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Article ; Online: Systematic literature review informing the 2022 EULAR recommendations for screening and prophylaxis of chronic and opportunistic infections in adults with autoimmune inflammatory rheumatic diseases

George E Fragoulis / Jan Schoones / Delphine Courvoisier / Elena Nikiphorou / Mrinalini Dey / James Galloway / Kimme L Hyrich / Sizheng Zhao

RMD Open, Vol 8, Iss

2022 Volume 2

Abstract: Objective To conduct a systematic literature review (SLR) on the screening and prophylaxis of opportunistic and chronic infections in autoimmune inflammatory rheumatic diseases (AIIRD).Methods SLR (inception-12/2021) based on the following search domains: ...

Abstract	Objective To conduct a systematic literature review (SLR) on the screening and prophylaxis of opportunistic and chronic infections in autoimmune inflammatory rheumatic diseases (AIIRD).Methods SLR (inception-12/2021) based on the following search domains: (1) infectious agents, (2) AIIRD, (3) immunosuppressives/immunomodulators used in rheumatology, (4) screening terms and (5) prophylaxis terms. Articles were retrieved having the terms from (1) AND (2) AND (3) plus terms from (4) OR(5). Databases searched: PubMed, Embase and Cochrane Library. Exclusion criteria: studies on postoperative infections, paediatric AIIRD, COVID-19, vaccinations and non-Εnglish literature. Study quality was assessed with Newcastle-Ottawa scale for non-randomised controlled trials (RCTs), RoB-Cochrane for RCTs, AMSTAR2 for SLRs.Results From 5641 studies were retrieved, 568 full-text articles were assessed for eligibility, with 194 articles finally included. For tuberculosis, tuberculin skin test (TST) is affected by treatment with glucocorticoids and conventional synthetic disease modifying anti-rheumatic drugs (DMARDs) and its performance is inferior to interferon gamma release assay (IGRA). Agreement between TST and IGRA is moderate to low. For hepatitis B virus (HBV): risk of reactivation is increased in patients positive for hepatitis B surface antigen. Anti-HBcore positive patients are at low risk for reactivation but should be monitored periodically with liver function tests and/or HBV-viral load. Risk for Hepatitis C reactivation is existing but low in patients treated with biological DMARDs. For Pneumocystis jirovecii, prophylaxis treatment should be considered in patients treated with prednisolone ≥15–30 mg/day for >2–4 weeks.Conclusions Different screening and prophylaxis approaches are described in the literature, partly determined by individual patient and disease characteristics.
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2022-11-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Infection profile of immune-modulatory drugs used in autoimmune diseases

Catherine Smith / Andrew Cope / Elena Nikiphorou / Mrinalini Dey / James Galloway / Kimme L Hyrich / Katie Bechman / Sizheng Zhao

RMD Open, Vol 8, Iss

analysis of summary of product characteristic data

2022 Volume 2

Abstract: Objective Serious infection remains a concern when prescribing immune-modulatory drugs for immune-mediated inflammatory diseases. The ‘summary of product characteristics’ (SmPCs) provide information on adverse events for example, infections, from ... ...

Abstract	Objective Serious infection remains a concern when prescribing immune-modulatory drugs for immune-mediated inflammatory diseases. The ‘summary of product characteristics’ (SmPCs) provide information on adverse events for example, infections, from clinical trials and postmarketing pharmacovigilance.This review aimed to compare infection frequency, site and type across immune-modulatory drugs, reported in SmPCs.Methods The Electronic Medicines Compendium was searched for commonly prescribed immune-modulatory drugs used for: rheumatoid arthritis, spondyloarthritis, connective tissue disease, autoimmune vasculitis, autoinflammatory syndromes, inflammatory bowel disease, psoriasis, multiple sclerosis and/or other rarer conditions.Information was extracted on infection frequency, site and organisms. Frequency was recorded as per the SmPCs: very common (≥1/10); common (≥1/100 to<1/10); uncommon (≥1/1,000 to<1/100); rare (≥1/10,000 to<1/1,000); very rare (<1/10 000).Results 39 drugs were included, across 20 indications: 9 conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), 6 targeted synthetic DMARDs, 24 biologic (b)DMARDs.Twelve infection sites were recorded. Minimal/no site information was available for most csDMARDs, certolizumab pegol and rituximab. Upper respiratory tract was the most common site, especially with bDMARDs. Lower respiratory, ear/nose/throat and urinary tract infections were moderately common, with clustering within drug groups.Data for 27 pathogens were recorded, majority viruses, with herpes simplex and zoster and influenza most frequent. Variable/absent reporting was noted for opportunistic and certain high-prevalence infections for example, Epstein-Barr.Conclusion Our findings show differences between drugs and can aid treatment decisions alongside real-world safety data. However, data are likely skewed by trial selection criteria and varying number of trials per drug and highlight the need for robust postmarketing pharmacovigilance.
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2022-11-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Stream geochemical response to reductions in acid deposition in headwater streams: Chronic versus episodic acidification recovery

