interpretation Prophylaxis with azithromycin did not affect the likelihood that a woman would retain her IUD at 90 days or the frequency of postinsertion medical attention. In appropriately screened women, the risk of upper-genitaltract infection is negligible after IUD insertion, with or without the administration of prophylactic antibiotics.

Objective: To review the literature on medical abortion in early pregnancy. Data Sources: I performed a MEDLINE search, supplemented by bibliographies of articles and textbooks. In addition, investigators in the field were consulted to identify other sources. The review was limited to reports in English or French concerning antiprogestins or methotrexate used either alone or in combination with a prostaglandin. Methods of Study Selection: Only those mifepristone studies with 100 or more participants were included. Those participants who received the prostaglandin sulprostone were excluded because this drug is no longer used with mifepristone. Methotrexate studies of any size were included. All reports were categorized by study type, and the evidence was evaluated using the U.S. Preventive Services Task Force rating system. Tabulation, Integration, and Results: Both mifepristone and methotrexate, when used with a prostaglandin, can induce abortion safely in early pregnancy. Class I evidence supports a class A (good) recommendation that oral, single mifepristone doses of 200 mg and 600 mg have similar efficacy when used with a prostaglandin. Sequential and single-dose regimens have comparable efficacy. Vaginal misoprostol at 800 μg as an augmenting agent appears superior to the same dose given orally. With methotrexate abortion, 800 μg of misoprostol given vaginally 7 days after methotrexate is superior to the same dose given 3 days after. In addition, methotrexate in combination with misoprostol is more effective than misoprostol alone. Conclusion: Medical abortion with mifepristone or methotrexate in combination with a prostaglandin is safe and effective. However, the risk of hemorrhage and gastrointestinal side effects is greater with medical abortion than with suction curettage. Further research should be done to compare mifepristone and methotrexate abortions, to determine the upper gestational age limit, and to find the best way to provide this service in the U.S. health care system.

BACKGROUND: Worldwide, hormonal contraceptives are among the most popular reversible contraceptives. Despite high perfect‐use effectiveness rates, typical‐use effectiveness rates for shorter‐term methods such as oral and injectable contraceptives are much lower. In large part, this disparity reflects difficulties in ongoing adherence to the contraceptive regimen and low continuation rates. Correct use of contraceptives to ensure effectiveness is vital to reducing unintended pregnancy. OBJECTIVES: To determine the effectiveness of strategies aiming to improve adherence to, and continuation of, shorter‐term hormonal methods of contraception compared with usual family planning care. SEARCH METHODS: We searched to July 2018 in the following databases (without language restrictions): The Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 7), PubMed via MEDLINE, POPLINE, Web of Science, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP). SELECTION CRITERIA: We included randomized controlled trials (RCTs) comparing strategies aimed to facilitate adherence and continuation of shorter‐term hormonal methods of contraception (such as oral contraceptives (OCs), injectable depot medroxyprogesterone acetate (DMPA or Depo‐Provera), intravaginal ring, or transdermal patch) with usual family planning care in reproductive age women seeking to avoid pregnancy. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. Primary outcomes were continuation or discontinuation of contraceptive method, rates of discontinuation due to adverse events (menstrual disturbances and all other adverse events), and adherence to method use as indicated by missed pills and on‐time/late injections. Pregnancy was a secondary outcome. MAIN RESULTS: We included 10 RCTs involving 6242 women. Six trials provided direct in‐person counseling using either multiple counseling contacts or multiple components during one visit. Four trials provided intensive reminders of appointments or next dosing, of which two provided additional educational health information as well as reminders. All trials stated 'usual care' as the comparison. The certainty of the evidence ranged from very low to moderate. Main limitations were risk of bias (associated with poor reporting of methodological detail, lack of blinding, and incomplete outcome data), inconsistency, indirectness, and imprecision. Continuation of hormonal contraceptive methods It is uncertain whether intensive counseling improves continuation of hormonal contraceptive methods compared with usual care (OR 1.28, 95% CI 1.07 to 1.54; 2624 participants; 6 studies; I(2) = 79%; very low certainty evidence). The evidence suggested: if the chance of continuation with usual care is 39%, the chance of continuation with intensive counseling would be between 41% and 50%. The overall pooled OR suggested continuation of improvement, however, when stratified by contraceptive method type, the positive results were restricted to DMPA. It is uncertain whether reminders (+/‐ educational information) improve continuation of hormonal contraceptive methods compared with usual care (OR 1.33, 95% CI 1.03 to 1.73; 933 participants; 2 studies; I(2) = 69%; very low certainty evidence).The evidence suggested: if the chance of continuation with usual care is 52%, the chance of continuation with reminders would be between 52% and 65%. Discontinuation due to adverse events The evidence suggested that counseling may be associated with a decreased rate of discontinuation due to adverse events compared with usual care, with a lower rate of discontinuation due to menstrual disturbances (OR 0.20, 95% CI 0.11 to 0.37; 350 participants; 1 study; low certainty evidence), but may make little or no difference to all other adverse events (OR 0.73, 95% CI 0.36 to 1.47; 350 participants; 1 study; low certainty evidence). The evidence suggested: if the chance of discontinuation with usual care due to menstrual disturbances is 32%, the chance of discontinuation with intensive counseling would be between 5% and 15%; and that if the chance of discontinuation with usual care due to other adverse events is 55%, the chance of discontinuation with intensive counseling would be between 30% and 64%. Discontinuation was not reported among trials that investigated the use of reminders (+/‐ educational information). Adherence Adherence was not reported among trials that investigated the use of intensive counseling. Among trials that investigated reminders (+/‐ educational information), there was no conclusive evidence of a difference in adherence as indicated by missed pills (MD 0.80, 95% CI ‐1.22 to 2.82; 73 participants; 1 study; moderate certainty evidence) or by on‐time injections (OR 0.84, 95% CI 0.54 to 1.29; 350 participants; 2 studies; I(2) = 0%; low certainty evidence). The evidence suggested: if the chance of adherence to method use as indicated by on‐time injections with usual care is 50%, the chance of adherence with method use as indicated by on‐time injections with reminders would be between 35% and 56%. Pregnancy There was no conclusive evidence of a difference in rates of pregnancy between intensive counseling and usual care (OR 1.24, 95% CI 0.98 to 1.57; 1985 participants; 3 studies; I(2) = 0%, very low certainty evidence). The evidence suggested: if the chance of pregnancy with usual care is 18%, the chance of pregnancy with counseling would be between 18% and 25%. Pregnancy was not reported among trials that investigated the use of reminders (+/‐ educational information). AUTHORS' CONCLUSIONS: Despite the importance of this topic, studies have not been published since the last review in 2013 (nine studies) with only one study added in 2019 that neither changed the results nor improved the certainty of evidence. Overall, the certainty of evidence for strategies to improve adherence and continuation of contraceptives is low. Intensive counseling and reminders (with or without educational information) may be associated with improved continuation of shorter‐term hormonal contraceptive methods when compared with usual family planning care. However, this should be interpreted with caution due to the low certainty of the evidence. Included trials used a variety of shorter‐term hormonal contraceptive methods which may account for the high heterogeneity. It is possible that the effectiveness of strategies for improving adherence and continuation are contingent on the contraceptive method targeted. There was limited reporting of objectively measurable outcomes (e.g. electronic monitoring device) among included studies. Future trials would benefit from standardized definitions and measurements of adherence, and consistent terminology for describing interventions and comparisons. Further research requires larger studies, follow‐up of at least one year, and improved reporting of trial methodology.

