Differences in reporting Pearl Indices in the United States and Europe: Focus on a 91-day extended-regimen combined oral contraceptive with low-dose ethinyl estradiol supplementation

P, Lobo Abascal; Luzar-Stiffler,; Giljanovic, S; Howard, Brandon; Weiss, Herman

doi:10.3109/13625187.2015.1059416

Cited by 4 publications

(4 citation statements)

References 5 publications

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“…Similar to findings from other investigations, the youngest participants in our study had the highest contraceptive failure rates 20, 21. The higher pregnancy rate at US versus European sites is also consistent with results from other contraceptive studies,22, 23 and might reflect regional differences in following instructions for contraceptive use.…”

Section: Discussionsupporting

confidence: 92%

Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials

Archer

Merkatz

Bahamondes

et al. 2019

The Lancet Global Health

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Summary Background A ring-shaped, contraceptive vaginal system designed to last 1 year (13 cycles) delivers an average of 0·15 mg segesterone acetate and 0·013 mg ethinylestradiol per day. We evaluated the efficacy of this contraceptive vaginal system and return to menses or pregnancy after use. Methods In two identically designed, multicentre, open-label, single-arm, phase 3 trials (one at 15 US academic and community sites and one at 12 US and international academic and community sites), participants followed a 21-days-in, 7-days-out segesterone acetate and ethinylestradiol contraceptive vaginal system schedule for up to 13 cycles. Participants were healthy, sexually active, non-pregnant, non-sterilised women aged 18–40 years. Women were cautioned that any removals during the 21 days of cyclic use should not exceed 2 h, and used daily paper diaries to record vaginal system use. Consistent with regulatory requirements for contraceptives, we calculated the Pearl Index for women aged 35 years and younger, excluding adjunctive contraception cycles, as the primary efficacy outcome measure. We also did intention-to-treat Kaplan-Meier life table analyses and followed up women who did not use hormonal contraceptives or desired pregnancy after study completion for 6 months for return to menses or pregnancy. The trials are registered with ClinicalTrials.gov , numbers NCT00455156 and NCT00263341 . Findings Between Dec 19, 2006, and Oct 9, 2009, at the 15 US sites, and between Nov 1, 2006, and July 2, 2009, at the 12 US and international sites we enrolled 2278 women. Our overall efficacy analysis included 2265 participants (1130 in the US study and 1135 in the international study) and 1303 (57·5%) participants completed up to 13 cycles. The Pearl Index for the primary efficacy group was 2·98 (95% CI 2·13–4·06) per 100 woman-years, and was well within the range indicative of efficacy for a contraceptive under a woman's control. The Kaplan-Meier analysis revealed the contraceptive vaginal system was 97·5% effective, which provided further evidence of efficacy. Pregnancy occurrence was similar across cycles. All 290 follow-up participants reported return to menses or became pregnant (24 [63%] of 38 women who desired pregnancy) within 6 months. Interpretation The segesterone acetate and ethinylestradiol contraceptive vaginal system is an effective contraceptive for 13 consecutive cycles of use. This new product adds to the contraceptive method mix and the 1-year duration of use means that women do not need to return to the clinic or pharmacy for refills every few months. Funding Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health, the US Agency for International Development, and the WHO Reproductive Health Research Department.

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Section: Discussionsupporting

confidence: 92%

Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials

Archer

Merkatz

Bahamondes

et al. 2019

The Lancet Global Health

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“…This corpus, composed of articles testing the efficacy of Pediatric HAART, sought to evaluate the linguistic framing of studies originating from either the United States or Europe. We intentionally selected this comparison to compliment the extended history of comparative EU/US medical research (Philipson, 2005 ; Lobo Abascal et al, 2016 ), in addition to the high rate at which studies in either region publish in the English language. To compose this corpus, we searched PubMed, EbscoHost, Web of Science, and Medline using various iterations of pediatric (or paediatric) HAART, including infant HAART and perinatal HAART.…”

Section: Methodsmentioning

confidence: 99%

Language Bias in Health Research: External Factors That Influence Latent Language Patterns

Valdez

Goodson

2020

Front. Res. Metr. Anal.

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Background: Concerns with problematic research are primarily attributed to statistics and methods used to support data. Language, as an extended component of problematic research in published work, is rarely given the same attention despite language's equally important role in shaping the discussion and framings of presented data. Purpose: This study uses a topic modeling approach to study language as a predictor of potential bias among collected publication histories of several health research areas. Methods: We applied Latent Dirichlet Allocation (LDA) topic models to dissect publication histories disaggregated by three factors commonly cited as language influencers: (1) time, to study ADHD pharmacotherapy; (2) funding source, to study sugar consumption; and (3) nation of origin, to study Pediatric Highly-Active Anti-Retroviral Therapy (P-HAART). Results: We found that, for each factor, there were notable differences in language among each corpus when disaggregated by each factor. For time, article content changed to reflect new trends and research practices for the commonly prescribed ADHD medication, Ritalin. For funding source, industry and federally funded studies had differing foci, despite testing the same hypothesis. For nation of origin, regulatory structures between the United States and Europe seemingly influenced the direction of research. Conclusion: This work presents two contributions to ethics research: (1) language and language framing should be studied as carefully as numeric data among studies of rigor, reproducibility, and transparency; and (2) the scientific community should continue to apply topic models as mediums to answer hypothesis-driven research questions.

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“…Abascal reported that for a 91-day extended-regimen COC containing 150 μg of levonorgestrel and 30 μg EE, the US study reported a PI of 1,34 and the European study a PI of 0,76. In this scenario, the US study included all the pregnancies that happened up to 14 days after the end of the study, unlike the European study that only included pregnancies occurring up to 2 days after the end of the study [14].…”

Section: Effectiveness Of Oral Contraceptives: the Pearl Indexmentioning

confidence: 97%

The Pill at 56 and Counting: Still Contracepting After All These Years

Côté-Leduc

Roy

2016

Curr Obstet Gynecol Rep

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Oral contraceptives are one of the most popular contraceptive methods worldwide. They offer many benefits other than contraceptive efficacy; women also choose the pill for medical or personal reasons. While the pill is extremely safe, there are still concerns about side effects and complications, difficulties with cycle control and compliance. Several approaches have been developed to improve overall experience with oral contraceptives, including lowering doses of estrogen to diminish side effects, though that can create more bleeding irregularities and possibly reduce efficacy. Modifications of pill scheduling by proposing extended or continuous cycle have shown good results decreasing symptoms related to menses. Contraceptive pills can effectively decrease certain premenstrual and menstrual symptoms. Finally, the use of new technologies to try to increase adherence is being explored, though without convincing results so far.

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Differences in reporting Pearl Indices in the United States and Europe: Focus on a 91-day extended-regimen combined oral contraceptive with low-dose ethinyl estradiol supplementation

Cited by 4 publications

References 5 publications

Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials

Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials

Language Bias in Health Research: External Factors That Influence Latent Language Patterns

The Pill at 56 and Counting: Still Contracepting After All These Years

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