POS1177 REVAMPING BIOLOGIC THERAPY DURING COVID-19

Background:The COVID-19 pandemic has caught us all by surprise – from governments to individuals; the medical fraternity being no exception. It has affected all walks of life; with its immense contagiosity, diverse and intriguing pathogenesis and manifestations differing from other viruses. It has indeed left humanity in dark, unchartered waters; particularly in the early months of the pandemic.Objectives:This article shares the experience, in a Rheumatology department in a District General Hospital (DGH) in the United Kingdom, of managing patients on Biologic (b) and Targeted Synthetic (ts) DMARDs, in the midst of the COVID-19 Pandemic.Methods:All Rheumatology patients at the Princess Alexandra Hospital (PAH) in Harlow newly started on a biologic or targeted synthetic DMARD between 3rd July and 3rd Oct 2020 were identified. These patients had active inflammatory arthritis. Each patient was discussed in a dedicated Multi-Disciplinary Team (MDT) meeting and a consensus on treatment reached in-line with local and National guidelines.Figure 1.A slide presented at the Essex Rheumatology Association (ERA) meeting explaining the process adopted at the Rheumatology Department at Harlow during the peak of COVID-19 pandemic with new b/ts DMARD patients.Results:Of the 50 patients identified; 39 had Rheumatoid Arthritis, 6 had Ankylosing Spondylitis and 5 had Psoriatic Arthritis. Of these 50 patients, 5 patients decided against treatment during the stage of ‘Enhanced Verbal Consent’. These patients were flaring recurrently and were in regular contact with the department. However, they were afraid to start new Biologic treatment because of the risks of Covid-19. The breakdown of the biologic agents used in the remaining 45 patients were as follows: Adalimumab:11, Rituximab: 10, Etanercept: 9, Tofacitinib: 11, Tocilizumab SC: 3, Tocilizumab IV: 1, Sarilumab: 2, Secukinumab: 1, Infliximab: 1, Baricitinib: 1, Apremilast: 1Figure 2.Breakdown of the various b/ts DMARD agents newly started in the 45 patients between 3/7/20 - 3/10/20 at PA Hospital, Harlow, UKConclusion:The over-riding principle that guided the Department during the COVID crisis was: primum non nocere (first, do no harm). The adherence to the Case Based Discussions (CBDs) positively impacted on decision making, ensuring safe initiation of Biologic DMARDs even during the height of the pandemic. This is vital to achieve early disease remission. The MDT meetings comprising Doctors, Specialist Pharmacist and Nurse Specialists ensured prompt risk stratification of individual patients. It gave patients the opportunity to be part of the decision-making - evident in the five of the fifty patients, who opted to defer the start date of their treatments. The choice of the new Biologic agent was based on the latest National COVID-19 guidelines. The agents with the shortest half-life were selected. Moreover, patients for Rituximab were given one pulsed infusion, as opposed to two infusions. Only one of the 45 patients started on a Biologic agent over this period, either was tested positive or had symptoms suggestive of COVID-19.References:[1]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7261974[2]https://rmdopen.bmj.com/content/6/2/e001314[3]https://www.nejm.org/doi/full/10.1056/nejmc2009567[4]https://www.jrheum.org/content/early/2020/05/13/jrheum.200527[5]https://www.uptodate.com/contents/coronavirus-disease-2019-covid-19-care-of-adult-patients-with-systemic-rheumatic-disease[6]www.england.nhs.uk/clinical-guide-rheumatology-patients-v1-19-march-2020.pdf[7]https://www.rheumatology.org.uk/practice-quality/covid-19-guidance[8]https://www.nice.org.uk/guidance/ng167/chapter/4-Treatment-considerations[9]https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/decision-making-and-consentAcknowledgements:We acknowledge the whole Rheumatology Dept at Harlow for their sincere team work during the COVID-19 pandemic – Sabaa Naz (Rheumatology Pharmacist), Mona Kamal Zou (Biologics Nurse Specialist), Lily Robinson (DMARD Nurse Specialist), Mary Surendran (Osteoporosis Nurse Specialist), Janet Bell (Secretary to Dr Ahmed) and Claire Stroud (Secretary to Dr Farrow).Disclosure of Interests:None declared.

