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IntroductionRecent results from the IRONMAN trial add to previous data and demonstrate that correction of iron deficiency in patients with heart failure, with high dose IV iron can improve quality of life, and reduce the risk of heart failure hospitalisation (by around 25% in meta-analysis). Yet there are theoretical risks that IV iron administration may increase the risk from bacterial infection. A meta-analysis in 2021 (across many clinical indications) suggested an excess risk of infections with IV iron but noted most trials did not pre-specify infection as an end point, with risk of reporting bias. To answer this important question hospitalisation for infection or death due to infection were pre-specified safety endpoints in IRONMAN.MethodsIRONMAN was a prospective, randomised open-label, blinded endpoint (PROBE) event-driven trial of IV ferric derisomaltose (FDI) and usual care versus usual care alone in patients with heart failure (LVEF ≤45% ) and iron deficiency (ferritin <100 µg/L and/or TSAT <20%, provided ferritin ≤400 µg/L). Patients were enrolled if they had a current or recent hospitalisation for heart failure or elevated natriuretic peptide plasma concentration. Every four months, IV iron was administered if either ferritin was <100 µg/L or TSAT was <25% (provided ferritin ≤400 µg/L). All hospitalisations and deaths were adjudicated blindly. Given that a large part of the trial was conducted during the COVID-19 pandemic, we also evaluated COVID-19 related SAEs.Results1137 patients (26.4% women) with median (IQR) age 73 (63 to 79) years were recruited by the Ironman Study Group between Aug 2016 and Oct 2021 across 70 UK sites. Median (IQR) follow-up was 2·7 (1·8 to 3·6) years. 97% of patients consented to record linkage to national databases of deaths and hospital discharge summaries, thereby ensuring investigators were aware of all potential events. There were a similar number of hospitalisations due to infection for those assigned to ferric derisomaltose (175) and usual care (213) (p = 0.16) and infection related death (34 and 28, respectively, p = 0.43). When considering first events of hospitalisation for infection or infection death there were 120 (21.1%) events for those randomised to IV FDI and 146 (25.7%) for the usual care arm (figure). There were fewer patients with COVID related SAEs in those randomised to IV FDI (12) as compared with usual care (30), HR (95% CI) 0.40 (0.20, 0.78). p=0.007. For deaths attributed to COVID-19, 4 were seen in the IV FDI arm and 8 in the usual care arm: HR 0.51 (0.15, 1.68) p=0.27.ConclusionsThere was no excess risk of infection related hospitalisation or death in patients receiving IV ferric derisomaltose. Fewer COVID-19 related SAEs were seen in patients receiving IV FDI. Given that iron plays an important role in the T and B cell response to vaccination, further analysis needs to be done in this area.Conflict of InterestHonorarium for education from Pharmocosmos
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BACKGROUND: For patients with heart failure, reduced left ventricular ejection fraction and iron deficiency, intravenous ferric carboxymaltose administration improves quality of life and exercise capacity in the short-term and reduces hospital admissions for heart failure up to 1 year. We aimed to evaluate the longer-term effects of intravenous ferric derisomaltose on cardiovascular events in patients with heart failure. METHODS: IRONMAN was a prospective, randomised, open-label, blinded-endpoint trial done at 70 hospitals in the UK. Patients aged 18 years or older with heart failure (left ventricular ejection fraction ≤45%) and transferrin saturation less than 20% or serum ferritin less than 100 µg/L were eligible. Participants were randomly assigned (1:1) using a web-based system to intravenous ferric derisomaltose or usual care, stratified by recruitment context and trial site. The trial was open label, with masked adjudication of the outcomes. Intravenous ferric derisomaltose dose was determined by patient bodyweight and haemoglobin concentration. The primary outcome was recurrent hospital admissions for heart failure and cardiovascular death, assessed in all validly randomly assigned patients. Safety was assessed in all patients assigned to ferric derisomaltose who received at least one infusion and all patients assigned to usual care. A COVID-19 sensitivity analysis censoring follow-up on Sept 30, 2020, was prespecified. IRONMAN is registered with ClinicalTrials.gov, NCT02642562. FINDINGS: Between Aug 25, 2016, and Oct 15, 2021, 1869 patients were screened for eligibility, of whom 1137 were randomly assigned to receive intravenous ferric derisomaltose (n=569) or usual care (n=568). Median follow-up was 2·7 years (IQR 1·8-3·6). 336 primary endpoints (22·4 per 100 patient-years) occurred in the ferric derisomaltose group and 411 (27·5 per 100 patient-years) occurred in the usual care group (rate ratio [RR] 0·82 [95% CI 0·66 to 1·02]; p=0·070). In the COVID-19 analysis, 210 primary endpoints (22·3 per 100 patient-years) occurred in the ferric derisomaltose group compared with 280 (29·3 per 100 patient-years) in the usual care group (RR 0·76 [95% CI 0·58 to 1·00]; p=0·047). No between-group differences in deaths or hospitalisations due to infections were observed. Fewer patients in the ferric derisomaltose group had cardiac serious adverse events (200 [36%]) than in the usual care group (243 [43%]; difference -7·00% [95% CI -12·69 to -1·32]; p=0·016). INTERPRETATION: For a broad range of patients with heart failure, reduced left ventricular ejection fraction and iron deficiency, intravenous ferric derisomaltose administration was associated with a lower risk of hospital admissions for heart failure and cardiovascular death, further supporting the benefit of iron repletion in this population. FUNDING: British Heart Foundation and Pharmacosmos.
