- Email: [email protected]
A 1-year randomized trial comparing cycle control and user acceptability between NuvaRing® and Yasmin®
234
Abstracts / Contraception 72 (2005) 229 –245
under collaborative prescribing agreements with physicians. Feasibility depends partly on women being able to screen themselves for safe use of oral contraceptives, contraceptive patches or vaginal rings. Materials and Methods: Our NICHD-funded study adapted the Family Health International’s published Provider Checklists for Reproductive Health Services for self-administration by pharmacy clients. The resultant 20 -item screening tool was validated in six public health family planning clinics in the Seattle metropolitan area. Participants were 399 women, aged between 15 and 45 years, who completed the anonymous questionnaire. A matching medical evaluation form was administered to each participant’s health care provider. Patient–provider agreement was measured by the overall percentage in agreement on method of contraception. Results: Patient–provider medical eligibility agreement was obtained for 392 participant pairs. The estimated proportion of the overall agreement was 84% (95% CI, 0.78 – 0.89). Women were more likely to report bad headaches (12.4% vs. 3.3%), smoking (6.2% vs. 2.1%), possible pregnancy (7.3% vs. 3.5%) and having regular periods (9.9% vs. 6.5%) than were providers but less likely to report smoking more than 15 cigarettes per day (2.6% vs. 9.2%). The self-screening questionnaire for the selection of hormonal contraception was appropriately completed by the women regardless of age, income, education or prior contraceptive history. Conclusion: Compared with medical provider evaluation, women are more likely to exclude themselves from the potentially unsafe use of hormonal contraceptives. 17 A 1-YEAR RANDOMIZED TRIAL COMPARING CYCLE CONTROL AND USER ACCEPTABILITY BETWEEN NUVARINGR AND YASMINR Rosen K, Ahrendt H -J, Rosen K. Introduction: The objectives of this open-label, randomized, comparative, multicenter trial were to assess cycle control and user acceptability between a monthly contraceptive vaginal ring (NuvaRingR) and a combined oral contraceptive (COC; YasminR) containing 30-Ag EE+3-mg drospirenone over 1 year. Materials and Methods: Women were randomized to NuvaRingR (n = 516) or the COC (n = 501) for 13 cycles. Bleeding was evaluated using diary cards and user acceptability was examined through a questionnaire. Results: A total of 716 women completed the study (NuvaRingR, 71.1%; COC, 74.6%). Breakthrough bleeding or spotting (bleeding/spotting) during Cycles 2 –13 was less frequent with NuvaRingR (3.6 – 6.2%) than with the COC (4.7–10.4%). The incidence of breakthrough bleeding/spotting was lower with NuvaRingR than with the COC for all cycles except for Cycles 11 and 12. The incidence of cycles (1–13) without withdrawal bleeding ranged from 0.2% to 3.2% for the NuvaRingR group and from 0.5% to 1.7% for the COC group, with no statistically significant differences between the groups in any cycle. Intended bleeding (scheduled bleeding occurring during the ring/pill-free week and no unscheduled bleeding occurring during ring/pill use) was statistically significantly better for all cycles with NuvaRingR (55.2–68.5%) than with the COC (35.6 – 56.6%) (p b .01). Most of the women were satisfied with NuvaRingR
(very satisfied, 59%; satisfied, 25%) and the COC (very satisfied, 54%; satisfied, 33%) and would recommend the methods to others (NuvaRingR, 87%; COC, 92%). Conclusion: NuvaRingR (15-Ag EE/day) was associated with better cycle control as compared with the COC (30 - Ag EE/day). Both contraceptives were highly acceptable. 18 ABORTION TRAINING IN FAMILY MEDICINE RESIDENCY PROGRAMS Brahmi D, Dehlendorf C, Engel D. Introduction: Although clearly within the scope of practice of family physicians, abortion training is not consistently integrated into family medicine residency programs. Family physicians have a potentially important role in increasing abortion access in this country. The aims of this study were to describe the status of medication and suction abortion training for family physicians and to document the process of creating such training. Materials and Methods: Surveys and semistructured interviews were conducted with third-year residents and faculty at nine American family medicine residency programs that offer integrated abortion training. Results: The average number of suction abortion procedures provided by residents in integrated training programs was 37, with the average resident performing 10 medication abortions. Five of the nine integrated programs offered onsite medication abortion training, with only three providing onsite suction abortion training. Most programs (5/9) exclusively used family physician trainers. Overall, 91% of the residents were satisfied with their training. Thematic analysis highlights the challenges facing programs offering abortion training, including community and departmental politics, soliciting the support of clinic staff, funding and ensuring dedicated faculty time. Residents exposed to training perceive increased competence in gynecologic procedures. Residents consistently valued nonprocedural aspects of the curriculum such as options counseling, values clarification and debriefing sessions. Discussion: Although family medicine residents exposed to abortion training overall are satisfied, there are opportunities for improvement. Conclusion: Programs interested in offering integrated abortion training continue to face multiple challenges in implementation and maintenance but can build upon the experiences of dedicated faculty in preexisting programs. 19 AN INCREASED RATE OF CHOLECYSTECTOMY IN A COHORT OF WOMEN INITIATING USE OF ORAL CONTRACEPTIVE PILLS Stuart G, Tang J, Heartwell SF, Westhoff C, QuickStart Study Group. Introduction: Among women of reproductive age in the United States, the most recently reported cholecystectomy rate is 4.2/1000. The objective of this study was to describe the experiences of women initiating use of oral contraceptive pills when enrolling in a multicenter study and the factors associated with cholecystectomy in eight of those women. Materials and Methods: Women younger than 25 years were enrolled from three academic centers in a randomized clinical trial
