Evaluation of a fertility awareness-based shared decision-making tool part 2: Patient experiences.

Objective: To assess patient experiences using a Shared Decision-Making (SDM) Tool for fertility awareness-based methods (FABMs) of family planning. Methods: The study employed a prospective crossover design to evaluate impact of the SDM tool compared to usual practice when discussing FABMs with patients. Patients completed pre- and post-office visit surveys and an online survey six months later. The primary outcomes evaluated the effect of the SDM tool on patient satisfaction and FABM continuity of use rates. Results: There was no significant difference in likelihood of changing family planning methods immediately after the office visit; however, by six months a significantly larger proportion of patients had started or changed FABMs in the experimental group (52%, 34/66) compared to the control group (36%, 24/66) (p = 0.04). Significantly more patients who used the tool and changed their FABM after their visit reported increased satisfaction with their FABM compared to control (50% vs. 17%, p = 0.022). Conclusions: Use of the SDM tool increased persistent use of and satisfaction with chosen FABMs at six months. Innovations: The novel SDM tool can enhance patients' understanding and facilitate the selection of a more suitable method leading to increased satisfaction.

A comparison of app-defined fertile days from two fertility tracking apps using identical cycle data.

OBJECTIVE: The Natural Cycles app employs daily basal body temperature to define the fertile window via a proprietary algorithm and is clinically established effective in preventing pregnancy. We sought to (1) compare the app-defined fertile window of Natural Cycles to that of CycleProGo, an app that uses BBT and cervical mucus to define the fertile window and (2) compare the app-defined fertile windows to the estimated physiologic fertile window. STUDY DESIGN: Daily BBT were entered into Natural Cycles from 20 randomly selected regularly cycling women with at least 12 complete cycles from the CycleProGo database. The proportion of cycles with equivalent (±1 cycle day) fertile-window starts and fertile-window ends was determined. The app-defined fertile windows were then compared to the estimated physiologic fertile window using Peak mucus to estimate ovulation. RESULTS: Fifty seven percent of cycles (136/238) had equivalent fertile-window starts and 36% (72/181) had equivalent fertile-window end days. The mean overall fertile-window length from Natural Cycles was 12.8 days compared to 15.1 days for CycleProGo (p < 0.001). The Natural Cycles algorithm declared 12% to 30% of cycles with a fertile-window start and 13% to 38% of cycles with a fertile-window end within the estimated physiologic fertile window. The CycleProGo algorithm declared 4% to 14% of cycles with a fertile-window start and no cycles with a fertile-window end within the estimated physiologic fertile window. CONCLUSIONS: Natural Cycles designated a higher proportion of cycles days as infertile within the estimated physiologic fertile window than CycleProGo. IMPLICATIONS: Use of cervical mucus in addition to BBT may improve the accuracy of identifying the fertile window. Additional studies with other markers of ovulation and the fertile window would give additional insight into the clinical implications of app-defined fertile window differences.

Evaluation of a fertility awareness-based shared decision-making tool part 1: Study design and impact on clinician knowledge.

Objective: To assess the impact of a Shared Decision-Making (SDM) tool for fertility awareness-based methods (FABMs) of family planning. Methods: Clinicians familiar with at least one FABM were randomly invited to participate in a prospective cross-over study to compare usual practice to the use of the SDM tool when discussing FABMs with patients. Patients completed surveys pre- and post-office visit and six months later. The primary outcome explored the effect of online education on use of the SDM tool on clinicians' knowledge of FABMs. Results: Of 278 clinicians contacted, 54% could not be reached, and 15% did not provide women's health services. The 26 clinicians enrolled were experienced, with more than half recommending FABMs for ≥10 years, and 73% recommending more than one FABM to patients. Knowledge scores significantly improved after online training and use of the SDM tool (baseline mean score = 9.54 (scale of 0-12); post-training mean score = 10.73, p < 0.002). Conclusions: Education about FABMs and training on use of the SDM tool improved knowledge scores even among an experienced cohort of clinicians. Innovation: The novel SDM tool can better equip clinicians to meet the rising patient interest in FABMs.

Hormonally Active Contraceptives, Part II: Sociological, Environmental, and Economic Impact.

