\documentclass[10pt]{article}

\usepackage{fullpage}
\usepackage{setspace}
\usepackage{parskip}
\usepackage{titlesec}
\usepackage[section]{placeins}
\usepackage{xcolor}
\usepackage{breakcites}
\usepackage{lineno}
\usepackage{hyphenat}





\PassOptionsToPackage{hyphens}{url}
\usepackage[colorlinks = true,
            linkcolor = blue,
            urlcolor  = blue,
            citecolor = blue,
            anchorcolor = blue]{hyperref}
\usepackage{etoolbox}
\makeatletter
\patchcmd\@combinedblfloats{\box\@outputbox}{\unvbox\@outputbox}{}{%
  \errmessage{\noexpand\@combinedblfloats could not be patched}%
}%
\makeatother


\usepackage{natbib}




\renewenvironment{abstract}
  {{\bfseries\noindent{\abstractname}\par\nobreak}\footnotesize}
  {\bigskip}

\titlespacing{\section}{0pt}{*3}{*1}
\titlespacing{\subsection}{0pt}{*2}{*0.5}
\titlespacing{\subsubsection}{0pt}{*1.5}{0pt}


\usepackage{authblk}


\usepackage{graphicx}
\usepackage[space]{grffile}
\usepackage{latexsym}
\usepackage{textcomp}
\usepackage{longtable}
\usepackage{tabulary}
\usepackage{booktabs,array,multirow}
\usepackage{amsfonts,amsmath,amssymb}
\providecommand\citet{\cite}
\providecommand\citep{\cite}
\providecommand\citealt{\cite}
% You can conditionalize code for latexml or normal latex using this.
\newif\iflatexml\latexmlfalse
\providecommand{\tightlist}{\setlength{\itemsep}{0pt}\setlength{\parskip}{0pt}}%

\AtBeginDocument{\DeclareGraphicsExtensions{.pdf,.PDF,.eps,.EPS,.png,.PNG,.tif,.TIF,.jpg,.JPG,.jpeg,.JPEG}}

\usepackage[utf8]{inputenc}
\usepackage[greek,ngerman,english]{babel}



\usepackage{float}








\begin{document}

\title{Effectiveness, safety and acceptability of no-test medical abortion
provided via telemedicine: a national cohort study}



\author[1]{Abigail Aiken}%
\author[2]{Patricia Lohr}%
\author[3]{Jonathan Lord}%
\author[4]{Nabanita Ghosh}%
\author[5]{Jennifer Starling}%
\affil[1]{University of Texas at Austin}%
\affil[2]{British Pregnancy Advisory Service}%
\affil[3]{MSI Reproductive Choices}%
\affil[4]{National Unplanned Pregnancy Advisory Service}%
\affil[5]{Mathematica Policy Research inc Cambridge Office}%


\vspace{-1em}



  
  \date{June 07, 2024}


\begingroup
\let\center\flushleft
\let\endcenter\endflushleft
\maketitle
\endgroup





\selectlanguage{english}
\begin{abstract}
Objective To compare the effectiveness, safety and acceptability of
medical abortion before and after the introduction of no-test
telemedicine Design Cohort study Setting The three main abortion
providers in England Population All patients having an early medical
abortion (comprising 85\% of all medical abortions performed nationally)
Methods Comparison of no-test telemedicine hybrid model vs. traditional
model (blanket in-person provision including ultrasound), adjusted for
baseline differences Main outcome measures Access: waiting time,
gestation Effectiveness: successful medical abortion Safety: significant
adverse events; ectopic pregnancy and late gestation Acceptability:
Patient-reported outcomes Results 52,142 medical abortions were
conducted, 29,984 in the telemedicine-hybrid cohort and 22,158 in the
traditional cohort. Mean waiting times were 4.2 days shorter in the
telemedicine-hybrid cohort and 40\% were [?]6 weeks' gestation vs. 25\% in
the traditional cohort (p\textless{}0.001). There was no difference in
success rates (98.8\% vs. 98.2\%, p=1.0), nor in prevalence of serious
adverse events (0.02\% vs. 0.04\%, p=0.557). Incidence of ectopic
pregnancy was equivalent in both cohorts (0.2\%, p=0.796); 0.04\% of
abortions appeared to have been provided after 10 weeks' gestation with
all completed safely at home. In the telemedicine-hybrid cohort,
effectiveness was higher in the telemedicine group vs. the in-person
group (99.2\% vs. 98.1\%, p\textless{}0.001). Acceptability was high
(96\% satisfied), 80\% reported a future preference for telemedicine,
and none reported that they were unable to consult in private using
teleconsultation. Conclusions Medical abortion provided through a hybrid
model that includes no-test telemedicine without ultrasound is
effective, safe, acceptable, and improves access to care. Funding None%
\end{abstract}%



\sloppy


\textbf{Effectiveness, safety and acceptability of no-test medical
abortion provided via telemedicine: a national cohort study}

\textbf{Authors:}

Abigail Aiken, MD, MPH, PhD

Associate Professor of Public Affairs, LBJ School of Public Affairs

University of Texas at Austin

araa2@utexas.edu

Orcid: 0000-0002-1555-3025

Patricia A Lohr, MD MPH

Medical Director, British Pregnancy Advisory Service

Stratford upon Avon, CV37 9BF

patricia.lohr@bpas.org

Orcid: 0000-0003-1862-5730

Jonathan Lord*, MD FRCOG

Medical Director, MSI Reproductive Choices. Consultant gynaecologist.

