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BACKGROUND: The international scale and spread of evidence-based perioperative medicine for older people undergoing surgery (POPS) services has not yet been fully realised. Implementation science provides a structured approach to understanding factors that act as barriers and facilitators to the implementation of POPS services. In this study, we aimed to identify factors that influence the implementation of POPS services in the UK. METHODS: A qualitative case study at three UK health services was undertaken. The health services differed across contextual factors (population, workforce, size) and stages of POPS service implementation maturity. Semi-structured interviews with purposively sampled clinicians (perioperative medical, nursing, allied health, and pharmacy) and managers (n = 56) were conducted. Data were inductively coded, then thematically analysed using the Consolidated Framework for Implementation Research (CFIR). RESULTS: Fourteen factors across all five CFIR domains were relevant to the implementation of POPS services. Key shared facilitators included stakeholders understanding the rationale of the POPS service, with support from their networks, POPS champions, and POPS clinical leads. We found substantial variation and flexibility in the way that health services responded to these shared facilitators and this was relevant to the implementation of POPS services. CONCLUSIONS: Health services planning to implement a POPS service should use health service-specific strategies to respond flexibly to local factors that are acting as barriers or facilitators to implementation. To support implementation of a POPS service, we recommend health services prioritise understanding local networks, identifying POPS champions, and ensuring that stakeholders understand the rationale for the POPS service. Our study also provides a structure for future research to understand the factors associated with 'unsuccessful' implementation of a POPS service, which can inform ongoing efforts to implement evidence-based perioperative models of care for older people.
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Medicina Perioperatoria , Humanos , Anciano , Investigación CualitativaRESUMEN
BACKGROUND: Lidocaine patches, applied over rib fractures, may reduce pulmonary complications in older patients. Known barriers to recruiting older patients in emergency settings necessitate a feasibility trial. We aimed to establish whether a definitive randomised controlled trial (RCT) evaluating lidocaine patches in older patients with rib fracture(s) was feasible. METHODS: This was a multicentre, parallel-group, open-label, feasibility RCT in seven hospitals in England and Scotland. Patients aged ≥65 years, presenting to ED with traumatic rib fracture(s) requiring hospital admission were randomised to receive up to 3×700 mg lidocaine patches (Ralvo), first applied in ED and then once daily for 72 hours in addition to standard care, or standard care alone. Feasibility outcomes were recruitment, retention and adherence. Clinical end points (pulmonary complications, pain and frailty-specific outcomes) and patient questionnaires were collected to determine feasibility of data collection and inform health economic scoping. Interviews and focus groups with trial participants and clinicians/research staff explored the understanding and acceptability of trial processes. RESULTS: Between October 23, 2021 and October 7, 2022, 206 patients were eligible, of whom 100 (median age 83 years; IQR 74-88) were randomised; 48 to lidocaine patches and 52 to standard care. Pulmonary complications at 30 days were determined in 86% of participants and 83% of expected 30-day questionnaires were returned. Pulmonary complications occurred in 48% of the lidocaine group and 59% in standard care. Pain and some frailty-specific outcomes were not feasible to collect. Staff reported challenges in patient compliance, unfamiliarity with research measures and overwhelming the patients with research procedures. CONCLUSION: Recruitment of older patients with rib fracture(s) in an emergency setting for the evaluation of lidocaine patches is feasible. Refinement of data collection, with a focus on the collection of pain, frailty-specific outcomes and intervention delivery are needed before progression to a definitive trial. TRIAL REGISTRATION NUMBER: ISRCTN14813929.