To investigate the sociological, environmental, and economic impact of hormonally active contraceptives, a series of comprehensive literature surveys were employed. Sociological effects are discussed including abortion, exploitation of women, a weakening of marriage, and an increase in divorce with deleterious effects on children such as child poverty, poorer health, lower educational achievement, suicide risks, drug and alcohol abuse, criminality, and incarceration, among others. The environmental impact is discussed briefly and includes the feminization and trans-gendering of male fish downstream from the effluent of city wastewater treatment plants with declining fish populations. The potential economic impact of most of these side effects is estimated based on epidemiologic data and published estimates of costs of caring for the diseases which are linked to the use of hormonally active contraceptives. Hormonally active contraceptives appear to have a deleterious impact on multiple aspects of women's health as well as negative economic and environmental impacts. These risks can be avoided through the use of nonhormonal methods and need to be more clearly conveyed to the public. SUMMARY: Hormonal contraceptives have wide-ranging effects.  The potential economic impact of the medical side effects is estimated. Sociological effects are discussed including abortion, exploitation of women, a weakening of marriage and an increase in divorce with negative effects on children such as child poverty, poorer health, lower educational achievement, suicide risks, drug and alcohol abuse, criminality and incarceration among others. The environmental impact includes hormonal effects on fish with declining fish populations. Women seeking birth control have a right to know about how to avoid these risks by using effective hormone-free methods like Fertility Awareness Methods.

Hormonally Active Contraceptives Part I: Risks Acknowledged and Unacknowledged.

Hormonal contraceptives have been on the market for over fifty years and, while their formulations have changed, the basic mechanism of action has remained the same. During this time, numerous studies have been performed documenting side effects, some of which appear over time, some within weeks or months, but all can have a serious impact on health and quality of life. An effort was made to perform a series of comprehensive literature surveys to better understand immediate and long-term side effects of these agents. The results of this literature review uncovered a number of potential side effects, some of which are acknowledged and many of which are not noted in the prescribing information for these agents. Among the unacknowledged side effects are: an increased risk of HIV transmission for depot medroxyprogesterone acetate (DMPA), and for combination contraceptives breast cancer, cervical cancer, Crohn's disease, ulcerative colitis, systemic lupus erythematosus, depression, mood disorders and suicides (especially among women twenty-five years of age and younger, in the first six months of use), multiple sclerosis, interstitial cystitis, female sexual dysfunction, osteoporotic bone fractures (especially for progesterone-only contraceptives), and fatty weight gain. Misleading prescribing information regarding cardiovascular and thrombotic risks are also noted. Women seeking birth control have a right to be informed and educated about risk avoidance through the use of effective nonhormonal methods like fertility awareness methods. In one case-that of DMPA-the increased risk of HIV acquisition has been conclusively demonstrated to be both real and unique to this drug. Considering the availability of numerous alternatives, there is no justification for the continued marketing of DMPA to the public. SUMMARY: We reviewed the effect of hormonal contraceptives on women's health. A number of potential side effects were noted including increased risks of breast cancer, cervical cancer, inflammatory bowel  disease, lupus, multiple sclerosis, cystitis, bone fractures, depression, mood disorders and suicides,  fatty weight gain, and female sexual dysfunction.  With the long-acting injectable contraceptives there is an increased risk of getting HIV.  Misleading prescribing information regarding the risks of heart attacks, strokes and blood clotting problems were also noted. Women seeking birth control have a right to know about how to avoid these risks by using effective hormone-free Fertility Awareness Methods.

Natural Family Planning and Marital Chastity: The Effects of Periodic Abstinence on Marital Relationships.