Spermicides have been used as contraceptives for thousands of years. Despite this long use, only recently have studies examined the comparative efficacy and acceptability of these vaginal medications. Spermicides contain an active ingredient (most commonly nonoxynol-9) and a formulation used to disperse the product, such as foam or vaginal suppository.This review examined all known randomized controlled trials of a spermicide used alone for contraception.In August 2013, we searched the following computerized databases for randomized controlled trials of spermicides for contraception: CENTRAL, MEDLINE, POPLINE, LILACS, EMBASE, ClinicalTrials.gov, and ICTRP. For the initial review, we examined the reference lists of trials found as well as those of review articles and textbook chapters.We included any trial of a commercial product used alone for contraception. Each included trial must have provided sufficient information to determine pregnancy rates.Two authors independently extracted information from the trials identified. We did not conduct a meta-analysis, since most trials had large losses to follow up. We entered the data into tables and presented the results descriptively.We located reports from 14 trials for the initial review, but have not identified any new trials since then. In the largest trial to date, the gel (Advantage S) containing the lowest dose of nonoxynol-9 (52.5 mg) was significantly less effective in preventing pregnancy than were gels with higher doses of the same agent (100 mg and 150 mg). Probabilities of pregnancy by six months were 22% for the 52.5 mg gel, 16% for the 100 mg dose, and 14% for the 150 mg dose. In the same trial, the three different vehicles with 100 mg of nonoxynol-9 had similar efficacy. Interpretation of these figures is limited, since 39% of participants discontinued the method or were lost from the trial. Few important differences in efficacy emerged in other trials.The probability of pregnancy varied widely in reported trials. A gel containing nonoxynol-9 52.5 mg was inferior to two other products tested in the largest trial. Aside from this finding, personal characteristics and behavior of users may be more important than characteristics of the spermicide products in determining the probability of pregnancy. Gel was liked more than the film or vaginal suppository in the largest trial. Spermicide trials have the dual challenges of difficult recruitment and high discontinuation rates; the latter threatens trial validity.

BACKGROUND: Concern about estrogen‐related adverse effects has led to progressive reductions in the estrogen dose in combination oral contraceptives (COCs). However, reducing the amount of estrogen to improve safety could result in decreased contraceptive effectiveness and unacceptable changes in bleeding patterns. OBJECTIVES: To test the hypothesis that COCs containing ≤ 20 μg ethinyl estradiol (EE) perform similarly as those containing > 20 μg in terms of contraceptive effectiveness, bleeding patterns, discontinuation, and side effects. SEARCH METHODS: In July 2013, we searched CENTRAL, MEDLINE, and POPLINE, and examined references of potentially eligible trials. We also searched for recent clinical trials using ClinicalTrials.gov and ICTRP. No new trials met the inclusion criteria. Previous searches included EMBASE. For the initial review, we wrote to oral contraceptive manufacturers to identify trials. SELECTION CRITERIA: English‐language reports of randomized controlled trials were eligible that compare a COC containing ≤ 20 μg EE with a COC containing > 20 μg EE. We excluded studies where the interventions were designed to be administered for less than three consecutive cycles or to be used primarily as treatment for non‐contraceptive conditions. Trials had to report on contraceptive effectiveness, bleeding patterns, trial discontinuation due to bleeding‐related reasons or other side effects, or side effects to be included in the review. DATA COLLECTION AND ANALYSIS: One author evaluated all titles and abstracts from literature searches to determine whether they met the inclusion criteria. Two authors independently extracted data from studies identified for inclusion. We wrote to the researchers when additional information was needed. Data were entered and analyzed with RevMan. MAIN RESULTS: No differences were found in contraceptive effectiveness for the 13 COC pairs for which this outcome was reported. Compared to the higher‐estrogen pills, several COCs containing 20 μg EE resulted in higher rates of early trial discontinuation (overall and due to adverse events such as irregular bleeding) as well as increased risk of bleeding disturbances (both amenorrhea or infrequent bleeding and irregular, prolonged, frequent bleeding, or breakthrough bleeding or spotting). AUTHORS' CONCLUSIONS: While COCs containing 20 μg EE may be theoretically safer, this review did not focus on the rare events required to assess this hypothesis. Data from existing randomized controlled trials are inadequate to detect possible differences in contraceptive effectiveness. Low‐dose estrogen COCs resulted in higher rates of bleeding pattern disruptions. However, most trials compared COCs containing different progestin types, and changes in bleeding patterns could be related to progestin type as well as estrogen dose. Higher follow‐up rates are essential for meaningful interpretation of results.

BACKGROUND: The contraceptive vaginal sponge was developed as an alternative to the contraceptive diaphragm. The sponge, made of polyurethane impregnated with nonoxynol‐9 (1g), releases 125 mg of the spermicide over 24 hours of use. Unlike the diaphragm, the sponge can be used for more than one coital act within 24 hours without the insertion of additional spermicide, and the sponge does not require fitting or a prescription from a physician. How the sponge compares with the diaphragm in terms of efficacy and continuation is not clear. OBJECTIVES: To compare the efficacy and continuation rates of the sponge with the diaphragm (used with nonoxynol‐9). Our a priori hypothesis was that the sponge would have higher rates for failure and discontinuation than the diaphragm. SEARCH METHODS: In April 2013, we searched the computerized databases MEDLINE, POPLINE, LILACS, CENTRAL, ClinicalTrials.gov and ICTRP. Earlier searches also included EMBASE. For the initial review, we searched the reference lists of relevant articles and book chapters. We also contacted investigators involved with the identified trials for other published or unpublished trials. SELECTION CRITERIA: We included randomized controlled trials comparing the vaginal contraceptive sponge (Today; Collatex) with any diaphragm used with nonoxynol‐9 to prevent pregnancy. DATA COLLECTION AND ANALYSIS: We examined the studies identified through the literature searches for possible inclusion and evaluated their methodological quality using the Cochrane guidelines. We entered data into RevMan and calculated Peto odds ratios for overall pregnancy and 12‐month discontinuation using numbers of women as the denominator. We also abstracted 12‐month cumulative life‐table ratios for these same outcomes but were unable to aggregate these data. MAIN RESULTS: Two trials met the inclusion criteria. The sponge was significantly less effective in both trials in preventing overall pregnancy than was the diaphragm. In the larger USA trial, the 12‐month cumulative life‐table termination rates per 100 women for overall pregnancy were 17.4 for the sponge and 12.8 for the diaphragm. The rates were 24.5 for the sponge and 10.9 for the diaphragm in the UK trial. Similarly, discontinuation rates at 12 months were higher with the sponge than with the diaphragm (Odds ratio 1.31; 95% CI 1.07 to 1.59). Allergic‐type reactions were more common with the sponge, although discontinuation for discomfort differed in the two trials. No new trials have been identified since the initial review. AUTHORS' CONCLUSIONS: The sponge was less effective than the diaphragm in preventing pregnancy. Discontinuation rates were higher at 12 months as well. Other randomized controlled trials will be needed to resolve the potential role of spermicides in preventing sexually transmitted infections or in causing adverse effects.

