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Objective To develop a minimum data set, known as a core outcome set, for future abortion randomized controlled trials. Study design We extracted outcomes from quantitative and qualitative systematic reviews of abortion studies to assess using a modified Delphi method. Via email, we invited researchers, clinicians, patients, and healthcare organization representatives with expertise in abortion to rate the importance of the outcomes on a 9-point Likert scale. After 2 rounds, we used descriptive analyses to determine which outcomes met the predefined consensus criteria. We finalized the core outcome set during a series of consensus development meetings. Results We entered 42 outcomes, organized in 15 domains, into the Delphi survey. Two-hundred eighteen of 251 invitees (87%) provided responses (203 complete responses) for round 1 and 118 of 218 (42%) completed round2. Sixteen experts participated in the development meetings. The final outcome set includes 15 outcomes: 10 outcomes apply to all abortion trials (successful abortion, ongoing pregnancy, death, hemorrhage, uterine infection, hospitalization, surgical intervention, pain, gastrointestinal symptoms, and patients’ experience of abortion); 2 outcomes apply to only surgical abortion trials (uterine perforation and cervical injury), one applies only to medical abortion trials (uterine rupture); and 2 apply to trials evaluating abortions with anesthesia (over-sedation/respiratory depression and local anesthetic systemic toxicity). Conclusion Using robust consensus science methods we have developed a core outcome set for future abortion research. Implications Standardized outcomes in abortion research could decrease heterogeneity among trials and improve the quality of systematic reviews and clinical guidelines. Researchers should select, collect, and report these core outcomes in future abortion trials. Journal editors should advocate for core outcome set reporting.

IntroductionThe National Institute for Health and Care Excellence, the Royal College of Obstetricians and Gynaecologists and the World Health Organization recommend that services provide a choice between medical and surgical methods of abortion. We analysed qualitative study data to examine patient perspectives on abortion method choice and barriers to meeting them.MethodsIn-depth interviews with 24 clients who had an abortion at British Pregnancy Advisory Service clinics were carried out between December 2018 and July 2019 to examine perspectives of quality of abortion care. In this article we focus on client perspectives on choice of abortion method. We performed thematic analysis of data relating to choice of abortion method, refined the analysis, interpreted the findings, and organised the data into themes.ResultsParticipants’ preferences for abortion method were shaped by prior experience of abortion, accessibility and privacy, perceptions of risk and experiences of abortion method, and information gathering and counselling. Participants’ ability to obtain their preferred method was impacted by intersecting constraints such as appointment availability, service location and gestational age.ConclusionsOur findings show that many factors shape participants’ preferences for abortion method. In response to the COVID-19 pandemic, some abortion services have constrained abortion method choices, with an emphasis on medical abortion and ‘no-touch’ care. Providers in the UK and beyond should aim to restore and expand more treatment options when the situation allows.

Objective Evaluate satisfaction and experience with telemedicine consultation and home use of mifepristone and misoprostol for abortion to 10 weeks’ gestation. Study Design Cross-sectional evaluation of British Pregnancy Advisory Service (BPAS) clients who used mifepristone and misoprostol at home from 11 May to 10 July 2020. We sent a text message with a link to a web-survey 2 to 3 weeks postabortion. Questions assessed satisfaction and experiences with a service model including telephone consultation and provision of medicines by mail or collection from the clinic. We used bivariate and multivariate regression to explore associations between client characteristics and outcomes. Our primary outcomes were overall satisfaction (5-point Likert scale) and reported contact with a health care provider. Results A total of 1,333 clients participated. Respondents described home use of medications as “straightforward” (75.8%) and most were “very satisfied” (78.3%) or “satisfied” (18.6%) overall. Being “very satisfied” was associated with parity (aOR 1.53, 95% CI 1.09−2.14) and pain control satisfaction (aOR 2.22, 95% CI 1.44−3.44). Health care provider contact was reported by 14.7%; mainly to BPAS’ telephone aftercare service (76.8%). Dissatisfaction with pain control (aOR 3.62, 95% CI 1.79−7.29) and waiting >1 week to use mifepristone (aOR3.71, 95% CI 1.48−9.28) were associated with health care provider contact. If needed in the future, most would prefer consultation by phone (74.3%) and home use of mifepristone and misoprostol (77.8%). Conclusions Satisfaction with telemedicine and home use of mifepristone and misoprostol is high. Most clients do not need health care provider support when administering medicines at home or post abortion.

