Recent Submissions

  • Determining the risk of developing symptomatic COVID-19 infection after attending hospital for radiological examinations: Controlled cohort study

    Evangelou, Nikos; Vaughan, Sian; Hibbert, Aimee; Morgan, Paul S.; Berry, Louise (2021)
    OBJECTIVE To determine whether brief attendance for outpatient radiological investigations is associated with increased risk of clinically significant coronavirus disease 2019 (covid-19) infection.DESIGN Observational cohort study with a historical control.SETTING 2 large UK University Hospitals located in Nottingham and Cardiff.PARTICIPANTS All 47,340 patients who attended an outpatient radiology appointment at Nottingham University Hospitals and University Hospital of Wales during the first wave of the pandemic in 2020, and 70,655 patients that comprised the control cohort who attended for outpatient radiology the same period in 2019.MAIN OUTCOME MEASURES The risk of developing clinically significant covid-19 infection within 28-days of attending a radiological examination. Covid-19 infection rates for the 2020 cohort were compared against a control group who attended in 2019.RESULTS 84 positive SARS-CoV-2 tests were temporally associated with 47,340 radiological examinations across two hospitals in 2020. This low infection rate was higher than the 2019 control cohort; OR 2.507 (1.766 – 3.559) and equates to an approximate 1 positive covid-19 infection per 1000 radiology investigations.CONCLUSIONS Our data suggests that attending hospitals for outpatient radiological investigations during the pandemic is associated with a very small absolute risk of acquiring clinically significant covid-19 infection. It is unlikely that this risk is directly attributable to radiology attendance, considering the reasons leading individuals to attend hospitals during the pandemic, the true attributable risk will likely be even lower.TRIAL REGISTRATION ClinicalTrials.gov NCT04544176Competing Interest StatementThe authors have declared no competing interest.Clinical TrialNCT04544176Funding StatementNo specific funding was provided for this study.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This study was approved by the Health Research Authority (20/HRA/4783) and was not reviewed by a research ethics committee as the research was limited to using previously collected, non-identifiable information.All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesData sharing: A summary of the data may be provided by application to the corresponding author at nikos.evangelou{at}nottingham.ac.uk subject to the necessary ethical and regulatory approvals by the applicant, and subject to data availability.
  • An approach for combining clinical judgment with machine learning to inform medical decision making: Analysis of nonemergency surgery strategies for acute appendicitis in patients with multiple long-term conditions

    Vohra, Ravinder (2024)
    BACKGROUND: Machine learning (ML) methods can identify complex patterns of treatment effect heterogeneity. However, before ML can help to personalize decision making, transparent approaches must be developed that draw on clinical judgment. We develop an approach that combines clinical judgment with ML to generate appropriate comparative effectiveness evidence for informing decision making. METHOD(S): We motivate this approach in evaluating the effectiveness of nonemergency surgery (NES) strategies, such as antibiotic therapy, for people with acute appendicitis who have multiple long-term conditions (MLTCs) compared with emergency surgery (ES). Our 4-stage approach 1) draws on clinical judgment about which patient characteristics and morbidities modify the relative effectiveness of NES; 2) selects additional covariates from a high-dimensional covariate space (P > 500) by applying an ML approach, least absolute shrinkage and selection operator (LASSO), to large-scale administrative data (N = 24,312); 3) generates estimates of comparative effectiveness for relevant subgroups; and 4) presents evidence in a suitable form for decision making. RESULT(S): This approach provides useful evidence for clinically relevant subgroups. We found that overall NES strategies led to increases in the mean number of days alive and out-of-hospital compared with ES, but estimates differed across subgroups, ranging from 21.2 (95% confidence interval: 1.8 to 40.5) for patients with chronic heart failure and chronic kidney disease to -10.4 (-29.8 to 9.1) for patients with cancer and hypertension. Our interactive tool for visualizing ML output allows for findings to be customized according to the specific needs of the clinical decision maker. CONCLUSION(S): This principled approach of combining clinical judgment with an ML approach can improve trust, relevance, and usefulness of the evidence generated for clinical decision making. HIGHLIGHTS: Machine learning (ML) methods have many potential applications in medical decision making, but the lack of model interpretability and usability constitutes an important barrier for the wider adoption of ML evidence in practice.We develop a 4-stage approach for integrating clinical judgment into the way an ML approach is used to estimate and report comparative effectiveness.We illustrate the approach in undertaking an evaluation of nonemergency surgery (NES) strategies for acute appendicitis in patients with multiple long-term conditions and find that NES strategies lead to better outcomes compared with emergency surgery and that the effects differ across subgroups.We develop an interactive tool for visualizing the results of this study that allows findings to be customized according to the user's preferences.
  • LAsting Symptoms after Oesophageal Resectional Surgery (LASORS): Multicentre validation cohort study