Pharyngeal pouch patients often present with dysphagia and risk perforation when undergoing gastroscopy. Knowledge of pharyngeal pouch incidence and predictive demographic features in patients referred for dysphagia would help determine those patients who should have barium swallow as an initial investigation. The prospectively collected data of 2,797 consecutive referrals were analysed. Logistic regression determined significant variables for predicting pharyngeal pouches. Of the 2,430 patients investigated [mean age = 67.7 years, range 17-103; 48.2 % male], 49 (2.0 %) had a pharyngeal pouch [mean age = 79.8 years (range 58-93); 53.1 % male]. Significant predictors of pharyngeal pouch were pharyngeal level dysphagia (odds ratio [OR] 3.8-19.2), age over 65 years (OR 2.2-14.1), symptom duration over 12 weeks (OR 1.1-3.9), and no weight loss (OR 1.1-5.5). Only 18 patients (36.7 %) underwent surgery for their pouch. Midsternal dysphagia alone occurred in 16 % of all patients with pouches. From our results we conclude that pharyngeal pouches in a dysphagic population are more common than previously recognised. Patients aged over 65 years with pharyngeal level dysphagia for more than 12 weeks should have a barium swallow as their initial investigation.

"Therapeutic" bed rest continues to be used widely, despite evidence of no benefit and known harms. In this commentary, we summarize the Cochrane reviews of bed rest and propose an ethical argument for discontinuing this practice. Cochrane systematic reviews do not support "therapeutic" bed rest for threatened abortion, hypertension, preeclampsia, preterm birth, multiple gestations, or impaired fetal growth. This assessment has been echoed in other comprehensive reviews. Prescribing bed rest is inconsistent with the ethical principles of autonomy, beneficence, and justice. Hence, if bed rest is to be used, it should be only within a formal clinical trial.

Background Combination injectable contraceptives (CICs) provide a highly effective, reversible method of preventing pregnancy, and they do not require daily administration or use at the time of coitus. Although they are used in many countries, their acceptability could be limited by method characteristics, such as the need to obtain a monthly injection or bleeding pattern changes. Objectives To assess the contraceptive efficacy, bleeding patterns, discontinuation, user preferences, and side effects of CICs. Search methods In January and February 2013, we searched for randomized controlled trials (RCTs) of combination injectable contraceptives. Databases include MEDLINE, POPLINE, CENTRAL, EMBASE, and LILACS. We searched for current trials in ClinicalTrials.gov and ICTRP. Earlier searches also included AIM and IMEMR. For the initial review, we also assessed the references listed in review articles and in the eligible trial reports. Selection criteria RCTs were eligible if they compared a combination injectable contraceptive with any other contraceptive method (e.g., a second CIC, a progestin-only injectable contraceptive, another hormonal contraceptive or a barrier method) or a placebo. We limited the review to marketed CICs. Data collection and analysis Two authors independently extracted data on contraceptive efficacy, bleeding patterns, continuation, and side effects. We calculated the Peto odds ratio or mean difference with 95% confidence interval for dichotomous or continuous outcome, respectively. Survival analysis estimates for method discontinuation were presented where available. Main results Twelve trials met the inclusion criteria. Combination injectable contraceptives include depot medroxyprogesterone acetate (DMPA) 25 mg plus estradiol cypionate (E2C) 5 mg, as well as norethisterone enanthate (NET-EN) 50 mg plus estradiol valerate (E2V) 5 mg. These contraceptives resulted in lower rates of early study discontinuation due to amenorrhea or other bleeding problems than progestin-only contraceptives. However, rates were higher for overall discontinuation and discontinuation due to other medical reasons. Acceptability results favored the CIC in one study and the progestin-only in another. Studies comparing two CICs found that NET-EN 50 mg plus E2V 5 mg resulted in less overall discontinuation and less discontinuation due to amenorrhea or prolonged bleeding than DMPA 25 mg plus E2C 5 mg. However, these differences were not detected in all trials. The NET-EN plus E2V group also had more regular bleeding and fewer prolonged bleeding reference periods than the DMPA plus E2C group. The groups did not differ in their amenorrhea rates. Authors' conclusions While discontinuation rates can be viewed as a measure of method acceptability, the findings should be interpreted with caution since discontinuation depends on many factors. Future research should be directed toward improving the acceptability of combination injectable contraceptives, such as providing injections in settings more convenient than clinics, methods for women to administer their own injections, and counseling about possible bleeding pattern changes.

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 METHODS: Through February 2013 we searched the computerized databases of MEDLINE POPLINE CENTRAL PsycINFO and CINAHL ClinicalTrials.gov and ICTRP. Previous searches also included EMBASE. We also examined references lists of relevant articles. For the initial review we 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.Outcome measures were knowledge of contraceptive effectiveness attitude about contraception or toward any particular contraceptive and choice or use of contraceptive method. DATA COLLECTION AND ANALYSIS: For the initial review two authors independently extracted the data. One author entered the data into RevMan and a second author verified accuracy. For the update an author and a research associate extracted entered and checked the data.For dichotomous variables we calculated the Mantel-Haenszel odds ratio with 95% confidence intervals (CI). For continuous variables we computed the mean difference (MD) with 95% CI. MAIN RESULTS: Seven trials met the inclusion criteria and had a total of 4526 women. Five were multi-site studies. Four trials were conducted in the USA while Nigeria and Zambia were represented by one study each and one trial was done in both Jamaica and India.Two trials provided multiple sessions for participants. In one study that 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) i.e. sterilization pills injectable intrauterine device or barrier method. For the other study the groups received educational interventions with differing format and intensity. Both groups reportedly had increases in contraceptive use but they did not differ significantly by six months in consistent use of an effective contraceptive i.e. sterilization IUD injectable implant and consistent use of oral contraceptives diaphragm or male condoms.Five trials provided one session and focused on testing educational material or media. In one study knowledge gain favored a slide-and-sound presentation versus a physicians oral presentation (MD -19.00; 95% CI -27.52 to -10.48). In another trial a table with contraceptive effectiveness categories led to more correct answers than a table based on pregnancy 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 effectiveness categories and pregnancy numbers [ORs were 2.58 (95% CI 1.5 to 4.42) and 2.03 (95% CI 1.13 to 3.64)]. Still another trial provided structured counseling with a flipchart on contraceptive methods. The intervention and usual-care groups did not differ significantly in choice of contraceptive method (by effectiveness category) or in continuation of the chosen method at three months. Lastly a study with couples used videos to communicate contraceptive information (control motivational contraceptive methods and both motivational and methods videos). The analyses showed no significant difference between the groups in the types of contraceptives chosen. AUTHORS CONCLUSIONS: These trials varied greatly in the types of participants and interventions to communicate contraceptive effectiveness. Therefore we cannot say overall what would help consumers choose an appropriate contraceptive method. For presenting pregnancy risk data one trial showed that effectiveness categories were better than pregnancy numbers. In another trial audiovisual aids worked better than the usual oral presentation. Strategies should be tested in clinical settings and measured for their effect on contraceptive choice. More detailed reporting of intervention content would help in interpreting results. Reports could also include whether the instruments used to assess knowledge or attitudes were tested for validity or reliability. Follow-up should be incorporated to assess retention of knowledge over time. The overall quality of evidence was considered to be low for this review given that five of the seven studies provided low or very low quality evidence.