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Anestésicos Locales , Estudios de Factibilidad , Lidocaína , Fracturas de las Costillas , Humanos , Lidocaína/administración & dosificación , Lidocaína/uso terapéutico , Femenino , Fracturas de las Costillas/complicaciones , Fracturas de las Costillas/tratamiento farmacológico , Anciano , Masculino , Anciano de 80 o más Años , Anestésicos Locales/administración & dosificación , Anestésicos Locales/uso terapéutico , Inglaterra , Escocia , Parche Transdérmico , Servicio de Urgencia en Hospital , Encuestas y CuestionariosRESUMEN
OBJECTIVE: To evaluate the effect of geriatrician review on 1-year mortality in older adults admitted with trauma. BACKGROUND: Comprehensive geriatric assessment (CGA) has been associated with improved outcomes in older adults with hip fracture, but has not been evaluated in a broader trauma population. METHODS: Trauma patients aged ≥ 65years admitted to an English Major Trauma Centre between November 2018 and September 2019 were included. Patients were divided into 3 cohorts: no geriatric assessment, reactive geriatric assessment, and proactive CGA. The primary outcome was time to mortality, secondary outcomes were time to discharge and frequency of complications. Analyses were adjusted for factors known to be associated with outcomes including age, frailty, injury severity, and complications. RESULTS: Five hundred eighty-five patients were included (no geriatric assessment = 125; reactive geriatric assessment = 134; proactive CGA = 326): median age was 81 years (IQR 74-88); 326 (55.7%) were women; 297 (50.8%) were living with frailty (Clinical Frailty Scale ≥5). Median Injury Severity Score was 13 (IQR9-25). At 1-year follow-up, 147 (25.1%) patients had died. In multivariate analysis, both types of geriatric assessment were associated with reduced mortality [reactive aHR = 0.31, 95% CI 0.18-0.53; proactive adjusted hazard ratio (aHR) = 0.41, 95% CI 0.26-0.64]. There was no association between either type of geriatric assessment and length of stay (reactive aHR = 0.84, 95% CI 0.62-1.15; proactive aHR = 0.80, 95% CI 0.63-1.02). CONCLUSIONS: Geriatrician assessment is associated with reduced mortality in older adults admitted following trauma. Further research should focus on defining optimal models of geriatrician intervention.
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Fragilidad , Centros Traumatológicos , Anciano , Humanos , Femenino , Anciano de 80 o más Años , Masculino , Anciano Frágil , Hospitalización , Alta del PacienteRESUMEN
Subdural haematoma (SDH) is a common injury sustained by older people living with frailty and multimorbidity, and typically following falls from a standing height. Anticoagulant and antiplatelet use are commonly indicated in older people with SDH, but few data inform decision-making surrounding these agents in the context of intracranial bleeding. Opposing risks of rebleeding and thrombosis must therefore be weighed judiciously. Decision-making can be complex and requires detailed awareness of the epidemiology to ensure the safest course of action is selected for each patient. Outcomes of surgical decompression in acute SDH are very poor in older people. However, burr hole drainage can be safe and effective in older adults with symptomatic chronic SDH (cSDH). Such patients need careful assessment to ensure symptoms arise from cSDH and not from coexisting medical pathology. Furthermore, the emerging treatment of middle meningeal artery embolisation offers a well-tolerated, minimally invasive intervention which may reduce the risks of rebleeding in older adults. Nonetheless, UK SDH management is heterogenous, and no accepted UK or European guidelines exist at present. Further randomised trial evidence is required to move away from clinical practice based on historic observational data.
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Hematoma Subdural Agudo , Hematoma Subdural Crónico , Humanos , Anciano , Hematoma Subdural Crónico/cirugía , Drenaje/efectos adversos , Descompresión Quirúrgica , RecurrenciaRESUMEN
INTRODUCTION: Patients aged ≥65 years currently account for approximately 55% of all emergent operations. However, these patients account for 75% of post-operative mortality. Older age has long been associated with adverse outcomes from emergency surgery. However, old age is a heterogenous state. Recent studies have indicated that frailty may more accurately reflect true biological age and perioperative risk than chronological age alone in patients undergoing elective surgery. Few studies have evaluated the impact of frailty on post-operative outcomes in this setting. METHODS: A systematic, electronic search for relevant publications was performed in November 2019 using Pubmed and Embase from 2009 to 2019. The latest search for articles was performed on February 16th, 2020. Articles were excluded if frailty was not measured using a frailty tool, or if patients did not undergo emergency general surgery (EGS). RESULTS: The prevalence of frailty amongst patients undergoing emergency abdominal surgery was 30.8%. The all-cause mortality rate was 15.68%. The mortality rate amongst the frail undergoing EGS was 24.7%. Frailty was associated with an increased mortality rate compared with the non-frail (odds ratio (OR) 4.3, 95% CI 2.25-8.19%, p < 0.05, I2 = 80%). CONCLUSIONS: There is strong evidence to suggest that frailty in the older population predicts post-operative mortality, complications, prolonged length of stay and the loss of independence. Collaborative working with medicine for the elderly physicians to target modifiable aspects of the frailty syndrome in the perioperative pathway may improve outcomes. Frailty scoring should be integrated into acute surgical assessment practice to aid decision-making and development of novel postoperative strategies.
