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Effectiveness, safety, and acceptability of first-trimester medical termination of pregnancy performed by non-doctor providers: a systematic review.

ABSTRACT: BACKGROUND:Previous systematic reviews have concluded that medical termination of pregnancy (TOP) performed by non-doctor providers may be as effective and safe as when provided by doctors. Medical treatment of incomplete miscarriage by non-doctor providers and the treated women's acceptance of non-doctor providers of TOP has not previously been reviewed. OBJECTIVES:To review the effectiveness, safety, and acceptability of first-trimester medical TOP, including medical treatment for incomplete miscarriage, by trained non-doctor providers. SEARCH STRATEGY AND SELECTION CRITERIA:A search strategy using appropriate medical subject headings was developed. Electronic databases (PubMed, Popline, Cochrane, CINAHL, Embase, and ClinicalTrials.gov) were searched from inception through April 2016. Randomised controlled trials and comparative observational studies were included. DATA COLLECTION AND ANALYSIS:Meta-analyses were performed for included randomised controlled trials regarding the outcomes of effectiveness and acceptability to women. Certainty of evidence was established using the GRADE approach assessing study limitations, consistency of effect, imprecision, indirectness and publication bias. MAIN RESULTS:Six papers were included. Medical TOP and medical treatment of incomplete miscarriage is probably equally effective when performed by non-doctor providers as when performed by doctors (RR 1.00; 95% CI 0.99-1.01). Women's acceptance, reported as overall satisfaction with the allocated provider, is probably equally high between groups (RR 1.00; 95% CI 1.00-1.01). CONCLUSION:Medical TOP and medical treatment of incomplete miscarriage provided by trained non-doctor providers is probably equally as effective and acceptable to women as when provided by doctors. TWEETABLE ABSTRACT:Medical termination of pregnancy performed by doctors and non-doctors can be equally effective and acceptable.

SUBMITTER: Sjostrom S

PROVIDER: S-EPMC5724486 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Effectiveness, safety, and acceptability of first-trimester medical termination of pregnancy performed by non-doctor providers: a systematic review.

Sjöström S S Dragoman M M Fønhus M S MS Ganatra B B Gemzell-Danielsson K K

BJOG : an international journal of obstetrics and gynaecology 20170817 13

<h4>Background</h4>Previous systematic reviews have concluded that medical termination of pregnancy (TOP) performed by non-doctor providers may be as effective and safe as when provided by doctors. Medical treatment of incomplete miscarriage by non-doctor providers and the treated women's acceptance of non-doctor providers of TOP has not previously been reviewed.<h4>Objectives</h4>To review the effectiveness, safety, and acceptability of first-trimester medical TOP, including medical treatment f ...[more]

PMID: 28445596

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Project description:ObjectiveTo compare outcomes before and after implementation of medical abortion (termination of pregnancy) without ultrasound via telemedicine.DesignCohort analysis.SettingThe three main abortion providers.Population or sampleMedical abortions at home at ≤69 days' gestation in two cohorts: traditional model (in-person with ultrasound, n = 22 158) from January to March 2020 versus telemedicine-hybrid model (either in person or via telemedicine without ultrasound, n = 29 984, of whom 18 435 had no-test telemedicine) between April and June 2020. Sample (n = 52 142) comprises 85% of all medical abortions provided nationally.MethodsData from electronic records and incident databases were used to compare outcomes between cohorts, adjusted for baseline differences.Main outcome measuresTreatment success, serious adverse events, waiting times, gestation at treatment, acceptability.ResultsMean waiting time from referral to treatment was 4.2 days shorter in the telemedicine-hybrid model and more abortions were provided at ≤6 weeks' gestation (40% versus 25%, P < 0.001). Treatment success (98.8% versus 98.2%, P > 0.999), serious adverse events (0.02% versus 0.04%, P = 0.557) and incidence of ectopic pregnancy (0.2% versus 0.2%, P = 0.796) were not different between models. In the telemedicine-hybrid model, 0.04% were estimated to be over 10 weeks' gestation at the time of the abortion; all were completed safely at home. Within the telemedicine-hybrid model, effectiveness was higher with telemedicine than in-person care (99.2% versus 98.1%, P < 0.001). Acceptability of telemedicine was high (96% satisfied) and 80% reported a future preference for telemedicine.ConclusionsA telemedicine-hybrid model for medical abortion that includes no-test telemedicine and treatment without an ultrasound is effective, safe, acceptable and improves access to care.Tweetable abstractCompelling evidence from 52 142 women shows no-test telemedicine abortion is safe, effective and improves care.