    Vohra, Ravinder (2025)
    Background: Long-term symptom burden and health-related quality-of-life outcomes after curative oesophageal cancer treatment are poorly understood. Existing tools are cumbersome and do not address the post-treatment population specifically. The aim of this study was to validate the six-symptom LASORS tool for identifying patients after curative oesophageal cancer treatment with poor health-related quality of life and to assess its clinical utility. Method(s): Between 2015 and 2019, patients from 15 UK centres who underwent curative-intent oesophageal cancer treatment, and were disease-free at least 1 year after surgery, were invited to participate in the study and complete LASORS and European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-OG25 questionnaires. Receiver operating characteristic curve analysis was used to examine the accuracy of the LASORS tool for identifying patients with poor health-related quality of life. Result(s): A total of 263 patients completed the questionnaire. Four of the six LASORS symptoms were associated with poor health-related quality of life: reduced energy (OR 2.13 (95% c.i. 1.45 to 3.13)); low mood (OR 1.86 (95% c.i. 1.20 to 2.88)); diarrhoea more than three times a day unrelated to eating (OR 1.48 (95% c.i. 1.06 to 2.07)); and bloating or cramping after eating (OR 1.35 (95% c.i. 1.03 to 1.77)). The LASORS tool showed good diagnostic accuracy with an area under the receiver operating characteristic curve of 0.858 for identifying patients with poor health-related quality of life. Conclusion(s): The six-symptom LASORS tool generated a reliable model for identification of patients with poor health-related quality of life after curative treatment for oesophageal cancer. This is the first tool of its kind to be prospectively validated in the post-esophagectomy population. Clinical utility lies in identification of patients at risk of poor health-related quality of life, ease of use of the tool, and in planning survivorship services.Copyright © 2025 The Author(s).
  • Adapting patient and public Involvement processes in response to the COVID-19 pandemic

    Vohra, Ravinder (2023)
    BACKGROUND: The COVID-19 pandemic brought rapid and major changes to research, and those wishing to carry out Patient and Public Involvement (PPI) activities faced challenges, such as restrictions on movement and contact, illness, bereavement and risks to potential participants. Some researchers moved PPI to online settings during this time but remote consultations raise, as well as address, a number of challenges. It is important to learn from PPI undertaken in this period as face-to-face consultation may no longer be the dominant method for PPI. METHOD(S): UK stay-at-home measures announced in March 2020 necessitated immediate revisions to the intended face-to-face methods of PPI consultation for the ESORT Study, which evaluated emergency surgery for patients with common acute conditions. PPI plans and methods were modified to all components being online. We describe and reflect on: initial plans and adaptation; recruitment; training and preparation; implementation, contextualisation and interpretation. Through first-hand accounts we show how the PPI processes were developed, experienced and viewed by different partners in the process. DISCUSSION AND CONCLUSION(S): While concerns have been expressed about the possible limiting effects of forgoing face-to-face contact with PPI partners, we found important benefits from the altered dynamic of the online PPI environment. There were increased opportunities for participation which might encourage the involvement of a broader demographic, and unexpected benefits in that the online platform seemed to have a 'democratising' effect on the meetings, to the benefit of the PPI processes and outcomes. Other studies may however find that their particular research context raises particular challenges for the use of online methods, especially in relation to representation and inclusion, as new barriers to participation may be raised. It is important that methodological challenges are addressed, and researchers provide detailed examples of novel methods for discussion and empirical study. PATIENT AND PUBLIC CONTRIBUTION: We report a process which involved people with lived experience of emergency conditions and members of the public. A patient member was involved in the design and implementation, and two patients with lived experience contributed to the manuscript.Copyright © 2023 The Authors. Health Expectations published by John Wiley & Sons Ltd.
  • Post-cancer treatment reflections by patients concerning the provisions and support required for a prehabilitation programme