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Fragilidad , Anciano , Humanos , Fragilidad/complicaciones , Anciano Frágil , Evaluación Geriátrica , Complicaciones Posoperatorias/etiología , Abdomen/cirugía , Factores de Riesgo , Tiempo de InternaciónRESUMEN
Spinal fractures are the third most common traumatic injury in older people, of which cervical spine injuries make up around 15%. They are predominantly seen in people living with frailty who fall from standing height. Spinal fractures in this patient group are associated with substantial morbidity and mortality (over 40% at 1 year). For many older people who survive, their injuries will be life changing. Practice between EDs varies significantly, with no universally accepted guidelines on either assessment, investigation or management specific to older people experiencing trauma. This expert practice review examines the current evidence and emergency management options in this patient group through clinical scenarios, with the aim of providing a more unified approach to management.
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Traumatismos del Cuello , Fracturas de la Columna Vertebral , Traumatismos Vertebrales , Anciano , Vértebras Cervicales/lesiones , Humanos , Fracturas de la Columna Vertebral/terapia , Traumatismos Vertebrales/terapiaRESUMEN
BACKGROUND: the Geriatric Perioperative Care clinic at North Bristol NHS Trust was suspended in March 2020 during the COVID-19 pandemic. A virtual clinic was piloted to deliver preoperative health optimisation and shared decision-making for patients undergoing critical elective surgery. No literature existed on virtual preoperative clinics for older people to support the development. OBJECTIVE: this healthcare improvement study describes the setup and delivery of the virtual clinic as its primary aim. Secondary aims included: assessing older people's access to technology and their digital literacy for virtual consultation; to describe barriers and facilitators for consultations, as well as evaluation of patient and clinician satisfaction with the consultations' mode of delivery and outcomes. METHODS: a mixed methods healthcare improvement study was undertaken through plan-do-study-act cycles, semi-structure interviews, and quantitative service benchmarking. RESULTS: the pilot evaluated 67 preoperative consultations (43.3% video, 56.7% telephone, mean age 75) with a mix of surgical pathology (vascular 88.1%, colorectal 10.4%, urological 1.5%). Patient feedback demonstrated improved understanding of conditions (90.6%), and adequate opportunity to express opinions and questions (96.2%). Clinicians preferred video consultations (adequate to deliver services: 89.7% video; 68.4% telephone). The greatest barriers to engagement, none of which were exclusions to participation, included cognitive impairment, sensory impairment, or needing technical assistance setting up video consultations (52.2%). CONCLUSIONS: delivering a virtual preoperative medical optimisation and shared decision clinic for older people is feasible. This study will aid other units in developing their own virtual preoperative clinics. Future work should evaluate perioperative outcomes of delivering a face-to-face versus virtual clinic.