Riscassi, Ami / James Galloway / Todd Scanlon

Hydrological processes. 2019 Feb. 15, v. 33, no. 4

2019

Abstract: In the decades since dramatic reductions in acid emissions and subsequent deposition in North America and Europe, the vast majority of research on aquatic chemical recovery has focused on trends in acid–base concentrations during baseflow conditions. ... ...

Abstract	In the decades since dramatic reductions in acid emissions and subsequent deposition in North America and Europe, the vast majority of research on aquatic chemical recovery has focused on trends in acid–base concentrations during baseflow conditions. Missing from such assessments is consideration of higher flow periods, when flow paths and chemical concentrations change and episodic acidification may occur. Stream samples collected weekly and bi‐hourly during high‐flow storm events from 1992 to 2015 at three watersheds representing a gradient in response to acid deposition in the south‐eastern United States were used to evaluate temporal trends in acid anions, base cations, acid neutralizing capacity (ANC), and pH for each of five distinct flow exceedance regimes, as well as trends in concentration–discharge (C–Q) relationships. For the most well‐buffered watershed (mean ANC = 220 μeq L−1), ANC and pH increased at a similar rate for baseflow and storm flow conditions. Decreases in sulfate controlled ANC trends at higher flows, whereas smaller sulfate decreases in combination with base cation increases resulted in similar ANC improvements for low‐flow periods. For the most acid sensitive watershed (mean ANC = 10 μeq L−1), no trends in ANC or pH were observed for the lowest flows (>90% flow exceedance), whereas reductions in sulfate resulted in significant increases in ANC during higher flow conditions. At all sites, greater rates of sulfate decline during high‐flow, as compared with low‐flow, conditions are likely a result of a reduced capacity of near surface soils to adsorb and retain sulfur in these non‐glaciated watersheds. Overall, consistent increases in pH (~0.01–0.02 pH units year−1) during higher flow conditions (<10% flow exceedance) in contrast to the variable trends observed during lower flows (>50% flow exceedance) illustrate that episodic acidification is recovering at an equal or greater rate than chronic acidification in these watersheds.
Keywords	acid deposition ; acidification ; anions ; base flow ; cations ; chemical bases ; emissions ; neutralization ; pH ; soil ; storms ; streams ; sulfates ; sulfur ; watersheds ; Europe ; Southeastern United States
Language	English
Dates of publication	2019-0215
Size	p. 512-526.
Publishing place	John Wiley & Sons, Ltd
Document type	Article
Note	JOURNAL ARTICLE
ZDB-ID	1479953-4
ISSN	1099-1085 ; 0885-6087
ISSN (online)	1099-1085
ISSN	0885-6087
DOI	10.1002/hyp.13349
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Risk of venous thromboembolism in immune-mediated inflammatory diseases

Peter Irving / Kaivan Khavandi / James Galloway / Kevin Barrett / Monica Nijher / Ruth Nicholson

RMD Open, Vol 6, Iss

a UK matched cohort study

2020 Volume 3

Abstract: Objectives To describe the risk of venous thromboembolism (VTE), and risk factors for VTE, in people with immune-mediated inflammatory diseases (IMID) (ulcerative colitis, Crohn’s disease (CD), rheumatoid arthritis (RA) and psoriatic arthritis (PsA)), ... ...

