Permanent URI for this collection

Research ouputs from RD&E staff


Recent Submissions

Now showing 1 - 5 of 118
  • Item
    Diminished Physical Activity in Older Hospitalised Patients with and without COVID-19
    (MDPI, 2023-09-28) Piotrowicz, K.; Perera, I.; Ryś, M.; Skalska, A.; Hope, S. V.; Gryglewska, B.; Michel, J. P.; Grodzicki, T.; Gąsowski, J.
    Acute viral respiratory infections have proven to be a major health threat, even after the Corona Virus Disease 2019 (COVID-19) pandemic. We aimed to check whether the presence or absence of an acute respiratory infection such as COVID-19 can influence the physical activity of older hospitalised patients. We cross-sectionally studied patients aged ≥60 years, hospitalized during the pandemic in the non-COVID-19 and COVID-19 ward at the University Hospital, Kraków, Poland. Using activPAL3(®) technology, we assessed physical activity for 24 h upon admission and discharge. In addition, we applied the sarcopenia screening tool (SARC-F); measured the hand grip strength and calf circumference; and assessed the Modified Early Warning Score (MEWS), age-adjusted Charlson Index, SpO2%, and length of stay (LoS). Data were analysed using SAS 9.4. The mean (min, max) age of the 31 (58% women, eight with COVID-19) consecutive patients was 79.0 (62, 101, respectively) years. The daily time (activPAL3(®), median [p5, p95], in hours) spent sitting or reclining was 23.7 [17.2, 24] upon admission and 23.5 [17.8, 24] at discharge. The time spent standing was 0.23 [0.0, 5.0] upon admission and 0.4 [0.0, 4.6] at discharge. The corresponding values for walking were 0.0 [0.0, 0.4] and 0.1 [0.0, 0.5]. SARC-F, admission hand grip strength, calf circumference, and LoS were correlated with physical activity upon admission and discharge (all p < 0.04). For every unit increase in SARC-F, there was a 0.07 h shorter walking time upon discharge. None of the above results differed between patients with and without COVID-19. The level of physical activity in older patients hospitalised during the pandemic was low, and was dependent on muscular function upon admission but not on COVID-19 status. This has ramifications for scenarios other than pandemic clinical scenarios.
  • Item
    Evaluation of a COVID-19 fundamental nursing care guideline versus usual care: The COVID-NURSE cluster randomized controlled trial
    (Wiley, 2023-11-20) Richards, D. A.; Bollen, J.; Jones, B.; Melendez-Torres, G. J.; Hulme, C.; Cockcroft, E.; Cook, H.; Cooper, J.; Creanor, S.; Cruickshank, S.; Dawe, P.; Doris, F.; Iles-Smith, H.; Kent, M.; Logan, P.; O'Connell, A.; Onysk, J.; Owens, R.; Quinn, L.; Rafferty, A. M.; Romanczuk, L.; Russell, A. M.; Shepherd, M.; Singh, S. J.; Sugg, H. V. R.; Coon, J. T.; Tooze, S.; Warren, F. C.; Whale, B.; Wootton, S.
    AIM: To evaluate the impact of usual care plus a fundamental nursing care guideline compared to usual care only for patients in hospital with COVID-19 on patient experience, care quality, functional ability, treatment outcomes, nurses' moral distress, patient health-related quality of life and cost-effectiveness. DESIGN: Parallel two-arm, cluster-level randomized controlled trial. METHODS: Between 18th January and 20th December 2021, we recruited (i) adults aged 18 years and over with COVID-19, excluding those invasively ventilated, admitted for at least three days or nights in UK Hospital Trusts; (ii) nurses caring for them. We randomly assigned hospitals to use a fundamental nursing care guideline and usual care or usual care only. Our patient-reported co-primary outcomes were the Relational Aspects of Care Questionnaire and four scales from the Quality from the Patient Perspective Questionnaire. We undertook intention-to-treat analyses. RESULTS: We randomized 15 clusters and recruited 581 patient and 418 nurse participants. Primary outcome data were available for 570-572 (98.1%-98.5%) patient participants in 14 clusters. We found no evidence of between-group differences on any patient, nurse or economic outcomes. We found between-group differences over time, in favour of the intervention, for three of our five co-primary outcomes, and a significant interaction on one primary patient outcome for ethnicity (white British vs. other) and allocated group in favour of the intervention for the 'other' ethnicity subgroup. CONCLUSION: We did not detect an overall difference in patient experience for a fundamental nursing care guideline compared to usual care. We have indications the guideline may have aided sustaining good practice over time and had a more positive impact on non-white British patients' experience of care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: We cannot recommend the wholescale implementation of our guideline into routine nursing practice. Further intervention development, feasibility, pilot and evaluation studies are required. IMPACT: Fundamental nursing care drives patient experience but is severely impacted in pandemics. Our guideline was not superior to usual care, albeit it may sustain good practice and have a positive impact on non-white British patients' experience of care. REPORTING METHOD: CONSORT and CONSERVE. PATIENT OR PUBLIC CONTRIBUTION: Patients with experience of hospitalization with COVID-19 were involved in guideline development and writing, trial management and interpretation of findings.