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SETTING: Ottawa Public Health (OPH) provides public health programming and services in the Ottawa region. At the onset of the COVID-19 pandemic in March 2020, the OPH COVID-19 Case and Contact Management Team was established to help manage the spread of COVID-19 and support individuals who test positive, and their close contacts. INTERVENTION: In order to guide and support the COVID-19 Case and Contact Management Team, the COVID-19 Strategic Support Team implemented an anonymous internal communication tool called the COVID-19 Case Management Forum. Case and Contact Management employees were invited to submit their questions, concerns, and words of encouragement on the forum, and the COVID-19 Strategic Support Team routinely replied to forum submissions via team email. OUTCOMES: Qualitative analyses of employee forum submissions revealed 6 main themes and 31 unique sub-themes related to questions, concerns, and feelings that arose throughout this pandemic response. Recurrent themes emerged relating to process questions, communication challenges, solution generation, and feelings of frustration. Summative content analyses of the COVID-19 Strategic Support team's replies demonstrated 6 main answer types: explaining procedures, identifying resources, explaining rationales, human resource explanations, sharing employee feedback with relevant parties, and creating practice tools. IMPLICATIONS: The online forum tool was developed and implemented early in the pandemic response to provide key insights into OPH's public health workforce needs and well-being throughout the COVID-19 response. The forum encouraged open dialogue and provided opportunities to establish clarity in a time of rapid situational change.
RéSUMé: CONTEXTE: Santé publique Ottawa (SPO) offre des programmes et services de soins de santé publique dans la région d'Ottawa. Dès le début de la pandémie de COVID-19 en mars 2020, l'équipe chargée de la gestion des cas et des contacts de la COVID-19 de SPO a été créée pour faciliter la gestion de la propagation de la COVID-19 et soutenir les personnes qui ont obtenu un test positif. INTERVENTION: Afin de guider et de soutenir l'équipe de gestion des cas et des contacts de la COVID-19, l'équipe de soutien stratégique en gestion de la COVID-19 a mis en place un forum de communication interne anonyme appelé Forum de gestion des cas de la COVID-19. Les employés de la gestion des cas et des contacts ont été invités à soumettre leurs questions, préoccupations et mots d'encouragement sur le forum, et l'équipe de soutien stratégique en gestion de la COVID-19 a régulièrement répondu aux commentaires du forum par courrier électronique. RéSULTATS: Les analyses qualitatives des commentaires du forum envoyés par les employés ont révélé 6 thèmes principaux et 31 sous-thèmes liés aux questions, aux préoccupations et aux sentiments qui ont surgi tout au long de la lutte contre la pandémie. Les thèmes récurrents se rapportent aux questions de processus, aux défis liés à la communication, à la recherche de solutions et aux sentiments de frustration. Les analyses de contenu sommatives des réponses de l'équipe de soutien stratégique en gestion de la COVID-19 ont révélé 6 principaux types de réponses : expliquer les procédures, identifier les ressources, expliquer les justifications, expliquer les ressources humaines, partager les commentaires des employés avec les parties concernées et créer des outils pratiques. IMPLICATIONS: L'outil de forum en ligne a été élaboré et mis en oeuvre au début de l'intervention face à la pandémie pour fournir des informations clés sur les besoins et le bien-être du personnel de SPO tout au long de la lutte contre la COVID-19. Le forum encourageait un dialogue ouvert et a permis d'apporter plusieurs précisions dans un milieu en évolution constante et rapide.