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P731 Biologics use in elderly patients with IBD: Experience in a UK secondary care setting

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.859 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S588-S588

Author(s):

C Alexakis ◽

J Robinson ◽

R Yeates ◽

N Ho-Yen ◽

S Mathew ◽

...

Keyword(s):

Biologic Therapy ◽

Treatment Time ◽

District General Hospital ◽

Ageing Population ◽

Biologic Treatment ◽

Start Date ◽

Morbidity Index ◽

Clinical Records ◽

Infective Complications

Abstract Background The combination of an ageing population coupled with a rising incidence in inflammatory bowel disease (IBD) will undoubtedly result in increased use of biologic agents in older patients with IBD, yet long-term data on the use of these drugs in this population remains scarce. We describe our experience of biologic treatment in IBD patients aged 60 years or greater at a UK district general hospital. Methods This was a retrospective descriptive study performed at Royal Surrey NHS Foundation Trust which serves a population of 300,000 people. IBD patients on biologic therapy are all registered on a prospectively collated database. Patients were included in this study if their biologic start date was on or after their 60th birthday. Each patient had their clinical records assessed and the following baseline data were recorded: sex, IBD subtype, concurrent medication use, relevant medical history and co-morbid status (using the Charleston Morbidity Index (CMI)), age at biologic start date and biologic subtype. Patients were followed up from biologic start date to biologic end date, death or end of study period (01.07.2019). Kaplan Meier analysis was used to generate biologic survival or ‘persistence’. During follow-up, we recorded the incidence of both infective and non-infective complications, and the incidents of both IBD surgery and malignancy. Results Of 220 patients on biologic therapy, 19 (8.7%) were aged ≥60 years at initiation, of whom 18 had data included in the analysis including 431 patient-months of follow-up. 78% were male. Half of patients had Crohn’s disease. Median CMI was 4. Only 1 patient had a history of malignancy prior to biologic initiation. Mean age at biologic initiation was 69 years. 72% of patients were on concurrent immune suppression medication. Most patients (72%) were commenced on Infliximab (Adalimumab 17%, Vedolizumab 11%). Median biologic treatment time was 17 months. The 6, 12 and 24 month biologic persistence rates were 78%, 67% and 28% respectively. 22% of patients were subsequently treated with a second biologic. 17% required surgery despite biologic use. Over half (56%) of patients suffered a complication post first biologic initiation, the most frequent being infection which affected 44% of patients during follow-up. Where recorded or available, 41% of patients developed antibodies to biologic, with a mean time of 11.4 months treatment. There were no recorded malignancies in any patient following biologic initiation. Conclusion Just under one in 10 of our biologic cohort is above the age of 60 on commencement of therapy. Despite a heavy burden of infective complications, there is reasonable biologic persistence in this group, and importantly a negligible malignancy risk following treatment initiation.

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Ethical Guidance for Hard Decisions: A Critical Review of Early International COVID-19 ICU Triage Guidelines

Health Care Analysis ◽

10.1007/s10728-021-00442-0 ◽

2021 ◽

Author(s):

Yves Saint James Aquino ◽

Wendy A. Rogers ◽

Jackie Leach Scully ◽

Farah Magrabi ◽

Stacy M. Carter

Keyword(s):