1 Conway Street, Fitzroy Square, London W1T 6LP

J.lord@exeter.ac.uk

Orcid: 0000-0003-2819-5973

Nabanita Ghosh, FRCOG

Medical Director, National Unplanned Pregnancy Advisory Service (NUPAS)

nghosh@nhs.net

Jennifer Starling, PhD

Statistician, Mathematica~Policy Research, Cambridge, MA, 02139

jstarling@mathematica-mpr.com

Orcid: 0000-0003-4765-360X

* = Corresponding author

\textbf{MeSH / Keywords:}

Abortion, Induced {[}E04.520.050{]}

Telemedicine {[}N04.590.374.800{]}

Ambulatory Care Facilities {[}N02.278.035{]}

Health Planning {[}N03.349{]}

Pregnancy Complications {[}C13.703{]}

Mifepristone {[}D04.210.500.365.415.580{]}

Misoprostol {[}D23.469.700.660.500{]}

\textbf{Word count:} 3485 (abstract 247)



\textbf{Abstract}

\textbf{Objective}

To compare the effectiveness, safety and acceptability of medical
abortion before and after the introduction of no-test telemedicine

\textbf{Design}

Cohort study

\textbf{Setting}

The three main abortion providers in England

\textbf{Population}

All patients having an early medical abortion (comprising 85\% of all
medical abortions performed nationally)

\textbf{Methods}

Comparison of no-test telemedicine hybrid model vs. traditional model
(blanket in-person provision including ultrasound), adjusted for
baseline differences

\textbf{Main outcome measures}

Access : waiting time, gestation

Effectiveness : successful medical abortion

Safety : significant adverse events; ectopic pregnancy and late
gestation

Acceptability : Patient-reported outcomes

\textbf{Results}

52,142 medical abortions were conducted, 29,984 in the
telemedicine-hybrid cohort and 22,158 in the traditional cohort. Mean
waiting times were 4.2 days shorter in the telemedicine-hybrid cohort
and 40\% were [?]6 weeks' gestation vs. 25\% in the traditional cohort
(p\textless{}0.001). There was no difference in success rates (98.8\%
vs. 98.2\%, p=1.0), nor in prevalence of serious adverse events (0.02\%
vs. 0.04\%, p=0.557). Incidence of ectopic pregnancy was equivalent in
both cohorts (0.2\%, p=0.796); 0.04\% of abortions appeared to have been
provided after 10 weeks' gestation with all completed safely at home. In
the telemedicine-hybrid cohort, effectiveness was higher in the
telemedicine group vs. the in-person group (99.2\% vs. 98.1\%,
p\textless{}0.001). Acceptability was high (96\% satisfied), 80\%
reported a future preference for telemedicine, and none reported that
they were unable to consult in private using teleconsultation.

\textbf{Conclusions}

Medical abortion provided through a hybrid model that includes no-test
telemedicine without ultrasound is effective, safe, acceptable, and
improves access to care.

\textbf{Funding}

None

\textbf{Tweetable Abstract}

Compelling evidence from 52,145 women shows telemedicine abortion is
safe, effective \& improves care

\textbf{Introduction}

Improved access to abortion care would deliver significant advantages
for both healthcare systems and the women who use them. Abortion is a
common reason for needing healthcare -- the global abortion rate is
estimated at 39 abortions per 1000 women aged 15--49 years,(1) with 28\%
of all pregnancies in developed countries ending in abortion.(2) There
is clear evidence that restricting access to abortion does not reduce
abortion rates, it simply makes abortion less safe.(1, 3) Improving
access is likely to benefit those who are most vulnerable,(4) especially
in resource-poor settings or where care has to be self-funded. In its
2019 guideline on abortion care, the National Institute for Health and
Care Excellence (NICE) stated that improving access to abortion was a
key priority.(5)

Telemedicine, the use of information and communication technologies to
improve patient outcomes by increasing access to care and medical
information,(6) has been noted to decrease costs and increase
convenience and safety.(7) It is an established service delivery model
for abortion care in many settings,(8) and it is recommended to improve
access.(4) The COVID-19 pandemic required urgent action by clinicians
and policymakers to ensure delivery of essential health services,
including abortion. In March 2020, the Royal College of Obstetricians
and Gynaecologists (RCOG) published guidelines to safeguard abortion
care in the UK.(9) The guidelines profoundly changed the way medical
abortion care is delivered in Great Britain. Prior to the emergence of
COVID-19, all patients seeking medical abortion were required to attend
in-person to receive an ultrasound scan and have mifepristone
administered within the clinic. Under the new guidelines, consultations
were encouraged to take place by telephone or video call; an ultrasound
scan was required only if indicated. All the British governments had
issued emergency legal orders by March 30\textsuperscript{th} 2020 to
allow mifepristone to be used at home along with misoprostol up to 10
weeks' gestation.(10-12) These approvals permitted abortion providers to
implement a telemedical service delivery model for medical abortion.

Great Britain's new pathway for no-test telemedicine abortion is unusual
among existing models because it is fully remote: no clinic visit, tests
or ultrasound scan are required and both mifepristone and misoprostol
are delivered by mail or collected from a clinic for use at home. This
new service model thus presents an important opportunity to evaluate a
potentially better way to provide medical abortion that could improve
access and reduce the barriers posed by in-person care.(13) We examined
and compared the effectiveness, safety and acceptability of medical
abortion provided up to 10 weeks' gestation before and after the service
model change.

\textbf{Methods}

\textbf{Population and Cohorts}

The study population comprised all patients who accessed an early
medical abortion (EMA) at the three largest abortion providers in
England and Wales - British Pregnancy Advisory Service (BPAS), MSI
Reproductive Choices (MSUK), and the National Unplanned Pregnancy
Advisory Service (NUPAS) - two months before and after the service model
change. Medical abortion is defined as the use of medications to cause
termination of a pregnancy without primary surgical intervention and
`EMA' applies to these procedures in the first trimester.(14) The
recommended EMA regimen uses the anti-progestogen mifepristone in an
oral dose of 200mg then, after 24-48 hours, 800mcg of the prostaglandin
analogue misoprostol by the sublingual, vaginal or buccal route.

