The ORTHO BC-SAT – a satisfaction questionnaire for women using hormonal contraceptives

Colwell, Hilary H.; Mathias, Susan D.; Cimms, Tricia; Rothman, Margaret; Friedman, Andrew J.; Patrick, DL

doi:10.1007/s11136-006-0026-8

Cited by 24 publications

(21 citation statements)

References 11 publications

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“…Clinical practitioners and young women may find that in addition to tolerability, efficacy, and acceptability (52)(53)(54) there are important vascular benefits from using the vaginal ring compared with other hormonal contraceptive options. …”

Section: Limitations and Future Perspectivesmentioning

confidence: 99%

Endothelial Function, Endothelin-1, and Fibrinogen in Young Women Using the Vaginal Contraceptive Ring

Torgrimson

Kaplan

Minson

2008

Fertility and Sterility

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Objective-To assess the effects of the vaginal contraceptive ring cycle on indices of cardiovascular health and risk by studying healthy women during the active hormone phase compared with the ring-free phase of a standard 21/7-day cycle.Design-Observational prospective cohort; 4 weeks' duration. Setting-Department of Human Physiology, University of Oregon. Patient(s)-Twenty healthy women.Intervention(s)-Endothelial function testing using standard flow-mediated vasodilation of the brachial artery and sublingual nitroglycerin administration. All participants underwent venous blood collection.Main Outcome Measure(s)-Endothelium-dependent and endothelium-independent vasodilation of the brachial artery using Doppler ultrasound imaging. Baseline levels of highdensity lipoprotein, low-density lipoprotein, triglycerides, total cholesterol, endothelin-1, and fibrinogen. Result(s)-The active hormone phase of thevaginal ringcycle showed significantly higher vasodilation compared with the ring-free phase. The active hormone phase also showed increased fibrinogen levels compared with the ring-free phase. Low-density lipoprotein lipid levels also fluctuated and were significantly higher during the ring-free phase. Conclusion(s)-Preliminarystudy observations of improved endothelial function and lowered low-density lipoprotein levels during the active hormone phase versus the ring-free phase suggest that the vaginal contraceptive ring has beneficial effects on vascular health in women. KeywordsEstradiol; etonorgestrel; hormone delivery; vascular health; hormonal contraception; flowmediated dilation; progestin; estrogen Reprint requests to: Christopher T. Minson, Human Physiology, University of Oregon, 122 C Esslinger Hall, Eugene, OR 97403 (FAX: 541-346-7841; minson@uoregon.edu). B.T. has nothing to disclose. J.M. has nothing to disclose. N.M. has nothing to disclose. P.K. has nothing to disclose. C.M. has nothing to disclose.Presented at the 56th Annual Meeting, Pacific Coast Reproductive Society, Rancho Las Palmas Resort and Spa, Palm Springs, Florida, April 9-13, 2008. NIH Public Access Although decades of research have consistently shown that oral contraceptives increase the relative risk for vascular thromboembolic events (1-3), we know much less about nonoral hormonal contraceptives and cardiovascular risk. Historically, vascular thrombosis risk in oral contraceptive pills users has been associated with high oral estrogen dosing (3) and the subsequent effects of oral estrogen on coagulation pathways in the vasculature (4-8). To date, there are few data on coagulation factors and vascular function in women using nonoral hormonal contraceptives.The combination ethinyl estradiol/etonorgestrel monthly vaginal contraceptive ring is considered to be an advantageous route for hormone delivery compared with oral contraceptive pills (OCPs), because it avoids first-pass hepatic metabolism, allows for lower hormone doses, provides steady serum hormone levels, and requires less frequent administration. Compared with oral...

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Section: Limitations and Future Perspectivesmentioning

confidence: 99%

Endothelial Function, Endothelin-1, and Fibrinogen in Young Women Using the Vaginal Contraceptive Ring

Torgrimson

Kaplan

Minson

2008

Fertility and Sterility

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“…Despite limited application of the framework to prevention, findings from the qualitative studies described earlier are consistent with the framework’s adherence constructs. Predisposing factors which emerged in the qualitative HIV prevention literature and for which we identified potential screening measures include: reasons for trial participation [ 29 – 36 ]; beliefs about clinical trials or the products being tested [ 37 , 38 ]; and personal attributes such as commitment, self-efficacy, or agency [ 21 , 38 – 40 ]. The literature review also identified barriers and facilitators of adherence that might be experienced once a trial participant began using the study product and which could be assessed over time, including: the beneficial or negative impact of trial staff [ 38 , 41 , 42 ]; practical constraints, including travel, cost of participation, and impact on daily life [ 22 , 37 , 43 , 44 ]; experience of side effects [ 44 – 46 ]; and impact of stigma [ 30 , 44 ].…”