Summary Numerous obstacles stand in the way of evidence-based medicine in obstetrics and gynaecology. These include seduction by clinical authorities, the false idol of technology, the tendency to let sleeping dogmas lie, the pursuit of pedantry in medical education, and the problem of clinical numerators in search of a denominator. Recognizing the importance of placing our practice on a more scientific footing, we launched evidence-based medicine in our department in a municipal academic hospital in 1993. We orient all new clinicians to the process of evidence-based medicine and level the intellectual playing field. As clinical questions arise, we decide them in a group setting using the best available evidence. This has led to a number of changes in practice. Easy access to information around the clock is fundamentally important. Resources include access to literature searches, the Internet, the Cochrane Collaboration on Pregnancy and Childbirth, ACOGNET and Epi Info 6. Evidence-based medicine equips clinicians to practise safely and effectively both now and, what is more important, in the next century.

Estimation of the sample size is a fundamental but usually ignored requirement of the randomized controlled trial (RCT). Indeed, the publication of small trials without consideration of sample size is worrisome from both medical and ethical viewpoints. Type II errors are common, and readers and investigators may reject worthwhile treatments and interventions. Before embarking on an RCT, the investigator must choose an alpha, a beta, and the rates of outcomes anticipated in both treatment groups. This should reflect the characteristics of the condition and its treatment. If limited sample size or available resources pose a problem, the use of continuous outcome measures, paired before-after measurements, and more common outcome measures can minimize sample size requirements. If these approaches are not satisfactory, then a multicenter trial may be in order.

Around 600 BC, Daniel of Judah conducted what is widely regarded as the earliest recorded clinical trial. His trial compared the health effects of a vegetarian diet with those of a royal Babylonian diet over a 10-day period. The strengths of his study include the use of a contemporaneous control group, use of an independent assessor of outcome, and striking brevity in the published report. Weaknesses include probable selection bias, ascertainment bias, and confounding by divine intervention. Although Daniel probably never achieved tenure, he did get "learning and skill in all letters and wisdom ... and understanding in all visions and dreams" (well before Freud). Despite the trial's dramatic findings, over 4 centuries elapsed before publication of Daniel's results. Daniel apparently perished, then published.

Objective: To compare the safety and efficacy of outpatient and inpatient treatment of pyelonephritis in pregnancy. Methods: We performed a randomized controlled trial of pregnant women with pyelonephritis before 24 weeks' estimated gestational age, comparing inpatient and outpatient treatment. Sixty inpatients received cefazolin intravenously until afebrile for 48 hours, and 60 outpatients received two injections of ceftriaxone intramuscularly. All patients completed a 10-day course of oral cephalexin. We performed a urine culture 5–14 days after completion of therapy. Results: The two groups were similar with respect to age, parity, temperature, estimated gestational age, initial white blood cell count, and incidence of bacteremia. Escherichia coli was the major uropathogen isolated (86% of cultures, 95 of 111). Twelve percent (13 of 111) of bacteria were resistant to cefazolin. Eleven outpatients and 12 inpatients had positive urine cultures after therapy (relative risk 0.9, 95% confidence interval 0.4–1.9). Three patients in each group had recurrent pyelonephritis. We switched six inpatients to gentamicin because of a worsening clinical picture (two) or a prolonged febrile course (four); no outpatients required a change in antibiotic (Fisher exact test, P = .03). One preterm delivery occurred in an inpatient with recurrent pyelonephritis. Conclusion: Outpatient antibiotic therapy is effective and safe in selected pregnant women with pyelonephritis.

Ground-water, alluvium, and bedrock samples were collected from drill holes near the Chimney Creek, Preble, Summer Camp, and Rabbit Creek disseminated gold deposits in northern Nevada to determine if Au and ore-related metals, such as As, Sb, and W, are being hydromorphically mobilized from buried mineralized rock, and, if they are, to determine whether the metal-enriched ground water is reacting with the alluvial material to produce a geochemical anomaly within the overburden. Results of chemical analyses of drill-hole water samples show the presence of hydromorphic dispersion anomalies of Au, As, Sb, and W in the local ground-water systems associated with these deposits. Background concentrations for Au in the ground water up-gradient from the buried deposits was less than 1 nanogram per liter (ng/L), near the deposits the Au values ranged from 1 to 140 ng/ L, and in drill holes penetrating mineralized rock, concentrations of Au in the ground water were as high as 4700 ng/L. Highest concentrations of Au were found in ground-water samples where the measured Eh and the distribution of arsenic species, arsenite [As(III)] and arsenate [As(V)], indicated oxidizing redox potentials. Similarly, As, Sb, and W concentrations in the ground water near the deposits were significantly enriched relative to concentrations in the ground water up-gradient from the deposits. In general, however, the highest concentrations of As, Sb, and W occurred in ground-water samples where the measured Eh and the distribution of arsenic species indicated reducing conditions. Arsenic concentrations ranged from 9 to 710 micrograms per liter (μg/L); Sb, from less than 0.1 to 250 μg/L; and W, from 1 to 260 μg/L. In addition, analysis of sequential dissolution and extraction solutions of drill cuttings of alluvium and bedrock indicate geochemical anomalies of gold and ore-related metals in the overburden at depths corresponding to the location of the present-day water table. This relationship suggests that water-rock reactions around these buried deposits are active and that this information could be very useful in exploration programs for concealed disseminated gold deposits.