Our dataset consisted of information on EMAs extracted directly from
electronic service records and included fully de-identified patient
clinical and demographic characteristics, as well as clinical outcomes.
All data were extracted six weeks after the end of the study period to
ensure the reporting of complications was as complete as possible.

Two cohorts were defined. The ``traditional'' cohort comprises all
patients having an EMA between January 1\textsuperscript{st} and March
1st 2020, prior to service model change. All patients in this cohort
received care using the traditional pathway that included an in-person
assessment and an ultrasound scan. The ``telemedicine-hybrid'' cohort
comprises all patients accessing an EMA between April
6\textsuperscript{th} and June 30\textsuperscript{th} 2020, in a two
month period after the service model change at each provider. Patients
in this cohort received care using no-test telemedicine if they had low
risk of ectopic pregnancy and their self-reported last menstrual period
(LMP) indicated a gestation of less than 10 weeks. Those who were not
eligible for telemedicine had an in-person assessment with ultrasound.
Providers followed organisation-specific evidence-based policies
informed by the RCOG(9) and associated decision aid(15) (figures 1 and
2) and earlier RCOG and NICE guidelines for general abortion care
including in-person medical abortion.(16, 17)

In the traditional cohort, whilst some aspects of the pre-abortion
consultation may have been carried out by phone, an in-person assessment
with ultrasound scan and in-clinic administration of mifepristone were
always required. In the telemedicine-hybrid cohort, we defined patients
served by telemedicine as those who received medications for home use
(either by mail or collection with minimal contact from a clinic)
following a phone or video consultation and who did not receive an
ultrasound scan or other tests.

We omitted the month of March 2020 because of the uncertainty and
challenges posed by the emergence of COVID prior to the definitive
service model change. The dates of the telemedicine-hybrid cohort take
into account the roll-out of the telemedicine service across individual
clinics within a provider network. For the analysis of ectopic
pregnancies, we applied the timeframes stated above to all abortion
consultations rather than all abortions provided because some patients
with suspected ectopic pregnancies were referred to Early Pregnancy
Assessment Units (EPAU) and did not proceed to an abortion.

\textbf{Outcome Measures}

\textbf{Access}

Waiting time and gestation at treatment were used to assess how the two
models impacted access. Waiting time was defined as the interval from
first contact with the abortion provider to when medication was
dispensed (either in-person in clinic or posted). Gestation was recorded
as that applicable on the date mifepristone was dispensed or provided.
Analysis was of mean gestation and the proportion of abortions performed
at [?]6 weeks' gestation.

\textbf{Effectiveness}

Effectiveness was defined as the proportion of medical abortions that
were successful. Success was defined according to the MARE Guidelines as
successful expulsion of an intrauterine pregnancy without need for
surgical intervention.(14) Sub-categories of unsuccessful abortion
included: surgical management of continuing pregnancy, surgical
evacuation of retained products of conception, and continuing pregnancy
where the patient opted for continuation or the outcome is unknown.

\textbf{Safety}

Safety was defined according to the proportions of medical abortions
that involved one or more significant adverse events. We defined
significant adverse events as haemorrhage requiring transfusion,
significant infection requiring hospital admission, major surgery, and
death. We also examined the incidence of ectopic pregnancy and when it
was diagnosed in the care pathway. All patients referred for further
diagnostics (e.g. serial \selectlanguage{greek}β\selectlanguage{english}hCG monitoring) but who had no further
treatment are included in the ectopic pregnancy group although a
proportion of these will be pregnancy of unknown locations (PULs) that
includes failed early intrauterine pregnancies. We analysed the
proportion of cases where treatment was reported to have occurred at [?]10
weeks' gestation in the telemedicine-hybrid cohort (this outcome does
not apply to the traditional cohort since all gestations were determined
by ultrasound scan).

\textbf{Acceptability}

Given the constraints of delivering healthcare during COVID-19 it was
not possible to follow up with all patients to capture patient-reported
outcomes. Two of the providers (BPAS and MSUK) collected data on patient
feedback during the study period. Patients were invited to provide
feedback one to three weeks after treatment, either by telephone using a
structured interview tool (MSUK)(18) or using an online form (BPAS)(19).
We analysed data on questions reporting on satisfaction, future
preference and privacy. Although the questions were similar, only the
MSUK survey included questions on the privacy of teleconsultation. All
contact was by a non-clinician who had not been involved in the
patient's care.

\textbf{Analysis}

The primary analysis was to assess whether the telemedicine-hybrid care
model was non-inferior to the traditional service model. Non-inferiority
is established by comparing effectiveness and safety in the two cohorts
under the null hypothesis that the rates of successful abortion and
serious adverse events are not different.

We first compared patient demographic and clinical characteristics
between the cohorts to assess the need to covariate-adjust our
hypothesis tests for systematic differences in the two groups that might
affect abortion outcomes. All hypothesis tests were covariate adjusted
for patient age, race/ethnicity, gestational age, parity, and prior
abortions using logistic regression and weighted risk differences.(20)

We evaluated effectiveness by testing the alternative hypothesis that
the rate of successful medical abortion in the telemedicine-hybrid
cohort is lower than in the traditional cohort using a
covariate-adjusted test of difference in proportions. We also performed
a chi-squared test to evaluate whether the distribution of unsuccessful
abortion sub-categories differed between the cohorts. We evaluated
safety by testing the alternative hypothesis that significant adverse
events occurred at higher rates in the telemedicine-hybrid cohort
compared to the traditional cohort using a covariate-adjusted hypothesis
test for difference of proportions. We also evaluated whether the
prevalence of ectopic pregnancies managed before EMA and after EMA were
different between the traditional and telemedicine-hybrid cohorts using
chi-squared difference of proportions tests.