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COVID-19 , Medicina Perioperatoria , Telemedicina , Anciano , Atención a la Salud , Humanos , Pandemias , SARS-CoV-2RESUMEN
BACKGROUND: Frailty assessment using the Clinical Frailty Scale (CFS) has been mandated for older people admitted to English major trauma centres (MTC) since April 2019. Little evidence is available as to CFS-associated outcomes in the trauma population. OBJECTIVE: To investigate post-injury outcomes stratified by the CFS. METHODS: A single centre prospective observational cohort study was undertaken. CFS was prospectively assigned to patients ≥ 65 years old admitted to the MTC over a 5-month period. Primary outcome was 30-day post-injury mortality. Secondary outcomes were length of hospital stay, complications and discharge level of care. RESULTS: In 300 patients median age was 82; 146 (47%) were frail (CFS 5-9) and 28 (9.3%) severely frail (CFS 7-9). Frail patients had lower injury severity scores (median 9 vs 16) but greater 30-day mortality (CFS 5-6 odds ratio (OR) 5.68; P < 0.01; CFS 7-9 OR 10.38; P < 0.01). Frailty was associated with delirium (29.5% vs 17.5%; P = 0.02), but not complication rate (50.7% vs 41.6%; P = 0.20) or length of hospital stay (13 vs 11 days; P = 0.35). Mild to moderate frailty was associated with increased care level at discharge (OR 2.31; P < 0.01). CONCLUSIONS: Frailty is an independent predictor of 30-day mortality, inpatient delirium and increased care level at discharge in older people experiencing trauma. CFS can therefore be used to identify those at risk of poor outcome who may benefit from comprehensive geriatric review, validating its inclusion in the 2019 best practice tariff for major trauma.
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Fragilidad , Anciano , Anciano de 80 o más Años , Anciano Frágil , Fragilidad/diagnóstico , Evaluación Geriátrica , Humanos , Estudios Prospectivos , Centros Traumatológicos , Reino Unido/epidemiologíaRESUMEN
AIM: To determine if frailty is associated with poor outcome following in-hospital cardiac arrest; to find if there is a "frailty threshold" beyond which cardiopulmonary resuscitation (CPR) becomes futile. METHODS: Retrospective review of patients aged over 60 years who received CPR between May 2017 and December 2018, in a tertiary referral hospital, which does not provide primary coronary revascularisation. Clinical Frailty Scale (CFS) and Charlson Comorbidity Index were retrospectively assigned. RESULTS: Data for 90 patients were analysed, the median age was 77 (IQR 70-83); 71% were male; 44% were frail (CFS > 4). Frailty was predictive of in-hospital mortality independent of age, comorbidity and cardiac arrest rhythm (OR 2.789 95% CI 1.145-6.795). No frail patients (CFS > 4) survived to hospital discharge, regardless of cardiac arrest rhythm, whilst 13 (26%) of the non-frail (CFS ≤ 4) patients survived to hospital discharge. Of the 13 survivors (Age 72; range 61-86), 12 were alive at 1 year and had a good neurological outcome, the outcome for the remaining patient was unknown. CONCLUSION: Frail patients are unlikely to survive to hospital discharge following in-hospital cardiac arrest, these results may facilitate clinical decision making regarding whether CPR may be considered futile. The Clinical Frailty Scale is a simple bedside assessment that can provide invaluable information when considering treatment escalation plans, as it becomes more widespread, larger scale observations using prospective assessments of frailty may become feasible.
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Reanimación Cardiopulmonar , Fragilidad , Anciano , Fragilidad/diagnóstico , Fragilidad/terapia , Humanos , Masculino , Inutilidad Médica , Estudios Prospectivos , Estudios RetrospectivosRESUMEN
Adults aged ≥60 years now represent the majority of patients presenting with major trauma. Falls are the most common cause of injury, accounting for nearly three-quarters of all traumas in this population. Trauma to the thorax represents the second most common site of injury in this population, and is often associated with other serious injuries. Mortality rates are 2-5 times higher in older adults compared to their younger counterparts, often despite equivalent injury severity scores. Risk scoring systems have been developed to identify rib fracture patients at high risk of deterioration. Overall mortality from rib fractures is high, at approximately 10% for all ages. Mortality and morbidity from rib fractures primarily derive from pain-induced hypoventilation, pneumonia and respiratory failure. The main goal of care is therefore to provide sufficient analgesia to allow respiratory rehabilitation and prevent pulmonary complications. The provision of analgesia has evolved to incorporate novel regional anaesthesia techniques into conventional multimodal analgesia. Analgesia algorithms may aid early aggressive management and escalation of pain control. The current role for surgical fixation of rib fractures remains unclear for older adults who have been underrepresented in the research literature. Older adults with rib fractures often have multi-morbidity and frailty which complicate their injuries. Trauma services are evolving, and increasingly geriatricians will be embedded into trauma services to deliver comprehensive geriatric assessment. This review aims to provide an evidence-based overview of the management of rib fractures for the physician treating older patients who have sustained trauma.