Most reported associations in observational clinical research are false, and the minority of associations that are true are often exaggerated. This credibility problem has many causes, including the failure of authors, reviewers, and editors to recognize the inherent limitations of these studies. This issue is especially problematic for weak associations, variably defined as relative risks (RRs) or odds ratios (ORs) less than 4. Such associations, commonly reported in the medical literature, are more likely to be attributable to bias than to causal association. All observational research has bias (which can include selection, information, and confounding bias). Hence, detection of small associations falls below the discriminatory ability of observational studies. In general, unless RRs in cohort studies exceed 2 to 3 or ORs in case-control studies exceed 3 or 4, associations in observational research findings should not be considered credible. However, these guidelines are not foolproof: strong (yet spurious) associations can result when large amounts of bias are present. Only in a properly performed randomized controlled trial, free of bias, should small associations merit attention. Better training and more circumspection on the part of investigators, tougher editorial standards on the part of journals, and hefty skepticism on the part of referees and readers are necessary to avoid the dangers of false alarms, pseudo-epidemics, and their unfortunate consequences.

BACKGROUND: Providing contraceptive education is now considered a standard component of postpartum care. The effectiveness is seldom examined. Questions have been raised about the assumptions on which such programs are based, e.g., that postpartum women are motivated to use contraception and that they will not return to a health center for family planning advice. Surveys indicate that women may wish to discuss contraception both prenatally and after hospital discharge. Nonetheless, two-thirds of postpartum women may have unmet needs for contraception. In the USA, many adolescents become pregnant again within a year a giving birth. OBJECTIVES: Assess the effects of educational interventions for postpartum mothers about contraceptive use SEARCH METHODS: In May 2012, we searched the computerized databases of MEDLINE, CENTRAL, CINAHL, PsycINFO, and POPLINE. We also searched for current trials via ClinicalTrials.gov and ICTRP. Previous searches also included EMBASE. In addition, we examined reference lists of relevant articles, and contacted subject experts to locate additional reports. SELECTION CRITERIA: Randomized controlled trials were considered if they evaluated the effectiveness of postpartum education about contraceptive use. The intervention must have started postpartum and have occurred within one month of delivery. DATA COLLECTION AND ANALYSIS: We assessed for inclusion all titles and abstracts identified during the literature searches with no language limitations. The data were abstracted and entered into RevMan. Studies were examined for methodological quality. For dichotomous outcomes, the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI) was calculated. For continuous variables, we computed the mean difference (MD) with 95% CI. Due to varied study designs, we did not conduct meta-analysis. MAIN RESULTS: Ten trials met the inclusion criteria. Of four trials that provided one or two counseling sessions, two showed some evidence of effectiveness. In a study from Nepal, women with an immediate postpartum and a session three months later were more likely to use contraception at six months than those with only the later session (OR 1.62; 95% CI 1.06 to 2.50). However, most comparisons did not show evidence of effectiveness. In a trial conducted in Pakistan, women in the counseling group were more likely than those without counseling to use contraception at 8 to 12 weeks postpartum (OR 19.56; 95% CI 11.65 to 32.83). The assessments were short-term. The remaining two studies were from the USA; one did not provided sufficient data and one had too small a sample to detect differences.Six trials provided multifaceted programs with many contacts. Three showed evidence of effectiveness. Of those, two USA studies focused on adolescents. Adolescents in a home-visiting program were less likely to have a second birth in two years compared to adolescents who received usual care (OR 0.41; 95% CI 0.17 to 1.00). In the other trial, adolescents receiving enhanced well-baby care were less likely to have a repeat pregnancy by 18 months compared to those with usual well-baby care (OR 0.35; 95% CI 0.17 to 0.70). In an Australian study, teenagers in a structured home-visiting program were more likely to use contraception at six months than those who had standard home visits (OR 3.24; 95% CI 1.35 to 7.79). The trials without evidence of effectiveness included two for adolescents in the USA (computer-assisted motivational interviewing and cell phone counseling) and a home-visiting program for women in Syria. AUTHORS' CONCLUSIONS: The overall quality of evidence was moderate. Half of these postpartum interventions led to fewer repeat pregnancies or births or more contraceptive use. However, the evidence of intervention effectiveness was of low to moderate quality. Trials with evidence of effectiveness included two that provided one or two sessions and three that had multiple contacts. The former had limitations, such as self-reported outcomes and showing no effect for many comparisons. The interventions with multiple sessions were promising but would have to be adapted for other locations and then retested. Researchers and health care providers will have to determine which intervention might be appropriate for their setting and level of resources.

Background Tubal sterilization by hysteroscopy involves inserting a foreign body in both fallopian tubes. Over a three-month period, the tubal lumen is occluded by tissue growth stimulated by the insert. Tubal sterilization by hysteroscopy has advantages over laparoscopy or mini-laparotomy, including the avoidance of abdominal incisions and the convenience of performing the procedure in an office-based setting. Pain, an important determinant of procedure acceptability, can be a concern when tubal sterilization is performed in the office. Objectives To review all randomized controlled trials that evaluated interventions to decrease pain during tubal sterilization by hysteroscopy. Search methods From January to March 2011, we searched the computerized databases of MEDLINE, POPLINE, CENTRAL, EMBASE, LILACS, and CINAHL for relevant trials. We searched for current trials via Clinicaltrials.gov. We also examined the reference lists of pertinent articles and wrote to known investigators for information about other published or unpublished trials. Selection criteria We included all randomized controlled trials that evaluated pain management at the time of sterilization by hysteroscopy. The intervention could be compared to another intervention or placebo. Data collection and analysis Initial data were extracted by one review author. A second review author verified all extracted data. Whenever possible, the analysis was conducted with all women randomized and in the original assigned groups. Data were analyzed using RevMan software. Pain was measured using either a 10-cm or 100-point visual analog scale (VAS). When pain was measured at multiple points during the procedure, the overall pain score was considered the primary treatment effect. If this was not measured, a summation of all pain scores for the procedure was considered to be the primary treatment effect. For continuous variables, the mean difference with 95% confidence interval was computed. Main results Two trials met the inclusion criteria. The total number of participants was 167. Using a 10-cm VAS to measure pain, no significant difference emerged in overall pain for the entire procedure between women who received a paracervical block with lidocaine versus normal saline (mean difference -0.77; 95% CI -2.67 to 1.13). No significant difference in pain score was noted at the time of injection of study solution to the anterior lip of the cervix (mean difference -0.6; 95% CI -1.3 to 0.1), placement of the device in the tubal ostia (mean difference -0.60; 95% CI -1.8 to 0.7), and postprocedure pain (mean difference 0.2; 95% CI -0.8 to 1.2). Procedure time (mean difference -0.2 minutes; 95% CI -2.2 to 1.8 minutes) and successful bilateral placement (OR 1.0; 95% CI 0.19 to 5.28) was not significantly different between groups. During certain portions of the procedure, such as placement of the tenaculum (mean difference -2.03; 95% CI -2.88 to -1.18), administration of the paracervical block (mean difference -1.92; 95% CI -2.84 to -1.00), and passage of the hysteroscope through the external (mean difference -2.31; 95% CI -3.30 to -1.32) and internal os (mean difference -2.31; 95% CI -3.39 to -1.23), use of paracervical block with lidocaine resulted in lower pain scores. Using a 600-point scale calculated by adding 100-point VAS scores from six different portions of the procedure, no significant difference emerged in overall pain between women who received intravenous conscious sedation versus oral analgesia (mean difference -23.00; CI -62.02 to 16.02). Using a 100-point VAS, no significant difference emerged at the time of speculum insertion (mean difference 4.0; 95% CI -4.0 to 12.0), cervical injection of lidocaine (mean difference -1.8; 95% CI -10.0 to 6.4), insertion of the hysteroscope (mean difference -8.7; 95% CI -19.7 to 2.3), placement of the first device (mean difference -4.4; 95% CI -15.8 to 7.0), and removal of the hysteroscope (mean difference 0.9; 95% CI -3.9 to 5.7). Procedure time (mean difference -0.2 minutes; 95% CI -2.0 to 1.6 minutes) and time in the recovery area (mean difference 3.6 minutes; 95% CI -11.3 to 18.5 minutes) was not different between groups. However, women who received intravenous conscious sedation had lower pain scores at the time of insertion of the second tubal device compared to women who received oral analgesia (mean difference -12.60; CI -23.98 to -1.22). Authors' conclusions The available literature is insufficient to determine the appropriate analgesia or anesthesia for sterilization by hysteroscopy. Compared to paracervical block with normal saline, paracervical block with lidocaine reduced pain during some portions of the procedure. Intravenous sedation resulted in lower pain scores during insertion of the second tubal device. However, neither paracervical block with lidocaine nor conscious sedation significantly reduced overall pain scores for sterilization by hysteroscopy.