The secondary analysis was to compare effectiveness and safety of
medical abortion for patients who received fully remote no-test
telemedicine vs. in-person care in the telemedicine-hybrid cohort,
primarily to assess whether any differences between the cohort service
models were driven by one particular group. We evaluated patient
demographic and clinical characteristic differences between the two
groups to assess the need to covariate-adjust our hypothesis tests for
systematic differences and all hypothesis tests were covariate adjusted
for patient age, race/ethnicity, gestational age, parity, and prior
abortions using the framework described above. We note, however, that
these cohorts are fundamentally different despite covariate adjustment,
as patients in the telemedicine-hybrid cohort were selected into
in-person treatment based on characteristics that would affect the
outcome of their abortion. We performed covariate-adjusted hypothesis
tests under the null hypothesis of equal effectiveness and equal rates
of significant adverse events in the telemedicine vs. in-person groups.

All analyses were performed using R, version 3.6.2. Statistical
significance was defined using an alpha level of 0.05.

\textbf{Ethics Approval}

The study was reviewed by the Institutional Review Board (IRB) at the
University of Texas at Austin and a determination was made that the
research did not meet the criteria for human subjects research as
defined in the Common Rule (45 CFR 46) or FDA Regulations (21 CFR 56).
Each provider ensured compliance with their own internal ethics and
governance systems. The principles of the STROBE statement, and the MARE
supplement, were followed.(14)

\textbf{Results}

In total, 52,142 medical abortions were provided during the study
period; 22,158 in the traditional pathway and 29,984 in the
telemedicine-hybrid cohort. Among those that took place in the
telemedicine-hybrid cohort, 18,435 (61\%) were provided entirely via
telemedicine and 11,549 (39\%) were provided in- person. Our sample
represents 85\% of the total number of medical abortions performed in
England and Wales during the study period.(21) The clinical and
demographic characteristics of patients in the two cohorts are described
in Table 1.

\textbf{Access}

Mean waiting time to treatment declined from 10.7 days (SD 19.9) in the
traditional pathway to 6.5 days (SD 13.5) in the telemedicine-hybrid
cohort (p\textless{}0.001). Mean gestational age at treatment also
declined in the telemedicine-hybrid cohort resulting in 40\% of
abortions performed at 6 weeks' gestation or less vs. 25\% in the
traditional pathway (p\textless{}0.001).

\textbf{Effectiveness}

Rates of successful medical abortion were high under both service
delivery models (Table 2): 98.2\% in the traditional cohort vs. 98.8\%
in the telemedicine-hybrid cohort. We found no evidence of a lower
success rate with the telemedicine-hybrid pathway (p=1.0). The
distribution of the different sub-categories of unsuccessful medical
abortion did not differ between the cohorts (p=0.268).

\textbf{Safety}

Significant adverse events in both cohorts were rare (Table 3).
Haemorrhage requiring transfusion was reported in 8 (0.04\%) cases in
the traditional cohort and 7 (0.02\%) cases in the telemedicine-hybrid
cohort. No cases of significant infection requiring hospital admission,
major surgery or death were reported. We found no evidence that
significant adverse events were higher in the telemedicine-hybrid cohort
(p=0.557).

The overall incidence of ectopic pregnancy was equivalent in both
cohorts, 39 (0.2\%) in the traditional pathway and 49 (0.2\%) in the
telemedicine pathway, p=0.796 (Table 4). The proportions managed after
EMA were not significantly different between the cohorts (0.01\% in the
traditional pathway and 0.03\% in the telemedicine-hybrid pathway,
p=0.123). There were 11 cases (0.04\%) in the telemedicine-hybrid cohort
where the gestational age after abortion was reported as being greater
than the expected 10 weeks. In all these cases, the medical abortion was
completed at home without additional medical complications.

\textbf{Acceptability}

Patient-reported outcome data was available from 2453 respondents. 96\%
were ``satisfied'' or ``very satisfied'' with their care, or rated their
experience as ``good'' or ``very good''. 80\% reported that they would
choose telemedicine in the future or that it was their preferred option,
with 13\% choosing in-person care and the remainder being unsure. No
patient reported that they were unable to consult in private using
teleconsultation (n=1243).

\textbf{Secondary Outcome Measures}

Comparison of clinical outcomes for the telemedicine vs. in-person
groups in the telemedicine-hybrid cohort are shown in Tables S1-S3.
Rates of successful medical abortion were higher in the telemedicine
group (99.2\% vs. 98.1\%, p\textless{}0.001), and rates of significant
adverse outcomes were not significantly different between the two
groups, 3 (0.02\%) for telemedicine vs. 4 (0.03\%) for in-person,
p=0.532.

\textbf{Discussion}

\textbf{Main Findings}

We found that no-test telemedicine without routine ultrasound for
medical abortion up to 10 weeks' gestation is an effective, safe and
acceptable service model. Clinical outcomes with telemedicine are
equivalent to in-person care and access to abortion care is better, with
both waiting times and gestational age at the time of abortion
significantly reduced. Further evidence that the new telemedicine-hybrid
model improved access comes from a study showing that the rate of women
seeking abortion medication outside the formal healthcare setting
reduced significantly in the UK following implementation of
telemedicine.(22) The most likely explanation is easier access as the
opposite effect was seen in several other European countries who made no
such provision. The implication is that those previously too vulnerable
to attend in-person have been able to access care through telemedicine,
potentially benefiting from the safeguarding, counselling and
contraceptive services provided by regulated providers.

Our study confirms previous literature that medical abortion is safe and
effective with low rates of significant complications.(23) The slight
increase in effectiveness we observed in the group that received
telemedicine -- even after controlling for lower average gestational age
compared to the in-person group -- may be due to the ability of patients
to better control the timing at which they took the medication.