Section: Introductionmentioning

confidence: 99%

Optimizing adherence in HIV prevention product trials: Development and psychometric evaluation of simple tools for screening and adherence counseling

et al. 2018

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BackgroundLow adherence in recent HIV prevention clinical trials highlights the need to better understand, measure, and support product use within clinical trials. Conventional self-reported adherence instruments within HIV prevention trials, often relying on single-item questions, have proven ineffective. While objective adherence measures are desirable, none currently exist that apply to both active and placebo arms. Scales are composed of multiple items in the form of questions or statements that, when combined, measure a more complex construct that may not be directly observable. When psychometrically validated, such measures may better assess the multiple factors contributing to adherence/non-adherence. This study aimed to develop and psychometrically evaluate tools to screen and monitor trial participants’ adherence to HIV prevention products within the context of clinical trial research.Methods and findingsBased on an extensive literature review and conceptual framework, we identified and refined 86 items assessing potential predictors of adherence and 48 items assessing adherence experience. A structured survey, including adherence items and other variables, was administered to former ASPIRE and Ring Study participants and similar non-trial participants (n = 709). We conducted exploratory factor analyses (EFA) to identify a reduced set of constructs and items that could be used at screening to predict potential adherence, and at follow-up to monitor and intervene on adherence. We examined associations with other variables to assess content and construct validity. The EFA of screener items resulted in a 6-factor solution with acceptable to very good internal reliability (α: .62-.84). Similar to our conceptual framework, factors represent trial-related commitment (Distrust of Research and Commitment to Research); alignment with trial requirements (Visit Adherence and Trial Incompatibility); Belief in Trial Benefits and Partner Disclosure. The EFA on monitoring items resulted in 4 Product-specific factors that represent Vaginal Ring Doubts, Vaginal Ring Benefits, Ring Removal, and Side Effects with good to very good internal reliability (α = .71-.82). Evidence of content and construct validity was found; relationship to social desirability bias was examined.ConclusionsThese scales are easy and inexpensive to administer, available in several languages, and are applicable regardless of randomization. Once validated prospectively, they could (1) screen for propensity to adhere, (2) target adherence support/counselling, and (3) complement biomarker measures in determining true efficacy of the experimental product.

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“…Clinical practitioners and young women may find that in addition to tolerability, efficacy, and acceptability (52–54) there are important vascular benefits from using the vaginal ring compared with other hormonal contraceptive options.…”

Section: Discussionmentioning

confidence: 99%

Endothelial function, endothelin-1, and fibrinogen in young women using the vaginal contraceptive ring

Torgrimson¹,

Meendering²,

Miller³

et al. 2009

Fertility and Sterility

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Objective To assess the effects of the vaginal contraceptive ring cycle on indices of cardiovascular health and risk by studying healthy women during the active hormone phase compared with the ring-free phase of a standard 21/7-day cycle. Design Observational prospective cohort; 4 weeks’ duration. Setting Department of Human Physiology, University of Oregon. Patient(s) Twenty healthy women. Intervention(s) Endothelial function testing using standard flow-mediated vasodilation of the brachial artery and sublingual nitroglycerin administration. All participants underwent venous blood collection. Main Outcome Measure(s) Endothelium-dependent and endothelium-independent vasodilation of the brachial artery using Doppler ultrasound imaging. Baseline levels of high-density lipoprotein, low-density lipoprotein, triglycerides, total cholesterol, endothelin-1, and fibrinogen. Result(s) The active hormone phase of thevaginal ringcycle showed significantly higher vasodilation compared with the ring-free phase. The active hormone phase also showed increased fibrinogen levels compared with the ring-free phase. Low-density lipoprotein lipid levels also fluctuated and were significantly higher during the ring-free phase. Conclusion(s) Preliminary study observations of improved endothelial function and lowered low-density lipoprotein levels during the active hormone phase versus the ring-free phase suggest that the vaginal contraceptive ring has beneficial effects on vascular health in women.

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The ORTHO BC-SAT – a satisfaction questionnaire for women using hormonal contraceptives

Abstract: Our results support the reliability and validity of the ORTHO BC-SAT. It may be used in future studies to evaluate satisfaction among hormonal contraceptive users.

Cited by 24 publications

References 11 publications

Endothelial Function, Endothelin-1, and Fibrinogen in Young Women Using the Vaginal Contraceptive Ring

Endothelial Function, Endothelin-1, and Fibrinogen in Young Women Using the Vaginal Contraceptive Ring

Optimizing adherence in HIV prevention product trials: Development and psychometric evaluation of simple tools for screening and adherence counseling

Endothelial function, endothelin-1, and fibrinogen in young women using the vaginal contraceptive ring

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