Abstracts / Contraception 72 (2005) 229 –245
under collaborative prescribing agreements with physicians. Feasibility depends partly on women being able to screen themselves for safe use of oral contraceptives, contraceptive patches or vaginal rings. Materials and Methods: Our NICHD-funded study adapted the Family Health International’s published Provider Checklists for Reproductive Health Services for self-administration by pharmacy clients. The resultant 20 -item screening tool was validated in six public health family planning clinics in the Seattle metropolitan area. Participants were 399 women, aged between 15 and 45 years, who completed the anonymous questionnaire. A matching medical evaluation form was administered to each participant’s health care provider. Patient–provider agreement was measured by the overall percentage in agreement on method of contraception. Results: Patient–provider medical eligibility agreement was obtained for 392 participant pairs. The estimated proportion of the overall agreement was 84% (95% CI, 0.78 – 0.89). Women were more likely to report bad headaches (12.4% vs. 3.3%), smoking (6.2% vs. 2.1%), possible pregnancy (7.3% vs. 3.5%) and having regular periods (9.9% vs. 6.5%) than were providers but less likely to report smoking more than 15 cigarettes per day (2.6% vs. 9.2%). The self-screening questionnaire for the selection of hormonal contraception was appropriately completed by the women regardless of age, income, education or prior contraceptive history. Conclusion: Compared with medical provider evaluation, women are more likely to exclude themselves from the potentially unsafe use of hormonal contraceptives. 17 A 1-YEAR RANDOMIZED TRIAL COMPARING CYCLE CONTROL AND USER ACCEPTABILITY BETWEEN NUVARINGR AND YASMINR Rosen K, Ahrendt H -J, Rosen K. Introduction: The objectives of this open-label, randomized, comparative, multicenter trial were to assess cycle control and user acceptability between a monthly contraceptive vaginal ring (NuvaRingR) and a combined oral contraceptive (COC; YasminR) containing 30-Ag EE+3-mg drospirenone over 1 year. Materials and Methods: Women were randomized to NuvaRingR (n = 516) or the COC (n = 501) for 13 cycles. Bleeding was evaluated using diary cards and user acceptability was examined through a questionnaire. Results: A total of 716 women completed the study (NuvaRingR, 71.1%; COC, 74.6%). Breakthrough bleeding or spotting (bleeding/spotting) during Cycles 2 –13 was less frequent with NuvaRingR (3.6 – 6.2%) than with the COC (4.7–10.4%). The incidence of breakthrough bleeding/spotting was lower with NuvaRingR than with the COC for all cycles except for Cycles 11 and 12. The incidence of cycles (1–13) without withdrawal bleeding ranged from 0.2% to 3.2% for the NuvaRingR group and from 0.5% to 1.7% for the COC group, with no statistically significant differences between the groups in any cycle. Intended bleeding (scheduled bleeding occurring during the ring/pill-free week and no unscheduled bleeding occurring during ring/pill use) was statistically significantly better for all cycles with NuvaRingR (55.2–68.5%) than with the COC (35.6 – 56.6%) (p b .01). Most of the women were satisfied with NuvaRingR
(very satisfied, 59%; satisfied, 25%) and the COC (very satisfied, 54%; satisfied, 33%) and would recommend the methods to others (NuvaRingR, 87%; COC, 92%). Conclusion: NuvaRingR (15-Ag EE/day) was associated with better cycle control as compared with the COC (30 - Ag EE/day). Both contraceptives were highly acceptable. 18 ABORTION TRAINING IN FAMILY MEDICINE RESIDENCY PROGRAMS Brahmi D, Dehlendorf C, Engel D. Introduction: Although clearly within the scope of practice of family physicians, abortion training is not consistently integrated into family medicine residency programs. Family physicians have a potentially important role in increasing abortion access in this country. The aims of this study were to describe the status of medication and suction abortion training for family physicians and to document the process of creating such training. Materials and Methods: Surveys and semistructured interviews were conducted with third-year residents and faculty at nine American family medicine residency programs that offer integrated abortion training. Results: The average number of suction abortion procedures provided by residents in integrated training programs was 37, with the average resident performing 10 medication abortions. Five of the nine integrated programs offered onsite medication abortion training, with only three providing onsite suction abortion training. Most programs (5/9) exclusively used family physician trainers. Overall, 91% of the residents were satisfied with their training. Thematic analysis highlights the challenges facing programs offering abortion training, including community and departmental politics, soliciting the support of clinic staff, funding and ensuring dedicated faculty time. Residents exposed to training perceive increased competence in gynecologic procedures. Residents consistently valued nonprocedural aspects of the curriculum such as options counseling, values clarification and debriefing sessions. Discussion: Although family medicine residents exposed to abortion training overall are satisfied, there are opportunities for improvement. Conclusion: Programs interested in offering integrated abortion training continue to face multiple challenges in implementation and maintenance but can build upon the experiences of dedicated faculty in preexisting programs. 19 AN INCREASED RATE OF CHOLECYSTECTOMY IN A COHORT OF WOMEN INITIATING USE OF ORAL CONTRACEPTIVE PILLS Stuart G, Tang J, Heartwell SF, Westhoff C, QuickStart Study Group. Introduction: Among women of reproductive age in the United States, the most recently reported cholecystectomy rate is 4.2/1000. The objective of this study was to describe the experiences of women initiating use of oral contraceptive pills when enrolling in a multicenter study and the factors associated with cholecystectomy in eight of those women. Materials and Methods: Women younger than 25 years were enrolled from three academic centers in a randomized clinical trial