The telemedicine-hybrid model resulted in very low rates of undiagnosed
ectopic pregnancy and later than expected gestations. Although the rate
of ectopic pregnancy in the general population in the UK and USA is
reported as 1-2\%,(24, 25) the rate reported among patients having an
abortion is 10 times lower,(26) which is consistent with our findings.
Ultrasound is not used to screen for ectopic pregnancy in the general
population -- it is only used where signs and symptoms suggest a
need.(25) Routine screening of symptom-free women is associated with a
high false positive rate when the prevalence of ectopic pregnancy is
low, as is the case in women seeking abortion, and therefore it is
unlikely there would be significant benefits.(27) There is no clinical
justification for maintaining this inconsistency in care between women
wishing to continue their pregnancies and those choosing EMA.(28, 29)

However, given that over 200,000 people access abortion care each year
in the UK alone, some will inevitably have an asymptomatic ectopic
pregnancy and so will proceed with having mifepristone and misoprostol
either through telemedicine or after a false negative scan. The
essential issue for safety is that these are detected prior to causing
harm rather than prior to beginning medical abortion treatment;
treatment with mifepristone and misoprostol in itself will have no
effect on an underlying ectopic pregnancy. Indeed, the reduction in
waiting times afforded by the telemedicine model may facilitate earlier
detection than traditional pathways where women present later, or are
sent away to give additional time to visualise an intrauterine pregnancy
on scan. Proceeding with early medical abortion without a scan may
permit earlier diagnosis of a developing ectopic pregnancy owing to
increased surveillance and index of suspicion, for example where there
is minimal bleeding after misoprostol.(9, 16)

The proportion of cases where gestational age was later than expected
based on LMP was low, as might have been expected given the evidence
that women can determine the gestational age of their pregnancy with
reasonable accuracy by LMP alone.(29) Nevertheless inadvertent treatment
of gestations over 10 weeks is inevitable and, consistent with our
findings, the consequences for most are unlikely to be medically
significant.(30) The 10 weeks' gestation limit in the English
government's approval order is arbitrary, and not based on evidence of
safety or effectiveness. The Scottish government did not stipulate a
limit, leaving the decision to the discretion of the clinician in
consultation with their patient. Moreover, the reported success of
self-managed abortions at \textgreater{}12--24 weeks' gestation is 93\%,
with safety similar to that expected in earlier gestations.(31)

\textbf{Strengths and Limitations}

While the study is not a clinical trial and we were not able to control
the assignment of patients to treatment groups to conduct a direct
comparison of fully remote telemedicine with in-person care, the policy
changes precipitated by COVID-19 created a rare opportunity to conduct
an evaluation of a major change in service delivery model with a very
large sample size. We were able to evaluate the outcomes of both the
telemedicine-hybrid and traditional in-person services as they operate
in the real world, and we were able to adjust for key covariates. A key
strength of the study is the generalisability of our findings given that
our sample included 85\% of all medical abortions provided in England
and Wales during the study period.

The main limitation of this study is that we were unable to actively
follow-up patients post-abortion and therefore only significant adverse
events can be reported with confidence. There is a potential gap in the
consistency of reporting incidents, due to some complications not
meeting the threshold of serious incidents, multiple routes of entry
into the NHS and informal communication between the NHS and abortion
providers. Although it is possible that some patients presented to other
providers and a significant adverse event was not reported in our
dataset, the risk management and reporting systems within the NHS are
well defined, with serious incidents being routinely shared. Regulators
expect providers to ensure actions are taken to mitigate risks to
patients in the future. More importantly, there is no reason to suspect
that any under-reporting that did occur would be more likely in either
cohort so as to introduce bias. The governing body of the NHS in England
alerted all commissioners of the need to report incidents relating to
telemedicine and there were review meetings of key stakeholders to
ensure compliance. We consulted with regulators and national agencies to
ensure that we accounted for reports made directly to them. The
independent regulator of all health and social care services in England,
the Care Quality Commission (CQC), confirmed that all cases reported
directly to them through various routes, for example, statutory
notifications and the central NHS database of patient safety incident
reports (the National Reporting and Learning System (NRLS) and the
Strategic Executive Information System (StEIS)), were known to the
providers.

\textbf{Interpretation}

NICE conducted a systematic review and recommended using telemedicine to
improve access to medical abortion care(4). Several models for using
telemedicine to facilitate medical abortion have been described, but
most existing trials are small, and many required attendances to have
medicines administered or for an ultrasound scan or blood tests(8). Our
study is the first to assess a real-world no-test telemedicine abortion
care pathway in a national population. This new national model
demonstrates how a permissive framework for medical abortion can deliver
significant quality improvements to those needing to access abortion
care.

\textbf{Conclusion}

This large study of 52,145 medical abortions demonstrates that
incorporating no-test telemedicine into the care pathway is not inferior
to the traditional pathway where all patients are seen in person and
have an ultrasound scan. There are advantages - waiting times and
gestation at abortion are reduced and it is highly rated by patients.
There was no evidence of worse outcomes in failure rate, haemorrhage,
need for surgery or in failure to detect ectopic pregnancy. In the
0.04\% of cases where the abortion appeared to have been provided at
over 10 weeks' gestation, these were all completed at home without
additional medical complications. Given the advantages of improving
access to care, especially in vulnerable groups and in resource-poor
healthcare systems or where patients often have to fund their own care,
the evidence is compelling that no-test telemedicine should become
routine in the provision of abortion care.

\textbf{Acknowledgements}

We would like to thank the Care Quality Commission (CQC), NHS England
and NHS Improvement (NHSE \& I), and the National Child Mortality
Database (NCMD) for their advice and assistance in ensuring all
complications reported within NHS systems have been included.