We assessed whether a low-sensitivity pregnancy test is effective at identifying ongoing pregnancy after medication abortion at 64 to 70 days of gestation.From October 2018 to March 2020, we performed a prospective observational study of participants in England and Wales undergoing medication abortion. Participants were scheduled to return to the clinic 14 ± 3 days after mifepristone administration to perform a low-sensitivity pregnancy test (human chorionic gonadotropin threshold of 1000 mIU/mL) and symptom checklist, and state whether they thought the abortion was complete. Clinicians also assessed the low-sensitivity pregnancy test and performed an ultrasound to determine abortion status. We calculated the sensitivity, specificity, negative and positive predictive value of the low-sensitivity pregnancy test (with and without a symptom checklist) for detecting ongoing pregnancy.We enrolled 757 participants. Thirty-one did not progress to abortion and 558 (76.9%) completed follow-up. Most (79.6%) attended per-protocol; 22 (3.9%) attended earlier than 11 days and 92 (16.5%) later than 17 days. Thirteen participants (2.3%) had an ongoing pregnancy. The low-sensitivity pregnancy test correctly identified all the ongoing pregnancies (sensitivity = 100%; specificity = 84.8%; negative predictive value = 100%; positive predictive value = 13.5%). The symptom checklist alone had a sensitivity of 76.9% and a negative predictive value of 99.4% for identifying ongoing pregnancies. Participants and clinicians agreed on the interpretation of the low-sensitivity pregnancy test 94.6% of the time.Patient self-assessment of a low-sensitivity pregnancy test after medication abortion between 64- and 70 days' gestation has high sensitivity and negative predictive value for identification of ongoing pregnancy.Patients can be offered a low-sensitivity pregnancy test to assess for ongoing pregnancy after medication abortion up to 70 days of gestation thereby reducing the need for in-person visits. Services should be prepared to provide in-person assessments after positive or inconclusive results to ensure early identification of abortion complications.

Background Quality of care (QOC) is increasingly identified as an important contributor to healthcare outcomes, however little agreement exists on what constitutes quality in abortion care or the recommended indicators from the service-user perspective. Our study aimed to explore perceptions and experiences of abortion QOC in England and Wales. Methods We performed in-depth interviews (via phone or in-person) with participants who had an abortion at a nationwide independent sector provider in the previous 6 months. We explored their experiences of the abortion service at each point in the care pathway, their perspectives on what contributed to and detracted from the experience meeting their definitions of quality, and their reflections on different aspects of QOC. We used content analysis to generate themes. Results From December 2018 to July 2019, we conducted 24 interviews. Ten participants had a surgical and 14 had a medical abortion. Seventeen (71%) were treated in the first 12 weeks of pregnancy and 7 (29%) beyond that, with an average gestational age of 10 weeks + 5 days (range 5–23 + 6). We identified 4 major themes that contributed to participant’s perception of high quality care: (1) interpersonal interactions with staff or other patients, (2) being informed and prepared, (3) participation and choices in care and (4) accessibility. Nearly all participants identified interpersonal interactions with staff as an important contributor to quality with positive interactions often cited as the best part of their abortion experience and negative interactions as the worst. For information and preparation, participant described not only the importance of being well prepared, but how incongruencies between information and the actual experience detracted from quality. Participants said that making choices about their care, for example, method of abortion, was a positive contributor. Finally, participants identified access to care, specifically in relation to waiting times and travel, as an important aspect of QOC. Conclusions Participants situated quality in abortion care in 4 domains: interpersonal aspects of care, information and preparation, choices, and accessibility. Indicators identified can be used to develop standard metrics to ensure care meets service-user needs., Plain English summary Quality of care is an important aspect of delivering healthcare in a patient-centred manner. There is a lack of agreement about what consititutes quality care for an abortion service. In our study, we interviewed 24 participants who had an abortion in the last 6 months to assess their perceptions of quality of care. Based on our analysis, we identified 4 themes that were important contributors to quality: (1) interactions with clinic staff or other patients, (2) information and preparation for the abortion, (3) making choices about care, and (4) access to abortion care. Almost all of our study participants said that positive interactions with clinic staff contributed to a quality experience. Participants wanted to be well-prepared for their abortion. They reported a negative experience when the information they were given did not match their experience. Participants felt that active participation in choices around their abortion experience improved quality. Finally, ease of access to abortion care made for a more positive experience. Abortion providers and researchers should consider using the results of our study to ensure their services meet patients’ needs.

