Meaningful patient and public involvement in digital health innovation, implementation and evaluation: A systematic review.

INTRODUCTION: The importance of meaningfully involving patients and the public in digital health innovation is widely acknowledged, but often poorly understood. This review, therefore, sought to explore how patients and the public are involved in digital health innovation and to identify factors that support and inhibit meaningful patient and public involvement (PPI) in digital health innovation, implementation and evaluation. METHODS: Searches were undertaken from 2010 to July 2020 in the electronic databases MEDLINE, EMBASE, PsycINFO, CINAHL, Scopus and ACM Digital Library. Grey literature searches were also undertaken using the Patient Experience Library database and Google Scholar. RESULTS: Of the 10,540 articles identified, 433 were included. The majority of included articles were published in the United States, United Kingdom, Canada and Australia, with representation from 42 countries highlighting the international relevance of PPI in digital health. 112 topic areas where PPI had reportedly taken place were identified. Areas most often described included cancer (n = 50), mental health (n = 43), diabetes (n = 26) and long-term conditions (n = 19). Interestingly, over 133 terms were used to describe PPI; few were explicitly defined. Patients were often most involved in the final, passive stages of an innovation journey, for example, usability testing, where the ability to proactively influence change was severely limited. Common barriers to achieving meaningful PPI included data privacy and security concerns, not involving patients early enough and lack of trust. Suggested enablers were often designed to counteract such challenges. CONCLUSIONS: PPI is largely viewed as valuable and essential in digital health innovation, but rarely practised. Several barriers exist for both innovators and patients, which currently limits the quality, frequency and duration of PPI in digital health innovation, although improvements have been made in the past decade. Some reported barriers and enablers such as the importance of data privacy and security appear to be unique to PPI in digital innovation. Greater efforts should be made to support innovators and patients to become meaningfully involved in digital health innovations from the outset, given its reported benefits and impacts. Stakeholder consensus on the principles that underpin meaningful PPI in digital health innovation would be helpful in providing evidence-based guidance on how to achieve this. PATIENT OR PUBLIC CONTRIBUTION: This review has received extensive patient and public contributions with a representative from the Patient Experience Library involved throughout the review's conception, from design (including suggested revisions to the search strategy) through to article production and dissemination. Other areas of patient and public contributor involvement include contributing to the inductive thematic analysis process, refining the thematic framework and finalizing theme wording, helping to ensure relevance, value and meaning from a patient perspective. Findings from this review have also been presented to a variety of stakeholders including patients, patient advocates and clinicians through a series of focus groups and webinars. Given their extensive involvement, the representative from the Patient Experience Library is rightly included as an author of this review.

Meaningful use of imaging resources to rule out cerebral venous sinus thrombosis after ChAdOx1 COVID-19 vaccination: Evaluation of the AHA diagnostic algorithm with a clinical cohort and a systematic data review.

Vaccine-induced immune thrombotic thrombocytopenia (VITT) with cerebral venous thrombosis (CVST) is an improbable (0.0005%), however potentially lethal complication after ChAdOx1 vaccination. On the other hand, headache is among the most frequent side effects of ChAdOx1 (29.3%). In September 2021, the American Heart Association (AHA) suggested a diagnostic workflow to facilitate risk-adapted use of imaging resources for patients with neurological symptoms after ChAdOx1. We aimed to evaluate the AHA workflow in a retrospective patient cohort presenting at four primary care hospitals in Germany for neurological complaints after ChAdOx1. Scientific literature was screened for case reports of VITT with CVST after ChAdOx1, published until September 1st, 2021. One-hundred-thirteen consecutive patients (77 female, mean age 38.7 +/- 11.9 years) were evaluated at our institutes, including one case of VITT with CVST. Further 228 case reports of VITT with CVST are published in recent literature, which share thrombocytopenia (225/227 reported) and elevated d-dimer levels (100/101 reported). The AHA workflow would have recognized all VITT cases with CVST (100% sensitivity), the number needed to diagnose (NND) was 1:113. Initial evaluation of thrombocytopenia or elevated d-dimer levels would have lowered the NND to 1:68, without cost of sensitivity. Hence, we suggest that in case of normal thrombocyte and d-dimer levels, the access to further diagnostics should be limited by the established clinical considerations regardless of vaccination history.

Laboratory information system requirements to manage the COVID-19 pandemic: A report from the Belgian national reference testing center.

OBJECTIVE: The study sought to describe the development, implementation, and requirements of laboratory information system (LIS) functionality to manage test ordering, registration, sample flow, and result reporting during the coronavirus disease 2019 (COVID-19) pandemic. MATERIALS AND METHODS: Our large (>12 000 000 tests/y) academic hospital laboratory is the Belgian National Reference Center for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing. We have performed a moving total of >25 000 SARS-CoV-2 polymerase chain reaction tests in parallel to standard routine testing since the start of the outbreak. A LIS implementation team dedicated to develop tools to remove the bottlenecks, primarily situated in the pre- and postanalytical phases, was established early in the crisis. RESULTS: We outline the design, implementation, and requirements of LIS functionality related to managing increased test demand during the COVID-19 crisis, including tools for test ordering, standardized order sets integrated into a computerized provider order entry module, notifications on shipping requirements, automated triaging based on digital metadata forms, and the establishment of databases with contact details of other laboratories and primary care physicians to enable automated reporting. We also describe our approach to data mining and reporting of actionable daily summary statistics to governing bodies and other policymakers. CONCLUSIONS: Rapidly developed, agile extendable LIS functionality and its meaningful use alleviates the administrative burden on laboratory personnel and improves turnaround time of SARS-CoV-2 testing. It will be important to maintain an environment that is conducive for the rapid adoption of meaningful LIS tools after the COVID-19 crisis.