    Beed, Martin; Lobo, Dileep N.; Vohra, Ravinder (2023)
    BACKGROUND: Evidence suggests that physical fitness interventions, mental health support and nutritional advice before surgery (prehabilitation) could reduce hospital stay and improve quality of life of patients with cancer. In this study we captured the opinions of a group of patients with cancer undergoing these interventions after treatment to discover what a prehabilitation programme should encompass. METHOD(S): Patients from the Cancer and Rehabilitation Exercise (CARE) programme based in Nottingham took part in a 26-point online questionnaire about the design of prehabilitation programmes. RESULT(S): The questionnaire was completed over a 2-week period in December 2021 by 54 patients from the CARE programme. Their responses were as follows: 44 (81.5%) participants would have participated in prehabilitation had it been available to them and 28 (51.9%) ranked physical exercise as the most important component. Forty (74.1%) participants believed the counselling aspect of prehabilitation would have contributed to a successful outcome and 35 (64.8%) thought dietary advice would have benefitted them before surgery. Thirty-one (57.4%) participants preferred the programme to take place in a fitness centre, rather than at home or hospital and 43 (79.6%) would have liked to have known about prehabilitation from their doctor at the time of diagnosis. CONCLUSION(S): Patients are interested in prehabilitation to become more physically fit and mentally prepared for surgery. They expressed the need for a focus on physical exercise, counselling to improve mental health and personalised nutritional advice. Tailoring a prehabilitation programme, with input from patients, could contribute to improving patient outcomes following cancer treatments.Copyright © 2023. The Author(s).
  • Multicenter, prospective cohort study of oesophageal injuries and related clinical outcomes (MUSOIC study)

    Vohra, Ravinder (2023)
    Objective: To identify prognostic factors associated with 90-day mortality in patients with oesophageal perforation (OP), and characterize the specific timeline from presentation to intervention, and its relation to mortality. Background(s): OP is a rare gastro-intestinal surgical emergency with a high mortality rate. However, there is no updated evidence on its outcomes in the context of centralized esophago-gastric services; updated consensus guidelines; and novel non-surgical treatment strategies. Method(s): A multi-center, prospective cohort study involving eight high-volume esophago-gastric centers (January 2016 to December 2020) was undertaken. The primary outcome measure was 90-day mortality. Secondary measures included length of hospital and ICU stay, and complications requiring re-intervention or re-admission. Mortality model training was performed using random forest, support-vector machines, and logistic regression with and without elastic net regularisation. Chronological analysis was performed by examining each patient's journey timepoint with reference to symptom onset. Result(s): The mortality rate for 369 patients included was 18.9%. Patients treated conservatively, endoscopically, surgically, or combined approaches had mortality rates of 24.1%, 23.7%, 8.7%, and 18.2%, respectively. The predictive variables for mortality were Charlson comorbidity index, haemoglobin count, leucocyte count, creatinine levels, cause of perforation, presence of cancer, hospital transfer, CT findings, whether a contrast swallow was performed, and intervention type. Stepwise interval model showed that time to diagnosis was the most significant contributor to mortality. Conclusion(s): Non-surgical strategies have better outcomes and may be preferred in selected cohorts to manage perforations. Outcomes can be significantly improved through better risk-stratification based on afore-mentioned modifiable risk factors.Copyright © 2023 Lippincott Williams and Wilkins. All rights reserved.
  • Role of staging laparoscopy on oesophageal and junctional cancer management

    Tokhi, Ashraf; Redi, Eleanor; North, Samuel; Clarke, Simone; Vohra, Ravinder; Parsons, Simon (2024)
  • A protocol to assess risk of fractures associated with use of menopausal hormone therapy: Nested case-control study using CPRD