Project description:BackgroundThank you letters to physicians and medical facilities are an untapped resource, providing an invaluable glimpse into what patients notice and appreciate in their care.ObjectiveThe aim of this study was to analyze such thank you letters as posted on the Web by medical institutions to find what patients and families consider to be good care. In an age of patient-centered care, it is pivotal to see what metrics patients and families apply when assessing their care and whether they grasp specific versus general qualities in their care.MethodsOur exploratory inquiry covered 100 thank you letters posted on the Web by 26 medical facilities in the United States and the United Kingdom. We systematically coded and descriptively presented the aspects of care that patients and their families thanked doctors and medical facilities for. We relied on previous work outlining patient priorities and satisfaction (Anderson et al, 2007), to which we added a distinction between global and specific evaluations for each of the already existing categories with two additional categories: general praise and other, and several subcategories, such as treatment outcome, to the category of medical care.ResultsIn 73% of the letters (73/100), physicians were primarily thanked for their medical treatment. In 71% (71/100) of the letters, they were thanked for their personality and demeanor. In 52% cases (52/100), these two aspects were mentioned together, suggesting that from the perspective of patient as well as the family member, both are deemed necessary in positive evaluation of medical care. Only 8% (8/100) of the letters lacked reference to medical care, personality or demeanor, or communication. No statistically significant differences were observed in the number of letters that expressed gratitude for the personality or demeanor of medical care providers versus the quality of medical care (χ21, N=200=0.1, not statistically significant). Letters tended to express more specific praise for personality or demeanor, such as being supportive, understanding, humane and caring (48/71, 68%) but more general praise for medical care (χ21, N=424=63.9, P<.01). The most often mentioned specific quality of medical care were treatment outcomes (30/73, 41%), followed by technical competence (15/73, 21%) and treatment approach (14/73, 19%). A limitation of this inquiry is that we analyzed the letters that medical centers chose to post on the Web. These are not necessarily a representative sample of all thank you letters as are sent to health care institutions but are still indicative of what centers choose to showcase on the Web.ConclusionsPhysician demeanor and quality of interaction with patients are pivotal in how laymen perceive good care, no less so than medical care per se. This inquiry can inform care providers and medical curricula, leading to an improvement in the perceived quality of care.

Project description:Given the significant physiological changes that take place during and resulting from pregnancy, as well as the relative absence of such information in relation to pregnancy termination, this study investigated the potential for developing a valid animal model to objectively assess the biological, physiological and behavioral consequences of drug-induced pregnancy termination. Female Long-Evans rats were divided into four groups (n = 19-21/group), controlling for drug [mifepristone (50 mg/kg/3 ml, i.g.)/misoprostol (0.3 mg/kg/ml, i.g.) or vehicle (1% Carboxymethylcellulose Sodium/0.2% Tween® 80 suspension, i.g.)] and pregnancy. Drug administration took place on days 12-14 of gestation (days 28-40 human gestational equivalent). Vehicle was administered to the controls on the same days. Parameters measured included rat body weight, food intake, vaginal impedance, sucrose consumption/preference, locomotor activity, forced swim test, and home-cage activity. At the termination of the study, rats were deeply anesthetized using urethane, and blood, brain, and liver were collected for biochemical analysis. Following drug/vehicle administration, only the pregnancy termination group (pregnant, drug) displayed a significant decrease in body weight, food intake, locomotor activity-related behaviors and home-cage activity relative to the control group (non-pregnant, vehicle). Additionally, the pregnancy termination group was the only group that displayed a significant reduction in sucrose consumption/preference during Treatment Week relative to Pre-Treatment Week. Vaginal impedance did not significantly decrease over time in parous rats in contrast to all other groups, including the rats in the pregnancy termination group. Biochemical analysis indicated putative drug- and pregnancy-specific influences on oxidative balance. Regression analysis indicated that pregnancy termination was a predictor variable for body weight, food intake and all locomotor activity parameters measured. Moreover, pertaining to body weight and food intake, the pregnancy termination group displayed significant changes, which were not present in a group of naturally miscarrying rats following pregnancy loss. Overall, our results appear to suggest negative biological and behavioral effects following pregnancy termination, that appear to also be distinct from natural miscarriage, and potential benefits of parity pertaining to fecundity. Thus, our findings indicate the importance for further objective investigation of the physiological and behavioral consequences of medical abortion, in order to provide further insight into the potential implications in humans.

