Dataset Information

Self reported outcomes and adverse events after medical abortion through online telemedicine: population based study in the Republic of Ireland and Northern Ireland.

ABSTRACT: Objectives To assess self reported outcomes and adverse events after self sourced medical abortion through online telemedicine.Design Population based study.Setting Republic of Ireland and Northern Ireland, where abortion is unavailable through the formal healthcare system except in a few restricted circumstances.Population 1000 women who underwent self sourced medical abortion through Women on Web (WoW), an online telemedicine service, between 1 January 2010 and 31 December 2012.Main outcome measures Successful medical abortion: the proportion of women who reported ending their pregnancy without surgical intervention. Rates of adverse events: the proportion who reported treatment for adverse events, including receipt of antibiotics and blood transfusion, and deaths reported by family members, friends, or the authorities. Care seeking for symptoms of potential complications: the frequency with which women reported experiencing symptoms of a potentially serious complication and the proportion who reported seeking medical attention as advised.Results In 2010-12, abortion medications (mifepristone and misoprostol) were sent to 1636 women and follow-up information was obtained for 1158 (71%). Among these, 1023 women confirmed use of the medications, and follow-up information was available for 1000. At the time women requested help from WoW, 781 (78%) were <7 weeks pregnant and 219 (22%) were 7-9 weeks pregnant. Overall, 94.7% (95% confidence interval 93.1% to 96.0%) reported successfully ending their pregnancy without surgical intervention. Seven women (0.7%, 0.3% to 1.5%) reported receiving a blood transfusion, and 26 (2.6%, 1.7% to 3.8%) reported receiving antibiotics (route of administration (IV or oral) could not be determined). No deaths resulting from the intervention were reported by family, friends, the authorities, or the media. Ninety three women (9.3%, 7.6% to 11.3%) reported experiencing any symptom for which they were advised to seek medical advice, and, of these, 87 (95%, 87.8% to 98.2%) sought attention. None of the five women who did not seek medical attention reported experiencing an adverse outcome.Conclusions Self sourced medical abortion using online telemedicine can be highly effective, and outcomes compare favourably with in clinic protocols. Reported rates of adverse events are low. Women are able to self identify the symptoms of potentially serious complications, and most report seeking medical attention when advised. Results have important implications for women worldwide living in areas where access to abortion is restricted.

SUBMITTER: Aiken ARA

PROVIDER: S-EPMC5431774 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Self reported outcomes and adverse events after medical abortion through online telemedicine: population based study in the Republic of Ireland and Northern Ireland.

Aiken Abigail R A ARA Digol Irena I Trussell James J Gomperts Rebecca R

BMJ (Clinical research ed.) 20170516

Objectives To assess self reported outcomes and adverse events after self sourced medical abortion through online telemedicine.Design Population based study.Setting Republic of Ireland and Northern Ireland, where abortion is unavailable through the formal healthcare system except in a few restricted circumstances.Population 1000 women who underwent self sourced medical abortion through Women on Web (WoW), an online telemedicine service, between 1 January 2010 and 31 D ...[more]

PMID: 28512085

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Project description:ObjectivesTo compare telephone consultations with in-person consultations for the provision of medical abortion (using mifepristone 200 mg and misoprostol 800 µg). We hypothesised that telemedicine consultations would be non-inferior to in-person consultations with a non-inferiority limit of 3%.DesignRandomised controlled trial with 1:1 allocation.SettingCommunity abortion service housed within an integrated sexual and reproductive health service in Edinburgh, UK.ParticipantsThe trial began on 13 January 2020, but was stopped early due to COVID-19; recruitment was suspended on 31 March 2020, and was formally closed on 31 August 2021. A total of 125 participants were randomised, approximately 10% of the total planned, with 63 assigned to telemedicine and 62 to in-person consultation.Primary and secondary outcome measuresPrimary outcome: efficacy of medical abortion, defined as complete abortion without surgical intervention.Secondary outcomessatisfaction with consultation type, preparedness, unscheduled contact with care, complication rate, time spent in clinical contact and uptake of long-acting contraception.ResultsPrimary outcome was available for 115 participants (lost-to-follow-up telemedicine=2, in-person=8), secondary outcomes were available for 110 participants (n=5 and n=10 in telemedicine and in-person groups did not complete questionnaires). There were no significant differences between groups in treatment efficacy (telemedicine 57/63 (90.5%), in-person 48/62 (77.4%)). However, non-inferiority was not demonstrated (+3.3% in favour of telemedicine, CI -6.6% to +13.3%, lower than non-inferiority margin). There were no significant differences in most secondary outcomes, however, there was more unscheduled contact with care in the telemedicine group (12 (19%) vs 3 (5%), p=0.01). The overall time spent in clinical contact was statistically significantly lower in the telemedicine group (mean 94 (SD 24) vs 111 (24) min, p=0.0005).ConclusionsTelemedicine for medical abortion appeared to be effective, safe and acceptable to women, with less time spent in the clinic. However, due to the small sample size resulting from early cessation, the study was underpowered to confirm this conclusion. These findings warrant further investigation in larger scale studies.Trial registration numberNCT04139382.

