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.