Project description:OBJECTIVES:To assess the safety, effectiveness, and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia. METHODS:We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing. RESULTS:Four hundred and ninety-six men comprised the analysis population, with 255 in the Standard Sizing arm and 241 in the Modified Sizing arm. Three men experienced a moderate or severe AEs (0.6%), including 2 in the Standard Sizing arm (0.8%) and 1 in the Modified Sizing arm (0.4%). 73.2% of participants were completely healed at the scheduled day 42 healing check visit, with similar percentages across study arms. Virtually all (99.6%) men, regardless of study arm, stated that they were very satisfied or satisfied with the appearance of their circumcised penis, and 98.6% stated that they would recommend ShangRing circumcision to family/friends. CONCLUSIONS:The moderate/severe AE rate was low and similar in the 2 study arms, suggesting that provision of one-half the number of adult device sizes is sufficient for safe service delivery. Effectiveness, time to healing, and acceptability were similar in the study arms. The simplicity of the ShangRing technique, and its relative speed, could facilitate VMMC program goals. In addition, sufficiency of fewer device sizes would simplify logistics and inventory.

Project description:BACKGROUND:A large proportion of abortion-related mortality and morbidity occurs in the second trimester of pregnancy. The Uganda Ministry of Health policy restricts management of second-trimester incomplete abortion to physicians who are few and unequally distributed, with most practicing in urban regions. Unsafe and outdated methods like sharp curettage are frequently used. Medical management of second-trimester post-abortion care by midwives offers an advantage given the difficulty in providing surgical management in low-income settings and current health worker shortages. The study aims to assess the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians. METHODS:A randomized controlled equivalence trial implemented at eight hospitals and health centers in Central Uganda will include 1192 eligible women with incomplete abortion of uterine size >?12?weeks up to 18?weeks. Each participant will be randomly assigned to undergo a clinical assessment and treatment by either a midwife (intervention arm) or a physician (control arm). Enrolled participants will receive 400 ?g misoprostol administered sublingually every 3 h up to five doses within 24?h at the health facility until a complete abortion is confirmed. Women who do not achieve complete abortion within 24?h will undergo surgical uterine evacuation. Pre discharge, participants will receive contraceptive counseling and information on what to expect in terms of side effects and signs of complications, with follow-up 14?days later to assess secondary outcomes. Analyses will be by intention to treat. Background characteristics and outcomes will be presented using descriptive statistics. Differences between groups will be analyzed using risk difference (95% confidence interval) and equivalence established if this lies between the predefined range of -?5% and +?5%. Chi-square tests will be used for comparison of outcome and t tests used to compare mean values. P ? 0.05 will be considered statistically significant. DISCUSSION:Our study will provide evidence to inform national and international policies, standard care guidelines and training program curricula on treatment of second-trimester incomplete abortion for improved access. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03622073 . Registered on 9 August 2018.

Dataset Information

Effectiveness, safety, and acceptability of first-trimester medical termination of pregnancy performed by non-doctor providers: a systematic review.

Publications

Effectiveness, safety, and acceptability of first-trimester medical termination of pregnancy performed by non-doctor providers: a systematic review.

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