Haywards Heath Hospital

Effective regulatory oversight is a key step in ensuring that artificial intelligence as a medical device (AIaMD) is safe in real-world clinical settings. In this Perspective, we provide insights from our experience working with international regulatory databases, informed by our recent research and the expertise of the multidisciplinary authorship team. We highlight four key challenges, discuss attempts to circumvent these limitations, and highlight emerging initiatives. Nevertheless, the underlying issue of the quality and availability of input data from regulatory databases remains. We discuss considerations for improving accessibility and transparency, outline key aspects for a next-generation regulatory data ecosystem for AIaMDs, and call on global stakeholders to come together and align efforts to develop a clear roadmap to accelerate safe innovation and improve outcomes for patients worldwide.

The TRIPOD (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis) statement was published in 2015 to provide the minimum reporting recommendations for studies developing or evaluating the performance of a prediction model. Methodological advances in the field of prediction have since included the widespread use of artificial intelligence (AI) powered by machine learning methods to develop prediction models. An update to the TRIPOD statement is thus needed. TRIPOD+AI provides harmonised guidance for reporting prediction model studies, irrespective of whether regression modelling or machine learning methods have been used. The new checklist supersedes the TRIPOD 2015 checklist, which should no longer be used. This article describes the development of TRIPOD+AI and presents the expanded 27 item checklist with more detailed explanation of each reporting recommendation, and the TRIPOD+AI for Abstracts checklist. TRIPOD+AI aims to promote the complete, accurate, and transparent reporting of studies that develop a prediction model or evaluate its performance. Complete reporting will facilitate study appraisal, model evaluation, and model implementation.

Abstract Outdoor food markets represent important locations where foodborne illnesses and other infectious diseases can spread. Countries in Africa face particular challenges given the importance of these markets in food supply and low rates of access to safely managed water and sanitation. We undertook a scoping review of evidence related to disease transmission in food markets in sub-Saharan Africa, North Africa and identified 46 papers for data extraction and synthesis. Vendor behaviour or awareness was reported in the majority of papers and about half reported on market infrastructure. Fewer studies have been reported on regulatory environments or food contamination. Studies on water supply, sanitation and handwashing facilities focused on the presence of services and did not evaluate quality, thus conclusions cannot be drawn on service adequacy. Studies of vendor behaviour were primarily based on self-reporting and subject to bias. Most studies reported high levels of vendor awareness of the need for hygiene, but where observations were also conducted, these showed lower levels of behaviours in practice. Our findings suggest that there are limited studies on environmental hygiene in outdoor food markets and this is an area warranting further research, including into the quality of services and addressing methodological weaknesses.

IntroductionMedication errors are an important cause of morbidity and mortality. The pharmacist-led IT-based intervention to reduce clinically important medication errors (PINCER) intervention was shown to reduce medication errors when tested in a cluster randomised controlled trial and when implemented across one region of England. Now that it has been rolled out nationally, and to enhance findings from evaluations with staff and stakeholders, this paper is the first to report patients’ perceived acceptability on the use of PINCER in primary care and proposes suggestions on how delivery of PINCER related care could be delivered in a way that is acceptable and not unnecessarily burdensome.MethodsA total of 46 participants living with long-term health conditions who had experience of medication reviews and/or monitoring were recruited through patient participant groups and social media. Semi-structured, qualitative interviews and focus groups were conducted face-to-face or via telephone. A thematic analysis was conducted and findings mapped to the constructs of the Theoretical Framework of Acceptability (TFA).ResultsTwo themes were identified and interpreted within the most relevant TFA construct: Perceptions on the purpose and components of PINCER (Affective Attitude and Intervention Coherence) and Perceived patient implications (Burden and Self-efficacy). Overall perceptions on PINCER were positive with participants showing good understanding of the components. Access to medication reviews, which PINCER related care can involve, was reported to be limited and a lack of consistency in practitioners delivering reviews was considered challenging, as was lack of communication between primary care and other health-care providers. Patients thought it would be helpful if medication reviews and prescription renewal times were synchronised. Remote medication review consultations were more convenient for some but viewed as a barrier to communication by others. It was acknowledged that some patients may be more resistant to change and more willing to accept changes initiated by general practitioners.ConclusionsParticipants found the concept of PINCER acceptable; however, acceptability could be improved if awareness on the role of primary care pharmacists is raised and patient-pharmacist relationships enhanced. Being transparent with communication and delivering streamlined and consistent but flexible PINCER related care is recommended.