Abstract	Objectives To describe the risk of venous thromboembolism (VTE), and risk factors for VTE, in people with immune-mediated inflammatory diseases (IMID) (ulcerative colitis, Crohn’s disease (CD), rheumatoid arthritis (RA) and psoriatic arthritis (PsA)), compared with a matched control population.Methods A total of 53 378 people with an IMID were identified over 1999–2019 in the UK Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) primary care database and were matched to 213 512 people without an IMID. The association between the presence of any IMID, and each IMID separately, and risk of VTE was estimated using unadjusted and multivariable-adjusted Cox proportional hazards models. The prevalence of VTE risk factors, and associations between VTE risk factors and risk of VTE, were estimated in people with and without an IMID.Results People with an IMID were at increased risk of VTE (adjusted HR [aHR] 1.46, 95% CI 1.36,1.56), compared with matched controls. When assessing individual diseases, risk was increased for CD (aHR 1.74, 95% CI 1.45 to 2.08), ulcerative colitis (aHR 1.27, 95% CI 1.10 to 1.45) and RA (aHR 1.54, 95% CI 1.40 to 1.70) but there was no evidence of an association for PsA (aHR 1.21, 95% CI 0.96 to 1.52). In people with an IMID, independent risk factors for VTE included male sex, overweight/obese body mass index, current smoking, history of fracture, and, across study follow-up, abnormal platelet count.Conclusions VTE risk is increased in people with IMIDs. Routinely available clinical information may be helpful to identify individuals with an IMID at increased future risk of VTE.Observational study registration number Clinicaltrials.gov (NCT03835780).
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2020-11-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The evidence for biologic immunotherapy in Sarcoidosis

Pooja Shah / Katie Bechman / James Galloway

Australasian Medical Journal , Vol 10, Iss 9, Pp 829-

A systematic review

2017 Volume 837

Abstract: Background Sarcoidosis is a chronic inflammatory disease with a myriad of clinical manifestations. Treatment involves immunosuppression with corticosteroids or steroid-sparing agents. A proportion of patients does not respond to or are intolerant to ... ...

Abstract	Background Sarcoidosis is a chronic inflammatory disease with a myriad of clinical manifestations. Treatment involves immunosuppression with corticosteroids or steroid-sparing agents. A proportion of patients does not respond to or are intolerant to therapy. Targeted immunotherapy with biologic agents has emerged as a novel approach with plausible mechanistic reasons to warrant study. Aims The aim of this review was to evaluate the evidence for the efficacy of biological therapy in sarcoidosis. Methods We conducted a systematic literature review and meta-analysis of all published randomised-controlled trials (RCT) evaluating biological therapy in sarcoidosis, using MEDLINE and Embase databases, through to September 2017. The search terms included sarcoidosis, infliximab, adalimumab, etanercept, golimumab, certolizumab, rituximab, abatacept, tocilizumab, anakinra, ustekinumab, secukinumab. Only articles reporting RCTs were selected. Improvements in respiratory disease were assessed by changes in forced vital capacity (FVC) by weighted mean difference (WMD). There were insufficient data on outcome measures in other organ systems to comparatively assess efficacy. Results The search identified 2,324 studies of which only 5 provided relevant and original data. This comprised a total of 364 patients, evaluating pulmonary, cutaneous and ocular sarcoidosis. One study in pulmonary disease and one study in cutaneous disease demonstrated improvements in the primary outcome. In pulmonary disease, meta-analysis of the treatment effect of anti-TNF therapy versus placebo on FVC revealed a WMD of 1.69 per cent (95 per cent confidence interval, 1.44–1.94). Conclusion There are insufficient data to suggest the long-term efficacy of anti-TNFα inhibitors in the treatment of sarcoidosis. This may be due to heterogeneity, small sample sizes and the lack of consistent reporting of outcome measures.
Keywords	Sarcoidosis ; TNF inhibition ; biological therapy ; systematic review ; meta-analysis ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2017-09-01T00:00:00Z
Publisher	Australasian Medical Journal pty ltd.
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Points to consider for cost-effective use of biological and targeted synthetic DMARDs in inflammatory rheumatic diseases

Daniel Aletaha / Katerina Chatzidionysiou / Alfons A den Broeder / Paco M J Welsing / Rieke Alten / Bart van den Bemt / Denis Mulleman / James Galloway / John Isaac / P Verschueren / Arnold G Vulto / Céleste J T van der Togt / Lise Verhoef

RMD Open, Vol 9, Iss

results from an umbrella review and international Delphi study

2023 Volume 1

Abstract: Objectives To develop evidence-based points to consider for cost-effective use of biological and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in the treatment of inflammatory rheumatic diseases, specifically rheumatoid arthritis, ...

