Oral medical assistance in dying (MAiD): informing practice to enhance utilization in Canada.

The legislation Bill C-14 legalized medical assistance in dying (MAiD) in Canada. After thorough assessments of eligibility by two clinicians, Bill C-14 allows for both intravenous-assisted death by a clinician (euthanasia) and prescription of oral medication for self-administration (assisted suicide). Nevertheless, since inception in June 2016, intravenous euthanasia is the main form of delivery of assisted death in Canada. The reasons why oral MAiD is underutilized in Canada are multifactorial. Currently, there is no consensus on either the medications or the protocols for oral administration, nor a comprehensive understanding of the potential side effects and complications associated with different regimens. The quality of evidence for optimal MAiD medications is low, so any suggested recommendations can only be informed by the global but generally anecdotal experience. The challenges for implementing oral MAiD in Canada include a need to enhance clinician comfort in prescribing oral medications as an alternative to intravenous administration. The goals for ideal oral MAiD medications are 100% effectiveness and minimal side effects, while ensuring that the needed dose is both palatable and deliverable in a tolerable oral volume. The Netherlands has the most experience worldwide and barbiturates have emerged as the most common, efficacious, and tolerable agents by patients. Based on this global experience and the over-arching goals for oral MAiD, we recommend the use of a secobarbital suspension combined with antiemetic prophylaxis.

Reasons for requesting medical assistance in dying.

OBJECTIVE: To review the charts of people who requested medical assistance in dying (MAID) to examine their reasons for the request. DESIGN: Retrospective chart survey. SETTING: British Columbia. PARTICIPANTS: Patients who requested an assisted death and were assessed by 1 of 6 physicians in British Columbia during 2016. MAIN OUTCOME MEASURES: Patients' diagnoses and reasons for requesting MAID. RESULTS: Data were collected from 250 assessments for MAID: 112 of the patients had assisted deaths, 11 had natural deaths, 35 were assessed as not eligible for MAID, and most of the rest were not ready. For people who had assisted deaths, disease-related symptoms were given as the first or second most important reason for requesting assisted death by 67 people (59.8%), while 59 (52.7%) gave loss of autonomy, 55 (49.1%) gave loss of ability to enjoy activities, and 27 (24.1%) gave fear of future suffering. People who were assessed as eligible but who had not received assisted deaths were more likely to list fear of future suffering (33.7% vs 7.1%) and less likely to list disease-related symptoms (17.4% vs 40.2%) than those who received MAID were. There was a difference in reasons for MAID given by people with different diagnoses; disease-related symptoms were given as the most important reason by 39.0% of patients with malignancies, 6.8% of patients with neurological diseases, and 28.9% of patients with end-organ failure. Loss of autonomy was given as the most important reason by 16.0% of patients with malignancies, 36.4% of patients with neurological diseases, and 23.7% of patients with end-organ failure. CONCLUSION: This study shows that the reasons patients give for requesting an assisted death are similar to those reported in other jurisdictions with similar laws, but in different proportions. Loss of autonomy and loss of ability to enjoy activities were less common reasons among patients in this study compared with other jurisdictions. This might be related to the method of data collection, as in this study, the patients' reasons were recorded by physicians.

Medical Abortion.

OBJECTIVE: This guideline reviews the evidence relating to the provision of first-trimester medical induced abortion, including patient eligibility, counselling, and consent; evidence-based regimens; and special considerations for clinicians providing medical abortion care. INTENDED USERS: Gynaecologists, family physicians, registered nurses, midwives, residents, and other healthcare providers who currently or intend to provide pregnancy options counselling, medical abortion care, or family planning services. TARGET POPULATION: Women with an unintended first trimester pregnancy. EVIDENCE: Published literature was retrieved through searches of PubMed, MEDLINE, and Cochrane Library between July 2015 and November 2015 using appropriately controlled vocabulary (MeSH search terms: Induced Abortion, Medical Abortion, Mifepristone, Misoprostol, Methotrexate). Results were restricted to systematic reviews, randomized controlled trials, clinical trials, and observational studies published from June 1986 to November 2015 in English. Additionally, existing guidelines from other countries were consulted for review. A grey literature search was not required. VALUES: The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force for Preventive Medicine rating scale (Table 1). BENEFITS, HARMS AND/OR COSTS: Medical abortion is safe and effective. Complications from medical abortion are rare. Access and costs will be dependent on provincial and territorial funding for combination mifepristone/misoprostol and provider availability. SUMMARY STATEMENTS: Introduction Pre-procedure care Medical abortion regimens Providing medical abortion Post-abortion care RECOMMENDATIONS: Introduction Pre-procedure care Medical abortion regimens Providing medical abortion Post-abortion care.

