Pharmacist checklist and resource guide for mifepristone medical abortion: User-centred development and testing.
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SUBMITTER: Rebic N
PROVIDER: S-EPMC8165881 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo estimate effectiveness and acceptability of medication abortion with mifepristone dispensed by pharmacists.MethodsWe conducted a prospective cohort study at eight clinical sites and pharmacies in California and Washington State from July 2018 to March 2020. Pharmacists at participating pharmacies underwent a 1-hour training on medication abortion. We approached patients who had already been evaluated, counseled, and consented for medication abortion per standard of care. Patients interested in study participation gave consent, and the clinician electronically sent a prescription to the pharmacy for mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 800 micrograms buccally. Participants were sent web-based surveys about their experience and outcomes on days 2 and 14 after enrollment and had routine follow-up with study sites. We extracted demographic and clinical data, including abortion outcome and adverse events, from medical records. We performed multivariable logistic regression to assess the association of pharmacy experience and other covariates with satisfaction.ResultsWe enrolled 266 participants and obtained clinical outcome information for 262 (98.5%), of whom two reported not taking either medication. Of the 260 participants with abortion outcome information, 252 (96.9%) and 237 (91.2%) completed day 2 and 14 surveys, respectively. Complete medication abortion (primary outcome) occurred for 243 participants (93.5%, 95% CI 89.7-96.1%). Four participants (1.5%, 95% CI 0.4-3.9%) had an adverse event, none of which was serious or related to pharmacist dispensing. In the day 2 survey, 91.3% (95% CI 87.1-94.4%) of participants reported satisfaction with the pharmacy experience. In the day 14 survey, 84.4% (95% CI 79.1-88.8%) reported satisfaction with the medication abortion experience. Those reporting being very satisfied with the pharmacy experience had higher odds of reporting overall satisfaction with medication abortion (adjusted odds ratio 2.96, 95% CI 1.38-6.32).ConclusionPharmacist dispensing of mifepristone for medication abortion is effective and acceptable to patients, with a low prevalence of adverse events.Clinical trial registrationClinicalTrials.gov, NCT03320057.
| S-EPMC7984759 | biostudies-literature
Project description:ObjectiveTo evaluate the acceptability and efficacy of medical abortion at home up to 63 days' gestation without limits on travel distance to a registered institution.DesignObservational prospective study.SettingHaukeland University Hospital between May 2006 and May 2009.PopulationA total of 1018 women requesting abortion before 63 days' gestation who chose medical termination with mifepristone and home administration of misoprostol.MethodsThe women took 200 mg mifepristone under nurse supervision and self-administered 800 ?g misoprostol vaginally 36-48 h later at home. All were contacted by phone for follow-up and assessment of bleeding, pain and acceptability.Main outcome measuresEvacuation rate, pain, bleeding, acceptability, influence of distance on treatment.ResultsMedian gestational age was 50 (range 35-63) days and 70 (7.1%) of the women lived more than 60 min travel from the clinic. The rate of completed abortion was 93.6% and surgical evacuation was performed in 50 (4.9%) cases. Two women requested treatment on the day of misoprostol use. Moderate to strong pain was experienced by 68.4%, and 74.7% reported moderate to heavy bleeding. Parous women experienced less pain than nulliparous women (odds ratio 0.27; 95% confidence interval 0.19-0.34). In all, 95.1% of the women were satisfied with staying at home. Travel distance did not influence treatment outcome variables.ConclusionsIn our experience, home administration of misoprostol is an effective and acceptable method for abortion up to 63 days of gestation and women should be eligible for this treatment option regardless of their travel distance from hospital.
| S-EPMC4670695 | biostudies-literature
Project description:Polygenic indexes (PGIs) are DNA-based predictors. Their value for research in many scientific disciplines is growing rapidly. As a resource for researchers, we used a consistent methodology to construct PGIs for 47 phenotypes in 11 datasets. To maximize the PGIs' prediction accuracies, we constructed them using genome-wide association studies-some not previously published-from multiple data sources, including 23andMe and UK Biobank. We present a theoretical framework to help interpret analyses involving PGIs. A key insight is that a PGI can be understood as an unbiased but noisy measure of a latent variable we call the 'additive SNP factor'. Regressions in which the true regressor is this factor but the PGI is used as its proxy therefore suffer from errors-in-variables bias. We derive an estimator that corrects for the bias, illustrate the correction, and make a Python tool for implementing it publicly available.