Marital chastity is the practice of periodic abstinence with use of natural family planning (NFP). The purpose of this study was to determine the influence of the most common methods of contraception (female sterilization, oral contraceptive pills, and condoms) and NFP on divorce/separation and cohabitation rates among reproductive age women. The study involved an extensive review of the literature on the effects of practice of NFP on marital dynamics and a statistical analysis of 2,550 ever-married women in the (2015-2017) National Survey of Family Growth data set. Importance of religion and frequency of church attendance were included in the analysis. With ever-use of NFP, 14 percent were divorced or separated, and 27 percent to 39 percent were divorced or separated with ever-use of oral contraceptive pills. Stepwise logistic regression indicated that ever-use of contraception was associated with increased odds of divorce or separation (odds ratio [OR] = 2.05; confidence interval [CI]: 1.96-2.49) and cohabitation (2.95, CI: 2.20-3.95). Ever-use of NFP yielded 58 percent lower odds for divorce or separation. Frequent church attendance was associated with lower odds of divorce or separation and cohabitation. Although there are lower odds of divorce among NFP users, the reason might be due to their religiosity. SUMMARY: This study showed that ever-use of natural family planning (NFP) among ever-married women was associated with 58 percent lower odds of divorce than among women who never-used NFP. Ever-use of contraceptive methods was associated with two times the odds of divorce and four times for cohabitation compared to those women who never-used those methods. Use of periodic abstinence with NFP is the practice of marital chastity and is thought to strengthen the marital relationship.

A Comparison of User Behaviors for a Fertility-Tracking App: Does Training in an NFP Method Improve Persistence and Use?

This study explores differences in the use of CycleProGo™ (CPG), a fertility-tracking app developed by Couple to Couple League (CCL), between those exposed to it as a part of natural family planning (NFP) instruction versus those who find it on their own. An anonymous data set of 17,543 CPG accounts opened between April 2013 and June 2016 was used for analysis. Nonmember users opened the most accounts (58 percent, n = 10,134), CCL members represented 38 percent (n = 6,758) of new accounts, and 207 CCL teachers (4 percent) were using CPG for personal charting. Significantly more nonmember accounts had zero days of use after the initial opening compared to CCL member accounts (61 percent vs. 23 percent, respectively, χ2 = 2,405.9, p < .001). Conversely, significantly more CCL member accounts were used for ninety days or longer than nonmember accounts (47 percent vs. 13 percent, respectively, χ2 = 2,404.2, p < .001). CCL students-those who began using the app as part of a formal NFP teaching curriculum-were more likely to use the app for > six cycles compared to nonmembers. In accounts with at least one complete cycle, CCL students were the most diligent at daily recording (95 percent of cycle days with observation recorded) followed by CCL members (88 percent) and nonmembers (76 percent). CCL teachers had the lowest frequency of cycle days with a recorded observation (73 percent). Within each cohort, accounts with > six recorded cycles had a lower proportion of cycle days with an observation recorded, likely reflecting increasing knowledge of their personal fertility patterns. Long-term users who had no known formal training in NFP still had the lowest proportion cycle days with a fertility observation. We conclude formal NFP instruction increases the probability of long-term app use, and regardless of training, long-term users will likely record observations on about 70 percent of cycle days. SUMMARY: "CycleProGo™ users with NFP training were more persistent and diligent about daily data input than those without training."

The State of the Science of Natural Family Planning Fifty Years after Humane Vitae: A Report from NFP Scientists' Meeting Held at the US Conference of Catholic Bishops, April 4, 2018.

A one-day meeting of physicians, professional nurses, and scientists actively involved in Natural Family Planning (NFP) research was held to review the state of the science of NFP and consider future priorities. The meeting had four objectives: (i) determine the gaps in research evidence for secure methods of NFP among women of all reproductive categories, (ii) determine the gaps in the research and development of new technology for providing NFP services, (iii) determine the gaps in the research that determine the benefits and challenges with use of NFP among married couples, and (iv) provide prioritized ideas for future research needs from the analysis of evidence gaps from objectives above. This article summarizes the discussion and conclusions drawn from topics reviewed. While much has been accomplished in the fifty years since Humane vitae, there are still many gaps to address. Five areas for future research in NFP were identified as high priority: (1) well-designed method effectiveness studies among various reproductive categories including important subpopulations (postpartum, perimenopause, posthormonal contraceptive), normally cycling women (especially US women), and comparative studies between NFP methods; (2) validation studies to establish the benefit of charting fertility signs (both currently known and potential new indicators) as a screening tool for women's health issues; (3) ongoing independent evaluation of fertility monitoring apps to provide users perspective on the relative merits of each and to identify those most worthy of further effectiveness testing; (4) studies evaluating the impact of new technologies on NFP adoption, use, and persistence; and (5) creation of a shared database across various NFP methods to collaborate on shared research interests, longitudinal studies, and so on. This summarizes a meeting to review the scientific and medical progress related to natural family planning made in the 50 years since Humane Vitae and to define priorities for future work. Areas reviewed included the evidence for avoiding pregnancy in normally cycling, postpartum, and perimenopausal women, the impact of new technology, including fertility charting apps, on NFP, and the impact on relationships and personal well-being from use of NFP. Five priority focus areas for future research were also identified.