  • Item
    Omicron BA.1-containing mRNA-1273 boosters compared with the original COVID-19 vaccine in the UK: a randomised, observer-blind, active-controlled trial
    (Elsevier, 2023-09-01) Lee, I. T.; Cosgrove, C. A.; Moore, P.; Bethune, C.; Nally, R.; Bula, M.; Kalra, P. A.; Clark, R.; Dargan, P. I.; Boffito, M.; Sheridan, R.; Moran, E.; Darton, T. C.; Burns, F.; Saralaya, D.; Duncan, C. J. A.; Lillie, P. J.; San Francisco Ramos, A.; Galiza, E. P.; Heath, P. T.; Girard, B.; Parker, C.; Rust, D.; Mehta, S.; de Windt, E.; Sutherland, A.; Tomassini, J. E.; Dutko, F. J.; Chalkias, S.; Deng, W.; Chen, X.; Feng, J.; Tracy, L.; Zhou, H.; Miller, J. M.; Das, R.
    BACKGROUND: The omicron BA.1 bivalent booster is used globally. Previous open-label studies of the omicron BA.1 (Moderna mRNA-1273.214) booster showed superior neutralising antibody responses against omicron BA.1 and other variants compared with the original mRNA-1273 booster. We aimed to compare the safety and immunogenicity of omicron BA.1 monovalent and bivalent boosters with the original mRNA-1273 vaccine in a large, randomised controlled trial. METHODS: In this large, randomised, observer-blind, active-controlled, phase 3 trial in the UK (28 hospital and vaccination clinic sites), individuals aged 16 years or older who had previously received two injections of any authorised or approved COVID-19 vaccine, with or without an mRNA vaccine booster (third dose), were randomly allocated (1:1) using interactive response technology to receive 50 μg omicron BA.1 monovalent or bivalent vaccines or 50 μg mRNA-1273 administered as boosters via deltoid intramuscular injection. The primary outcomes were safety and immunogenicity at day 29, including prespecified non-inferiority and superiority of booster immune responses, based on the neutralising antibody geometric mean concentration (GMC) ratios of the monovalent and bivalent boosters compared with mRNA-1273. Safety was assessed in all participants who received first or second boosters, and primary immunogenicity outcomes were assessed in all participants who received the planned booster dose, had pre-booster and day 29 antibody data, had no major protocol deviations, and who were SARS-CoV-2-negative. The study is registered with EudraCT (2022-000063-51) and (NCT05249829) and is ongoing. FINDINGS: Between Feb 16 and March 24, 2022, 724 participants were randomly allocated to receive omicron BA.1 monovalent (n=366) or mRNA-1273 (n=357), and between April 2 and June 17, 2022, 2824 participants were randomly allocated to receive omicron BA.1 bivalent (n=1418) or mRNA-1273 (n=1395) vaccines as second boosters. Median durations (months) between the most recent COVID-19 vaccine and study boosters were similar for omicron BA.1 monovalent (4·0 months [IQR 3·6-4·7]) and mRNA-1273 (4·1 [3·5-4·7]), and for the omicron BA.1 bivalent (5·5 [4·8-6·2]) and mRNA-1273 (5·4 [4·8-6·2]) boosters. The omicron BA.1 monovalent and bivalent boosters elicited superior neutralising GMCs against the omicron BA.1 variant compared with mRNA-1273, with GMC ratios of 1·68 (99% CI 1·45-1·95) and 1·53 (1·41-1·67) at day 29 post-booster doses in participants without previous SARS-CoV-2 infection. Both boosters induced non-inferior ancestral SARS-CoV-2 (Asp614Gly) immune responses with GMCs that were similar for the bivalent (2987·2 [95% CI 2814·9-3169·9]) versus mRNA-1273 (2911·3 [2750·9-3081·0]) and lower for the monovalent (2699·7 [2431·3-2997·7] vs 3020·6 [2776·5-3286·2]) boosters, with respective GMC ratios of 1·05 (99% CI 0·96-1·15) and 0·82 (95% CI 0·74-0·91). Results were comparable regardless of previous SARS-CoV-2 infection status. Incidences of solicited adverse reactions with the omicron BA.1 monovalent (335 [91·3%] of 367 participants) and omicron BA.1 bivalent (1285 [90·4%] of 1421 participants) boosters were similar to those observed previously for mRNA-1273, with no new safety concerns identified and no occurrences of fatal adverse events. INTERPRETATION: Omicron-containing booster vaccines generated superior immunogenicity against omicron BA.1 and comparable immunogenicity against the original strain with no new safety concerns. It remains important to continuously monitor the immune responses and real-world vaccine effectiveness as divergent SARS-CoV-2 variants emerge. FUNDING: Moderna.