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Fracturas de las Costillas/terapia , Factores de Edad , Anciano , Humanos , Manejo del Dolor/métodos , Fracturas de las Costillas/diagnóstico , Fracturas de las Costillas/mortalidad , Fracturas de las Costillas/cirugía , Medición de RiesgoRESUMEN
Trauma in the elderly (>65 years) is an increasingly common presentation to the ED. A fall from standing height is the most common mechanism after which such patients present, and rib fracture is the most common non-spinal fracture. Thoracic injury in patients aged over 65 is associated with significant morbidity and mortality. There are currently no universally applied guidelines for assessment, investigation and management of such patients. In this expert practice review, we discuss the evidence base and options for clinical management in this vulnerable patient group.
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Geriatría/métodos , Guías de Práctica Clínica como Asunto , Traumatismos Torácicos/terapia , Heridas no Penetrantes/terapia , Factores de Edad , Anciano , Anciano de 80 o más Años , Analgesia/efectos adversos , Analgesia/métodos , Femenino , Geriatría/normas , Geriatría/tendencias , Humanos , MasculinoRESUMEN
Developed populations are ageing rapidly and by 2040, approximately 1 in 4 adults will be over 65 years of age. This is resulting in higher incidence of traumatic injury in older patients. Cognitive and physical comorbidities in this group can pose significant challenges. Due to mechanisms of injury and pre-existing degenerative spinal disease, cervical spine fractures are particularly prevalent in elderly patients. These are associated with significant morbidity and mortality. In this literature review we examine current evidence surrounding the use of cervical spine immobilisation in elderly patients in the pre-hospital and emergency department setting and also as a treatment option for cervical spine fractures. We explore evidence surrounding the complications that can arise from cervical spine immobilisation, including the development of pressure sores, raised intracranial pressure, dysphagia, breathing difficulties, delirium, compliance issues, mobility and functional outcome.
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Anciano Frágil , Restricción Física/instrumentación , Restricción Física/métodos , Fracturas de la Columna Vertebral/terapia , Anciano , Vértebras Cervicales/lesiones , Comorbilidad , Servicios Médicos de Urgencia , Diseño de Equipo , Medicina Basada en la Evidencia , Humanos , Masculino , Evaluación de Procesos y Resultados en Atención de Salud , Restricción Física/efectos adversos , Medición de RiesgoAsunto(s)
Anestesistas , Fragilidad , Geriatras , Anciano , Evaluación Geriátrica , Humanos , Periodo PerioperatorioRESUMEN
In the context of an ageing population, the demographic sands of trauma are shifting. Increasingly, trauma units are serving older adults who have sustained injuries in low-energy falls from a standing height. Older age is commonly associated with changes in physiology, as well as an increased prevalence of frailty and multimorbidity, including cardiac, renal and liver disease. These factors can complicate the safe and effective administration of analgesia in the older trauma patient. Trauma services therefore need to adapt to meet this demographic shift and ensure that trauma clinicians are sufficiently skilled in treating pain in complex older people. This article is dedicated to the management of acute trauma pain in older adults. It aims to highlight the notable clinical challenges of managing older trauma patients compared with their younger counterparts. It offers an overview of the evidence and practical opinion on the merits and drawbacks of commonly used analgesics, as well as more novel and emerging analgesic adjuncts. A search of Medline (Ovid, from inception to 7 November 2022) was conducted by a medical librarian to identify relevant articles using keyword and subject heading terms for trauma, pain, older adults and analgesics. Results were limited to articles published in the last 10 years and English language. Relevant articles' references were hand-screened to identify other relevant articles. There is paucity of dedicated high-quality evidence to guide management of trauma-related pain in older adults. Ageing-related changes in physiology, the accumulation of multimorbidity, frailty and the risk of inducing delirium secondary to analgesic medication present a suite of challenges in the older trauma patient. An important nuance of treating pain in older trauma patients is the challenge of balancing iatrogenic adverse effects of analgesia against the harms of undertreated pain, the complications and consequences of which include immobility, pneumonia, sarcopenia, pressure ulcers, long-term functional decline, increased long-term care needs and mortality. In this article, the role of non-opioid agents including short-course non-steroidal anti-inflammatory drugs (NSAIDs) is discussed. Opioid selection and dosing are reviewed for older adults suffering from acute trauma pain in the context of kidney and liver disease. The evidence base and limitations of other adjuncts such as topical and intravenous lidocaine, ketamine and regional anaesthesia in acute geriatric trauma are discussed.
