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.