ABSTRACT
BACKGROUND: Social prescribing encourages health-care and other professionals to refer patients to a link worker, who will develop a personalised plan to improve the patient's health and well-being. We explore the feasibility of evaluating the service. OBJECTIVE: The objective was to answer the following research questions. (1) What are the most important evaluation questions that an impact study could investigate? (2) What data are already available at a local or national level and what else would be needed? (3) Are there sites delivering at a large enough scale and in a position to take part in an impact study? (4) How could the known challenges to evaluation (e.g. information governance and identifying a control group) be addressed? DATA SOURCES: Data sources included MEDLINE ALL (via Ovid), searched from inception to 14 February 2019, and the first 100 hits of a Google (Google Inc., Mountain View, CA, USA) search. REVIEW METHODS: Rapid systematic review - electronic searches up to February 2019. Studies included any study design or outcomes. Screening was conducted by one reviewer;eligibility assessment and data extraction were undertaken by two reviewers. Data were synthesised narratively. Qualitative interviews - data from 25 participants in different regions of England were analysed using a pragmatic framework approach across 12 areas including prior data collection, delivery sites, scale and processes of current service delivery, and known challenges to evaluation. Views of key stakeholders (i.e. patients and academics) were captured. RESULTS: Rapid systematic review - 27 out of 124 studies were included. We identified outcomes and highlighted research challenges. Important evaluation questions included identification of the most appropriate (1) outcomes and (2) methods for dealing with heterogeneity. Qualitative interviews - social prescribing programmes are holistic in nature, covering domains such as social isolation and finance. Service provision is heterogeneous. The follow-on services that patients access are often underfunded or short term. Available data - there was significant heterogeneity in data availability, format and follow-up. Data were collected using a range of tools in ad hoc databases across sites. Non-attendance data were frequently not captured. Service users are more deprived and vulnerable than the overall practice population. Feasibility and potential limitations of an evaluation - current data collection is limited in determining the effectiveness of the link worker social prescribing model;therefore, uniform data collection across sites is needed. Standardised outcomes and process measures are required. Cost-utility analysis could provide comparative values for assessment alongside other NHS interventions. LIMITATIONS: This was a rapid systematic review that did not include a systematic quality assessment of studies. COVID-19 had an impact on the shape of the service. We were not able to examine the potential causal mechanisms in any detail. CONCLUSIONS: We describe possible future research approaches to determine effectiveness and cost-effectiveness evaluations;all are limited in their application. (1) Evaluation using currently available, routinely collected health-care, costing and outcomes data. (2) Evaluative mixed-methods research to capture the complexity of social prescribing through understanding heterogeneous service delivery across comparative settings. Cost-effectiveness evaluation using routinely available costing and outcomes data to supplement qualitative data. (3) Interventional evaluative research, such as a cluster randomised controlled trial focused on the link worker model. Cost-effectiveness data collected as part of the trial. FUTURE WORK: Mature data are currently not available. There needs to be an agreement across schemes on the key outcomes that need to be measured, harmonisation of data collection, and follow-up referrals (how and when). FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research;Vol. 10, No. 29. See the NIHR Journals Library website for further project information.
ABSTRACT
Background: Immune checkpoint inhibitors (ICIs) can cause a variety of inflammatory autoimmune tissue damage, referred to as immune-related adverse events (irAEs). COVID-19 is associated with increased amounts of proinflammatory cytokines, which may synergistically affect the outcome of irAEs. Data are limited regarding the impact of COVID-19 on irAEs in ICI-treated cancer patients. Methods: We retrospectively analyzed adult patients with malignant solid tumors treated with ICIs at AdventHealth Orlando between August 2020 and August 2021. All COVID-19 infections were confirmed by PCR. Patients who had the most recent ICI treatment over one month before or after the positive COVID- 19 test were excluded from the study. For COVID-19 positive group, only the irAEs that developed after COVID-19 infection were considered as events. Results: A total of 579 patients were included in our study, with 46 (7.9%) in COVID-19 positive group, and 533 (92.1%) in COVID-19 negative group. The baseline characteristics of patients in the two groups were similar in terms of age, ethnicity, ECOG, cancer histology, and type of ICI. With a median follow-up of 10 months (1-73 months), no differences in the time from ICI initiation to irAE onset, corticosteroid use, or additional immunosuppressant use were seen. A trend in higher incidence of all-grade diarrhea/colitis (8.7% vs. 3.0%, p=0.07) and grade 3 and 4 hepatitis (4.3% vs. 0.8%, p=0.08) was noted in the COVID-19 positive group, however the difference was not statistically significant. No significant difference in the incidence of pneumonitis (2.2% vs. 1.1%, p=0.44), nephritis (2.2% vs. 0.8%, p=0.34) or dermatitis (6.5% vs. 6.4%, p=1.00) were noted between COVID-19 positive and negative groups. We noticed a higher incidence of all-grade irAEs in the COVID-19 positive group (30.4% vs. 19.9%, p=0.18), but the difference was not statistically significant. The incidence of grade 3 and 4 irAEs was significantly higher in the COVID- 19 positive group (10.9% vs. 3.2%, p=0.02). Nine COVID-19 related death occurred while no irAE-related death was noted in the entire cohort. Conclusions: Our study suggested that COVID-19 may pose a risk of severe irAEs in cancer patients receiving ICIs. Close monitoring and possible delaying ICI administration could be considered when cancer patients were infected with COVID-19. (Table Presented).