Background Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women. Objectives To determine the effectiveness of combined oral contraceptives (COCs) for the treatment of facial acne compared to placebo or other active therapies. Search methods In January 2012, we searched for randomized controlled trials of COCs and acne in the computerized databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, and LILACS. We also searched for clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) (Aug 2011). For the initial review, we wrote to researchers to seek any unpublished or published trials that we might have missed. Selection criteria We considered randomized controlled trials reported in any language that compared the effectiveness of a COC containing an estrogen and a progestin to placebo or another active therapy for acne in women. Data collection and analysis We extracted data on facial lesion counts, both total and specific (i.e., open or closed comedones, papules, pustules and nodules); acne severity grades; global assessments by the clinician or the participant, and discontinuation due to adverse events. Data were entered and analyzed in RevMan. For continuous data, we calculated the mean difference (MD) and 95% confidence interval (CI). For dichotomous data, we calculated the Peto odds ratio (OR) and 95% CI. Main results The review includes 31 trials with 12,579 participants. Of 24 comparisons made, 6 compared a COC to placebo, 17 different COCs, and 1 compared a COC to an antibiotic. Of nine placebo-controlled trials with data for analysis, all showed COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. A levonorgestrel-COC group had fewer total lesion counts (MD -9.98; 95% CI -16.51 to -3.45), inflammatory and non-inflammatory lesion counts, and were more likely to have a clinician assessment of clear or almost clear lesions and participant self-assessment of improved acne lesions. A norethindrone acetate COC had better results for clinician global assessment of no acne to mild acne (OR 1.86; 95% CI 1.32 to 2.62). In two combined trials, a norgestimate COC showed reduced total lesion counts (MD-9.32; 95% CI -14.19 to -4.45), reduced inflammatory lesion and comedones counts, and more with clinician assessment of improved acne. For two combined trials of a drospirenone COC, the investigators' assessment of clear or almost clear skin favored the drospirenone group (OR 3.02; 95% CI 1.99 to 4.59). In one trial, the drospirenone-COC group showed greater (more positive) percent changes for total lesion count (MD 29.08; 95% CI 3.13 to 55.03), inflammatory and non-inflammatory lesion counts, and papule and closed comedone counts. A dienogest-COC group had greater percentage decreases in total lesion count (MD -15.30; 95% CI -19.98 to -10.62) and inflammatory lesion count, and more women assessed with overall improvement of facial acne. A CMA-COC group had more 'responders,' those with 50% or greater decrease in facial papules and pustules (OR 2.31; 95% CI 1.50 to 3.55) Differences in the comparative effectiveness of COCs containing varying progestin types and dosages were less clear, and data were limited for any particular comparison. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel. A COC with cyproterone acetate showed better acne outcomes than one with desogestrel, but the studies produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes, but results were not consistent. A drospirenone COC appeared to be more effective than norgestimate or nomegestrol acetate plus 17β-estradiol but less effective than cyproterone acetate. Authors' conclusions This update yielded six new trials but no change in conclusions. The six COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions. Few important and consistent differences were found between COC types in their effectiveness for treating acne. How COCs compare to alternative acne treatments is unknown since only one trial addressed this issue. The use of standardized methods for assessing acne severity would help in synthesizing results across trials as well as aid in interpretation.

UVR phototherapy cabins exist in a huge variety of configurations and geometries. An accurate dose model has been developed which can be used to examine the question of cabin design to investigate factors influencing dose on a patient.This work extends the existing dose model to entire cabins and investigates how cabin and reflector geometry influence resultant dose.The model predictions are in line with what is measured. It is found that the length and angle of the reflectors have a large influence on received dose.The influence of cabin geometry is important in estimating patient dose, and the findings of this work are applicable to future cabin designs.

Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women.To determine the effectiveness of combined oral contraceptives (COCs) for the treatment of facial acne compared to placebo or other active therapies.In January 2012, we searched for randomized controlled trials of COCs and acne in the computerized databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, and LILACS. We also searched for clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) (Aug 2011). For the initial review, we wrote to researchers to seek any unpublished or published trials that we might have missed.We considered randomized controlled trials reported in any language that compared the effectiveness of a COC containing an estrogen and a progestin to placebo or another active therapy for acne in women.We extracted data on facial lesion counts, both total and specific (i.e., open or closed comedones, papules, pustules and nodules); acne severity grades; global assessments by the clinician or the participant, and discontinuation due to adverse events. Data were entered and analyzed in RevMan. For continuous data, we calculated the mean difference (MD) and 95% confidence interval (CI). For dichotomous data, we calculated the Peto odds ratio (OR) and 95% CI.The review includes 31 trials with 12,579 participants. Of 24 comparisons made, 6 compared a COC to placebo, 17 different COCs, and 1 compared a COC to an antibiotic. Of nine placebo-controlled trials with data for analysis, all showed COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. A levonorgestrel-COC group had fewer total lesion counts (MD -9.98; 95% CI -16.51 to -3.45), inflammatory and non-inflammatory lesion counts, and were more likely to have a clinician assessment of clear or almost clear lesions and participant self-assessment of improved acne lesions. A norethindrone acetate COC had better results for clinician global assessment of no acne to mild acne (OR 1.86; 95% CI 1.32 to 2.62). In two combined trials, a norgestimate COC showed reduced total lesion counts (MD-9.32; 95% CI -14.19 to -4.45), reduced inflammatory lesion and comedones counts, and more with clinician assessment of improved acne. For two combined trials of a drospirenone COC, the investigators' assessment of clear or almost clear skin favored the drospirenone group (OR 3.02; 95% CI 1.99 to 4.59). In one trial, the drospirenone-COC group showed greater (more positive) percent changes for total lesion count (MD 29.08; 95% CI 3.13 to 55.03), inflammatory and non-inflammatory lesion counts, and papule and closed comedone counts. A dienogest-COC group had greater percentage decreases in total lesion count (MD -15.30; 95% CI -19.98 to -10.62) and inflammatory lesion count, and more women assessed with overall improvement of facial acne. A CMA-COC group had more 'responders,' those with 50% or greater decrease in facial papules and pustules (OR 2.31; 95% CI 1.50 to 3.55)Differences in the comparative effectiveness of COCs containing varying progestin types and dosages were less clear, and data were limited for any particular comparison. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel. A COC with cyproterone acetate showed better acne outcomes than one with desogestrel, but the studies produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes, but results were not consistent. A drospirenone COC appeared to be more effective than norgestimate or nomegestrol acetate plus 17β-estradiol but less effective than cyproterone acetate.This update yielded six new trials but no change in conclusions. The six COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions. Few important and consistent differences were found between COC types in their effectiveness for treating acne. How COCs compare to alternative acne treatments is unknown since only one trial addressed this issue. The use of standardized methods for assessing acne severity would help in synthesizing results across trials as well as aid in interpretation.