Abstract	Objectives To develop evidence-based points to consider for cost-effective use of biological and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in the treatment of inflammatory rheumatic diseases, specifically rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis.Methods Following EULAR procedures, an international task force was formed, consisting of 13 experts in rheumatology, epidemiology and pharmacology from seven European countries. Twelve strategies for cost-effective use of b/tsDMARDs were identified through individual and group discussion. For each strategy, PubMed and Embase were systematically searched for relevant English-language systematic reviews and, for six strategies, additionally for randomised controlled trials (RCTs). Thirty systematic reviews and 21 RCTs were included. Based on the evidence, a set of overarching principles and points to consider was formulated by the task force using a Delphi procedure. Level of evidence (1a–5) and grade (A–D) were determined for each point to consider. Individual voting on the level of agreement (LoA; between 0 (completely disagree) and 10 (completely agree)) was performed anonymously.Results The task force agreed on five overarching principles. For 10 of 12 strategies, the evidence was sufficient to formulate one or more points to consider, leading to 20 in total, regarding response prediction, drug formulary use, biosimilars, loading doses, low-dose initial therapy, concomitant conventional synthetic DMARD use, route of administration, medication adherence, disease activity–guided dose optimisation and non-medical drug switching. Ten points to consider (50%) were supported by level 1 or 2 evidence. The mean LoA (SD) varied between 7.9 (1.2) and 9.8 (0.4).Conclusion These points to consider can be used in rheumatology practices and complement inflammatory rheumatic disease treatment guidelines to incorporate cost-effectiveness in b/tsDMARD treatment.
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2023-03-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The HAVEN study—hydroxychloroquine in ANCA vasculitis evaluation—a multicentre, randomised, double-blind, placebo-controlled trial

Annastazia E. Learoyd / Lauren Arnold / Fiona Reid / Nicholas Beckley-Hoelscher / Alina Casian / Shirish Sangle / Neil Morton / Louise Nel / Angela Cape / Susan John / Sangmi Kim / Dharshene Shivapatham / Raashid Luqmani / David Jayne / James Galloway / Abdel Douiri / David D’Cruz / on behalf of the HAVEN study group

Trials, Vol 24, Iss 1, Pp 1-

study protocol and statistical analysis plan

2023 Volume 14

Abstract: Abstract Background Patients with non-severe ANCA-associated vasculitis (AAV) are often prescribed immunosuppressive medications that are associated with severe side effects and a reduced quality of life. There is an unmet need for safer effective ... ...

Abstract	Abstract Background Patients with non-severe ANCA-associated vasculitis (AAV) are often prescribed immunosuppressive medications that are associated with severe side effects and a reduced quality of life. There is an unmet need for safer effective treatments for these patients. Hydroxychloroquine is being explored due to its effect in similar autoimmune conditions such as systemic lupus erythematosus. Methods Double-blind, placebo-controlled multicentre trial recruiting 76 patients across 20 sites. Participants will be randomised 1:1 to hydroxychloroquine or placebo in addition to standard of care immunosuppressive therapies over the course of 52 weeks. A phase II selection design will be used to determine hdroxychloroquine’s efficacy, using prednisolone dosage and Birmingham Vasculitis Activity Score as a measure of disease activity. Secondary outcomes will explore other elements of AAV progression, including disease flares and time to remission. Discussion This trial aims to explore Hydroxychloroquine as a treatment for patients with AAV. If effective, the need for immunosuppressive treatments such as prednisolone could be reduced. Hydroxychloroquine is safer, cheaper and has fewer adverse effects than conventional immunosuppressive treatments. This could improve patient outcomes while saving money for the NHS. Trial registration ISRCTN: ISRCTN79334891. Registered 07 June 2021. EudraCT: 2018-001268-40. Registered 13 September 2019. Clinicaltrials.gov: NCT04316494. Registered 20 March 2020.
Keywords	Hydroxychloroquine ; AAV ; Auto-immune conditions ; ANCA ; Vasculitis ; Prednisolone ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2023-04-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Repurposed immunomodulatory drugs for Covid-19 in pre-ICu patients - mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 – Repurposed Drugs (TACTIC-R)