Use of Natural Family Planning (NFP) and Its Effect on Couple Relationships and Sexual Satisfaction: A Multi-Country Survey of NFP Users from US and Europe.

PURPOSE: Birth control is a persistent global health concern. Natural family planning (NFP) comprises methods to achieve or avoid pregnancy independent of mechanical or pharmacological intervention. The sympto-thermal method (STM) of NFP employs daily observation of cervical fluids and measurement of basal body temperature. This multi-country study was undertaken to describe the characteristics of STM users, understand their perceptions of NFP, and its perceived impact on relationships. METHODS AND RESULTS: Questionnaires for women and men were developed in German and translated to English, Polish, Italian, Czech, and Slovak by native speakers. A total of 2,560 respondents completed the online questionnaire (37.4% response). Participants were married (89%) and well educated, and their self-perceived financial status was described as "good" or "very good" by 65% of the respondents. Forty-seven percent had previously used contraceptives. Ninety-five percent of women and 55% of men said using NFP has helped them to know their body better. Large majorities of men (74%) and women (64%) felt NFP helped to improve their relationship while <10% felt use of NFP had harmed their relationship. Most women (53%) and men (63%) felt using NFP improved their sex life while 32% of women and 24% of men felt it was unchanged from before they used NFP. Seventy-five percent of women and 73% of men said they are either "satisfied" or "very satisfied" with their frequency of sexual intercourse. CONCLUSION: This survey demonstrates STM of NFP is a well-accepted approach to family planning across several Western cultures. It is consistently viewed as being beneficial to couples' self-knowledge, their relationship, and satisfaction with frequency of sexual intercourse.

Natural Family Planning Instruction as a Marriage Requirement a Retrospective Analysis of the First Two Years' Experience in the Diocese of Covington.

Beginning January 1, 2009, the Roman Catholic Diocese of Covington mandated that all engaged couples take a full course of NFP instruction as part of preparation for marriage within the Church. Using data from the Couple to Couple League and its Covington-based instructors, overall NFP instruction and characteristics of the couples attending classes before and after the mandate were examined. In the first two years, 66 percent and 77 percent of couples who married in the diocese, respectively, attended an NFP class. The mandate shifted the reasons for couples taking NFP instruction; prior to the mandate, 40 percent of engaged couples attended classes solely due to a pastor's requirement while 74 percent of engaged couples did so afterward (p < 0.001). Hormonal contraceptive use was common; 54 percent reported current use while another 23 percent reported former use. Current hormonal contraceptive use was significantly more common among those attending solely due to the mandate compared to those attending for multiple reasons (59 percent vs. 41 percent respectively, p = 0.004) and was significantly more common among engaged compared to married couples (53 percent vs. 8 percent respectively, p < 0.001). Cohabiting engaged couples were significantly more likely to have ever used hormonal contraceptives (91 percent vs. 71 percent, p < 0.0001), compared to engaged couples who were not cohabiting at the time of NFP instruction, and were significantly less likely to both be Catholic (55 percent vs. 70 percent, p = 0.002). Overall, implementation of mandatory NFP instruction as part of marriage preparation was successful; in post-class surveys, over 90 percent of couples acknowledged they had a better understanding of their fertility, and 83 percent would recommend the classes to a friend. Longer-term prospective follow-up is needed to evaluate the long-term impacts to couples exposed to such a requirement.

Relationship between changes in bone mineral density and vertebral fracture risk associated with risedronate: greater increases in bone mineral density do not relate to greater decreases in fracture risk.