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Dolor Agudo , Fragilidad , Humanos , Anciano , Antiinflamatorios no Esteroideos , Analgésicos/efectos adversos , Dolor Agudo/tratamiento farmacológico , Analgésicos Opioides/efectos adversosRESUMEN
Background: Topical lidocaine patches, applied over rib fractures, have been suggested as a non-invasive method of local anaesthetic delivery to improve respiratory function, reduce opioid consumption and consequently reduce pulmonary complications. Older patients may gain most benefit from improved analgesic regimens yet lidocaine patches are untested as an early intervention in the Emergency Department (ED). The aim of this trial is to investigate uncertainties around trial design and conduct, to establish whether a definitive randomised trial of topical lidocaine patches in older patients with rib fractures is feasible. Methods: RELIEF is an open label, multicentre, parallel group, individually randomised, feasibility randomised controlled trial with economic scoping and nested qualitative study. Patients aged ≥ 65 years presenting to the ED with traumatic rib fracture(s) requiring admission will be randomised 1:1 to lidocaine patches (intervention), in addition to standard clinical management, or standard clinical management alone. Lidocaine patches will be applied immediately after diagnosis in ED and continued daily for 72 hours or until discharge. Feasibility outcomes will focus on recruitment, adherence and follow-up data with a total sample size of 100. Clinical outcomes, such as 30-day pulmonary complications, and resource use will be collected to understand feasibility of data collection. Qualitative interviews will explore details of the trial design, trial acceptability and recruitment processes. An evaluation of the feasibility of measuring health economics outcomes data will be completed. Discussion: Interventions to improve outcomes in elderly patients with rib fractures are urgently required. This feasibility trial will test a novel early intervention which has the potential of fulfilling this unmet need. The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF) feasibility trial will determine whether a definitive trial is feasible. ISRCTN Registration: ISRCTN14813929 (22/04/2021).
BACKGROUND AND AIMS: Patches containing a numbing medication (lidocaine), put on the skin over broken ribs, may help to improve outcomes in older people. We will carry out a clinical trial of these patches, to see whether this research would work in Accident and Emergency (A&E) and whether patients will take part. DESIGN: We will ask 100 older people who need to stay in hospital with broken ribs to take part in this research. We will ask permission from relatives to include people with dementia. We will put those who agree to take part into one of two groups by chance. One group will have the patch put over their broken ribs in A&E for up to 3 days, along with usual pain killers if needed. We will treat people in the other group in the normal way, without a patch. We will track how many people are willing to take part. We will collect information on patient recovery in the 30 days after going to A&E and ask people to complete questionnaires about their health. We will interview patients and clinicians to get feedback. Patient and Public Involvement: Patient volunteers helped us design this research and will provide advice throughout. They agreed that including older people was appropriate, people with dementia and their carers should take part, and side-effects of strong pain killers are important to patients. FINDINGS: We will use the research findings to develop a larger trial to see if lidocaine patches help patients with broken ribs. We will write up results for scientific journals, speak at conferences and to our patient group.
