Trials and Reviews

• Protocol
• Therapies for Long COVID in non-hospitalised individuals: from symptoms, patient-reported outcomes and immunology to targeted therapies (The TLC Study)
• Subramanian, A., Nirantharakumar, K., Hughes, S. et al. Symptoms and risk factors for long COVID in non-hospitalized adults. Nat Med 28, 1706–1714 (2022).
• Hughes S E, Haroon S, Subramanian A, McMullan C, Aiyegbusi O L, Turner G M et al. Development and validation of the symptom burden questionnaire for long covid (SBQ-LC): Rasch analysis BMJ 2022; 377 :e070230 doi:10.1136/bmj-2022-070230
• Chandan JS, Brown KR, Simms-Williams N, Bashir NZ, Camaradou J, Heining D, Turner GM, Rivera SC, Hotham R, Minhas S, et al. Non-Pharmacological Therapies for Post-Viral Syndromes, Including Long COVID: A Systematic Review. International Journal of Environmental Research and Public Health. 2023; 20(4):3477.
• Aiyegbusi OL, Davies EH, Myles P, et al. Digitally enabled decentralised research: opportunities to improve the efficiency of clinical trials and observational studiesBMJ Evidence-Based Medicine 2023;28:328-331
• Routen, A., O’Mahoney, L., Aiyegbusi, O.L. et al. Patient and public involvement within epidemiological studies of long COVID in the UK. Nat Med 29, 771–773 (2023).
• Turner, G.M., McMullan, C., Aiyegbusi, O.L. et al. Co-production of a feasibility trial of pacing interventions for Long COVID. Res Involv Engagem 9, 18 (2023).
• Aiyegbusi, O.L., McMullan, C., Hughes, S.E. et al. Considerations for patient and public involvement and engagement in health research. Nat Med 29, 1922–1929 (2023).
• Syed, U., Subramanian, A., Wraith, D.C. et al. Incidence of immune-mediated inflammatory diseases following COVID-19: a matched cohort study in UK primary care. BMC Med 21, 363 (2023).
• The cost of primary care consultations associated with long COVID in non-hospitalised adults: a retrospective cohort study using UK primary care data
• Blood biomarkers and biological age among patients with long COVID

NOAH-AFNET 6 was the first trial to investigate the efficacy and safety of oral anticoagulation in patients with atrial high-rate episodes, but without ECG-documented atrial fibrillation.

Related links:

• Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes

The RATE-AF trial has shown that 12-month treatment with digoxin is safe and effective, and has the same effect on physical wellbeing as beta-blockers for patients with permanent AF.

Related links:

• Effect of Digoxin vs Bisoprolol for Heart Rate Control in Atrial Fibrillation on Patient-Reported Quality of Life: The RATE-AF Randomized Clinical Trial | Atrial Fibrillation | JAMA | JAMA Network

IMPRESS-AF was a randomized placebo  controlled clinical trial of spironolactone versus placebo in patients with chronic atrial fibrillation and preserved ejection fraction. Spironolactone therapy does not improve exercise capacity, endothelial function assessed as echocardiographic E/e’ ratio, or quality of life in the tested population.

Related links:

• Spironolactone in Atrial Fibrillation With Preserved Cardiac Fraction: The IMPRESS‐AF Trial | Journal of the American Heart Association (ahajournals.org)

Heal Covid website

The fellowship programme, a partnership between UoB and Healthcare KgA -R&D, aims to advance the application of qualitative and mixed-methods research to inform patient-directed drug development, to help address key development challenges across therapeutic areas.

Related links:

• The effect of disease modifying therapies on fatigue in multiple sclerosis

SMILE T1D was an ongoing 26-week randomised, treat-to-range, open label, parallel-group, national multi-centre trial to assess safety and efficacy of once weekly injectable semaglutide as adjunctive therapy to insulin in children and young people (CYPD) (10-24 years old) with Type 1 Diabetes, with usual standard of care (insulin) as the comparator.

Related links:

• Type 1 diabetes research at the University of Birmingham

Chimeric Antigen Receptor T-cell (CAR-T) therapy is a new approach to cancer treatment in which the body’s own immune cells, which fight infection, are used to recognise and kill off cancer cells. CAR-T therapy is promising but the side effects of treatment can be serious. Early detection of CAR-T side effects is important so people can receive the medicines they need to help treat them. One way of monitoring the effects of treatment is by using patient-reported outcomes (or 'PROs') which involve patients filling out questionnaires to record their symptoms and feeding back the questionnaire results to their healthcare team. Collecting PROs can be done using paper questionnaires but increasingly PROs are completed electronically, using handheld devices such as a patient’s own smartphone or tablet. Digital tools to assess CAR-T patients’ symptoms are not yet widely available. 

This study will develop and feasibility test a new digital system to collect patient-reported symptoms and quality of life data from CAR-T patients to facilitate clinical intervention and promote patient safety.

Related links: 

• Self-reported outcome measures could improve quality of life for CAR T-Cell therapy patients - University of Birmingham

• Protocol for a mixed-methods study to develop and feasibility test a digital system for the capture of patient-reported outcomes (PROs) in patients receiving chimeric antigen receptor T-cell (CAR-T) therapies (the PRO-CAR-T study) | BMJ Open

• Measure selection for an electronic patient-reported outcome (ePRO) system for CAR T-cell therapy patients: a modified Delphi consensus study - PubMed