Moving beyond the rhetoric to a sustainable NHS patient safety culture

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses World Patient Safety Day and some recent patient safety reports

Understanding short-term transmission dynamics of methicillin-resistant Staphylococcus aureus in the patient room

Objective: Little is known about the short-term dynamics of methicillin-resistant Staphylococcus aureus (MRSA) transmission between patients and their immediate environment. We conducted a real-life microbiological evaluation of environmental MRSA contamination in hospital rooms in relation to recent patient activity. Design: Observational pilot study. Setting: Two hospitals, hospital 1 in Zurich, Switzerland, and hospital 2 in Ann Arbor, Michigan, United States. Patients: Inpatients with MRSA colonization or infection. Methods: At baseline, the groin, axilla, nares, dominant hands of 10 patients and 6 environmental high-touch surfaces in their rooms were sampled. Cultures were then taken of the patient hand and high-touch surfaces 3 more times at 90-minute intervals. After each swabbing, patients’ hands and surfaces were disinfected. Patient activity was assessed by interviews at hospital 1 and analysis of video footage at hospital 2. A contamination pressure score was created by multiplying the number of colonized body sites with the activity level of the patient. Results: In total, 10 patients colonized and/or infected with MRSA were enrolled; 40 hand samples and 240 environmental samples were collected. At baseline, 30% of hands and 20% of high-touch surfaces yielded MRSA. At follow-up intervals, 8 (27%) of 30 patient hands, and 10 (6%) of 180 of environmental sites were positive. Activity of the patient explained 7 of 10 environmental contaminations. Patients with higher contamination pressure score showed a trend toward higher environmental contamination. Conclusion: Environmental MRSA contamination in patient rooms was highly dynamic and was likely driven by the patient’s MRSA body colonization pattern and the patient activity.

Examining the new NHS National Patient Safety Syllabus

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, introduces the recently published NHS National Patient Safety Syllabus and some recent patient safety reports

Considering reasonable standards

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses some recent patient safety reports that have important implications for patients and for all those who work in the NHS

Personal digital health in Parkinson's disease: Case histories and commentary

The use of self-tracking of bio-behavioral states along with prescription dosing information is increasingly popular in the care and study of many human diseases. Parkinson’s Disease is particularly amenable to such tracking, as patients live with the progressive disease for many years, increasing motivation to pursue quality of life changes through careful monitoring of symptoms and self-guided management of their medications and lifestyle choices. Through the use of digital self-tracking technologies, patients independently or in conjunction with professional medical advice are modulating their medications and behavioral regimens based on self-tracking data. Self-trackers engage in self-experimentation with their health, and more broadly, in personal digital health. This paper briefly depicts notable, recent patient accounts of self-tracking and the uses of digital health in Parkinson’s disease: those of Sara Riggare and Kevin Krejci. It also highlights important facets of a previously unreported case: Velva Walden’s care as managed jointly by her caregiver son. Key aspects of self-tracking inherent to these cases are examined and potential opportunities to advance personalized medicine through the use of digital health and self-experimentation are outlined.

To learn the lessons, think beyond the specialty

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses some recent patient safety reports and how they can help better inform care and quality practices across the NHS

Validation and equivalency of electronic clinical outcomes assessment systems

<p>The US food and drug administration (FDA) has long called for clinical outcomes assessments (COA), such as patient-reported outcomes (PRO), to be ‘fit-for-purpose’ meaning the COA has been validated to support the context of use. The FDA’s recent patient-focused drug development guidance series has renewed the importance of ensuring that COA is ‘fit-for-purpose’ and valid. In addition, the FDA has recommended that COA be collected electronically and that the electronic (eCOA) system and devices also be validated. Advancing technology requires eCOA systems and devices to evolve; eCOA devices may change over time. As bring your own device (BYOD) models gain popularity and acceptance, devices may also be mixed within trials. Changes in eCOA devices or mixing devices may require equivalence testing to prove validity across platforms. The aim of this article is to provide an overview of the different types of validation at both the assessment level and the eCOA system (device) level to help clinical trial sponsors determine the appropriate level of validation or equivalence testing required for COA used in their clinical trials. </p>

Patient and Family Participation in Clinical Guidelines Development: The Cystic Fibrosis Foundation Experience

Patient and family participation in guideline development is neither standardized nor uniformly accepted in the guideline development community, despite the 2011 Institute of Medicine’s Guidelines We Can Trust and the Guideline International Network’s GIN-Public Toolkit recommendations. The Cystic Fibrosis Foundation has included patients and/or family members directly in guideline development since 2004. Over time, various strategies for increasing patient and family member participation have been implemented. Surveys of recent patient/family and clinical guidelines committee members have shown that inclusion of individuals with cystic fibrosis and their family members on guidelines committees has provided insight otherwise invisible to clinicians.

Medical cannabis in the UK: From principle to practice

Background: In the UK, medical cannabis was approved in November 2018, leading many patients to believe that the medicine would now be available on the NHS. Yet, to date, there have been only 12 NHS prescriptions and less than 60 prescriptions in total. In marked contrast, a recent patient survey by the Centre for Medical Cannabis (Couch, 2020) found 1.4 m people are using illicit cannabis for medical problems. Aims: Such a mismatch between demand and supply is rare in medicine. This article outlines some of the current controversies about medical cannabis that underpin this disparity, beginning by contrasting current medical evidence from research studies with patient-reported outcomes. Outcomes: Although definite scientific evidence is scarce for most conditions, there is significant patient demand for access to medical cannabis. This disparity poses a challenge for prescribers, and there are many concerns of physicians when deciding if, and how, to prescribe medical cannabis which still need to be addressed. Potential solutions are outlined as to how the medical profession and regulators could respond to the strong demand from patients and families for access to medical cannabis to treat chronic illnesses when there is often a limited scientific evidence base on whether and how to use it in many of these conditions. Conclusions: There is a need to maximise both clinical research and patient benefit, in a safe, cautious and ethical manner, so that those patients for whom cannabis is shown to be effective can access it. We hope our discussion and outlines for future progress offer a contribution to this process.

Patient safety reports round-up during the COVID-19 pandemic

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses some recent patient safety reports, revealing that patient safety concerns continue during the current pandemic