Decision Making ◽

Critical Care ◽

Development Process ◽

National Guidelines ◽

Scarce Resources ◽

Medical Need ◽

Ethical Guidance ◽

Pluralistic Approach ◽

Procedural Values ◽

Allocation Decisions

AbstractThis article provides a critical comparative analysis of the substantive and procedural values and ethical concepts articulated in guidelines for allocating scarce resources in the COVID-19 pandemic. We identified 21 local and national guidelines written in English, Spanish, German and French; applicable to specific and identifiable jurisdictions; and providing guidance to clinicians for decision making when allocating critical care resources during the COVID-19 pandemic. US guidelines were not included, as these had recently been reviewed elsewhere. Information was extracted from each guideline on: 1) the development process; 2) the presence and nature of ethical, medical and social criteria for allocating critical care resources; and 3) the membership of and decision-making procedure of any triage committees. Results of our analysis show the majority appealed primarily to consequentialist reasoning in making allocation decisions, tempered by a largely pluralistic approach to other substantive and procedural values and ethical concepts. Medical and social criteria included medical need, co-morbidities, prognosis, age, disability and other factors, with a focus on seemingly objective medical criteria. There was little or no guidance on how to reconcile competing criteria, and little attention to internal contradictions within individual guidelines. Our analysis reveals the challenges in developing sound ethical guidance for allocating scarce medical resources, highlighting problems in operationalising ethical concepts and principles, divergence between guidelines, unresolved contradictions within the same guideline, and use of naïve objectivism in employing widely used medical criteria for allocating ICU resources.

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307 Improving Compliance with Standard of Care Guidelines for Suspected Cauda Equina Syndrome Across A District General Hospital Network

British Journal of Surgery ◽

10.1093/bjs/znab134.400 ◽

2021 ◽

Vol 108 (Supplement_2) ◽

Author(s):

D Richardson ◽

F Greenway ◽

A Mostofi ◽

E Pereira

Keyword(s):

Cauda Equina Syndrome ◽

Guideline Implementation ◽

Cauda Equina ◽

Clinical Information ◽

Standard Of Care ◽

District General Hospital ◽

Service Improvement ◽

Local Policy ◽

National Guidelines ◽

Care Guidelines

Abstract Introduction Cauda equina syndrome (CES) is a spinal emergency that cannot be reliably detected through clinical examination alone and as a result requires prompt MR imaging to provide a diagnosis. This audit examined compliance to standard of care following service improvements in line with the updated SBNS/BASS national guidelines for CES. Method A retrospective analysis of 200 patients referred to neurosurgery for suspected CES: 100 pre- and 100 post-service improvement SBNS guideline implementation. The online neurosurgical database was reviewed, cases assessed for completeness of referral information (including appropriate exam and pre-referral MRI) with patient demographics, referring hospital and outcome also recorded. Results Prior to the SBNS guidelines only 19 patients received MRI prior to referral, 70% of all referrals were incomplete or contained erroneous clinical information. Post-service improvements there was a 68% increase of pre-referral MRI (32 cases), and an improvement in quality of clinical information with only 19% of referrals providing insufficient or unreliable information. Conclusions Through relatively simple changes to local policy, patient care flow and education of emergency department clinicians we have significantly improved pre-referral MRI rates as well as overall referral quality across the whole DGH network.

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Understanding patient journey in ulcerative colitis prior to biologic initiation: a 5-year exploration

BMC Gastroenterology ◽

10.1186/s12876-021-01708-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Yiting Wang ◽

Rupa Makadia ◽

Christopher Knoll ◽

Jill Hardin ◽

Erica A. Voss ◽

...

Keyword(s):

Ulcerative Colitis ◽

Health Care ◽

Health Care Utilization ◽

Corticosteroid Treatment ◽

Biologic Agent ◽

Care Utilization ◽

Biologic Treatment ◽

Patient Journey ◽

Care Experience ◽

Oral Corticosteroids

Abstract Background There has been a more pronounced shift toward earlier, more aggressive therapies in Crohn’s disease than in ulcerative colitis (UC). The aim of this study was to describe the pre-biologic treatment and health care experience, including co-morbidities and overall health care utilization, for UC patients who initiated biologic therapies, in the 5 years prior to the initiation of the first biologic agent. Methods UC patients who initiated a biologic agent approved for UC between 9/15/2005 and 1/30/2018 were identified from the IBM® MarketScan® Commercial Database, a large US database. The date of the first recorded UC biologic exposure was defined as the index date, and ≥ 5 years of pre-index records were required to evaluate patients’ treatment, disease progression and overall health care utilization prior to initiating biologic agents. Results Among the 1891 eligible patients, treatment with oral corticosteroids, 5-aminosalicylates, and other non-biologic immunomodulators, all increased progressively across the 5 years prior to the index. From within year-five to within year-one prior to the index, the median duration of oral corticosteroid treatment increased from 34 to 88 days per year and the proportion of patients who experienced more extensive/pancolitis disease increased from 16 to 59%. Overall, the frequency of all-cause health care visits also increased. Conclusions Patients with UC experienced increasing morbidity and treatment burden in the 5 years prior to initiating biologic therapy. To achieve reduced corticosteroids in UC management, better risk stratification is needed to help identify patients for more timely biologic treatment.