Low bone mineral density (BMD) is correlated with increased fracture risk. Whether greater BMD increases induced by osteoporosis drugs are related to greater decreases in fracture risk is controversial. We analyzed the relationship between BMD change and fracture risk in postmenopausal osteoporotic women receiving antiresorptive treatment. The analysis combined data from three pivotal risedronate fracture end-point trials. Women received risedronate (n = 2047) or placebo (n = 1177) daily for up to 3 yr. The BMD and vertebral radiographs were assessed periodically during 3 yr. The estimated risk of new vertebral fracture was compared between patients whose BMD increased and those whose BMD decreased. Risedronate-treated patients whose BMD decreased were at a significantly greater risk (p = 0.003) of sustaining a vertebral fracture than patients whose BMD increased. The fracture risk was similar (about 10%) in risedronate-treated patients whose increases in BMD were < 5% (the median change from baseline) and in those whose increases were >/= 5% (p = 0.453). The changes in lumbar spine BMD explained only 18% (95% confidence interval [CI], 10%, 26%; p < 0.001) of risedronate's vertebral fracture efficacy. Although patients showing an increase in BMD had a lower fracture risk than patients showing a decrease in BMD, greater increases in BMD did not necessarily predict greater decreases in fracture risk.

Risedronate preserves bone architecture in postmenopausal women with osteoporosis as measured by three-dimensional microcomputed tomography.

The deterioration of trabecular microarchitecture induced by elevated bone turnover is increasingly recognized as a factor in the pathogenesis of osteoporotic fractures. We investigated the effect of the reduction of turnover with risedronate on trabecular architecture in postmenopausal women with osteoporosis. Iliac crest bone biopsy specimens taken before and after 3 years of treatment from patients receiving risedronate 5 mg daily (n = 21) or placebo (n = 17) were analyzed using 3-D microcomputed tomography. We found a significant correlation between baseline bone turnover and bone loss in the placebo group, providing evidence that higher turnover induced higher bone loss leading to a greater degree of architectural degradation. When patients were classified into two groups based on baseline bone turnover (MS/BS less than or greater than the median value for the entire cohort), significant decreases in trabecular bone volume (BV/TV, P = 0.009) and trabecular thickness (Tb.Th*, P = 0.008) and an increase in marrow star volume (Ma.St.V, P = 0.008), a measure of trabecular porosity, were observed in the higher turnover (MS/BS> median) placebo-treated patients. The trabecular structure shifted from plates to rods as shown by an increase in structure model index (SMI, P = 0.028) and bone surface to bone volume ratio (BS/BV, P = 0.006). The changes from baseline in the lower turnover (MS/BS

Risedronate prevents new vertebral fractures in postmenopausal women at high risk.

Independent risk factors for fracture include advanced age, preexisting fractures, and low bone mineral density. Rised-ronate has been shown in several large trials to be safe and effective for patients with osteoporosis, but its effects in populations at high risk are not well characterized. To determine the effect of risedronate on vertebral fracture in high-risk subjects, we pooled data from two randomized, double-blind studies [Vertebral Efficacy with Risedronate Therapy (VERT) Multinational (VERT-MN) and VERT-North America (VERT-NA)] in 3684 postmenopausal osteoporotic women treated with placebo or risedronate 2.5 or 5 mg/d and analyzed fracture risk in subgroups of subjects at high risk for fracture due to greater age or more prevalent fractures (vs. median for overall study population), or lower bone mineral density (T-score, -2.5 or less). Fractures were diagnosed by quantitative and semiquantitative assessment of radiographs at baseline and 1 yr. In the overall population, treatment for 1 yr with risedronate 5 mg/d reduced the risk of new vertebral fractures by 62% vs. control (relative risk, 0.38; 95% confidence interval, 0.25, 0.56; P < 0.001) and of multiple new vertebral fractures by 90% vs. control (relative risk, 0.10; 95% confidence interval, 0.04, 0.26; P < 0.001). Consistent risk reductions were observed at 1 yr in the risedronate-treated high-risk subgroups. Significant reduction in fracture risk after 1 yr is an important benefit in patients at high risk for fracture because, without treatment, these patients are likely to sustain new fractures in the near term.