    Masud, Tahir (2024)
    Menopausal hormone therapy (MHT) is prescribed to women with severe symptoms of menopause. Various studies have demonstrated increased bone density and decreased fracture risk in women using MHT. The randomised controlled trials were, however, run over only relatively short time periods, and there is no reliable or consistent evidence about fracture risk after MHT discontinuation. The proposed nested case-control study aims to fill this gap. We will use CPRD (GOLD and AURUM) and HES data. Every woman 40 years or over with a diagnosis of first fracture between 1998 and 2022 (a case) will be matched by age and general practice to up to 5 female controls with no previous records of fracture at the time of the case diagnosis (index date). MHT exposure will be assessed using prescriptions for the different types of MHT treatment historically available from the NHS. Conditional logistic regression will estimate fracture risk associated with duration of use and gap after discontinuation of MHT. The findings will be adjusted for smoking status, body mass index, family history of dementia, medical conditions and events, other medications and contraceptive drugs. A number of sensitivity analyses will be run to address the limitations of the study.Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license.
  • Establishing predictors of acute sarcopenia: A proof-of-concept study utilising network analysis

    Masud, Tahir (2024)
    Dynamic changes in sarcopenia status following stressor events are defined as acute sarcopenia; it is currently unknown how to stratify risk. Prospective observational study involving elective colorectal surgery, emergency abdominal surgery, and medical patients with infections aged >=70 years-old. Handgrip strength, muscle quantity (ultrasound Bilateral Anterior Thigh Thickness, BATT, and Bioelectrical Impedance Analysis), and muscle quality (rectus femoris echogenicity) were measured preoperatively in the elective group, and within 48hours, 7days after, and 13weeks after admission/surgery. Serum/plasma samples were collected preoperatively (elective group) and within 48hours of admission/surgery (all groups). LASSO models adjusting for baseline sarcopenia status were performed. Seventy-nine participants were included (mean age 79.1, 39.2% female). Chronic Obstructive Pulmonary Disease (COPD) (48hours beta 0.67, CI 0.59-0.75), and prescription of steroids during admission (48hours beta 1.11, CI 0.98-1.24) were positively associated with sarcopenia at 7days. Delirium was negatively associated with change in BATT to 7days (7days beta -0.47, CI -0.5- -0.44). COPD (Preoperative beta 0.35, CI 0.12-0.58) and delirium (48hours beta 0.13, CI 0.06-0.2) were positively associated with change in echogenicity to 7days in analysis including systemic biomarkers. Participants with sarcopenia at baseline had higher IL-7 concentrations during acute phase of illness (median 8.78pg/mL vs 6.52pg/mL; p=0.014). IL-1b within 48hours of admission/surgery was positively associated with sarcopenia status at 7days (beta 0.24, CI 0.06-0.42). Patients most at risk of acute sarcopenia or reductions in muscle quantity and quality included those prescribed steroids, with COPD or delirium, or with heightened systemic inflammation.
  • What are we teaching UK medical students about ageing? Results of the third BGS national curriculum survey

    Masud, Tahir; Blundell, Adrian; Gordon, Adam L. (2024)
    Introduction: The ageing population means all doctors, regardless of specialty, will need knowledge, skills, and attitudes to care for older people with complex health conditions. An essential component of preparing the medical workforce to best care for older people is by including teaching on ageing and geriatric medicine in undergraduate medical curricula. Here we present results of the British Geriatrics Society (BGS) national curriculum survey 2021-22, highlighting progress made in undergraduate teaching in geriatric medicine. Method(s): All 35 UK GMC-registered medical schools at the time of data collection were invited to participate in an online survey on content, methodology, timing, and duration of teaching in ageing and geriatric medicine. The survey was structured around the 2013 BGS recommended undergraduate curriculum, for consistency with previous surveys. Result(s): 30/35 of UK medical schools responded (83% response rate). Most teaching occurred in the fourth year of study (21/30, 70%).The majority (15/30, 50%) reported a discrete module for geriatric medicine lasting 4-8 weeks, an increase on previous surveys. However, several programmes have reduced the amount of in-person teaching since the COVID-19 pandemic. Notably, three schools reported geriatric medicine exposure lasting >12 weeks.Of these, two were integrated clerkships and one a dedicated geriatric medicine module. There is increasing focus on multidisciplinary education, with emphasis on combining virtual or simulated teaching with other healthcare professions (n = 7). Every school (n = 30) taught at least one topic as small-group or case-based learning. Conclusion(s): There is a trend towards increasing exposure to geriatric medicine compared to previous surveys in 2008 and 2013. However, several of the programmes reporting greater exposure incorporate geriatric medicine in an integrated clerkship rather than as a dedicated module. Programmes demonstrated a move from didactic teaching towards small-group and case-based learning, employing a wider variety of assessment methods than previous.
  • A European survey of older peoples' preferences, and perceived barriers and facilitators to inform development of a medication-related fall-prevention patient portal