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BACKGROUND: Docetaxel and vinorelbine have demonstrated efficacy in the treatment of metastatic breast cancer (MBC). This prospective feasibility study compared the efficacy of these two treatments in MBC. METHODS: Patients with MBC progressing following anthracycline treatment were randomly assigned to either docetaxel (100 mg/m(2)day 1 q3W) or vinorelbine (25mg/m(2) day 1 q2W). Patients were eligible to cross over at progression. Objective response rates (ORR), time to progression (TTP) and overall survival (OS) were measured. RESULTS: 37 patients were randomised. 2 patients were excluded due to protocol violations. Of 35 remaining patients 17 received docetaxel and 18 received vinorelbine per protocol. ORR was 12.5% and 6.0% respectively for docetaxel and vinorelbine. The median time to progression was 10.4 weeks (range 6-14 weeks) in docetaxel arm and 7.6 weeks (range 4-11 weeks) in vinorelbine arm (p = .82). The clinical benefit rate (defined as complete response, partial response plus stable disease) was 44% in the docetaxel arm and 12% in the vinorelbine arm. Based on intent to treat the median OS in the docetaxel arm was 34 weeks (95% CI, 20.7-48) and 21.2 weeks (95% CI, 17-25.4) in vinorelbine arm (p = .388). 16 patients crossed over, 5 from docetaxel to vinorelbine and 11 from vinorelbine to docetaxel. At cross over the ORR was 0% and 18% on cross over to vinorelbine and docetaxel respectively with a median TTP of 17.3 weeks (95% CI, 16.3-18.1) and 18.7 weeks (95% CI, 13.9-23.4) for those receiving vinorebine and docetaxel at cross over respectively. Vinorelbine however was much better tolerated with fewer grade 3-4 toxicity events (n = 4) than docetaxel (n = 27). DISCUSSION: While docetaxel resulted in a longer TTP and OS in this study it did not reach statistical significance. TTP duration for those patients who crossed over was similar, but overwhelmingly vinorelbine had fewer significant grade 3-4 toxicities than docetaxel. Only two previous randomized studies have compared the efficacy of single agent docetaxel and vinorelbine following prior anthracycline exposure, one in an unselected population [16], and the other, HERNATA, in HER2 positive disease with trastuzumab used in both arms [17]. The patients randomized in this study were relatively heavily pretreated with the majority having received 2-3 lines of prior treatment for their metastatic disease. The lower response rates with vinorelbine as compared to docetaxel in this study concur with results reported in other studies [16]. However, the numbers in both this study and the other unselected study [16] are small and need to be interpreted with caution. With regard to toxicity, in the present study, grade 3-4 hematological adverse events and infection were tenfold greater with docetaxel as compared with vinorelbine, consistent with results in HERNATA [17]. While others have reported a significantly higher number of overall grade 3-4 toxicities with vinorelbine [16], the fact that, as in HERNATA, discontinuations due to toxicities in that study [16] were significantly greater with docetaxel as compared to vinorelbine suggests either the toxicity data collected did not reflect the true toxicities on treatment or that docetaxel toxicities were in some way more severe or protracted leading to more numerous discontinuations [16]. Larger randomized studies are needed to determine (1) the efficacy of docetaxel versus vinorelbine in anthracycline pretreated disease and (2) the efficacy of vinorelbine after prior taxane exposure, and particularly how it may compares both with regard to efficacy and tolerability with other possible regimens that may utilized such as carboplatin-gemcitabine [20] or eribulin [21]. The longer as well as comparable TTP at cross over for both agents compared to that upfront suggests there may be enrichment at cross over of a group of patients who are not only fit for further treatment but are more likely to a derive continued benefit from additional treatment.
