Dynamic consent: a possible solution to improve patient confidence and trust in how electronic patient records are used in medical research

With one million people treated every 36 hours, routinely collected UK National Health Service (NHS) health data has huge potential for medical research. Advances in data acquisition from electronic patient records (EPRs) means such data are increasingly digital and can be anonymised for research purposes. NHS England’s care.data initiative recently sought to increase the amount and availability of such data. However, controversy and uncertainty following the care.data public awareness campaign led to a delay in rollout, indicating that the success of EPR data for medical research may be threatened by a loss of patient and public trust. The sharing of sensitive health care data can only be done through maintaining such trust in a constantly evolving ethicolegal and political landscape. We propose that a dynamic consent model, whereby patients can electronically control consent through time and receive information about the uses of their data, provides a transparent, flexible, and user-friendly means to maintain public trust. This could leverage the huge potential of the EPR for medical research and, ultimately, patient and societal benefit

Dynamic consent: a possible solution to improve patient confidence and trust in how electronic patient records are used in medical research

With one million people treated every 36 hours, routinely collected UK National Health Service (NHS) health data has huge potential for medical research. Advances in data acquisition from electronic patient records (EPRs) means such data are increasingly digital and can be anonymised for research purposes. NHS England’s care.data initiative recently sought to increase the amount and availability of such data. However, controversy and uncertainty following the care.data public awareness campaign led to a delay in rollout, indicating that the success of EPR data for medical research may be threatened by a loss of patient and public trust. The sharing of sensitive health care data can only be done through maintaining such trust in a constantly evolving ethicolegal and political landscape. We propose that a dynamic consent model, whereby patients can electronically control consent through time and receive information about the uses of their data, provides a transparent, flexible, and user-friendly means to maintain public trust. This could leverage the huge potential of the EPR for medical research and, ultimately, patient and societal benefit

A Multicenter, Randomized, Placebo‐Controlled Trial of Atorvastatin for the Primary Prevention of Cardiovascular Events in Patients With Rheumatoid Arthritis

Objective: Rheumatoid arthritis (RA) is associated with increased cardiovascular event (CVE) risk. The impact of statins in RA is not established. We assessed whether atorvastatin is superior to placebo for the primary prevention of CVEs in RA patients. Methods: A randomized, double‐blind, placebo‐controlled trial was designed to detect a 32% CVE risk reduction based on an estimated 1.6% per annum event rate with 80% power at P 50 years or with a disease duration of >10 years who did not have clinical atherosclerosis, diabetes, or myopathy received atorvastatin 40 mg daily or matching placebo. The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, transient ischemic attack, or any arterial revascularization. Secondary and tertiary end points included plasma lipids and safety. Results: A total of 3,002 patients (mean age 61 years; 74% female) were followed up for a median of 2.51 years (interquartile range [IQR] 1.90, 3.49 years) (7,827 patient‐years). The study was terminated early due to a lower than expected event rate (0.70% per annum). Of the 1,504 patients receiving atorvastatin, 24 (1.6%) experienced a primary end point, compared with 36 (2.4%) of the 1,498 receiving placebo (hazard ratio [HR] 0.66 [95% confidence interval (95% CI) 0.39, 1.11]; P = 0.115 and adjusted HR 0.60 [95% CI 0.32, 1.15]; P = 0.127). At trial end, patients receiving atorvastatin had a mean ± SD low‐density lipoprotein (LDL) cholesterol level 0.77 ± 0.04 mmoles/liter lower than those receiving placebo (P < 0.0001). C‐reactive protein level was also significantly lower in the atorvastatin group than the placebo group (median 2.59 mg/liter [IQR 0.94, 6.08] versus 3.60 mg/liter [IQR 1.47, 7.49]; P < 0.0001). CVE risk reduction per mmole/liter reduction in LDL cholesterol was 42% (95% CI −14%, 70%). The rates of adverse events in the atorvastatin group (n = 298 [19.8%]) and placebo group (n = 292 [19.5%]) were similar. Conclusion: Atorvastatin 40 mg daily is safe and results in a significantly greater reduction of LDL cholesterol level than placebo in patients with RA. The 34% CVE risk reduction is consistent with the Cholesterol Treatment Trialists’ Collaboration meta‐analysis of statin effects in other populations

Slides – Samantha Franklin, Kay Gallacher and Hawys Williams – Open Research Conference 2024

Slides used by Samantha Franklin, Kay Gallacher and Hawys Williams for the University of Manchester Open Research Conference 2024 Title: Evaluation of a Quality Mark to improve Patient and Public Involvement and Engagement (PPIE) in research and teaching Abstract: Patient and Public Involvement and Engagement (PPIE) supports a transparent and open research culture through building partnerships, listening and informing research and teaching from a public/patient perspective. The Quality Mark was created as a self-assessment tool for researchers, teachers and Public Contributors to measure their PPIE and signpost to resources for further improvement. This project aims to test the acceptability and evaluate the Quality Mark (https://www.staffnet.manchester.ac.uk/bmh/social-responsibility/ppie/ppie-chartermark/

Video - Samantha Franklin, Kay Gallagher, Hawys Williams - Open Research Conference 2024 (Subtitled)

Samantha Franklin, Kay Gallacher and Hawys Williams Evaluation of a Quality Mark to improve Patient and Public Involvement and Engagement (PPIE) in research and teaching Patient and Public Involvement and Engagement (PPIE) supports a transparent and open research culture through building partnerships, listening and informing research and teaching from a public/patient perspective. The Quality Mark was created as a self-assessment tool for researchers, teachers and Public Contributors to measure their PPIE and signpost to resources for further improvement. This project aims to test the acceptability and evaluate the Quality Mark (https://www.staffnet.manchester.ac.uk/bmh/social-responsibility/ppie/ppie-chartermark/

Using social media to improve communication with people with cystic fibrosis

Social media has the potential to improve communication with patients with cystic fibrosis http://ow.ly/Zdye