| S-EPMC8678380 | biostudies-literature
Project description:PurposeAccess to family planning health services in Canada has been historically inadequate and inequitable. A potential solution appeared when Health Canada approved mifepristone, the gold standard for medical abortion, in July 2015. We sought to investigate the factors that influence successful initiation and ongoing provision of medical abortion services among Canadian health professionals and how these factors relate to abortion policies, systems, and service access throughout Canada.MethodsWe conducted 1-on-1 semistructured interviews with a national sample of abortion-providing and nonproviding physicians and health system stakeholders in Canadian health care settings. Our data collection, thematic analysis, and interpretation were guided by Diffusion of Innovation theory.ResultsWe conducted interviews with 90 participants including rural practitioners and those with no previous abortion experience. In the course of our study, Health Canada removed mifepristone restrictions. Our results suggest that Health Canada's initial restrictions discouraged physicians from providing mifepristone and were inconsistent with provincial licensing standards, thereby limiting patient access. Once deregulated, remaining factors were primarily related to local and regional implementation processes. Participants held strong perceptions that mifepristone was the new standard of care for medical abortion in Canada and within the scope of primary care practice.ConclusionHealth Canada's removal of mifepristone restrictions facilitated the implementation of abortion care in the primary care setting. Our results are unique because Canada is the first country to facilitate provision of medical abortion in primary care via evidence-based deregulation of mifepristone.
| S-EPMC7489974 | biostudies-literature
Project description:Effective physical activity messaging plays an important role in the pathway towards changing physical activity behaviour at a population level. The Physical Activity Messaging Framework (PAMF) and Checklist (PAMC) are outputs from a recent modified Delphi study. This sought consensus from an international expert panel on how to aid the creation and evaluation of physical activity messages. In this paper, we (1) present an overview of the various concepts within the PAMF and PAMC, (2) discuss in detail how the PAMF and PAMC can be used to create physical activity messages, plan evaluation of messages, and aid understanding and categorisation of existing messages, and (3) highlight areas for future development and research. If adopted, we propose that the PAMF and PAMC could improve physical activity messaging practice by encouraging evidence-based and target population-focused messages with clearly stated aims and consideration of potential working pathways. They could also enhance the physical activity messaging research base by harmonising key messaging terminologies, improving quality of reporting, and aiding collation and synthesis of the evidence.
| S-EPMC8684545 | biostudies-literature
Project description:Genetic predisposition is one factor influencing interindividual drug response. Pharmacogenetic information can be used to guide the selection and dosing of certain drugs. However, the implementation of pharmacogenetics (PGx) in clinical practice remains challenging. Defining a formal structure, as well as concrete procedures and clearly defined responsibilities, may facilitate and increase the use of PGx in clinical practice. Over 140 patient cases from an observational study in Switzerland formed the basis for the design and refinement of a pharmacist-led pharmacogenetics testing and counselling service (PGx service) in an interprofessional setting. Herein, we defined a six-step approach, including: (1) patient referral; (2) pre-test-counselling; (3) PGx testing; (4) medication review; (5) counselling; (6) follow-up. The six-step approach supports the importance of an interprofessional collaboration and the role of pharmacists in PGx testing and counselling across healthcare settings.
| S-EPMC9326676 | biostudies-literature
Project description:ObjectiveTo document clinical outcomes and women's experiences following the introduction of mifepristone into South African public sector second-trimester medical abortion services, and compare with historic cohorts receiving misoprostol-only.MethodsRepeated cross-sectional observational studies documented service delivery and experiences of women undergoing second-trimester medical abortion in public sector hospitals in the Western Cape, South Africa. Women recruited to the study in 2008 (n = 84) and 2010 (n = 58) received misoprostol only. Those recruited in 2014 (n = 208) received mifepristone and misoprostol. Consenting women were interviewed during hospitalization by study fieldworkers with respect to socio-demographic information, reproductive history, and their experiences with the abortion. Clinical details were extracted from medical charts following discharge. Telephone follow-up interviews to record delayed complications were conducted 2-4 weeks after discharge for the 2014 cohort.ResultsThe 2014 cohort received 200 mg mifepristone, which was self-administered 24-48 hours prior to admission. For all cohorts, following hospital admission, initial misoprostol doses were generally administered vaginally: 800 mcg in the 2014 cohort and 600 mcg in the earlier cohorts. Women received subsequent doses of misoprostol 400 mcg orally every 3-4 hours until fetal expulsion. Thereafter, uterine evacuation of placental tissue was performed as needed. With one exception, all women in all cohorts expelled the fetus. Median time-to-fetal expulsion was reduced to 8.0 hours from 14.5 hours (p<0.001) in the mifepristone compared to the 2010 misoprostol-only cohort (time of fetal expulsion was not recorded in 2008). Uterine evacuation of placental tissue using curettage or vacuum aspiration was more often performed (76% vs. 58%, p<0.001) for those receiving mifepristone; major complication rates were unchanged. Hospitalization duration and extreme pain levels were reduced (p<0.001), but side effects of medication were similar or more common for the mifepristone cohort. Overall satisfaction remained unchanged (95% vs. 91%), while other acceptability measures were higher (p<0.001) for the mifepristone compared to the misoprostol-only cohorts.ConclusionThe introduction of a combined mifepristone-misoprostol regimen into public sector second-trimester medical abortion services in South Africa has been successful with shorter time-to-abortion events, less extreme pain and greater acceptability for women. High rates of uterine evacuation for placental tissue need to be addressed.