  • Item
    OpenSAFELY NHS Service Restoration Observatory 2: changes in primary care clinical activity in England during the COVID-19 pandemic
    (Royal College of General Practitioners, 2023-05-01) Curtis, H. J.; MacKenna, B.; Wiedemann, M.; Fisher, L.; Croker, R.; Morton, C. E.; Inglesby, P.; Walker, A. J.; Morley, J.; Mehrkar, A.; Bacon, S. C.; Hickman, G.; Evans, D.; Ward, T.; Davy, S.; Hulme, W. J.; Macdonald, O.; Conibere, R.; Lewis, T.; Myers, M.; Wanninayake, S.; Collison, K.; Drury, C.; Samuel, M.; Sood, H.; Cipriani, A.; Fazel, S.; Sharma, M.; Baqir, W.; Bates, C.; Parry, J.; Goldacre, B.
    BACKGROUND: The COVID-19 pandemic has disrupted healthcare activity across a broad range of clinical services. The NHS stopped non-urgent work in March 2020, later recommending services be restored to near-normal levels before winter where possible. AIM: To describe changes in the volume and variation of coded clinical activity in general practice across six clinical areas: cardiovascular disease, diabetes, mental health, female and reproductive health, screening and related procedures, and processes related to medication. DESIGN AND SETTING: With the approval of NHS England, a cohort study was conducted of 23.8 million patient records in general practice, in situ using OpenSAFELY. METHOD: Common primary care activities were analysed using Clinical Terms Version 3 codes and keyword searches from January 2019 to December 2020, presenting median and deciles of code usage across practices per month. RESULTS: Substantial and widespread changes in clinical activity in primary care were identified since the onset of the COVID-19 pandemic, with generally good recovery by December 2020. A few exceptions showed poor recovery and warrant further investigation, such as mental health (for example, for 'Depression interim review' the median occurrences across practices in December 2020 was down by 41.6% compared with December 2019). CONCLUSION: Granular NHS general practice data at population-scale can be used to monitor disruptions to healthcare services and guide the development of mitigation strategies. The authors are now developing real-time monitoring dashboards for the key measures identified in this study, as well as further studies using primary care data to monitor and mitigate the indirect health impacts of COVID-19 on the NHS.
  • Item
    Differential impact of COVID-19 on mental health and burnout
    (Oxford University Press, 2023-04-01) Maniero, C.; Ng, S. M.; Collett, G.; Godec, T.; Siddiqui, I.; Antoniou, S.; Kumar, A.; Janmohamed, A.; Nair, S.; Kotecha, A.; Khan, R.; Khanji, M. Y.; Kapil, V.; Gupta, J.; Gupta, A. K.
    BACKGROUND: There may be differential impact of the COVID-19 pandemic on mental health and burnout rates of healthcare professionals (HCPs) performing different roles. AIMS: To examine mental health and burnout rates, and possible drivers for any disparities between professional roles. METHODS: In this cohort study, online surveys were distributed to HCPs in July-September 2020 (baseline) and re-sent 4 months later (follow-up; December 2020) assessing for probable major depressive disorder (MDD), generalized anxiety disorder (GAD), insomnia, mental well-being and burnout (emotional exhaustion and depersonalization). Separate logistic regression models (at both phases) compared the risk of outcomes between roles: healthcare assistants (HCAs), nurses and midwives (nurses), allied health professionals (AHPs) and doctors (reference group). Separate linear regression models were also developed relating the change in scores to professional role. RESULTS: At baseline (n = 1537), nurses had a 1.9-fold and 2.5-fold increased risk of MDD and insomnia, respectively. AHPs had a 1.7-fold and 1.4-fold increased risk of MDD and emotional exhaustion, respectively. At follow-up (n = 736), the disproportionate risk between doctors and others worsened: nurses and HCAs were at 3.7-fold and 3.6-fold increased risk of insomnia, respectively. Nurses also had a significantly increased risk of MDD, GAD, poor mental well-being and burnout. Nurses also had significantly worsened anxiety, mental well-being and burnout scores over time, relative to doctors. CONCLUSIONS: Nurses and AHPs had excess risk of adverse mental health and burnout during the pandemic, and this difference worsened over time (in nurses especially). Our findings support adoption of targeted strategies accounting for different HCP roles.