    Masud, Tahir (2024)
    Purpose Falls are a major and growing health care problem in older adults. A patient portal has the potential to provide older adults with fall-prevention advice to reduce fall-risk. However, to date, the needs and preferences regarding a patient portal in older people who have experienced falls have not been explored. This study assesses content preferences, potential barriers and facilitators with regard to using a patient portal, as perceived by older people who have experienced falls, and explores regional differences between European participants. Methods We conducted a survey of older adults attending an outpatient clinic due to a fall or fall-related injury, to explore their content preferences, perceived barriers, and facilitators with respect to a fall-prevention patient portal. Older adults (N = 121, 69.4% female, mean age: 77.9) were recruited from seven European countries. Results Almost two-thirds of respondents indicated they would use a fall-prevention patient portal. The portal would preferably include information on Fall-Risk-Increasing Drugs (FRIDs), and ways to manage other related/relevant medical conditions. Facilitators included a user-friendly portal, with easily accessible information and physician recommendations to use the portal. The most-commonly-selected barriers were privacy issues and usage fees. A family member’s recommendation to use the portal was seemingly more important for Southern and Eastern European participants compared to the other regions. Conclusion The majority of older people with lived falls experience expressed an interest in a fall-prevention patient portal providing personalized treatment advice to prevent further falls. The results will be used to inform the development of a fall-prevention patient portal. The fall-prevention patient portal is intended to be used in addition to a consultation with a physician. Future research is needed to explore how to prevent falls in older patients who are not interested in a fall-prevention patient portal.
  • Whole-body vibration to improve physical function parameters in nursing home residents older than 80 years: A systematic review with meta-analysis

    Masud, Tahir (2024)
    OBJECTIVE: Loss of functional independence is more likely in older adults who reside in an institution as a consequence of a decline in muscle mass and a loss of force production capacity. The aim of this review was to assess the effect of whole-body vibration (WBV) interventions on the strength, balance, and mobility of nursing home residents older than 80 years. METHOD(S): An electronic search in MEDLINE, Scopus, and CINAHL databases was conducted. Randomized controlled trials that involved nursing home residents older than 80 years, that investigated WBV interventions compared with nonintervention, usual care, or placebo, and that measured physical function outcomes including strength, balance, gait, and mobility were included. Risk of bias was assessed by 2 reviewers using the Physiotherapy Evidence Database scale. The standardized mean differences (SMD) between the experimental and control groups were calculated with a random-effects model for each outcome, and subgroup analysis was conducted for different outcomes. RESULT(S): In total, 2864 articles were identified; of these, 14 randomized controlled trials met the inclusion criteria. The meta-analysis revealed that WBV significantly increased the lower limb muscle strength (SMD = 0.59; 95% CI = 0.16 to 1.03), mobility (SMD = 0.45; 95% CI = 0.10 to 0.81), gait score (SMD = 0.26; 95% CI = 0.01 to 0.51), balance (SMD = 0.41; 95% CI = 0.01 to 0.81), and physical performance (SMD = 1.33; 95% CI = 0.33 to 2.33). CONCLUSION(S): WBV may be an effective intervention to improve the strength, balance, mobility, walking ability, and physical performance of older nursing home residents. IMPACT: WBV presents a safe, accessible alternative for improving health in this vulnerable population, warranting further research and integration into health care practices.Copyright © The Author(s) 2024. Published by Oxford University Press on behalf of the American Physical Therapy Association.
  • Association of bradykinin receptor 2 (BDKRB2) variants with physical performance and muscle mass: Findings from the LACE sarcopenia trial