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Role of the Breast Clinical Nurse Specialist in bilateral risk reduction mastectomy decision–making

European Journal of Surgical Oncology ◽

10.1016/j.ejso.2017.01.048 ◽

2017 ◽

Vol 43 (5) ◽

pp. S9-S10

Author(s):

Charlotte Weston ◽

Sarah Adomah ◽

Vanda Ribeiro ◽

Karen Thomas ◽

Nichola Snuggs ◽

...

Keyword(s):

Decision Making ◽

Risk Reduction ◽

Clinical Nurse Specialist ◽

Nurse Specialist ◽

Clinical Nurse

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Decision-Making in the Transport Sector: A Sustainable Evaluation Method for Road Infrastructure

Sustainability ◽

10.3390/su12030764 ◽

2020 ◽

Vol 12 (3) ◽

pp. 764 ◽

Cited By ~ 11

Author(s):

Ilaria Henke ◽

Armando Cartenì ◽

Clorinda Molitierno ◽

Assunta Errico

Keyword(s):

Decision Making ◽

Environmental Sustainability ◽

Evaluation Method ◽

Social Economic ◽

Cost Benefit Analysis ◽

Point Of View ◽

Transport Sector ◽

National Guidelines ◽

Road Infrastructure ◽

Daily Movement

The transport sector is often the center of political and scientific debate on sustainability due to negative externalities produced by the daily movement of goods and people which impact both on the environment and on quality of life. Great interest has therefore focused on impact estimation of transport infrastructures/services with respect to social, economic, and environmental sustainability. Among the consolidated assessment methods, the cost–benefit analysis (CBA) is one of the quantitative tools representing the final stage (decision) in decision-making processes, which compares design alternatives and verifies the sustainability of a transport project. Recently the Italian Government proposed the national “Guidelines for Assessment of Investment Projects” based on CBA. The aim of this research is twofold: a) from a research point of view, to propose a sustainable evaluating method for impact assessment of the new transportation infrastructure aimed in performing both rational and shared decisions with the territories; b) for a practical point of view, to propose a first application of the CBA Italian guideline useful for the professional practice in the field of public investment evaluation. A quantitative impacts assessment of social, economic and environmental sustainability was performed for a revamping project of a new “greenway” in the south of Italy. Furthermore, also the social equity impacts produced by the new road infrastructure was also quantified, estimating the GINI indexes variation as a measure of effectiveness.

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Do Public Enterprises Need a Corporate Strategy?

Vikalpa The Journal for Decision Makers ◽

10.1177/0256090919870202 ◽

1987 ◽

Vol 12 (2) ◽

pp. 9-20 ◽

Cited By ~ 1

Author(s):

K R S Murthy

Keyword(s):

Decision Making ◽

Corporate Strategy ◽

Team Work ◽

Strategic Decision ◽

Strategic Decision Making ◽

Decision Making Process ◽

Public Enterprises ◽

Strategic Competence ◽

The Public ◽

Low Level

A large gap has arisen between the stated objectives of the public enterprises in India and their achievements, largely owing to inherent conflicts in their strategic decision making process. In this article, K R S Murthy stresses that any public enterprise's strategic competence depends on the interplay among three actors (managers, bureaucrats, and politicians) with diverse motivations, careers, and systems. Team work with common values and commitment among the three actors alone can improve the low level of strategic competence. Since the prerequisites for strategic formulations are riot met in public enterprises, it is a debatable point whether they should have a corporate strategy at all.

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