Spoorthy Kulkarni / Marie Fisk / Michalis Kostapanos / Edward Banham-Hall / Simon Bond / Elena Hernan-Sancho / Sam Norton / Joseph Cheriyan / Andrew Cope / James Galloway / Frances Hall / David Jayne / Ian B. Wilkinson

Trials, Vol 21, Iss 1, Pp 1-

A structured summary of a study protocol for a randomised controlled trial

2020 Volume 3

Abstract: Abstract Objectives To determine if a specific immunomodulatory intervention reduces progression of COVID-19-related disease to organ failure or death, compared to standard of care (SoC). Trial design Randomised, parallel 3-arm (1:1:1 ratio), open-label, ...

Abstract	Abstract Objectives To determine if a specific immunomodulatory intervention reduces progression of COVID-19-related disease to organ failure or death, compared to standard of care (SoC). Trial design Randomised, parallel 3-arm (1:1:1 ratio), open-label, Phase IV platform trial of immunomodulatory therapies in patients with late stage 1 or stage 2 COVID-19-related disease, with a diagnosis based either on a positive assay or high suspicion of COVID-19 infection by clinical and/or radiological assessment. Participants Patients aged 18 and over, with a clinical picture strongly suggestive of COVID-19-related disease (with/without a positive COVID-19 test) AND a Risk count (as defined below) >3 OR ≥3 if risk count includes “Radiographic severity score >3”. A risk count is calculated by the following features on admission (1 point for each): radiographic severity score >3, male gender, non-white ethnicity, diabetes, hypertension, neutrophils >8.0 x109/L, age >40 years and CRP >40 mg/L. Patients should be considered an appropriate subject for intervention with immunomodulatory therapies in the opinion of the investigator and be able to be maintained on venous thromboembolism prophylaxis during the inpatient dosing period, according to local guidelines. The complete inclusion and exclusion criteria as detailed in the additional file 1 should be fulfilled. Patients will be enrolled prior to the need for invasive mechanical ventilation, cardiac or renal support. Participants will be recruited across multiple centres including initially at Cambridge University Hospitals NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, Guy’s and St Thomas’ NHS Foundation Trust, University Hospital of Wales, Gloucestershire Royal Hospitals NHS Foundation Trust and The Royal Wolverhampton NHS Trust. Intervention and comparator Each active comparator arm will be compared against standard of care (SoC). The immunomodulatory drugs were selected from a panel of licenced candidates by a drug evaluation ...
Keywords	COVID-19 ; Randomised controlled trial ; Protocol ; Baricitinib ; Ravulizumab ; Open-label ; Medicine (General) ; R5-920 ; covid19
Subject code	610
Language	English
Publishing date	2020-07-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: muLTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19-Experimental drugs and mechanisms (TACTIC-E)

Ing Ni Lu / Spoorthy Kulkarni / Marie Fisk / Michalis Kostapanos / Edward Banham-Hall / Sonakshi Kadyan / Simon Bond / Sam Norton / Andrew Cope / James Galloway / Frances Hall / David Jayne / Ian B. Wilkinson / Joseph Cheriyan

Trials, Vol 21, Iss 1, Pp 1-

A structured summary of a study protocol for a randomized controlled trial

2020 Volume 3

Abstract: Abstract Objectives To determine if a specific intervention reduces the composite of progression of patients with COVID-19-related disease to organ failure or death as measured by time to incidence of any one of the following: death, invasive mechanical ... ...