We are also enormously grateful to the many people who helped to ensure
access to essential healthcare for women needing an abortion not only
continued, but was improved during the COVID-19 pandemic. There are too
many to list individually, but we would like to especially thank the
following who not only helped to implement a complete service change
within a few weeks, but also made this paper possible by ensuring the
data was collected and accessible:

BPAS -- Rebecca Blaylock, Steve Cheung, Pam Field, Stephen Franklin,
Jeanette Taylor, Katherine Whitehouse

MSUK -- Cat James, Andrew Lord, Kay Newey, Abigail Storan

NUPAS -- Aaron Flaherty, Linda Leach, Leanne MacCaffrey

\textbf{Authors' contributions \& Declarations of Interest}

All authors have completed the ICMJE uniform disclosure form at
www.icmje.org/coi\_disclosure.pdf and declare: no support from any
organisation for the submitted work; no financial relationships with any
organisations that might have an interest in the submitted work in the
previous three years; no other relationships or activities that could
appear to have influenced the submitted work beyond that described under
the roles held by each individual below.

\textbf{Abigail Aiken} -- Initial concept, developing study protocol,
data analysis, writing first draft and subsequent revisions,
verification of data. Overall responsibility for data analysis \&
principal investigator. Guarantor.

Member of the Council of the British Society of Abortion Care Providers
(BSACP).

\textbf{Nabanita Ghosh} -- Developing study protocol, revision of draft
paper. Overall responsibility for conduct of study including data
collection at NUPAS.

Nothing to disclose

\textbf{Patricia A. Lohr} -- Initial concept, developing study protocol,
writing first draft and subsequent revisions. Overall responsibility for
conduct of study including data collection at BPAS.

Co-author / committee member of national guidelines cited in this paper
from RCOG \& NICE; member RCOG abortion taskforce; council member of
British Society of Abortion Care Providers (BSACP); Medical Director of
BPAS.

\textbf{Jonathan Lord} -- Initial concept, developing study protocol,
writing first draft and subsequent revisions, co-ordination and liaison.
Overall responsibility for conduct of study including data collection at
MSUK.

Co-author / committee member of national guidelines cited in this paper
from RCOG \& NICE; co-chair of RCOG abortion taskforce and British
Society of Abortion Care Providers (BSACP); primary employment includes
work as an abortion care provider as a consultant gynaecologist and
medical director.

\textbf{Jennifer Starling} -- Data analysis including statistical
advice, writing first draft and subsequent revisions, verification of
data.

Nothing to disclose

\textbf{Copyright/license for publication}

The Corresponding Author has the right to grant on behalf of all authors
and does grant on behalf of all authors, a worldwide licence to the
Publishers and its licensees in perpetuity, in all forms, formats and
media (whether known now or created in the future), to i) publish,
reproduce, distribute, display and store the Contribution, ii) translate
the Contribution into other languages, create adaptations, reprints,
include within collections and create summaries, extracts and/or,
abstracts of the Contribution, iii) create any other derivative work(s)
based on the Contribution, iv) to exploit all subsidiary rights in the
Contribution, v) the inclusion of electronic links from the Contribution
to third party material where-ever it may be located; and, vi) licence
any third party to do any or all of the above

\textbf{Data Sharing Statement}

The collated datasets, which include participant data with anonymised
identifiers, are held by AA at the University of Texas. Consideration
will be given to sharing this with bone fide researchers on application.
The original data resides with the co-authors' own institutions.
Although the data is de-identified, some relate to very rare events and
could therefore result in identification. Therefore data on
complications, and data arising from clinical incident reports, will be
subject to the same access restrictions as those of the organisation
supplying it.

\textbf{Transparency Statement}

The authors affirm that the manuscript is an honest, accurate, and
transparent account of the study being reported; that no important
aspects of the study have been omitted; and that any discrepancies from
the study as originally planned (and, if relevant, registered) have been
explained.

\textbf{Funding Source}

None

\textbf{Ethics Statement}

The study was reviewed by the Institutional Review Board (IRB) at the
University of Texas at Austin and a determination was made that the
research did not meet the criteria for human subjects research as
defined in the Common Rule (45 CFR 46) or FDA Regulations (21 CFR 56).
Each provider ensured compliance with their own internal ethics and
governance systems. The principles of the STROBE statement, and the MARE
supplement, were followed.(14)

\textbf{References}

1. Bearak J, Popinchalk A, Ganatra B, Moller A-B, Tun\selectlanguage{ngerman}çalp Ö, Beavin C,
et al. Unintended pregnancy and abortion by income, region, and the
legal status of abortion: estimates from a comprehensive model for
1990-2019. The Lancet Global Health. 2020.

2. Sedgh G, Bearak J, Singh S, Bankole A, Popinchalk A, Ganatra B, et
al. Abortion incidence between 1990 and 2014: global, regional, and
subregional levels and trends. Lancet. 2016;388(10041):258-67.

3. Regan L, Glasier A. The British 1967 Abortion Act-still fit for
purpose? Lancet. 2017;390(10106):1936-7.

4. National Institute for Health and Care Excellence (NICE). Abortion
care. Evidence Review A - Accessibility and sustainability of abortion
services. London; 2019 9/2019.

5. O'Shea LE, Hawkins JE, Lord J, Schmidt-Hansen M, Hasler E, Cameron S,
et al. Access to and sustainability of abortion services: a systematic
review and meta-analysis for the National Institute of Health and Care
Excellence---new clinical guidelines for England. Human Reproduction
Update. 2020.

6. WHO Global Observatory for eHealth. Telemedicine: opportunities and
developments in Member States: report on the second global survey on
eHealth. Geneva: World Health Organization; 2010.