BASIC study: is intravaginal boric acid non-inferior to metronidazole in symptomatic bacterial vaginosis? Study protocol for a randomized controlled trial.

BACKGROUND: Bacterial vaginosis is associated with increased transmission of sexually transmitted infections, preterm labor, post-surgical infections, and endometritis. Current treatment for symptomatic bacterial vaginosis includes antibiotics, such as metronidazole, which are 70-80 % effective at one month after treatment and result in high recurrence rates and secondary candida infections. Intravaginal boric acid has been used for over a hundred years to treat vaginal infections, such as bacterial vaginosis. Boric acid is inexpensive, accessible, and has shown to be an effective treatment for other infections, such as vaginal candidiasis. To date, there has been no clinical trial evaluation of boric acid effectiveness to treat bacterial vaginosis. METHODS/DESIGN: The BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) trial is a randomized, double-blinded, multicenter study. The study will enroll a minimum of 240 women of 16-50 years of age who are symptomatic with bacterial vaginosis. Eligible participants will have Amsel and Nugent scores confirming bacterial vaginosis. Women who are pregnant or menopausal or have other active co-infections will be excluded. Consenting participants who meet exclusion and inclusion criteria will be randomly assigned to one of three treatment groups: boric acid, metronidazole, or an inert placebo. Self-administration of treatment intravaginally for 10 days will be followed by clinical assessment at 7 and 30 days (days 17 and 40, respectively) after the end of the treatment phase. Primary outcome is a non-inferiority, per-protocol comparison of the effectiveness of boric acid with that of metronidazole at day 17, as measured by the Nugent score in 16-50 year olds. Secondary outcomes include: non-inferiority, intention-to-treat comparison of effectiveness of boric acid with that of metronidazole at day 17, analysis for both per-protocol and intention-to-treat at day 40, and safety considerations, including adverse effects requiring patient discontinuation of treatment. DISCUSSION: This study will be the first to determine whether intravaginal boric acid is non-inferior to metronidazole in the treatment of bacterial vaginosis in symptomatic women. TRIAL REGISTRATION: ClinicalTrials.gov NCT00799214, registered online Nov 10, 2008.

Intrauterine device insertions: which variables matter?

OBJECTIVES: Many factors are suspected to influence the intrauterine device (IUD) insertion process. This study sought to examine the effects of a few key variables on IUD insertion tolerability, complications and follow-up issues. METHODS: A retrospective chart review was undertaken of all IUD insertions over an 11-month period at an urban Canadian women's clinic. Linear regression analysis of 354 insertions assessed the effects of parity, age, local anaesthesia and other variables on insertion pain. Chi square (χ(2)) and analysis of variance statistics were employed to evaluate differences in insertion complications by parity and age. A χ(2) test was performed to compare follow-up expulsion or removal rates by parity. RESULTS: Statistically significant differences were found, with nulliparous women and those who received local anaesthesia reporting more insertion pain. Age, IUD type and recent abortion status did not affect insertion pain. Nulliparous women did not experience significantly more insertion difficulty or complications, nor did they have higher rates of expulsion or removal at follow-up. CONCLUSIONS: These findings suggest that the practice of providing cervical anaesthesia at IUD insertion may cause slightly more pain, without any obvious additional benefit. The difference in insertion pain by parity, although statistically significant, is small enough to be of questionable clinical importance. Overall, these findings add to the growing body of evidence for IUDs being safe and well-tolerated in nulliparous women.

Does using tampons or menstrual cups increase early IUD expulsion rates?

BACKGROUND: Many intrauterine device (IUD) users utilize intravaginal menstrual cups or tampons during menses, but no studies have investigated the impact this practice may have on IUD expulsions. STUDY DESIGN: Retrospective chart survey. RESULTS: Of the 930 women having IUDs placed and reporting menstrual protection, 10.3% (96) used menstrual cups, 74.2% (690) used tampons, and 43.2% (402) used pads (many women reported using more than one method). In the 743 women with adequate follow-up information, there was a full or partial expulsion (i.e., part of the IUD in the cervical canal) rate of 2.5% (27) during the first 6 weeks after insertion. There was no difference in the women using cups, tampons or pads (confidence intervals overlap). CONCLUSIONS: From this study, there is no evidence that women who report using menstrual cups or tampons for menstrual protection had higher rates of early IUD expulsion.

Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial.

BACKGROUND: We describe the rationale and protocol for a randomized controlled trial (RCT) to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. METHODS/DESIGN: Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention) or four weeks (recommended care) post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion) and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014. DISCUSSION: The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one through five years among enrolled women. We highlight considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion.

FLOW (finding lasting options for women): multicentre randomized controlled trial comparing tampons with menstrual cups.

OBJECTIVE: To determine whether menstrual cups are a viable alternative to tampons. DESIGN: Randomized controlled trial. SETTING: Prince George, Victoria, and Vancouver, BC. PARTICIPANTS: A total of 110 women aged 19 to 40 years who had previously used tampons as their main method of menstrual management. INTERVENTION: Participants were randomized into 2 groups, a tampon group and a menstrual cup group. Using online diaries, participants tracked 1 menstrual cycle using their regular method and 3 menstrual cycles using the method of their allocated group. MAIN OUTCOME MEASURES: Overall satisfaction; secondary outcomes included discomfort, urovaginal infection, cost, and waste. RESULTS: Forty-seven women in each group completed the final survey, 5 of whom were subsequently excluded from analysis (3 from the tampon group and 2 from the menstrual cup group). Overall satisfaction on a 7-point Likert scale was higher for the menstrual cup group than for the tampon group (mean [standard deviation] score 5.4 [1.5] vs 5.0 [1.0], respectively; P=.04). Approximately 91% of women in the menstrual cup group said they would continue to use the cup and recommend it to others. Women used a median of 13 menstrual products per cycle, or 169 products per year, which corresponds to approximately 771,248,400 products used annually in Canada. Estimated cost for tampon use was $37.44 a year (similar to the retail cost of 1 menstrual cup). Subjective vaginal discomfort was initially higher in the menstrual cup group, but the discomfort decreased with continued use. There was no significant difference in physician-diagnosed urovaginal symptoms between the 2 groups. CONCLUSION: Both of the menstrual management methods evaluated were well tolerated by subjects. Menstrual cups are a satisfactory alternative to tampons and have the potential to be a sustainable solution to menstrual management, with moderate cost savings and much-reduced environmental effects compared with tampons. Trial registration number C06-0478 (ClinicalTrials.gov).

Motivation and experience of nulliparous women using intrauterine contraceptive devices.

OBJECTIVES: Use of an intrauterine contraceptive device (IUD) has not been recommended to nulliparous women in the past. There is now good evidence that there is no increased risk of pelvic inflammatory disease or infertility in nulliparas who use IUDs and the recommendations have changed. Our objective was to understand more about the motivations and experience of nulliparous women using IUDs. METHODS: This was a mixed method study. First, we asked 44 nulliparous women who had had an IUD inserted within the previous six months about their reasons for seeking the IUD, their history with other forms of contraception, their perception of the insertion experience, and their feelings after insertion. Questionnaires were then distributed to 154 nulliparous women presenting for IUDs, asking about their past experience with hormonal contraception. RESULTS: The main theme arising from the interviews was a desire to avoid hormonal contraception. Other reasons for choosing the IUD were greater contraceptive effectiveness than other methods, convenience of use, and lower cost. Responses to the questionnaire indicated that 138 women (89.7%) had used hormonal contraception in the past and, of those, 98 (63.0%) complained of mood side effects, 64 (41.6%) of sexual side effects, and 64 (41.6%) of physical side effects. CONCLUSION: The most important motivation for nulliparous women in this study to choose IUDs was to avoid the potential or actual side effects of hormonal contraception. Despite experiencing some discomfort at the time of insertion, this group of nulliparous women was very positive about using IUDs for contraception.

Comparing continuation rates and side effects of hormonal contraceptives in East Asian and Caucasian women after abortion.