Objective: Evaluate satisfaction and experience with telemedicine and home use of mifepristone and misoprostol for abortion to 10 weeks’ gestation. Design: Cross-sectional evaluation. Setting: British Pregnancy Advisory Service (BPAS) clinics in England and Wales. Population: 1,144 clients who used mifepristone and misoprostol at home from 11 May to 10 July 2020. Methods: We sent a text message with a link to a web-survey 2-3 weeks after treatment. Questions evaluated satisfaction and experiences, including telephone consultations and provision of medicines by post or collection from clinic. We used bivariate and multivariate regression to explore associations between client characteristics and outcomes. Main Outcome Measures: Overall satisfaction (5-point Likert scale) and reported contact with a healthcare provider (HCP). Results: Respondents primarily described home use of medications as ‘straightforward’ (75.8%) and most were ‘very satisfied’ (78.3%) or ‘satisfied’ (18.6%) with their overall experience. Being ‘very satisfied’ was associated with parity (aOR 1.53, 95% CI 1.09-2.14) and pain control satisfaction (aOR 2.22, 95% CI 1.44-3.44). HCP contact was reported by 14.7%; mainly to BPAS’ telephone aftercare service (76.8%). Dissatisfaction with pain control (aOR 3.62 95% CI 1.79-7.29) and waiting >1 week to use mifepristone (aOR3.71, 95% CI 1.48-9.28) were associated with HCP contact. If needed in future, most (77.8%) would prefer home use of mifepristone and misoprostol and pills by post (68.9%). Conclusions: Satisfaction with home use of mifepristone and misoprostol is high. Most clients do not need HCP support during or after home use, but aftercare should be available.

Background Mifepristone and misoprostol are recommended for second-trimester medical abortion, but consensus is unclear on the ideal regimen. Objectives The objectives were to systematically review randomized controlled trials (RCTs) investigating efficacy, safety and satisfaction of medical abortion at ≥ 12 weeks' gestation. Data sources We searched PubMed, Popline, Embase, Global Index Medicus, Cochrane Controlled Register of Trials and International Clinical Trials Registry Platform from January 2008 to May 2017. Study eligibility, participants and interventions We included RCTs on medical abortion at ≥ 12 weeks' gestation using mifepristone and/or misoprostol. We excluded studies with spontaneous abortion, fetal demise and mechanical cervical ripening and those not reporting ongoing pregnancy (OP). Study appraisal and synthesis methods After extracting prespecified data and assessing risk of bias in accordance with the Cochrane handbook, we used Revman5 software to combine data and GRADE to assess certainty of evidence. Results We included 43 of the 1894 references identified. Combination mifepristone–misoprostol had lower rates of OP [risk ratio (RR) 0.12, 95% confidence interval (CI) 0.04–0.35] vs. misoprostol only. A 24-h interval between mifepristone and misoprostol had lower OP rate at 24 h than simultaneous dosing (RR 3.13, 95% CI 1.23–7.94). Every 3-h dosing had lower OP rate at 48 h (RR 0.39, 95% CI 0.17–0.88). Limitations Direct comparisons of buccal misoprostol to sublingual or vaginal routes after mifepristone were limited. Evidence from clinical trials on how to best manage women with prior uterine incisions was lacking. Conclusion Our analysis supports the use of mifepristone 200 mg 1 to 2 days before misoprostol 400 mcg vaginally every 3 h at ≥ 12 weeks' gestation. Implications Where available, providers should use mifepristone plus misoprostol for second-trimester medical abortion. Vaginal misoprostol appears to be most efficacious with fewest side effects, but sublingual and buccal routes are also acceptable.