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Antineoplásicos/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Metástasis de la Neoplasia/tratamiento farmacológico , Taxoides/uso terapéutico , Vinblastina/análogos & derivados , Adulto , Anciano , Antineoplásicos/efectos adversos , Antineoplásicos Fitogénicos/efectos adversos , Antineoplásicos Fitogénicos/uso terapéutico , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/patología , Progresión de la Enfermedad , Docetaxel , Estudios de Factibilidad , Femenino , Humanos , Persona de Mediana Edad , Taxoides/efectos adversos , Resultado del Tratamiento , Vinblastina/efectos adversos , Vinblastina/uso terapéutico , VinorelbinaRESUMEN
BACKGROUND: Older people are the largest group admitted to hospital with serious injuries. Many older people are living with frailty, a risk factor for poor recovery. We aimed to examine the effect of preinjury frailty on outcomes. METHODS: In this multicentre observational study (FiTR 1), we extracted prospectively collected data from all 23 adult major trauma centres in England on older people (aged ≥65 years) admitted with serious injuries over a 2·5 year period from the Trauma Audit and Research Network (TARN) database. Geriatricians assessed the preinjury Clinical Frailty Scale (CFS), a 9-point scale of fitness and frailty, with a score of 1 indicating a patient is very fit and a score of 9 indicating they are terminally ill. The primary outcome was inpatient mortality, with patients censored at hospital discharge. We used a multi-level Cox regression model fitted with adjusted hazards ratios (aHRs) to assess the association between CFS and mortality, with CFS scores being grouped as follows: a score of 1-2 indicated patients were fit; a score of 3 indicated patients were managing well; and a score of 4-8 indicated patients were living with frailty (4 being very mild, 5 being mild, 6 being moderate, and 7-8 being severe). FINDINGS: Between March 31, 2019, and Oct 31, 2021, 193 156 patients had records were held by TARN, of whom 16 504 had eligible records. Median age was 81·9 years (IQR 74·7-88·0), 9200 (55·7%) were women, and 7304 (44·3%) were men. Of 16 438 patients with a CFS score of 1-8, 11 114 (67·6%) were living with frailty (CFS of 4-8). 1660 (10·1%) patients died during their hospital stay, with a median time from admission to death of 9 days (IQR 4-18). Compared in patients with a CFS score of 1-2, risk of inpatient death was increased in those managing well (CFS score of 3; aHR 1·82 [95% CI 1·39-2·40]), living with very mild frailty (CFS score of 4: 1·99 [1·51-2·62]), living with mild frailty (CFS score of 5: 2·61 [1·99-3·43]), living with moderate frailty (CFS score of 6: 2·97 [2·26-3·90]), and living with severe frailty (CFS score of 7-8: 4·03 [3·04-5·34]). INTERPRETATION: Our findings support inclusion of the CFS in trauma pathways to aid patient management. Additionally, people who exercise regularly (CFS of 1-2) have better outcomes than those with lower activity levels (CFS of ≥3), supporting exercise as an intervention to improve trauma outcomes. FUNDING: None.
Asunto(s)
Fragilidad , Anciano , Anciano de 80 o más Años , Inglaterra/epidemiología , Femenino , Fragilidad/epidemiología , Evaluación Geriátrica , Humanos , Masculino , Centros TraumatológicosRESUMEN
BACKGROUND: Older people are at the greatest risk of poor outcomes after serious injury. Evidence is limited for the benefit of assessment by a geriatrician in trauma care. We aimed to determine the effect of geriatrician assessment on clinical outcomes for older people admitted to hospital with serious injury. METHODS: In this multicentre observational study (FiTR 2), we extracted prospectively collected data on older people (aged ≥65 years) admitted to the 23 major trauma centres in England over a 2·5 year period from the Trauma Audit and Research Network (TARN) database. We examined the effect of a geriatrician assessment within 72 h of admission on the primary outcome of inpatient mortality in older people admitted to hospital with serious injury, with patients censored at discharge. We analysed data using a multi-level Cox regression model and estimated adjusted hazard ratios (aHRs). FINDINGS: Between March 31, 2019, and Oct 31, 2021, 193 156 patients had records held by TARN, of whom 35 490 were included in these analyses. Median age was 81·4 years (IQR 74·1-87·6), 19 468 (54·9%) were female, and 16 022 (45·1%) were male. 28 208 (79·5%) patients had experienced a fall from less than 2 m. 16 504 (46·5%) people received a geriatrician assessment. 4419 (12·5%) patients died during hospital stay, with a median time from admission to death of 6 days (IQR 2-14). Of those who died, 1660 (37·6%) had received a geriatrician assessment and 2759 (62·4%) had not (aHR 0·43 [95% CI 0·40-0·46]; p<0·0001). INTERPRETATION: Geriatrician assessment was associated with a reduced risk of death for seriously injured older people. These data support routine provision of geriatrician assessment in trauma care. Future research should explore the key components of a geriatrician assessment paired with a health economic evaluation. FUNDING: None.