Background Miscarriage is a common complication of early pregnancy that can have both medical and psychological consequences such as depression and anxiety. The need for routine surgical evacuation with miscarriage has been questioned because of potential complications such as cervical trauma, uterine perforation, hemorrhage, or infection. Objectives To compare the safety and effectiveness of expectant management versus surgical treatment for early pregnancy failure. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (9 February 2012), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2011, Issue 4 of 4), PubMed (2005 to 11 January 2012), POPLINE (inception to 11 January 2012), LILACS (2005 to 11 January 2012) and reference lists of retrieved studies. Selection criteria Randomized trials comparing expectant care and surgical treatment (vacuum aspiration or dilation and curettage) for miscarriage were eligible for inclusion. Data collection and analysis Two review authors assessed trial quality and extracted data. We contacted study authors for additional information. For dichotomous data, we calculated the Mantel-Haenszel risk ratio (RR) with 95% confidence interval (CI). For continuous data, we computed the mean difference (MD) and 95% CI. We entered additional data such as medians into 'Other data' tables. Main results We included seven trials with 1521 participants in this review. The expectant-care group was more likely to have an incomplete miscarriage by two weeks (RR 3.98; 95% CI 2.94 to 5.38) or by six to eight weeks (RR 2.56; 95% CI 1.15 to 5.69). The need for unplanned surgical treatment was greater for the expectant-care group (RR 7.35; 95% CI 5.04 to 10.72). The mean percentage needing surgical management in the expectant-care group was 28%, while 4% of the surgical-treatment group needed additional surgery. The expectant-care group had more days of bleeding (MD 1.59; 95% CI 0.74 to 2.45). Further, more of the expectant-care group needed transfusion (RR 6.45; 95% CI 1.21 to 34.42). The mean percentage needing blood transfusion was 1.4% for expectant care compared with none for surgical management. Results were mixed for pain. Diagnosis of infection was similar for the two groups (RR 0.63; 95% CI 0.36 to 1.12), as were results for various psychological outcomes. Pregnancy data were limited. Costs were lower for the expectant-care group (MD -499.10; 95% CI -613.04 to -385.16; in UK pounds sterling). Authors' conclusions Expectant management led to a higher risk of incomplete miscarriage, need for unplanned (or additional) surgical emptying of the uterus, bleeding and need for transfusion. Risk of infection and psychological outcomes were similar for both groups. Costs were lower for expectant management. Given the lack of clear superiority of either approach, the woman's preference should be important in decision making. Pharmacological ('medical') management has added choices for women and their clinicians and has been examined in other reviews.

BACKGROUND: Male hormonal contraception has been an elusive goal. Administration of sex steroids to men can shut off sperm production through effects on the pituitary and hypothalamus. However this approach also decreases production of testosterone so add-back therapy is needed. OBJECTIVES: To summarize all randomized controlled trials (RCTs) of male hormonal contraception. SEARCH METHODS: In January and February 2012 we searched the computerized databases CENTRAL MEDLINE POPLINE and LILACS. We also searched for recent trials in ClinicalTrials.gov and ICTRP. Previous searches included EMBASE. We wrote to authors of identified trials to seek additional unpublished or published trials. SELECTION CRITERIA: We included all RCTs that compared a steroid hormone with another contraceptive. We excluded non-steroidal male contraceptives such as gossypol. We included both placebo and active-regimen control groups. DATA COLLECTION AND ANALYSIS: The primary outcome measure was the absence of spermatozoa on semen examination often called azoospermia. Data were insufficient to examine pregnancy rates and side effects. MAIN RESULTS: We found 33 trials that met our inclusion criteria. The proportion of men who reportedly achieved azoospermia or had no detectable sperm varied widely. A few important differences emerged. 1) Levonorgestrel implants (160 mug daily) combined with injectable testosterone enanthate (TE) were more effective than levonorgestrel 125 microg daily combined with testosterone patches. 2) Levonorgestrel 500 mug daily improved the effectiveness of TE 100 mg injected weekly. 3) Levonorgestrel 250 mug daily improved the effectiveness of testosterone undecanoate (TU) 1000 mg injection plus TU 500 mg injected at 6 and 12 weeks. 4) Desogestrel 150 mug was less effective than desogestrel 300 mug (with testosterone pellets). 5) TU 500 mg was less likely to produce azoospermia than TU 1000 mg (with levonorgestrel implants). 6) Norethisterone enanthate 200 mg with TU 1000 mg led to more azoospermia when given every 8 weeks versus 12 weeks. 7) Four implants of 7-alpha-methyl-19-nortestosterone (MENT) were more effective than two MENT implants. We did not conduct any meta-analysis due to intervention differences.Several trials showed promising efficacy in percentages with azoospermia. Three examined desogestrel and testosterone preparations or etonogestrel and testosterone and two examined levonorgestrel and testosterone. AUTHORS CONCLUSIONS: No male hormonal contraceptive is ready for clinical use. Most trials were small exploratory studies. Their power to detect important differences was limited and their results imprecise. In addition assessment of azoospermia can vary by sensitivity of the method used. Future trials need more attention to the methodological requirements for RCTs. More trials with adequate power would also be helpful.