7. Dorsey ER, Topol EJ. Telemedicine 2020 and the next decade. The
Lancet. 2020;395(10227):859.

8. Endler M, Lavelanet A, Cleeve A, Ganatra B, Gomperts R,
Gemzell-Danielsson K. Telemedicine for medical abortion: a systematic
review. BJOG. 2019;126(9):1094-102.

9. Royal College of Obstetricians and Gynaecologists (RCOG), Royal
College of Midwives (RCM), Faculty of Sexual \& Reproductive Healthcare
(FSRH), British Society of Abortion Care Providers (BSACP). Coronavirus
(COVID-19) infection and abortion care. London, UK: Royal College of
Obstetricians and Gynaecologists; 2020 31/07/2020.

10. Department of Health \& Social Care (DHSC). The Abortion Act 1967 -
Approval of a Class of Places. London: English Government; 2020.

11. Scottish Government. Abortion -- Covid-19 -- Approval For
Mifepristone to be Taken At Home and Other Contingency Measures.
Edinburgh: Scottish Government; 2020.

12. Welsh Government. The Abortion Act 1967 -- Approval of a Class of
Place for Treatment for the Termination of Pregnancy (Wales) 2020. In:
Government W, editor. Cardiff: Welsh Government; 2020.

13. Aiken ARA, Guthrie KA, Schellekens M, Trussell J, Gomperts R.
Barriers to accessing abortion services and perspectives on using
mifepristone and misoprostol at home in Great Britain. Contraception.
2018;97(2):177-83.

14. Creinin MD, Chen MJ. Medical abortion reporting of efficacy: the
MARE guidelines. Contraception. 2016;94(2):97-103.

15. Royal College of Obstetricians and Gynaecologists (RCOG). Decision
aid for early medical abortion without ultrasound. London: Royal College
of Obstetricians and Gynaecologists (RCOG), ; 2020.

16. National Institute for Health and Care Excellence (NICE). Abortion
Care. London; 2019 9/25/2019. Report No.: NG140.

17. Royal College of Obstetricians and Gynaecologists (RCOG), Faculty of
Sexual \& Reproductive Healthcare (FSRH), British Society of Abortion
Care Providers (BSACP). Clinical Guidelines for Early Medical Abortion
at Home - England. London; 2019 1/3/2019.

18. Erlank CP, Lord J, Church K. Early medical abortion using
telemedicine -- acceptability to patients {[}preprint{]}. MedRxiv.
2020:2020.11.11.20229377.

19. Meurice M, Whitehouse K, Blaylock R, Chang J, P L. Client
satisfaction and experience of home use of mifepristone and misoprostol
for medical abortion up to 10 weeks' gestation at British Pregnancy
Advisory Service: a cross-sectional evaluation {[}preprint{]}. .
Authorea. 2020.

20. Ge M, Durham LK, Meyer RD, Xie W, Thomas N. Covariate-Adjusted
Difference in Proportions from Clinical Trials Using Logistic Regression
and Weighted Risk Differences. Drug information journal : DIJ / Drug
Information Association. 2011;45(4):481-93.

21. Department of Health \& Social Care (DHSC). Abortion statistics
during COVID-19: data tables. In: Department of Health \& Social Care
(DHSC), editor. London: UK Government; 2020.

22. Aiken ARA, Starling JE, Gomperts R, Scott JG, Aiken C. Demand for
Self-Managed Online Telemedicine Abortion in Eight European Countries
During the COVID-19 Pandemic: A Regression Discontinuity Analysis
{[}preprint{]}. MedRxiv. 2020:2020.09.15.20195222.

23. Upadhyay UD, Desai S, Zlidar V, Weitz TA, Grossman D, Anderson P, et
al. Incidence of emergency department visits and complications after
abortion. Obstet Gynecol. 2015;125(1):175-83.

24. Centers for Disease Control and Prevention (CDC). Ectopic
pregnancy---United States, 1990--1992. MMWR Morb Mortal Wkly Rep.
1995;44(46--8):46--8.

25. National Institute for Health and Care Excellence (NICE). Ectopic
pregnancy and miscarriage: diagnosis and initial management. London;
2019 4/17/2019. Report No.: NG126.

26. Shannon C, Brothers LP, Philip NM, Winikoff B. Ectopic pregnancy and
medical abortion. Obstet Gynecol. 2004;104:161--7.

27. Mol BW, van der Veen F, Bossuyt PM. Symptom-free women at increased
risk of ectopic pregnancy: should we screen? Acta Obstet Gynecol Scand.
2002;81(7):661-72.

28. Clark WH, Gold M, Grossman D, Winikoff B. Can mifepristone medical
abortion be simplified? A review of the evidence and questions for
future research. Contraception. 2007;75(4):245-50.

29. Bracken H, Clark W, Lichtenberg ES, Schweikert SM, Tanenhaus J,
Barajas A, et al. Alternatives to routine ultrasound for eligibility
assessment prior to early termination of pregnancy with
mifepristone-misoprostol. BJOG. 2011;118(1):17-23.

30. Raymond EG, Grossman D, Mark A, Upadhyay UD, Dean G, Creinin MD, et
al. Commentary: No-test medication abortion: A sample protocol for
increasing access during a pandemic and beyond. Contraception. 2020.