BACKGROUND: The purpose of this study was to determine whether East Asian women had more side effects and a higher discontinuation rate than Caucasian women when choosing to use hormonal contraceptives. STUDY DESIGN: This was an observational cohort study of usual care using questionnaires for 2 months after being given hormonal contraceptives following an abortion in Vancouver, Canada. RESULTS: In the first month, 73 (64.4%) of the 110 East Asian and 86 (80.4%) of the 107 Caucasian women took any of the sample provided (p=.020). In the second month, 52 (47.3%) of the East Asian and 62 (57%) of the Caucasian women used the prescription to buy and take their hormonal contraception (p=.12). Total side effects were similar, but there was more nausea in the East Asian women (23.3% vs. 8.1%) (p=.03) and more acne in the Caucasian women (8.2% vs. 20.9%) (p=.05). CONCLUSIONS: There may be both physiological and cultural differences leading East Asian women to use less hormonal contraception.

Ethnic Korean women's perceptions about birth control.

CONTEXT: We see many Korean women in our clinics and we have found them to have negative attitudes to hormonal contraception. We need to understand their perceptions and experiences with contraception in order to improve the effectiveness of our contraceptive counseling. METHODS: This was a qualitative descriptive study, conducted in an urban family practice office. The participants were a convenience sample of 40 ethnic Korean women. Data were collected in semistructured interviews by one interviewer who is fluent in English and Korean. Transcribed interviews were analyzed to identify salient themes. RESULTS: There was a deep distrust of hormonal methods of contraception and belief that hormones caused permanent harm. Unlike the findings in our other studies of Asian women, these women were satisfied with their usual methods of combining condoms, rhythm and withdrawal. They described good communication with their partners (which is necessary for the effective use of their chosen approaches). CONCLUSION: When counseling Korean women about contraception, it is important to discuss the cultural bias against hormonal contraception involving beliefs that hormones cause permanent harm. It is also important to recognize the very successful use of condoms, rhythm and withdrawal by these couples.

Comparing patients' telephone calls after medical and surgical abortions.

OBJECTIVE: The purpose of this study is to monitor the content, timing of and response to telephone calls from medical and surgical abortion patients in order to improve the counseling and nursing care and allay patient's concerns. METHODS: There were 43 calls from a possible 626 surgical patients and 100 calls from a possible 671 medical patients. Calls were considered preventable in 67% of the medical patients and 46.5% of the surgical patients. Women who were having their first abortion were more likely to place preventable calls. CONCLUSIONS: Calls could be reduced by explaining variations in normal bleeding and how to use analgesics and providing this information in diagrammatic form on an information sheet.

Antichoice attitudes to abortion in women presenting for medical abortions.

OBJECTIVE: To examine attitudes of women presenting for elective abortions. METHOD: Women presenting for elective abortion induced with medication at an urban free-standing abortion clinic were given semistructured interviews about their attitudes to abortion. RESULTS: Of the 60 women interviewed, 26 voiced antichoice attitudes. These interviews were transcribed and analyzed for themes. The women with antichoice attitudes were similar to the women with prochoice attitudes in age, education, and religion but were less likely to be white (61.8% of prochoice women identified themselves as white, compared with 30.8% of antichoice women, P = 0.02). The antichoice women felt most strongly that other women should not be allowed to have an abortion if they gave as their reason, "want no more children," "not married," or "cannot afford." The most common themes were that one needed "enough" reasons to have an abortion and that women should take better precautions to prevent conception. CONCLUSION: It is important for abortion clinic staff to realize that many women coming to an abortion clinic have antichoice views. These views may affect a woman's ability to recover emotionally after the procedure and will therefore have implications for the kind of supportive care women need both before and after the abortion.

Comparing vaginal and buccal misoprostol when used after methotrexate for early abortion.

OBJECTIVE: The primary objective of this study was to determine if buccal misoprostol was as effective as vaginal misoprostol in medical abortions. The secondary objectives were to compare side effects and acceptability. METHODS: This was a randomized controlled trial of 600 microg misoprostol by the buccal or vaginal routes used 3 to 6 days after 50 mg/m2 methotrexate. The participants were women presenting for abortion at 49 days or less gestation. The outcome measures were the number of women who had aborted by Day 8, side effects and acceptability. RESULTS: Day 8 completion rate was 53.5% for the buccal route and 67.5% for the vaginal route (p = 0.012). Side effects were similar in the two groups except that there was more burning with the buccal route. Overall acceptability and route acceptability were similar in the two groups. CONCLUSIONS: When used after methotrexate for early abortion, the vaginal route for misoprostol is more effective and preferred to the buccal route.