Project description:BackgroundThis study aimed to capture public beliefs about living with obesity, examine how these beliefs have changed over time and to explore whether certain characteristics were associated with them in a nationally representative sample of adults from the Republic of Ireland (RoI) and Northern Ireland (NI).MethodsA cross-sectional survey employed a random quota sampling approach to recruit a nationally representative sample of 1046 adults across NI and RoI. Telephone interviews captured information on demographics; health behaviours & attitudes; and beliefs about the consequences of obesity (measured using the Obesity Beliefs Scale). Univariable analyses compared beliefs about the consequences of living with obesity between participants with a self-reported healthy weight and those living with overweight or obesity, and non-responders (those for whom weight status could not be ascertained due to missing data). Multiple linear regression examined associations between obesity-related beliefs and socio-demographics, self-rated health and perceived ability to change health behaviours. Multiple linear regression also compared changes in obesity-related beliefs between 2013 and 2020 in the RoI.ResultsHigher endorsement of the negative outcomes of obesity was significantly associated with living with a healthy weight, higher self-rated health, dietary quality and perceived ability to improve diet and physical activity. Those who lived with overweight, with obesity and non-responders were less likely to endorse the negative consequences of obesity. Those living with obesity and non-responders were also more likely to support there is an increased cost and effort in maintaining a healthy weight. Comparison with survey data from 2013 showed that currently, there is a greater endorsement of the health benefits of maintaining a healthy weight (p < 0001), but also of the increased costs associated with it (p < 0001).ConclusionBeliefs about the consequences of maintaining a healthy body weight are associated with individuals' weight, self-rated health, diet and perceived ease of adoption of dietary and exercise-related improvements. Beliefs about the health risks of obesity and perceived greater costs associated with maintaining a healthy weight appear to have strengthened over time. Present findings are pertinent to researchers and policy makers involved in the design and framing of interventions to address obesity.

Project description:Background/aimsNew classes of cancer drugs bring a range of unknown and undesirable adverse events. Adverse event monitoring is essential in phase I trials to assess toxicity and safety. In phase II, the focus is also on efficacy but robust data on adverse events continue to inform the safety and the adverse event profile. Standard, clinician-led monitoring has been shown to underestimate patients' symptoms. Hence, patient-reported adverse event monitoring has been argued to complement and improve the information on adverse events in early phase clinical trials. With advances in information technology, real-time patient self-reported adverse events in trials are feasible. This study explored the experiences and procedures for reporting adverse events in early phase trials among patients, clinical staff, and trial staff, and their views on using an electronic patient-reported outcome adverse event system in this setting.MethodsQualitative interviews were conducted with patients, purposively sampled across ages, gender, and different phases of trials, and with clinical and trial-related staff involved in early phase trials (e.g. consultants, research nurses, hospital-based trial assistants/data managers, trial unit management staff). Interviews explored patient experiences and views on current adverse event reporting processes and electronic patient-reported outcome adverse event reporting. Framework analysis techniques were used to analyse the data.ResultsInterviewees were from two hospital trusts with early phase portfolios in England and a trial unit, and included sixteen patients, five consultants, four research nurses, five hospital-based trial staff, and two trial unit staff. Interviews identified three key themes (patient experiences, data flow, and views on electronic patient-reported outcome adverse event reporting). Stakeholders emphasised the intensity of trials for patients and the importance of extensive information provision within the uncertainty of early phase trial drugs. Regular face-to-face appointments for patients supplemented by telephone contact aimed to capture any adverse events. Delayed or under-reporting of mild- or low-severity symptoms was evident among patients. Hospital-based staff highlighted the challenges of current data collection including intense timescales, monitoring by trial sponsors, and high workload. Positive views on electronic patient-reported outcome adverse events highlighted that this could provide a more comprehensive and accurate view on the side effects of new drugs. Clinical staff emphasised patient safety and the need for clear responsibilities for monitoring. The need for careful decision-making about data flow and symptom attribution was highlighted; with trial unit staff emphasising the need for clinician review.ConclusionTechnology advances mean it is timely to explore the benefits and challenges of electronic patient-reported outcome adverse event reporting. This is a complex area warranting further consideration within the trial community. We have developed an online patient self-reporting tool and a small pilot with early phase trial patients is underway.

Dataset Information

Self reported outcomes and adverse events after medical abortion through online telemedicine: population based study in the Republic of Ireland and Northern Ireland.

Publications

Self reported outcomes and adverse events after medical abortion through online telemedicine: population based study in the Republic of Ireland and Northern Ireland.

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