31. Harris LH, Grossman D. Complications of Unsafe and Self-Managed
Abortion. N Engl J Med. 2020;382(11):1029-40.

\textbf{Tables and Figures}

\textbf{Table 1: Clinical and demographic characteristics in the
traditional and telemedicine-hybrid cohorts (n=52,142)}\selectlanguage{english}
\begin{longtable}[]{@{}llll@{}}
\toprule
\begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{Patient Characteristic}\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{Traditional (n=22,158)}\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{Telemedicine-hybrid} \textbf{(n=29,984)}\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{P-value}\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Mean gestational age in weeks (s.d.)}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
6.4 (1.3)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
6.0 (1.4)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textless{}0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Gestational age at treatment}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
6 weeks and under\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
5,582 (25.2)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
11,947 (39.8)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textless{}0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Over 6 weeks\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
16,576 (74.8)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
18,037 (60.2)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Mean age in years (s.d.)}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
27.8 (6.6)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
28.5 (6.7)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textless{}0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Ethnicity}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Asian\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
2,038 (9.2)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
2,652 (8.8)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textless{}0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Black\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
1,656 (7.5)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
2,282 (7.6)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Multiracial\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
1,004 (4.5)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
1,361 (4.5)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
White\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
15,840 (71.5)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
20,910 (69.7)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Other\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
489 (2.2)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
638 (2.1)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Unknown\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
1,131 (5.1)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
2,141 (7.1)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Previous abortions}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
13,098 (59.1)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
16,741 (55.8)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textless{}0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
1+\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
9,060 (40.9)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
13,243 (44.2)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Parity}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
10,133 (45.7)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
11,741 (39.2)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textless{}0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
1+\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
12,025 (54.3)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
18,243 (60.8)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Mean waiting time in days (s.d.)}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
10.7 (19.9)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
6.5 (13.5)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textless{}0.001\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

\textbf{Table 2: Comparison of effectiveness of medical abortions
conducted in the traditional and telemedicine-hybrid cohorts (n=52,142)}\selectlanguage{english}
\begin{longtable}[]{@{}llll@{}}
\toprule
\begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{Outcome}\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{Traditional} \textbf{n=22,158}\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{Telemedicine-hybrid} \textbf{n=29,984}\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{P-value}\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Successful medical abortion}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{21,769 (98.2)}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{29,618 (98.8)}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{1.0}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Unsuccessful medical abortion}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{389 (1.8)}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{366 (1.2)}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Continuing pregnancy treated with surgical management\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
161 (0.7)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
150 (0.5)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.268\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Continuing pregnancy opted to continue or unknown outcome\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
3 (0.01)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
8 (0.03)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Retained products treated with surgical management (ERPC)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
225 (1.0)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
208 (0.7)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

Note: As explained in the methods section, the p-value for successful
medical abortion~is the co-variate adjusted p-value (i.e. all
differences in patient clinical and demographic characteristics,
including gestational age, are controlled for) and was calculated using
a hypothesis test where the null hypothesis is that the traditional
cohort has the same effectiveness rate as the telemedicine-hybrid cohort
and the alternative hypothesis is that the traditional cohort has a
higher effectiveness rate than the telemedicine-hybrid cohort. The
p-value for~unsuccessful medication abortion~is for the chi-squared test
of whether the distribution of types of failure differ between the
cohorts.

\textbf{Table 3: Comparison of significant adverse events following
medical abortions conducted in the traditional and telemedicine-hybrid
cohorts (n=52,142)}\selectlanguage{english}
\begin{longtable}[]{@{}llll@{}}
\toprule
\begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{Outcome}\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{Traditional} \textbf{(n=22,158)}\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{Telemedicine-hybrid} \textbf{(n=29,984)}\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{P-value}\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Haemorrhage requiring transfusion}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
8 (0.04)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
7 (0.02)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.557\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Infection requiring hospital admission}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0 (0.0)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0 (0.0)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Major surgery}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0 (0.0)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0 (0.0)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Death}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0 (0.0)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0 (0.0)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

Note: As explained in the methods section, the p-value was calculated
using a hypothesis test where the null hypothesis is that the
traditional cohort the same rate of adverse events than the
telemedicine-hybrid cohort and the alternative hypothesis is that the
traditional cohort has a lower rate of adverse events than the
telemedicine-hybrid cohort.

\textbf{Table 4: Significant outcomes among patients presenting for
medical abortion in the traditional and telemedicine-hybrid cohorts
(n=52,218)}\selectlanguage{english}
\begin{longtable}[]{@{}llll@{}}
\toprule
\begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{Outcome}\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{Traditional} \textbf{(n=22,197)}\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{Telemedicine-hybrid} \textbf{(n=30,021)}\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\textbf{P-value}\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Ectopic Managed Pre-Treatment}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
37 (0.17)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
39 (0.13)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.796\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Ectopic Managed Post-Treatment}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
2 (0.01)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
10 (0.03)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.123\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Gestational age later than expected*}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0 (0.0)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
11 (0.04)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
N/A\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

Note: The column Ns include patients who presented for an EMA but did
not receive one because their ectopic pregnancy was identified
pre-treatment.

*Note: The column Ns for the gestational age later than expected
category are the same as those in Table 3, (all EMAs performed in the
two cohorts, i.e. N = 52,142).

\textbf{Figure 1 -- Summary of early medical abortion care management
during COVID-19 pandemic (adapted from RCOG Coronavirus (COVID-19)
infection and abortion care -- information for healthcare
professionals)} (9)

{[}Note for editors -- permission for reproduction obtained from RCOG{]}

Image from page 4:
2020-07-31-coronavirus-covid-19-infection-and-abortion-care.pdf
(rcog.org.uk)

If preferred, can provide original files in original Word format\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image1/image1}

\end{center}
\end{figure}

\textbf{Figure 2 -- Decision aid for early medical abortion without
ultrasound (adapted from RCOG Coronavirus (COVID-19) infection and
abortion care -- information for healthcare professionals)} (15)

{[}Note for editors -- permission for reproduction obtained from RCOG{]}

Image from:
2020-06-04-decision-aid-for-early-medical-abortion-without-ultrasound.pdf
(rcog.org.uk)

If preferred, can provide original files in original Powerpoint format\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image2/image2}

\end{center}
\end{figure}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image3/image3}

\end{center}
\end{figure}

\selectlanguage{english}
\FloatBarrier
\end{document}