To assess the safety of abortion compared with childbirth.We estimated mortality rates associated with live births and legal induced abortions in the United States in 1998-2005. We used data from the Centers for Disease Control and Prevention's Pregnancy Mortality Surveillance System, birth certificates, and Guttmacher Institute surveys. In addition, we searched for population-based data comparing the morbidity of abortion and childbirth.The pregnancy-associated mortality rate among women who delivered live neonates was 8.8 deaths per 100,000 live births. The mortality rate related to induced abortion was 0.6 deaths per 100,000 abortions. In the one recent comparative study of pregnancy morbidity in the United States, pregnancy-related complications were more common with childbirth than with abortion.Legal induced abortion is markedly safer than childbirth. The risk of death associated with childbirth is approximately 14 times higher than that with abortion. Similarly, the overall morbidity associated with childbirth exceeds that with abortion.II.

The efficacy of administering an antibiotic prior to IUD insertion to reduce the risk of introducing an upper genital tract infection during the procedure has not yet been established. Two double-blind randomized studies conducted in Africa comparing a 200 mg prophylactic dose of doxycycline with a placebo did not conclusively identify a reduced risk of post-insertion pelvic inflammatory disease (PID). A clinical trial of comparable design is currently under way in the US. This multi-site trial will evaluate whether use of an antibiotic prior to insertion reduces the risk of IUD removal for all medical reasons, including upper genital tract infection, within the first three months after insertion. This paper reports on the pilot phase of this study, which was designed to test the protocols and data collection instruments in advance of the full-scale clinical trial. A total of 447 prospective IUD (TCu-380A) users were randomly assigned to receive either a 200 mg dose of doxycycline or a placebo one hour before IUD insertion. 3.6% (8219) of participants who received the antibiotic had the device removed for medical reasons (infection, bleeding, cramping, etc.) within three months post-insertion compared to 4.5% (10223) of participants who received the placebo. This reduction in the removal rate was not statistically significant given the limited size of the pilot study ( RR = 0.81; 95% CI 0.28–2.29). Only two subjects, one from each treatment group, met the diagnostic criteria for acute PID. The overall three-month retention rate was 91.8% for the antibiotic group and 89.7% for the placebo group. These retention rates indicate that US women can exhibit a high degree of user acceptance.

BACKGROUND: The diaphragm is usually used with a spermicide. However, some practitioners have suggested that spermicides offer no additional contraceptive protection and have advocated alternative guidelines for the use of diaphragms. The objective of this review was to compare the effectiveness, safety and acceptability of the diaphragm with and without spermicide. METHODS AND RESULTS: We searched Medline, Embase, Popline, CINAHL, the Cochrane Controlled Trials Register and reference lists of relevant articles. In addition, we contacted experts in the field to identify unpublished studies. Randomized controlled trials comparing women of reproductive age using the diaphragm with and without spermicide as the sole contraceptive method that reported clinical outcomes were selected. Two reviewers independently extracted data on outcomes and trial characteristics and any discrepancies were resolved by consensus or by consultation with the third reviewer. The results of the one identified study are presented descriptively. We identified only one study. No significant difference was found in the pregnancy rates (with typical use or consistent use) or discontinuation rates between the diaphragm-with-spermicide and diaphragm-without-spermicide groups. There was a trend towards higher pregnancy rates in the diaphragm-without-spermicide group. However, this study failed to recruit the planned number of participants and was consequently underpowered. CONCLUSIONS: As only one underpowered study was identified, we cannot distinguish between the contraceptive effectiveness of the diaphragm with and without spermicide. We cannot draw any conclusion at this point; further research is needed.

BACKGROUND: Quadriphasic oral contraceptives have been developed to reduce the adverse effects of oral contraceptives and are presented as more physiological since they mimic the natural cycle. However suggested disadvantages of quadriphasic oral contraceptives include a possible increased risk of pill-taking errors caused by the array of different color pills complicated directions for catching up when a pill is missed the higher price and potential inferiority in terms of side effects. OBJECTIVES: To compare the contraceptive effectiveness bleeding pattern minor side effects and acceptability of quadriphasic contraceptive pills versus monophasic contraceptive pills. SEARCH STRATEGY: We searched CENTRAL MEDLINE EMBASE POPLINE ClinicalTrials.gov and ICTRP for trials comparing quadriphasic pills with monophasic pills. We contacted researchers and manufacturers of quadriphasic oral contraceptives to identify additional studies. SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing quadriphasic with monophasic oral contraceptives . Trials had to report on contraceptive effectiveness bleeding patterns minor side effects ease of use or trial discontinuation. We excluded studies where the intervention was primarily used as a treatment for disorders or was administered for fewer than three consecutive cycles. DATA COLLECTION AND ANALYSIS: T wo authors abstracted and entered data into RevMan. We critically appraised the methodological quality of the included trials. For continuous variables we computed the mean difference with 95% confidence interval (CI) using the random-effects model. For dichotomous variables we calculated the risk ratio with 95% CI using the random-effects model. MAIN RESULTS: We included one double-blind double-dummy RCT comparing a quadriphasic oral contraceptive composed of dienogest and estradiol valerate with a monophasic oral contraceptive composed of levonorgestrel and ethinylestradiol. Contraceptive effectiveness intracyclic bleeding and discontinuation due to side effects were similar for quadriphasic and monophasic pills. The number of women experiencing withdrawal bleeding was higher in the monophasic group compared to the quadriphasic group. Users of quadriphasic pills reported fewer bleeding/spotting days and fewer bleeding/spotting episodes than users of monophasic pills but the report did not specify whether the bleeding/spotting was scheduled or unscheduled. More women using quadriphasic oral contraceptives reported breast pain compared to women using monophasic oral contraceptives. AUTHORS CONCLUSIONS: The available evidence is insufficient to determine whether quadriphasic differ from monophasic oral contraceptives in contraceptive effectiveness bleeding pattern minor side effects and acceptability. Studies that compare quadriphasic and monophasic oral contraceptives with an identical progestogen and estrogen type are needed to determine whether the quadriphasic approach differs from the monophasic approach. Studies that compare quadriphasic pills with monophasic pills containing 30 mug ethinylestradiol are indicated to determine whether quadriphasic oral contraceptives have an advantage over the current first choice oral contraceptive . Until then we recommend monophasic pills containing 30 mug estrogen as the first choice for women starting oral contraceptive use.

Ultraviolet phototherapy is a widely used treatment which has exceptional success with a variety of skin conditions. Over-exposure to ultraviolet radiation (UVR) can however be detrimental and cause side effects such as erythema, photokeratisis, and even skin cancer. Quantifying patient dose is therefore imperative to ensure biologically effective treatment while minimizing negative repercussions. A dose model for treatment would be valuable in achieving these ends.Prior work by the authors concentrated on modeling the output of the lamps used in treatment and it was found a line source model described the output from the sources to a high degree. In practice, these lamps are surrounded by reflective anodized aluminum in patient treatment cabins and this work extends the model to quantify specular reflections from these planes on patient dose.The extension of the model to allow for reflected images in addition to tube output shows a remarkably good fit to the actual data measured.The reflection model yields impressive accuracy and is a good basis for full UVR cabin modeling.