    Masud, Tahir (2024)
    Introduction Understanding genetic contributors to sarcopenia (age-related loss of muscle strength and mass) is key to finding effective therapies. Variants of the bradykinin receptor 2 (BDKRB2) have been linked to athletic and muscle performance. The rs1799722-9 and rs5810761 T alleles have been shown to be overrepresented in endurance athletes, possibly due to increased transcriptional rates of the receptor. These variants have been rarely studied in older people or people with sarcopenia. Methods We performed a post hoc sub-study of the Leucine and ACE (LACE) inhibitor trial, which enrolled 145 participants aged >=70 years with low grip strength and low gait speed. Participants' blood samples were genotyped for rs179972 using TaqMan and rs5810761 by amplification through Hotstar Taq. Genotypes were compared with outcomes of physical performance and body composition measures. Results Data from 136 individuals were included in the analysis. For rs1799722 the genotype frequency (TT: 17, CC: 48, CT: 71) remained in Hardy-Weinberg Equilibrium (HWE p = 0.248). There was no difference between the genotypes for six-Minute Walk Distance (6MWD) or Short Physical Performance Battery (SPPB). Men with the TT genotype had a significantly greater 6MWD than other genotypes (TT 400m vs CT 310m vs CC 314m, p = 0.027), and greater leg muscle mass (TT 17.59kg vs CT 15.04kg vs CC 15.65kg, p = 0.007). For rs5810761, the genotype frequency (-9-9: 31, +9+9: 43, -9+9: 60) remained in HWE (p = 0.269). The +9+9 genotype was associated with a significant change in SPPB score at 12 months (-9-9 0 vs -9+9 0 vs +9+9-1, p<0.001), suggesting an improvement. In men, the -9- 9 genotype was associated with lower arm fat (-9-9 2.39kg vs -9+9 2.72kg vs +9+9 2.76kg, p = 0.019). Conclusion In men, the rs1799722 TT genotype was associated with longer 6MWD and greater leg muscle mass, while the rs5810761 -9-9 genotype was associated with lower arm fat mass.Copyright © 2024 Shrestha et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
  • Building a pan-European network to bridge gaps in geriatric medicine education: The PROGRAMMING COST Action 21,122-a call for endorsement

    Masud, Tahir (2025)
    Background: The growing challenges of population aging create a pressing need for specialized geriatric medicine services to effectively address the complex health needs of older adults and influence supportive healthcare policies. Older patients may present clinical complexity with multimorbidity, disability, and/or frailty, necessitating a shift from the traditional organ-oriented clinical approach to a holistic, patient-centered care model. Rationale of the action: Despite recommendations from the World Health Organization and scientific and professional societies, geriatric medicine is not universally recognized as a distinct specialty in Europe, and education in this field remains heterogeneous. A notable discrepancy in the availability of geriatric services and education in this field across European countries can be found. Many healthcare professionals lack basic training in geriatric medicine, contributing to fragmented care and poorer health outcomes. To address these challenges, it is essential to integrate geriatric medicine into undergraduate and postgraduate curricula for all healthcare professionals. Expected outcomes: The COST Action 21,122 PROGRAMMING (PROmoting GeRiAtric Medicine in countries where it is still eMergING) initiative aims to promote geriatric medicine by developing targeted educational goals and programs and fostering interdisciplinary collaboration. This initiative aims to assess the current state of geriatric medicine education and identify both global and local educational needs for developing clinical skills among healthcare professionals. In addition, it seeks to establish consensus on core curricula tailored to local contexts and disseminate findings and recommendations to stakeholders, policymakers, and the public. By uniting diverse stakeholders, PROGRAMMING aspires to create sustainable changes in geriatric care across Europe.Copyright © The Author(s) 2025.
  • Promoting activity, independence, and stability in early dementia and mild cognitive impairment (PrAISED): Randomised controlled trial