Abstract	Abstract Objectives To determine if a specific intervention reduces the composite of progression of patients with COVID-19-related disease to organ failure or death as measured by time to incidence of any one of the following: death, invasive mechanical ventilation, ECMO, cardiovascular organ support (inotropes or balloon pump), or renal failure (estimated Cockcroft Gault creatinine clearance <15ml/min). Trial design Randomised, parallel arm, open-label, adaptive platform Phase 2/3 trial of potential disease modifying therapies in patients with late stage 1/stage 2 COVID-19-related disease, with a diagnosis based either on a positive assay or high suspicion of COVID-19 infection by clinical, laboratory and radiological assessment. Participants Patients aged 18 and over, with a clinical picture strongly suggestive of COVID-19-related disease (with/without a positive COVID-19 test) AND a risk count (as defined below) >3 OR ≥3 if risk count includes “Radiographic severity score >3”. A risk count is calculated by the following features on admission (1 point for each): radiographic severity score >3, male gender, non-white ethnicity, diabetes, hypertension, neutrophils >8.0 x109/L, age >40 years and CRP >40 mg/L. Patients should be considered an appropriate subject for intervention with immunomodulatory or other disease modifying agents in the opinion of the investigator and are able to swallow capsules or tablets. The complete inclusion and exclusion criteria as detailed in the Additional file 1 should be fulfilled. Drug specific inclusion and exclusion criteria will also be applied to the active arms. Patients will be enrolled prior to the need for invasive mechanical ventilation, cardiac or renal support. Participants will be recruited across multiple centres in the UK including initially at Cambridge University Hospitals NHS Foundation Trust and St George’s University NHS Foundation Trust. Other centres will be approached internationally in view of the evolving pandemic. Intervention and ...
Keywords	COVID-19 ; Randomised controlled trial ; Protocol ; Open-label ; Adaptive trial ; EDP1815 ; Medicine (General) ; R5-920 ; covid19
Subject code	610
Language	English
Publishing date	2020-07-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Understanding health-care outcomes of older people with cognitive impairment and/or dementia admitted to hospital

Emma Reynish / Simona Hapca / Rebecca Walesby / Angela Pusram / Feifei Bu / Jennifer K Burton / Vera Cvoro / James Galloway / Henriette Ebbesen Laidlaw / Marion Latimer / Siobhan McDermott / Alasdair C Rutherford / Gordon Wilcock / Peter Donnan / Bruce Guthrie

Health Services and Delivery Research, Vol 9, Iss

a mixed-methods study

2021 Volume 8

Abstract: Background: Cognitive impairment is common in older people admitted to hospital, but previous research has focused on single conditions. Objective: This project sits in phase 0/1 of the Medical Research Council Framework for the Development and ... ...

Abstract	Background: Cognitive impairment is common in older people admitted to hospital, but previous research has focused on single conditions. Objective: This project sits in phase 0/1 of the Medical Research Council Framework for the Development and Evaluation of Complex Interventions. It aims to develop an understanding of current health-care outcomes. This will be used in the future development of a multidomain intervention for people with confusion (dementia and cognitive impairment) in general hospitals. The research was conducted from January 2015 to June 2018 and used data from people admitted between 2012 and 2013. Design: For the review of outcomes, the systematic review identified peer-reviewed quantitative epidemiology measuring prevalence and associations with outcomes. Screening for duplication and relevance was followed by full-text review, quality assessment and a narrative review (141 papers). A survey sought opinion on the key outcomes for people with dementia and/or confusion and their carers in the acute hospital (n = 78). For the analysis of outcomes including cost, the prospective cohort study was in a medical admissions unit in an acute hospital in one Scottish health board covering 10% of the Scottish population. The participants (n = 6724) were older people (aged ≥ 65 years) with or without a cognitive spectrum disorder who were admitted as medical emergencies between January 2012 and December 2013 and who underwent a structured nurse assessment. ‘Cognitive spectrum disorder’ was defined as any combination of delirium, known dementia or an Abbreviated Mental Test score of < 8 out of 10 points. The main outcome measures were living at home 30 days after discharge, mortality within 2 years of admission, length of stay, re-admission within 2 years of admission and cost. Data sources: Scottish Morbidity Records 01 was linked to the Older Persons Routine Acute Assessment data set. Results: In the systematic review, methodological heterogeneity, especially concerning diagnostic criteria, means ...
Keywords	dementia ; delirium ; cognitive impairment ; length of stay ; mortality ; readmission ; cost ; cognitive spectrum disorder ; Public aspects of medicine ; RA1-1270 ; Medicine (General) ; R5-920
Subject code	150
Language	English
Publishing date	2021-04-01T00:00:00Z
Publisher	National Institute for Health Research
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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