| S-EPMC5008795 | biostudies-literature
Project description:BackgroundMobile health (mHealth) has the potential to improve access to healthcare, especially in developing countries. The proliferation of mHealth has not been accompanied by a corresponding growth in design guidelines for mHealth applications. This paper proposes a framework for mHealth application design that combines the Information Systems Research (ISR) framework and design thinking. We demonstrate a use case for the proposed framework in the form of an app to read the result of the tuberculin skin test (TST), which is used to screen for latent tuberculosis infection. The framework was used in the re-design of the TST reading app but could also be used in earlier stages of mHealth app design.MethodsThe ISR framework and design thinking were merged based on how the modes of design thinking integrate with the cycles of the ISR framework. Using the combined framework, we re-designed an mHealth app for TST reading, intended to be used primarily in a developing context by healthcare workers. Using the proposed framework, the app was iterated upon and developed with the aid of personas, observations, prototyping and questionnaires.ResultThe combined framework was applied through engagement with end-users, namely ten healthcare workers and ten graduate students. Through review of the literature and iterations of the app prototype, we identified various usability requirements and limitations. These included challenges related to image capture and a misunderstanding of instructions. These insights influenced the development and improvement of the app.ConclusionThe combined framework allowed for engagement with end-users and for low-cost, rapid development of the app while addressing contextual challenges and needs. The integration of design thinking modes with the ISR cycles was effective in achieving the objectives of each approach. The combined framework acknowledges the importance of engaging users when implementing mHealth technologies, especially in developing and under-resourced contexts. Findings from this study support the use of this framework as a guide in the design of user-centred mHealth interventions.
| S-EPMC7444488 | biostudies-literature
Project description:ObjectivesThe primary objective of this study was to develop the Japanese version of the Patient Centred Assessment Method (PCAM) and its user guide. The secondary objective was to examine the validity and reliability in the primary care setting.DesignCross-sectional study.SettingThree family physician teaching clinics located in urban residential areas in Tokyo, Japan.ParticipantsPatients who were aged 20 years or older, and who had an appointment with physicians at the three participating clinics.Main outcome measuresPatient complexity measured by PCAM and complexity/burden level measured by a Visual Analogue Scale (VAS).ResultsAlthough confirmatory factor analysis using a model described in a previous study revealed that the indices did not meet the criteria for good fit, exploratory factor analysis revealed a new three-factor structure of 'Personal well-being,' 'Social interaction' and 'Needs for care/service.' Cronbach's alpha of PCAM was 0.86. Spearman's rank correlation coefficients between PCAM scores and VAS scores were 0.51 for complexity (p<0.001) and 0.41 for burden (p<0.001). There were 42 patients (14.3% of total patients) with PCAM scores greater than its mean of 16.5 but with complexity VAS scores less than its mean of 20.8.ConclusionsThe Japanese version of PCAM and its user guide were developed through Japanese translation and cultural adaptation by cognitive debriefing. PCAM is a valid and reliable tool to assess patient complexity in the primary care settings in Japan. Additionally, although the correlation between total PCAM scores and complexity/burden as assessed by VAS was moderate, PCAM can more precisely identify patient complexity than skilled physician's intuition.
| S-EPMC7689105 | biostudies-literature
Project description:BackgroundDepression and anxiety are two of the leading causes of disease burden in low-to-middle income coutnries. The World Health Organisation has engaged in a programme of scaling-up mental health services, but significant challenges remain. Improving mental health literacy in children and young people, a core part of recent, global health strategies has the potential to address some of these challenges. The study aims to co-develop and feasibility test, a culturally-appropriate toolkit to promote depression and anxiety focused mental health literacy and self-management skills in Indonesia, for children aged 11-15?years.MethodsA mixed methods study comprising four phases. Through a systematic review of existing evidence, phase 1 will review approaches to improve mental health literacy and self-management in South East Asia and critically review current evidence regarding intervention effect. Phase 2 will explore stakeholders' views on depression, anxiety and mental health more broadly and identify priorities for the intervention through the use of semi-structured interviews and/or focus groups with policy makers, clinicians, teachers, adolescent service users, carers and young people aged 11-15. Phase 3 will comprise iterative workshops with local stakeholders to present our findings and co-produce a testable, culturally appropriate toolkit to promote mental health literacy and depression/anxiety focused self-management in 11-15?year olds in Java, Indonesia. Phase 4 comprises feasibility evaluation of our developed intervention via nine in-depth case studies (Jakarta, Bogor and Magelang). We will examine the impact, acceptability and feasibility of our prototype intervention and produce evidence-based guidelines for wider implementation.DiscussionTools to support mental health literacy and self-management are a low cost way in which mental health services in LMICs can attempt to address the burden of anxiety and depression amongst children and young people. However, this is an underexplored area in Indonesia. Working closely with local stakeholders, this study will design and undertake feasibility evaluation of co-produced mental health literacy and anxiety and depression focussed interactive self-management tools. This abstract has also been published on the funders website (UK Research and Innovation. Improving Mental Health Literacy Among Young People aged 12-15 years in Indonesia 2019).
| S-EPMC6626417 | biostudies-literature