    Harwood, Rowan H.; Booth, Vicky; Cowley, Alison; Kearney, Fiona; Gladman, John R. F.; Masud, Tahir (2023)
    Abstract:Objective: To determine the effectiveness of an exercise and functional activity therapy intervention in adults with early dementia or mild cognitive impairment compared with usual care., Design: Randomised controlled trial., Setting: Participants' homes and communities at five sites in the United Kingdom., Participants: 365 adults with early dementia or mild cognitive impairment who were living at home, and family members or carers., Intervention: The intervention, Promoting activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED), was a specially designed, dementia specific, rehabilitation programme focusing on strength, balance, physical activity, and performance of activities of daily living, which was tailored and progressive and addressed risk and the psychological needs of people with dementia., Up to 50 therapy sessions were provided over 12 months., The control group received usual care plus a falls risk assessment., Procedures were adapted during the covid-19 pandemic., Main Outcome Measure(s): The primary outcome was score on the carer (informant) reported disability assessment for dementia scale 12 months after randomisation., Secondary outcomes were self-reported activities of daily living, physical activity, quality of life, balance, functional mobility, fear of falling, frailty, cognition, mood, carer strain, service use at 12 months, and falls between months 4 and 15., Results: 365 patient participants were randomised, 183 to intervention and 182 to control., The median age of participants was 80 years (range 65-95), median Montreal cognitive assessment score was 20 out of 30 (range 13-26), and 58% (n=210) were men., Intervention participants received a median of 31 therapy sessions (interquartile range 22-40) and reported completing a mean 121 minutes of PrAISED exercise each week., Primary outcome data were available for 149 intervention and 141 control participants., Scores on the disability assessment for dementia scale did not differ between groups: adjusted mean difference -1.3, 95% confidence interval -5.2 to 2.6; Cohen's d effect size -0.06, 95% confidence interval -0.26 to 0.15; P=0.51)., Upper 95% confidence intervals excluded small to moderate effects on any of the range of outcome measures., Between months 4 and 15 the intervention group experienced 79 falls and the control group 200 falls (adjusted incidence rate ratio 0.78, 95% confidence interval 0.5 to 1.3; P=0.3)., Conclusion(s): The intensive PrAISED programme of exercise and functional activity training did not improve activities of daily living, physical activity, or quality of life; reduce falls; or improve any other secondary health status outcomes, despite good uptake., Future research should consider alternative approaches to maintaining ability and wellbeing in people with dementia., Trial registration: ISRCTN Registry ISRCTN15320670.,Copyright © Author(s) (or their employer(s)) 2019., Re-use permitted under CC BY., No commercial re-use., See rights and permissions., Published by BMJ.
  • Factors influencing the commissioning and implementation of health and social care interventions for people with dementia: Commissioner and stakeholder perspectives

    Gladman, John R. F.; Masud, Tahir; Harwood, Rowan H. (2024)
    Background: Despite several interventions demonstrating benefit to people living with dementia and their caregivers, few have been translated and implemented in routine clinical practice. There is limited evidence of the barriers and facilitators for commissioning and implementing health and social care interventions for people living with dementia. The aim of the current study was to explore the barriers and facilitators to commissioning and implementing health and social care interventions for people with dementia, using a dementia friendly exercise and physical activity-based intervention (PrAISED Promoting Activity, Stability and Independence in Early Dementia and Mild Cognitive Impairment]) as a case study. Method(s): Qualitative semi-structured interviews were conducted with stakeholders from a range of backgrounds including individuals from health and social care, local government, the voluntary and community sector, universities, and research centres in England. The Consolidated Framework for Intervention Research (CFIR) was used to guide the design and analysis. Result(s): Fourteen participants took part, including commissioning managers, service managers, partnership managers, charity representatives, commercial research specialists, academics/researchers, and healthcare professionals. Data were represented in 33 constructs across the five CFIR domains. Participants identified a need for greater support for people diagnosed with dementia and their caregivers immediately post dementia diagnosis. Key barriers included cost/financing, the culture of commissioning, and available resources. Key facilitators included the adaptability of the intervention, cosmopolitanism/partnerships and connections, external policy and incentives, and the use of already existing (and untapped) workforces. Conclusion(s): Several barriers and facilitators for commissioning and implementing health and social care interventions for people with dementia were identified which need to be addressed. Recommended actions to facilitate the commissioning and implementation of dementia friendly services are: 1) map out local needs, 2) evidence the intervention including effectiveness and cost-effectiveness, 3) create/utilise networks with stakeholders, and 4) plan required resources. Copyright © The Author(s) 2024.

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