The study shows a considerable improvement of the assessed Stroke Pathway over the years both in terms of efficiency and effectiveness. As for activity volumes and patients’ characteristics, the number of stroke cases treated with pharmacological thrombolysis increased over the years, as well as their mean age and baseline disability level. This can be traced back to the change over time, according to guidelines [1, 8], of the inclusion criteria, in particular to the extension of the time span for pharmacological thrombolysis from 3 to 4.5 hours after the symptoms onset.
In addition, the incremental number of thrombolysis also led to the improvement of the Pathway’s performances, in particular those related to the hospital stroke management phase. The process analysis, indeed, highlighted a significant reduction of the DTN value, i.e. the time interval between the arrival to ED and the starting of pharmacological thrombolysis, parallel to the increased annual number of cases treated. This data reveals the learning curve of the system, which, in a virtuous circle, improves its parameters with higher treatment volumes. To this regard, the relationship between case volume and performance is widely reported in the scientific literature, for several clinical areas [18–25] including stroke treatment [26, 27].
Moreover, the lower restriction in patient selection related to the compliance of the Stroke Pathway with guidelines [1, 8] did not worsen the long-term prognosis. In fact, despite an increasing mean value of baseline disability, measured by the mRS score, over the years, the degree of disability 3 months after the ischemic event onset, as expressed by the 3m-mRS, remained stable. It was probably due to a balancing effect linked to improvements in the acute management, in particular DTN reduction, and therefore in the effectiveness of treatment. The relationship between the reduction in time metrics and a higher chance of getting a good neurological recovery at 3 months is also reported by scientific literature [28].
Unlike DTN, the time interval between the onset of symptomatology and the arrival to ED (OTD) did not change significantly over the years. The OTD stability can be traced back to a level of patients/caregivers’ education still not enough to timely recognize stroke signs and symptoms resulting in a delayed request for emergency healthcare. Some Authors recently underlined the need for enhancing patient awareness on timely emergence medical services usage at stroke onset by strengthening publicity and educational activities [29, 30].
It can also be said that, despite the onset of the COVID-19 pandemic and its negative impact on Italian healthcare system [12], the Stroke Pathway has proven effective both in terms of hospital processes and clinical outcomes for patients undergoing pharmacological thrombolysis. In fact, the comparison of the pre-pandemic (March-December 2019) and the pandemic periods (March-December 2020) showed a number of positive elements. Concerning hospital processes, both the DTI and DTN scores did not change significantly. As for patient outcomes, although a higher baseline disability level (mRS score), the long-term disability (3m-mRS) score did not show a statistically significant change, except for a slight improvement. These results show the resilience, during the emergency phase, of the Stroke Pathway - especially of the hospital phase - and its positive impact on outcomes, given that the long-term disability level didn't get worse. These data are in line with previous studies reporting the Stroke Pathway effectiveness and underlining its importance as a crucial clinical governance tool to improve patient clinical management [31–36]. On the other hand, the pre-post COVID-19 comparison showed an OTD increase, although not statistically significant. This data reveals the impact of the pandemic on the pre-hospital phase of the Stroke Pathway, unlike the hospital one. Indeed, it could be related to the hesitancy of people to go to ED or alert the emergency medical service [12] up to underestimate the stroke signs and symptoms, as also confirmed by the higher baseline disability level (mRS score).
This study has some weaknesses and strengths. Among weaknesses, there is the limited number of eligible patients, which made it more difficult to achieve statistical significance for all the variables considered. Among strengths, there is the use of data obtained from the SITS-MOST registry [11], which is a world-leading platform for stroke data, also used for extensive international studies for its completeness and systematicity. Moreover, there is an evident internal consistency of data over the 10 years range considered in terms of guidelines’ targets pursuit [1, 8, 16].
The results of the retrospective assessment of the Stroke Pathway performances highlighted its positive impact both on hospital processes, although the latter can be further improved, and patients’ outcomes, even during the COVID-19 pandemic. Moreover, the analysis showed the need to identify and implement improvement actions for the pre-hospital phase.
What the main study implications? As far as clinical management is concerned, the first objective is to improve the hospital stroke management phase, through a change of the Stroke Pathway with the thrombolysis starting in the diagnostic imaging department in order to reduce the DTN score and achieve the international guidelines standards [8]. The second objective is to promote health communication actions aimed at the general population, from specialists up to patients/caregivers, through information/education campaigns easily accessible to the public. The last should provide simple essential information to recognize stroke signs and symptoms in order to reduce the time between the onset of symptoms and the arrival to ED. In this regard, in 2018 the Emilia-Romagna Region, launched, through the Regional Health Website, the "I see, I recognize, I call" initiative, an awareness campaign for the early and timely recognition of stroke symptoms. The dissemination of information reaches users through an illustrative video available on the website and the distribution of leaflets/brochures to health providers and patients/citizens [37]. Other actions should be promoted and implemented to strengthen communication and make it more effective, such as the engagement of general practitioners and institutional health education initiatives/events involving all the stakeholders also through the use of social media. As for research, this study paves the way for a multicentric study, on a larger sample, to confirm the results of this retrospective assessment and better investigate the analyzed variables.