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COVID-19 , COVID-19/epidemiology , Health Workforce , Humans , Pandemics , Public HealthABSTRACT
INTRODUCTION: People diagnosed with neurodegenerative disorders often grapple with threats to their agency, prompting some to engage in advance care planning. Advance care plans are intended to protect autonomy by helping patients receive goal-consistent healthcare. Accordingly, there is a need to better understand factors associated with hospital doctors' application of advance care plans to treatment decisions of this patient cohort. PURPOSE: The purpose of this study was to explain the recommendations of multidisciplinary hospital-based clinicians about the benefits of advance care plans for people diagnosed with neurodegenerative disorders, and the elements that influence how doctors apply such plans. MATERIALS AND METHODS: Using a constructivist grounded theory informed thematic analysis, semi-structured interviews were conducted with purposively and theoretical sampled hospital-based clinicians: 16 doctors, six registered nurses and 10 allied health clinicians who self-reported having experience delivering healthcare to people with neurodegenerative disorders and an advance care plan. Allied health and nurse data helped to inform questions posed to doctors. Data were inductively analysed using open and focused coding. RESULTS: Analysis revealed two main themes: recommending agency through advance care plans; and limiting agency through advance care plans. These themes formed the basis of the core category: patient agency. All clinicians held positive attitudes towards advance care plans as a means to preserve patient voices and alleviate family of responsibility. However, the extent to which doctors shared decisions with family revealed a tension between individualistic agency associated with advance care plans and relational autonomy perceived by doctors as appropriate. CONCLUSION: Although doctors expressed positive attitudes towards advance care plans, they typically practiced relational autonomy wherein they partner with family in contemporaneous healthcare decision on patients' behalf. Accordingly, the healthcare preferences of hospitalised, incompetent people with neurodegenerative disorders are balanced against judgements of both doctors and family.
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Patients with heart failure (HF) who contract SARS-CoV-2 infection are at a higher risk of cardiovascular and non-cardiovascular morbidity and mortality. Regardless of therapeutic attempts in COVID-19, vaccination remains the most promising global approach at present for controlling this disease. There are several concerns and misconceptions regarding the clinical indications, optimal mode of delivery, safety and efficacy of COVID-19 vaccines for patients with HF. This document provides guidance to all healthcare professionals regarding the implementation of a COVID-19 vaccination scheme in patients with HF. COVID-19 vaccination is indicated in all patients with HF, including those who are immunocompromised (e.g. after heart transplantation receiving immunosuppressive therapy) and with frailty syndrome. It is preferable to vaccinate against COVID-19 patients with HF in an optimal clinical state, which would include clinical stability, adequate hydration and nutrition, optimized treatment of HF and other comorbidities (including iron deficiency), but corrective measures should not be allowed to delay vaccination. Patients with HF who have been vaccinated against COVID-19 need to continue precautionary measures, including the use of facemasks, hand hygiene and social distancing. Knowledge on strategies preventing SARS-CoV-2 infection (including the COVID-19 vaccination) should be included in the comprehensive educational programmes delivered to patients with HF.
Subject(s)
COVID-19 , Cardiology , Heart Failure , Iron Deficiencies , Aged , COVID-19 Vaccines , Frail Elderly , Humans , SARS-CoV-2 , VaccinationABSTRACT
AIM: People diagnosed with a neurodegenerative disorder often contend with a threat to independence and control, leading some to complete an advance care plan. Advance care plans are commonly associated with treatment limitations; however, key patient agents (such as doctors, allied health, nurses and family) may instead make temporal, best interests or good medical practice decisions on behalf of the patient. Accordingly, there is a need to better understand ancillary decision-maker's perspectives, particularly of doctors. PURPOSE: To explain how the potentially conflicting interests of bedside patient agents operates as a factor which influences doctors' application of advance care plans of people with a neurodegenerative disorder. PARTICIPANTS AND METHODS: Using a constructivist grounded theory informed thematic analysis, 38 semi-structured interviews were conducted with hospital-based doctors, allied health, nurses and family of people with a neurodegenerative disorder who had an advance care plan. Data were inductively analysed using open and focused coding. RESULTS: Analysis revealed two main themes: dynamics of discerning best interests; and avoiding conflict. Rather than applying advance care plans, doctors largely involved families to attempt best interests decision-making partnerships on patients' behalf. Bedside agents demonstrated significant intra and interpersonal challenges associated with their roles as patient agents. Doctors appeared protective of families and patients with neurodegenerative disorder. CONCLUSION: Although bedside agents value advance care plans, doctors often favour temporal healthcare decisions in consultation with family. We suggest there are limitations to the effectiveness of advance care plans in practice, with application typically only occurring close to death. Despite the intentions of advance care planning, bedside agents may still experience considerable dissonance.