Correct and consistent use of contraception decreases the risk of unintended pregnancy; yet outdated policies or practices can delay initiation or hinder continuation of contraceptive methods. To promote the quality of and access to family planning services WHO created a series of evidence-based guidance documents for family planning known as WHOs Four Cornerstones of Family Planning Guidance. The Medical eligibility criteria for contraceptive use (MEC) first published in 1996 provides guidance on the safety of various contraceptive methods in users with specific health conditions or characteristics (i.e. who can use a contraceptive method safely). The Selected practice recommendations for contraceptive use (SPR) is the second cornerstone outlining how to safely and effectively use contraceptive methods. These two documents can serve as a reference for policymakers and program managers as they develop their own national family planning policies in the context of local needs values and resources. The two other cornerstone documents -- the Decision making tool for family planning clients and providers and Family planning: a global handbook for providers -- provide guidance to healthcare providers for applying these recommendations in practice. Between 2013 and 2014 WHO convened a Guideline Development Group (GDG) to review and update the MEC and SPR in line with current evidence. As a result of these meetings the fifth edition of the MEC was published in 2015 and the third edition of the SPR will be released on December 14 2016. The purpose of the present report is to describe the methods used to develop the SPR recommendations research gaps identified during the guideline development process and future directions for the dissemination and implementation of the SPR among policymakers and family planning program managers worldwide. (excerpt)

Objective To systematically review the literature to determine if extended use of intrauterine devices including the copper or levonorgestrel intrauterine device beyond approved durations is effective and safe for preventing pregnancy. Data sources We searched PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, and Global Index Medicus from inception through June 2019. Study eligibility criteria We considered primary studies of women using the T380A Copper or currently available levonorgestrel intrauterine devices past their approved duration (extended use). The primary outcome was pregnancy. Safety outcomes included adverse events and side effects that led to discontinuation. Study appraisal and synthesis methods We abstracted study data into evidence tables and assessed study quality as related to the risk of bias, precision, and external validity. For each intrauterine device type, we calculated a pooled pregnancy rate during the first two years of extended use using the Poisson inverse variance method. Results Of 4,068 studies identified by our search, four good to poor quality studies of the 52 mg levonorgestrel intrauterine device (approved for five years) with a total of 2098 women starting extended use, and two good to fair quality studies of the T380A copper intrauterine device (approved for 10 years) with 245 women starting extended use met inclusion criteria. For the levonorgestrel intrauterine device, the pooled pregnancy rate was 0.02 per 100 person-years (95% confidence interval 0.00-0.45) in year six, 0.03 per 100 person-years (95% confidence interval 0.00-0.71) in year 7, and 0.02 per 100 person-years (95% confidence interval 0.00-0.29) in years six and seven combined. During this same time, annual rates of adverse events or discontinuation due to side effects ranged from 0-3.7 per 100 participants. For the copper intrauterine device, the pooled pregnancy rate for years 11 and 12 was 0.0 per 100 person-years (95% confidence interval 0.0-0.8), and annual rates of adverse events and discontinuation due to side effects during extended use ranged from 0-4.6 per 100 participants. Conclusion The available evidence suggests that rates of pregnancy, adverse events, and discontinuation due to side effects during the first two years of extended use of the 52 mg levonorgestrel intrauterine device and the T380A copper intrauterine device are low and comparable to rates during approved duration of use. Data were limited in quantity and quality, and may not be generalizable to all intrauterine device users.

Background Abortion is one of the most common events in women’s healthcare worldwide. Currently there is no standardization for the selection and reporting of outcomes in abortion clinical trials. This heterogeneity in clinical trials can make it difficult to draw meaningful conclusions across studies. Objective We aim to develop, disseminate, and implement a core outcome set (COS) for medical and surgical abortion trials. Materials and Methods To guide this project, we have assembled a local study management team and an international advisory group including abortion providers, researchers, methodologists, and abortion clients. A preliminary list of potential outcomes will be developed by undertaking a systematic review of abortion trials. A qualitative review will determine outcomes that are meaningful to women with experience of abortion. The modified Delphi method will use iterative group consensus to reduce the long list of outcomes. Participants in the modified Delphi method will include service-providers, researchers, clients, client advocates, and leaders of relevant medical journals and professional societies. Consensus on the COS will be reached via Delphi and a consensus meeting. Outcome measurements will be designated for each core outcome. Dissemination will be widespread including journals and professional societies. Discussion Results of this project will guide the development of future trials, advise trial reporting in collaborating journals, improve the strength of literature reviews and subsequent guidelines, and promote work in the field of COS development. Development and adoption of a COS in abortion would assist researchers in planning future trials, performing reviews, and creating guidelines or recommendations.